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Clinical Ethics in Anesthesiology

A Case-Based Textbook
Clinical Ethics in
Anesthesiology
A Case-Based Textbook
Edited by
Gail A. Van Norman

Co-editors
Stephen Jackson
Stanley H. Rosenbaum
Susan K. Palmer
c a mb rid g e un iv e r si t y pres s
Cambridge, New York, Melbourne, Madrid, Cape Town, Singapore,
São Paulo, Delhi, Dubai, Tokyo, Mexico City
Cambridge University Press
The Edinburgh Building, Cambridge, CB2 8RU, UK

Published in the United States of America by Cambridge University Press, New York

www.cambridge.org
Information on this title: www.cambridge.org/9780521130646

© Cambridge University Press 2011

This publication is in copyright. Subject to statutory exception

and to the provisions of relevant collective licensing agreements,
no reproduction of any part may take place without
the written permission of Cambridge University Press.

First published 2011

Printed in the United Kingdom at the University Press, Cambridge

A catalog record for this publication is available from the British Library

Library of Congress Cataloging in Publication data

Clinical ethics in anesthesiology : a case-based textbook / [edited by] Gail A. Van Norman;
  co-editors, Stephen Jackson, Stanley H. Rosenbaum, Susan K. Palmer.
   p.  cm.
  Includes bibliographical references and index.
  ISBN 978-0-521-13064-6 (pbk.)
  1.  Anesthesiology–Moral and ethical aspects.  I.  Van Norman, Gail A.  II.  Title.
­  [DNLM: 1.  Anesthesiology–ethics. WO 221]
­  RD82.C548 2011
  174.2′9796–dc22    2010027381

ISBN 978-0-521-13064-6 Paperback

Cambridge University Press has no responsibility for the persistence or

accuracy of URLs for external or t­ hird-party internet websites referred to in
this publication, and does not guarantee that any content on such websites is,
or will remain, accurate or appropriate.

Every effort has been made in preparing this book to provide accurate and up-to-date
information which is in accord with accepted standards and practice at the time of publication.
Although case histories are drawn from actual cases, every effort has been made to disguise the
identities of the individuals involved. Nevertheless, the authors, editors and publishers can make no
warranties that the information contained herein is totally free from error, not least because clinical
standards are constantly changing through research and regulation. The authors, editors and
publishers therefore disclaim all liability for direct or consequential damages resulting from the
use of material contained in this book. Readers are strongly advised to pay careful attention
to information provided by the manufacturer of any drugs or equipment that they plan to use.
This book is dedicated to Melvin F. Van Norman (1920–2006), a pilot and
flight instructor, who said that a good teacher listens to the question that is
asked, hears the questions that didn’t get asked, and answers the questions
that should have been asked.
Contents
List of contributors  page xi
Foreword  xv
Preface  xix

Section 1: Consent and refusal  12. Consent and cultural conflicts: ethical issues in
pediatric anesthesiologists’ participation
  1. Informed consent: respecting patient
in female genital cutting  69
autonomy  3
Maliha A. Darugar, Rebecca M. Harris, and
Gail A. Van Norman
Joel E. Frader
  2. Informed refusal – DNR orders in the patient
13. Communitarian values in medical ­
undergoing anesthesia and surgery
decision-making: Native Americans  74
and at the end-of-life  13
Susan K. Palmer
David M. Rothenberg
14. Informed consent for preoperative
  3. Informed refusal – the Jehovah’s Witness
testing: pregnancy testing and other tests
patient  19
involving sensitive patient issues  79
James M. West
Gail A. Van Norman
  4. Surrogate decision-making  27
Elizabeth K. Vig, Allen Gustin, and Kelly Section 2. End-of-life issues 
­Fryer-Edwards
15. The principle of double effect in palliative
  5. Informed consent and the pediatric care: euthanasia by another name?  87
patient  33 Denise M. Dudzinski
David Clendenin and David B. Waisel
16. Surgical interventions near the end of
  6. Do not resuscitate decisions in pediatric life: “therapeutic trials”  92
patients  39 Carl C. Hug, Jr.
Kelly N. Michelson and Joel E. Frader
17. Withholding and withdrawing life support
  7. Consent in laboring patients  44 in the intensive care unit  97
Joanna M. Davies Mark D. Siegel and Stanley H. Rosenbaum
  8. Maternal–fetal conflicts: cesarean 18. Discontinuing pacemakers, ventricular
delivery on maternal request  49 assist devices, and implanted cardioverter-
Ruth Landau and Steve Yentis defibrillators in end-of-life care  103
Cynthiane J. Morgenweck
  9. Consent for anesthesia for procedures
with special societal implications:  19. Brain death  108
psychosurgery and electroconvulsive Robert B. Schonberger and Stanley H. Rosenbaum
therapy  55
Sadek Beloucif 20. Ethical issues in organ donation after cardiac
death  114
10. Ethical use of restraints  61 Richard L. Wolman
Joan G. Quaine and David B. Waisel
21. Revising the Uniform Anatomical Gift
11. The use of ethics consultation regarding Act – the role of physicians in shaping
consent and refusal  64 legislation  123
Susan K. Palmer Gail A. Van Norman and Michael DeVita

vii
 Contents

22. Physician aid-in-dying and euthanasia  128 34. Conflicts of interest in research funding  204
Alex Mauron and Samia Hurst Michael Nurok and Carl C. Hug, Jr.
35. Publication ethics: obligations of authors,
peer-reviewers, and editors  209
Section 3. Pain management Gail A. Van Norman and Stephen Jackson
23. Ethical considerations in interventional pain
management  137
Andrea Trescot Section 5. Practice issues 
24. Conjoining interventional pain management 36. The impaired anesthesiologist –
and palliative care: considerations for practice, addiction  219
ethics and policy  143 Thomas Specht, Clarence Ward, and Stephen
James Giordano and Gerhard Höver Jackson

25. Opioid therapy in addicted patients: 37. The impaired anesthesiologist – sleep
background and perspective from the UK  148 deprivation  224
William Notcutt Steven K. Howard

26. Opioid therapy in addicted patients: 38. Ethical considerations regarding the disabled
background and perspective from the US  154 anesthesiologist  230
Jane C. Ballantyne and Joseph Klein Jonathan D. Katz
39. The abusive and disruptive
physician  235
Section 4. Research and publication  Stephen Jackson
27. Ethics in anaesthesiology research using 40. Sexual harassment, discrimination, and
human subjects  163 faculty–student intimate relationships in
A.M. Viens anesthesia practice  240
28. Animal subjects research Part I: Do animals Gail A. Van Norman
have rights?  168 41. Conflicts of interest – industry gifts to
Nancy S. Jecker physicians  245
29. Animal subjects research Part II: Ethics of Murali Sivarajan
animal experimentation  174 42. Disclosure of medical errors in anesthesiology
Gail A. Van Norman practice  250
30. Ethical function of human subjects Karen Souter
review boards: a US perspective  180
Jeffrey H. Silverstein
Section 6. Anesthesiologists, the state,
31. Research with vulnerable persons such as
children and prisoners  185 and society 
Samia Hurst and Bernice Elger 43. Physician conscientious objection in
32. The ethics of research on pain and other anesthesiology practice  257
symptoms for which effective treatments Cynthiane J. Morgenweck and Stephen Jackson
already exist  193 44. The ethics of expert testimony  261
Monica Escher and Samia Hurst Louise B. Andrew
33. Quality improvement initiatives: when is 45. Ethical principles regarding physician
quality improvement actually a form response to disasters: pandemics, natural
of human subjects research?  199 disasters, and terrorism  266
Michael A. Rie and W. Andrew Kofke Susan K. Palmer
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 Contents

46. Triage in civilian mass casualty situations  270 49. Physician participation in executions  285
Susan K. Palmer Gail A. Van Norman
47. Triage and treatment of wounded during
armed conflict  275
Craig D. McClain and David B. Waisel
Index  292
48. Physician facilitation of torture and coercive
interrogation  280
David B. Waisel

ix
Contributors

Louise B. Andrew MD, JD, FACEP Bernice Elger MD

American College of Emergency Physicians University Center of Legal Medicine of Geneva
Founding President, Coalition and Center for Ethical and Lausanne, Switzerland
Medical Testimony
Monica Escher MD
Jane C. Ballantyne MD, FRCA Pain and Palliative Care Consultation,
Professor of Anesthesiology and Critical Care, Division of Clinical Pharmacology and Toxicology,
Penn Pain Medicine Center, Geneva University Hospitals,
University of Pennsylvania, Geneva, Switzerland
Philadelphia, PA, USA
Joel E. Frader MD, MA
Sadek Beloucif MD, PhD Professor of Pediatrics, and Medical Humanities and
Department of Anesthesiology and Critical Care Bioethics, Northwestern University Feinberg School
Medicine, Avicenne University Hospital, France of Medicine, Chicago, IL, USA

David Clendenin MD Kelly Fryer-Edwards PhD

Associate in Anesthesia, Children’s Hospital Boston Associate Professor, Department of Bioethics and
and Instructor in Anaesthesia, Harvard Medical Humanities, University of Washington School of
School, Boston, MA, USA Medicine, Seattle, WA, USA

Maliha A. Darugar MD James Giordano PhD

MA Candidate, Medical Humanities and Bioethics, Director of the Center for Neurotechnology Studies,
Northwestern University, Feinberg School of Potomac Insitute for Policy Studies, Arlington, VA;
Medicine, Chicago, IL, USA Research Associate of the Wellcome Centre for
Neuroethics, and Uehiro
Joanna M. Davies MB BS, FRCA Centre for Practical Philosophy,
Associate Professor of Anesthesiology and Pain University of Oxford, UK
Medicine, University of Washington School of
Medicine, Seattle, WA, USA Allen Gustin MD FCCP
Assistant Professor, Anesthesiology and Pain
Michael DeVita MD Medicine, University of Washington, Seattle,
Executive Vice President of West Penn WA, USA
Allegheny Health System
Former Professor, Critical Care Medicine and Rebecca M. Harris
Medicine, University of MA Candidate, Medical Humanities and Bioethics,
Pittsburgh, PA, USA Northwestern University, Feinberg School of
Medicine, Chicago, IL, USA
Denise M. Dudzinski PhD MTS
Associate Professor, Department of Gerhard Höver PhD
Bioethics and Humanities, University of Moraltheologisches Seminar, Rheinische
Washington School of Medicine, Friedrich Wilhelms Universitat,
Seattle, WA, USA Bonn, Germany

xi
 List of contributors

Steven K. Howard MD Alex Mauron PhD

Associate Professor of Anesthesia, Professor, Institute of Biomedical Ethics,
Stanford University School of Medicine, Geneva, Switzerland
Palo Alto, CA, USA; Patient Safety Center of Inquiry,
VA Palo Alto Health Care System Kelly N. Michelson MD, MPH
Assistant Professor, Pediatrics,
Carl C. Hug Jr, MD, PhD Division of Critical Care,
Professor of Anesthesiology, Emeritus, Northwestern University Feinberg
and Faculty Affiliate, The Center for Ethics School of Medicine, Chicago, IL, USA
Emory University, Atlanta, GA, USA
Cynthiane J. Morgenweck MD, MA
Samia Hurst MD Associate Clinical Professor of Bioethics,
Institute for Biomedical Ethics, Center for Study of Bioethics
Geneva University Medical School, Medical College of Wisconsin, WI, USA
Switzerland
William Notcutt MB ChB, FRCA, FFPMRCA
Steven Jackson MD Consultant in Pain Medicine and Anaesthesiology,
Chief of Staff (retired), Department of James Paget University Hospital, Great Yarmouth,
Anesthesiology, and Chair of the Bioethics Norfolk, UK
Committee, Good Samaritan
Hospital San Jose, CA, USA Michael Nurok MD, PhD
Anesthesiology and Critical Care Medicine,
Nancy S. Jecker PhD Faculty member, Center for Bioethics, Brigham
Professor, Department of Bioethics and and Women’s Hospital; Faculty, Department of
Humanities, University of Washington School of Social Medicine, Harvard Medical School,
Medicine, Seattle, WA, USA Boston, MA, USA
Jonathan D. Katz MD Susan K. Palmer MD
Clinical Professor of Anesthesiology, Yale University Staff Anesthesiologist and Patient Safety Committee
School of Medicine, New Haven, CT, USA Chair, Oregon Anesthesiology Group (OAG),
Former Professor of Anesthesiology and Professor
Joseph Klein MD of Preventive Medicine, Faculty Program in Medical
Fellow, Critical Care Medicine, Dept of Ethics and Law, University of Colorado Health
Anesthesiology and Pain Medicine Sciences Center, Denver, CO, USA
University of Pennsylvania, Philadelphia, PA, USA
Joan G. Quaine MD
W. Andrew Kofke MD, MBA, FCCM Associate in Anesthesia, Children’s Hospital Boston,
Professor and Director of Neuroanesthesia, and and Instructor in Anesthesia, Harvard Medical
Co-Director of Neurocritical Care, University of School, Boston, MA, USA
Pennsylvania, PA, USA
Michael A. Rie MD
Ruth Landau MD Associate Professor Anesthesiology/Critical Care
Professor of Anesthesiology and Director of Medicine, Associate Scholar in Ethics, Department
Obstetric Anesthesia and Clinical Genetics Research, of Anesthesiology, University of Kentucky School of
Department of Anesthesiology, University of Medicine, Lexington, KY, USA
Washington Medical Center, Seattle, WA, USA
Stanley H. Rosenbaum MD, MA
Craig D. McClain MD Professor of Anesthesiology, Internal Medicine and
Senior Associate in Anesthesia, Children’s Hospital Surgery, Director, Section of Perioperative and Adult
Boston; Assistant Professor of Anaesthesia, Anesthesia, and Vice Chairman for Academic Affairs,
Harvard Medical School Department of Anesthesiology, Yale University School
Boston, MA, USA of Medicine, New Haven, CT, USA
xii
 List of contributors

David M. Rothenberg MD, FCCM Gail A. Van Norman MD

The Max S. Sadove MD Professor of Anesthesiology, Professor of Anesthesiology and Pain Medicine and
Associate Dean for Academic Affiliations Adjunct Professor of Biomedical Ethics, University of
Director, Division of Critical Care Medicine Washington, Seattle, Washington, USA
Rush Medical College, Chicago, IL, USA
A.M. Viens BA, BPhil
Robert B. Schonberger MD, MA School of Law, Queen Mary, University of London,
Fellow in Cardiac Anesthesiology Queen Mary Centre for Medical Ethics and Law,
and Clinical Research, London, UK and Joint Centre for Bioethics,
Dept of Anesthesiology, Yale University School of University of Toronto, Canada
Medicine, New Haven, CT, USA Elizabeth K. Vig MD MPH
Mark D. Siegel MD Assistant Professor, Medicine,
Associate Professor, Department of Internal Gerontology and Geriatric Medicine
Medicine, Pulmonary and Critical Care Section, University of Washington and VA Puget
and Director of Medical Critical Care, Sound Health Care System, Seattle, WA, USA
Yale University School of Medicine,
David B. Waisel MD
New Haven, CT, USA
Senior Associate in Anesthesia, Children’s Hospital
Jeffrey H. Silverstein MD, CIP Boston, and Associate Professor of Anaesthesia,
Professor, Vice-Chair for Research, Harvard Medical School, Boston, MA, USA
Anesthesiology; Associate Dean for Research,
Clarence Ward MD
Mount Sinai School of Medicine
California Society of Addiction Medicine
Murali Sivarajan MD
James M. West MD, MA
Professor, Anesthesiology and Pain Medicine,
Clinical Assistant Professor, Human Values and Ethics
University of Washington, Seattle, WA, USA
Assistant Professor, Anesthesiology
Karen Souter MD University of Tennessee Health Science Center
Associate Professor, Department of Anesthesiology Memphis, Tennessee, USA
and Pain Medicine, University of Washington,
Seattle, USA Richard L. Wolman MD, MA
Professor, Department of Anesthesiology, University
Thomas Specht MD of Wisconsin School of Medicine and Public Health,
Chair, California Society of Anesthesiologists’ Madison, WI, USA
Committee on Physicians’ Health and Well-Being
Steve Yentis BSc MBBS FRCA MD MA
Andrea Trescot MD Consultant Obstetric Anaesthetist, Chelsea and
Professor, Department of Anesthesia Westminster Hospital, and Honorary Senior Lecturer,
and Pain Medicine, University of Washington, Imperial College London, London, UK;
Seattle, WA, USA Editor-in-Chief, Anaesthesia

xiii
Foreword

The medical profession has had, virtually since John Paul II “for contribution to the improvement of the
its inception, codes of behavior and rules of con- welfare of people worldwide.” Henry Knowles Beecher
duct encompassing the physician’s obligations to MD, first chair of the Massachusetts General Hospital,
patients, colleagues and society. Classic versions of famously exposed breaches of the Nuremberg Code in
the Hippocratic Oath include exhortations to “do human research being conducted in the United States,
good,” “avoid harm,” and “remain free of intentional leading to the establishment of human subjects review
injustice,” three of the classic principles that are cited boards. He later chaired the Ad Hoc Committee of the
as the core of the moral practice of medicine even to Harvard Medical School that offered a definition of
this day. Modern medical practitioners have signifi- brain death, paving the way for withdrawal/withhold-
cant power, social importance and financial impact ing of life-sustaining care at end-of-life, and facilitating
that affect nearly everyone’s lives. Medical practice developments that made vital organ transplantation
crosses national boundaries, cultural enclaves and possible.
systems of spiritual beliefs. A fundamental challenge The clinical practice of anesthesiology includes
to the modern physician is achieving balance among many of the thorniest problems in medical eth-
patient values and needs, societal costs, and profes- ics. Anesthesiologists practice in operating rooms
sional standards and codes. Given the vast range of involving care that has profound impact on patients’
medical need, cultural beliefs and available resources, lives at a time when their ability to participate in
this challenge to practitioners of all medical specialties decision-making may be severely limited. Many
globally is daunting. anesthesiologists practice in intensive care units,
where end-of-life decision-making occurs, includ-
Anesthesiologists and Bioethics ing withdrawal and withholding of life-sustaining
While the moral foundation of medical practice has therapies, resuscitation and do-not-resuscitate
been long recognized, the study of bioethics is relatively orders, and initiation of vital organ transplantation.
new in the history of medicine, having solidified in Anesthesiologists are involved in obstetrical care,
the late 1970s. Ethical issues are common to all medi- where the interests of mothers and fetuses may not
cal specialties, but the specialty of anesthesiology has always be aligned. They are experts in the treatment
been at the forefront of bioethics, being among the first of acute, chronic, oncologic and palliative pain. They
historically to raise critical moral questions. In 1957, are researchers, authors and editors of medical jour-
Pope Pius XII was invited to address the International nals. They are on the front lines in caring for the casu-
Congress of Anesthesiologists about such fundamental alties of war and natural and man-made disasters. It
issues as whether the use of artificial respiratory equip- is no surprise therefore that anesthesiologists have
ment was required in even hopeless cases, whether the posed some of the most troubling ethical questions
physician was under obligation to remove such ther- confronting modern medicine.
apy if such withdrawal will result in imminent patient
death, and whether permanently comatose patients Ethical Theory
can be considered dead even before circulation has The classical style of medical practice until well into the
ceased. John J. Bonica, first chair of Anesthesiology at 20th century was paternalistic. Doctors did what they
the University of Washington in Seattle was an early considered best for patients, and patients usually com-
advocate for labor analgesia, at a time when religious plied. Such paternalism was derived from ‘virtue-based’
institutions considered pain relief for laboring women ethics, in which the physician was assumed to be a vir-
morally controversial. He was later honored by Pope tuous person with inherent qualities of competence,
xv
 Foreword

sincerity, and altruism, and who would naturally know individual needs, autonomy might not be recognized as
what was correct for the patient. an ethical principle at all.
In parallel with the rise of individualism, and What could be the cause of these differences? In
political activism surrounding human rights, the disci- the case of the French physician, has there been dif-
pline of bioethics has increasingly emphasized respect ficulty or lag in shifting from a purely paternalistic
for the definition, integrity and autonomy of persons. logic to a contract-based logic? Or a cultural-based
This has been expressed in bioethics as an emphasis reluctance to consider autonomy the dominant rel-
on appropriate consent free from moral, economic, evant principle? Are Pacific Islanders “backward” in
politic, scientific, or social pressures. Medicine is too placing autonomy low and communitarianism high
often practiced as a predominantly technical pursuit, on the list of important principles? Accordingly, an
however, and the education of physicians in the art excessive attention to the principle of respect for
of communication with patients has lagged behind autonomy has the potential to prevent us from striv-
the demands of society. Physicians are accustomed to ing for humanism, philosophy, and spirituality—and
explaining medical conditions to their patients, but the thereby promoting a true therapeutic alliance between
quality of their conversations concerning the patient’s the physician and the patient.
functional status, values or fears is often poor or even The aims and limits of beneficence are well known.
non-existent. Though intended to protect the vulnerable, and
Medical practice that minimizes the core of human ensure justice, a “beneficence” that is disrespectful of
interactions could be seen as a breach to patient dig- autonomy is unfair, representing a throwback to the
nity. As patients, we would certainly not like to be paternalism of the past. However, there is a growing
treated by physicians who are lacking concern for the realization that over-attention to autonomy which
humane components of medicine. A respectful and is not imbued with beneficence is also unfair. We,
proper way of practicing medicine therefore should as health care professionals, have an obligation to
lead us not only to concentrate on the hows of perform- respect the common good, with a fair balance between
ing ours tasks, but also on the whys that govern our care empowerment of patients and the concepts of benefi-
to unique individuals. cence and nonmaleficence.
In this regard, growing attention has been paid to In an opinion on education in medical ethics, the
the ethical dimensions of medical care, and how we French National Ethics Advisory Committee (available
can improve the fulfillment of our duties to patients. at http://www.ccne-ethique.fr), indicated four legit-
The publication and wide acceptance of Principles imate reasons for a “disquiet” in the field of bioethics,
of Biomedical Ethics by James F. Childress and Tom linked to:
Beauchamp more than thirty years ago was certainly • a depersonalizing effect of specialization, that
a cornerstone event for what became an authentic might limit true chances of personal relationships
discipline. They described cardinal ethical principles between the patient and his/her physician,
(Autonomy, Beneficence, Nonmaleficence and Justice)
• a relative eclipse of the clinical side of medicine
that are now routinely discussed and debated among
because of the increasing technology of medicine,
medical professionals.
• an emerging form of “excessive legalism” with
Although there is general acceptance of these prin-
judiciarisation of the relationships, a symptom of
ciples as being foundational to ethical medical care,
poor quality of communication, as “respect for
the exact prioritization of these principles is not as
patients is no longer dependent on the individual
clear or accepted. Ask virtually any physician in the
virtues of the doctor; it is commanded by the need
United States about the order of importance of these
to observe the law”,
ethical principles, and the answer will be “Autonomy
first, then Beneficence, Nonmaleficence and Justice.” • and finally, side effects of apportioning health care,
However, if we consider French-speaking textbooks, with a need for an ethical reflection linked to the
these principles are usually presented in a different attention for collective accountability of health
order: Beneficence, Nonmaleficence, then Autonomy care expenses.
and Justice. Among certain Pacific Island cultures, Ethical concerns, though not limited to these ques-
where community values receive more emphasis than tions, should be seen as an opportunity to share, in

xvi
 Foreword

harmony, a common understanding of medicine Nazi concentration camps, the prisoners held there--
among physicians and their patients. Among the val- although they were inhumanely treated--did not loose
ues that are at the core of bioethics, promoting dignity, their human dignity.
with its tensions between means and ends is of special One of the difficulties (and beauty) of the concept
interest. of dignity, is that it possesses all of these various mean-
ings. Taken as a general principle, it infers that it is a
The Concept of Dignity and Medical Ethics collective or community characteristic to be protected
Dignity is a concept not restricted to the medical field. against external aggressions. But it also represents an
It encompasses good manners and morals. For a poli- individual claim--a means to promote the individual’s
tician, it might mean putting national above personal conception of liberty.
interests, although it cannot be restricted to a battle Thus, in human interactions, and in medical prac-
between “my” autonomy and the collective interests tice, there is tension between the good (or dignity) of
of a group. Human dignity is a complex concept that the group versus the good (or dignity) of a single indi-
many believe is the very core of bioethics. It is present vidual. In this respect, if we consider the four cardinal
in numerous international texts such as the Universal bioethics principles, would the concept of dignity be
Declaration on the Human Genome and Human more aligned with the autonomy of the individual,
Rights (1997), or the Oviedo convention, but can be or the justice of the group? If justice is defined as the
found as early as in the opening of the Preamble of promotion of dignity (with the goal of first promot-
the 1948 Universal Declaration of Human Rights of ing equity and equality of chances, and then fighting
the United Nations (“Whereas recognition of the inher- against discriminations), we find a harmonious agree-
ent dignity and of the equal and inalienable rights of all ment that is valid with the different theories of justice,
members of the human family is the foundation of free- whether the theory be procedural (libertarian), utilita-
dom, justice and peace in the world”), as well as in its rism (“classic” economic reasoning), egalitarism of pri-
first Article (“All human beings are born free and equal mary goods (as expressed by John Rawls), egalitarism
in dignity and rights. They are endowed with reason and of “capabilities” (as expressed by Amartya Sen), or even
conscience and should act towards one another in a spirit elitism of merit.
of brotherhood.”). Promotion of human dignity plays out differently
Dignity however is difficult to define. Like the car- in different cultural settings. Comparing Western and
dinal principles of bioethics, it is rooted in practical Eastern philosophy, the classic: “I think, therefore I
grounds (preventing abuses) but it is also aiming for a am”, could be transposed for Eastern philosophers to:
clear respect for principles and values. Dignity is some- “You are, therefore I am”. An understanding of these
what ambiguous, as it can be understood to be: differences can be very useful in light of a trans-cultural
• a quality (dignitas) attached to a rank or an official approach to medical care. To enhance understand-
position (dignitaries); ing between physicians and patients, we must discuss
and promote the idea, not only of simple information
• a general principle protecting the sovereignty of
and communication, but of true and mature dialogue
humans. Dignity here, seen as humanity (i.e. what
about our differences. And dialogue is not enough. It
behavior I expect from my fellow human), would
is merely a means, a tool towards the goal of ensuring
be taken as the concept of equal dignity of all
relationships and bonds between us.
humans;
Dignity is a “human common denominator” in the
• an individual claim defined by the person itself,
promotion of peace and harmony. It encompasses the
that can be used to request new “rights.” In this
usual means of communication of culture (through
regard we will each have a personal or cultural
Art, Science, or Prayer), but avoids the accusation that
idea of what dignity is. Special requests have for
could have been made against culture of not further-
example been claimed by persons requesting a
ing integration (“…culture does not unite. It identifies,
right to “die with dignity”, because they believe
therefore it divides as much as it assembles. The word
that their dignity is now lost and that consequently
is ambiguous” says Alain Lamassoure, member of the
they have the “right” to obtain euthanasia.
European parliament).
Dignity, furthermore, is a characteristic that can- In the philosophic understanding of bioethi-
not be suppressed. Even if we consider the horror of cal principles in the practice of medicine, issues are

xvii
 Foreword

probably more complex even than imagined. Although the “rights” and interests of animals in research and
progress could mistakenly be seen as ever increasing our obligations to them, as well as the problem of
control over life, authentic control is knowing where to unethical publication practices. Issues of consider-
stop and think about what ought to be done, and not able discomfort are scrutinized, such as physician
just what can be done. The beauty of a mature, ethi- participation in torture, disaster and military triage,
cal practice of medicine is that it unites humans while and lethal injections of prisoners.
respecting cultural specificities of individuals, by tak- All are presented from the perspective of anesthe-
ing reference in our common humanity and through sia practice in all of its breadth, and by a wide range
the promotion of dignity. of experts from Canada, Europe and the United States.
This textbook attempts to explore many of the Some questions have clear answers that are already
issues that confront the modern anesthesiologist, incorporated widely into practice. For other questions,
even when those issues cause great uneasiness. They the answers are not as evident. For still others, anesthe-
include the variability of autonomy (in vulnerable siologists may not have widely adopted correct moral
persons), and respect for autonomy (via consent) in behaviors, even when there is global consensus about
medical practice, along with ideals of communitari- what such behaviors should be. For all, the explora-
anism (in Native American culture). End of life issues tion of moral questions occurring in anesthesia prac-
include not only concepts of death (e.g. brain death) tice involves consideration and balance of the ethical
and turning off bioprosthetic devices, such as pacers principles of medicine—respect for patient autonomy,
and ICDs, but the idea that physicians play a role in beneficence, nonmaleficence and justice—in the pro-
understanding and promoting humane legislation motion of human dignity, for our patients as well as for
to protect dignity at end-of-life. Cultural differences ourselves.
are examined in the management of pain in addicted
patients. Critical research issues are discussed, Sadek Beloucif, France
including new and more global concepts concerning Gail A. Van Norman, United States

xviii
Preface

Anesthesiologists have broad representation in pri- are explored in the context of “Ulysses directives”
vate and academic clinical practices, clinical and and maternal demand for cesarean section delivery.
laboratory research settings, intensive care units, pal- Consent issues in non-Westernized cultures where
liative care facilities, pain treatment centers, journal autonomy may not be the dominant principle are
review boards, and expert panels charged with legis- reviewed. In Section 2 (End-of-life issues), withholding
lative initiatives and practice guidelines, to name a and withdrawing treatments includes considerations
few. Ethical questions abound in all walks of anes- of discontinuing cardiac assist devices, organ trans-
thesia practice; this is abundantly clear to the editors plantation issues such as donation-after-cardiac death
of this book, all of whom have been members and/or (DCD) and the legislative efforts of anesthesiology
chairs of the American Society of Anesthesiologist’s experts, and euthanasia. Section 3 (Pain management)
Committee on Ethics since its inception in the early includes different considerations in management of
1990s*. The committee receives a steady flow of com- addicted patients in the UK and US settings. In Section
munications from anesthesiologists seeking answers 4 (Ethical issues in research and publication), contro-
to questions, wanting someone to vent their frustra- versial topics concerning the treatment of animals and
tions to, and/or asking for reassurance that they “did animal rights are included, as are the relatively new
the right thing.” It is moving testimony to the import- debates around quality improvement initiatives as
ance ethical principles hold for most members of the research, and the pivotal roles of authors, editors and
specialty. reviewers in publishing medical information. Dealing
But while the importance of physician under- with the addicted or disabled provider, sleep depriv-
standing of ethical principles in the practice of medi- ation, industry gifts to physicians, disclosure of errors
cine is almost universally recognized, few resources to patients, and physician conscientious objection are
exist specific to anesthesia practice or the issues fac- covered in Section 5. Section 6 concerns anesthesiolo-
ing anesthesiologists in other settings. This textbook gists in their roles and duties within the state: expert
respectfully follows the footsteps of such books as testimony, response to disasters, ethical issues in the
Draper and Scott (Ethics in Anaesthesia and Intensive military, torture, and physician involvement in lethal
Care, Butterworth-Heineman 2003), and Scott, injection of prisoners.
Vickers and Draper (Ethical Issues in Anaesthesia, Physicians are educated in their art by study and
Butterworth-Heineman, 1994). contemplation, but also, if not primarily, by involve-
While the ethical issues facing anesthesiologists ment in and discussion of cases and their manage-
are a numerous and varied as anesthesia practice itself, ment. Highly abstract analyses of ethical issues is not
some general themes emerge. We considered issues always well understood or received because physicians
roughly (and admittedly artificially) divided into 6 cat- deal in real-life situations, and seek both practical
egories. In Section 1 (Informed consent and refusal), understanding and advice. For the most part, we have
common issues such as Do-not-resuscitate orders, and tried to imitate and emphasize the case-based nature
the Jehovah’s Witness patient are covered as are more of medical education throughout the book. Chapters
controversial issues, such as anesthesiology involve- begin with a case example. By reading the case and
ment in female circumcision. Maternal-fetal issues subsequent discussion, the authors have attempted to
discuss the major issues and principles involved in each
*  This contents of this book are not a product of the American case. Where possible, they have proposed some exam-
Society of Anesthesiologists and does not, except where noted ple resolutions, and a list of important points close each
by references in the text, represent official policies, guidelines, or chapter. While it is not possible to anticipate the entire
statements of the American Society of Anesthesiologists.

xix
 Preface

scope of complexity of ethical issues that might present Palmer introduced me to the discipline of medical eth-
in any one case, it is our goal that the discussion fosters ics through their brilliant and compassionate teach-
thoughtful reflection and aids the physician in future ing and leadership. Stanley Rosenbaum has been the
case management. intellectual and ethical foil, and wonderful friend that
Because even among Western countries, the per- all students should be as lucky as I was to find early
spectives on ethical controversies in medicine are not in their studies. Not only has each been a teacher and
always in agreement, we have purposefully sought friend to me for many years, each has worked tirelessly
authors from different nationalities, educational back- to write, edit, and provide “moral” support throughout
grounds, and practice experiences to provide inter- the production of this book. Sadek Beloucif has gra-
national breadth to the book. Whenever possible, ciously and patiently providing insights about the dif-
resources are cited regarding management in both US ferent perspectives in Western medical ethics. A host of
and European settings. learned authors and ethics experts willingly and gener-
The chapter discussions are not meant to provide ously contributed their time and effort—many of them
an exhaustive list of references for each and every meeting last-minute requests and short deadlines to
issue—to do so would add unnecessarily to the volume provide chapters and changes. They all have my heart-
of the book, and distract from the main purpose, which felt thanks.
is both philosophical and practical discussion. Where From Cambridge University Press, thank you
needed, we have supplied in the References at the end also to Nick Dunton, who embraced the idea, and to
of each chapter any key resources. Other important, Deborah Russell, Laura Wood, Rachael Lazenby, Nisha
but non-cited readings are included in a “Further read- Doshi and Mary Sanders, who kept it going, to Jonathan
ing list” to aid readers in expanding their knowledge of Ratcliffe who didn’t complain about all of the changes,
specific topics. In both of these lists, those readings felt and everyone of the wonderful production staff who
to be especially helpful, historic, or even controversial made this book possible.
are highlighted with an asterisk.
I would like to personally acknowledge all of the Gail A. Van Norman MD
wonderful people who contributed so substantially to Seattle, WA USA
the creation of this book. Stephen Jackson and Susan Summer, 2010

xx
Section Consent and refusal

1
 Section 1 Consent and refusal
Chapter

1
section 1
Informed consent: respecting patient
autonomy
Gail A. Van Norman

The Case only what the patient wants, but also what is best for
them according to their family, society, and reason-
Allen, a 35-year-old man, presents for colectomy after a
able medical resources. Non-Western cultures often
20-year history of ulcerative colitis. He does not appear
nervous, but is animated and friendly. His sister explains depart almost completely from an “autonomy”-based
that Allen has developmental delay and is also fearful of ethic of informed consent, and resort to a more “col-
needles. He has permitted the nurse to start an intravenous lectivist” decision-making model, in which families
drip. Discussion of an epidural for anesthesia and analge- and groups make decisions together, based on obliga-
sia with Alan will take extra time, and the anesthesiologist tions to care for one another, concepts of preservation
is also concerned that he may not have the necessary self- of harmony, and values of group interdependence.
control to cooperate with an epidural. She decides to discuss (A summary of cultural aspects of medical decision-
only general anesthesia and patient-controlled analgesia making in Pacific Islander and Asian cultures can be
with the sister. found in Table 1.1, and a detailed account of Native
Moral imperatives for informed consent in Western American medical decision-making is explored in
medicine and medical research are founded in the ethi- Chapter 13).
cal principle of respect for patient autonomy. The term Many countries have codified patients’ rights to be
“autonomy” comes from the Greek autos (self) and informed and to give or refuse consent regarding med-
nomos (rule). Originally used to describe political self- ical treatments (Table 1.2).
governance, “autonomy” also has come to be associated Although the Nuremberg Code is often cited as the
with individuals. This concept of self-determination origin of the modern physician’s obligation to obtain
has attained a powerful vocabulary in Western culture, informed consent, legal precedents enforcing patients’
evoking debates over liberty, privacy, free will, rights rights actually predate Nuremberg. In France, legal
and responsibilities. Freedom to choose one’s destiny requirements for consent were established in 1910, and
is a prominent Western ideology. There is broad moral were reinforced by the French Supreme Court in 1942.1
and legal consensus that this freedom is essential when In the United States in 1914, the case of Schloendorff v.
such choices involve medical treatment. Society of New York Hospital established that “Every
Of the four “foundational” principles in medi- human being of sound mind and adult years has a right
cal ethics  – beneficence, nonmaleficence, respect to determine what shall be done with his own body.”2
for autonomy, and justice  – the principle with the
strongest influence in the United States is respect for
personal autonomy. Many ethical questions in US Autonomy
medical practice will be answered by asking foremost Informed consent involves the concept of “personal
what the patient wants, and not necessarily what the autonomy” – a patient’s ability to make choices – and
physician, family, or culture believe is best. Respect for “autonomous choice”  – whether an autonomous
autonomy is a key principle in other Western nations patient’s choice is made freely. Respect for patient
as well, but it is usually weighed against the other autonomy involves not only ethical obligations to
three principles. Thus, the same ethical question may respect patient choices, but also obligations to promote
be answered in other Western countries by asking not both patient autonomy and autonomous choice.

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
3
 Section 1. Consent and refusal

Table 1.1. Values emphasized in medical decision-making in some non-western cultures*

Japanese •  Collective family interests take priority over individual interests

•  Harmony must be preserved
•  The family is responsible to care for elders
•  Caring for parents must be done with deep feelings of gratitude and happiness
•  Shintoismis prominent – mention of death is taboo, discussing terminal illness may cause
kegare, or spiritual contamination
Chinese •  Confucian concepts of harmony, unity, survival of the family
•  Hierarchical family relationships
•  Elders treated with respect and protected from bad news
•  Discussing illness or death may cause it to happen
Vietnamese •  Concept of karma and fatalistic attitudes towards illness and death
•  Individuals do not control their lifespan, advance directives are de-emphasized
•  Saying “no” to a physician may be disrespectful and could create disharmony
Filipino •  Filial piety
•  Illness may be “deserved,” and seeking health care may be a “last resort”
•  Deference to the physician out of respect
Hawaiian •  Acceptance of medical condition
•  Western medicine is seen as autocratic
•  Holistic approach to health problems and collective decision-making
Samoan •  A specific decision-maker is designated
•  A chief may be asked to listen to the case and offer judgment
•  Mistrust of Western medicine
•  TraditionalSamoans do not want to be asked preferences, desiring instead a directive
physician.

Summarized from: McLaughlin, L.A. and Braun, K.L. (1998). Asian and pacific islander cultural values: considerations for health care
decision-making. Health and Soc Work, 23(2), 116–26.

with competence, no diagnosis in a conscious patient

Autonomous persons invariably identifies incompetence. The presence of
The terms “capacity” and “competence” are both used memory impairment, dementia, or mental illness,
to describe a group of capabilities necessary for deci- for example, does not prove a lack of capacity to make
sion-making. In the US, “capacity” usually is used by medical decisions.
medical experts to describe functional capabilities, and Physician paternalism and bias pervades assess-
“competence” is a legal term. In the United Kingdom, ments of patient competence. Patients are often referred
the usage is reversed, and “competence” usually refers for competency evaluations simply because they refuse
to functional capacity, while “capacity” is a legal term.3 medical advice, although such refusals are not gener-
In this chapter the terms are used interchangeably. ally evidence of incapacity.4 In one study, noncompli-
Capacity is a “threshold” element in informed con- ant patients comprised almost two-thirds of referrals
sent. Without the ability to make decisions, a person for competency evaluations, yet they were only slightly
is not autonomous. Capacity is task specific: patients less likely than compliant patients to be judged incom-
may be fully capable of making medical decisions petent by consultants. Patients who discharge them-
even if they are unable to care for themselves in selves against medical advice from hospitals have a
other ways. Capacity waxes and wanes depending somewhat higher prevalence of alcohol abuse than the
on many factors such as the patient’s medical condi- general population. However, studies have found that
tion, psychological state, level of stress, and ability such actions are more often related to insurance sta-
to orient to unfamiliar surroundings. Although any tus and lower income, or factors such as race (which
diagnosis of compromised mentation can interfere might be associated with mistrust of ­physicians or
4
 Table 1.2. Summary of patient rights to informed consent by country*

Right to have written Presumed consent in Patient can

Right to informed Right to refuse advance directives emergency situations Therapeutic waiver right to
Country consent treatment followed if incapacitated Privilege allowed know
Australia √ √ √ √ √ √
Belgium √ √ √ √
Bulgaria √ √ – must be in √ Not recognized √
writing
Canada11 √ √ √ Controversial in
common law12
Cyprus √ No explicit right √ √ √
to refuse
Czech √ √ √ – at physician No express
Republic discretion “right not to
know”
Denmark √ Only to refuse √ – only in specific Illegal since 1998 √
blood products, circumstances
or if in a terminal
condition
Estonia √ √ Not recognized
Finland √ √ √
France √ √
Greece √ √ Physician can √
override pt wishes
Hungary √ √ √ √ √
Italy √ √ √
Israel13 √ √ √

5
6
Table 1.2. (Cont.)

Right to have written Presumed consent in Patient can

Right to informed Right to refuse advance directives emergency situations Therapeutic waiver right to
Country consent treatment followed if incapacitated Privilege allowed know
Japan14 √ physician must √ √
inform patient or
family

Latvia √ √ √
Lithuania √ √ √ √
Luxembourg √ √ √
Netherlands √ √ √
New √ √ √ √
Zealand15
Poland √ No provision
Portugal √ √ No explicit rule, but √ √
would be acceptable
under other laws
Slovakia √ √ √
Slovenia √ √ √ √ √ √
South Africa √ √
Spain √ √ √ √ √
Sweden √ √
UK16 √ √ √ √ √ √
United √ √ √ √ √ √
States17
* Obtained from the Centre for Biomedical Ethics and Law unless otherwise noted http://europatientsrights.eu and http://www.kuleuven.be
Spaces were left blank when there was no explicit provision in law according to the Centre for Biomedical Ethics and Law at the time of access to the website on March 1, 2010. Reader
should note that provisions may nevertheless be implicit in other laws or regulations.
 Chapter 1. Informed consent

­ erceptions of disrespectful treatment) than to deci-

p decisions. Examples include severe pain or anxiety,
sional incompetence.5 intoxication, head injury, organic brain disease, devel-
Physicians frequently judge patient competence opmental delay, and young age. Criteria for capacity
based on their perception of the quality of a patient’s in such patients, however, are no different from in any
decision. A recent study of physicians’ attitudes toward other situation. Physicians have ethical obligations
patients who refuse cancer therapy found that physi- to promote autonomy by treating patients to restore
cians often regarded such decisions as “irrational,” and capacity if possible. Anxious patients or those suffering
therefore reflecting mental aberrations.6 Such judg- from pain ideally should have anxiety and pain treated
ments place the physician’s own values, prejudices, and prior to informed consent discussions, because they
perceptions about medical treatment and quality of life may then be better capable of listening to options, dis-
before those of the patient, and do not reflect appropri- cussing information, and making decisions. Patients
ate respect for patient autonomy. The same study found retain autonomy even with premedication if they are
that patients refuse medical therapy based on personal able to meet the four criteria cited above. Withholding
values and experience more than on medical facts such treatment until a consent form is signed is cruel,
alone. Most experts believe that quality of life measures probably coercive, and may cause such consent to be
are at least equal in relevance to medical outcomes in legally invalid as well.
determining if treatment results meet patient needs. If delaying surgery allows a patient suffering from
In general, competence to make medical decisions a temporary incapacity to recover competence in a
is adjudged to be present when the patient meets four time frame such that the surgery is still meaningful, the
criteria:  they can communicate a choice, understand surgery should be postponed. If an emergency surgery
the relevant information, appreciate the medical con- cannot be delayed for a patient with temporary inca-
sequences of the decision, and reason about treatment pacity, then the physician may need to locate a surro-
decisions (see also Chapter 4). These criteria generally gate decision-maker, or proceed without consent in the
can be assessed in pre-operative conversations with best medical interests of the patient.
patients, and do not usually require expert consultation.
When there is conflicting evidence about patient com-
petence, however, a formal evaluation may be helpful. Autonomous choices
The anesthesiologist in our introductory case made Three conditions must be met in order for an act (or
a hasty judgment about whether Allen was capable of choice) to be autonomous:  a person must act with
participating in a complete discussion of options for intention, with understanding, and without controlling
his anesthesia care. An actual conversation with Allen influences.
would have revealed to her that he is employed, and lives
independently – although these circumstances do not Intention
guarantee he has capacity for medical decision-mak-
Ethical theory regarding “intention” is complex, but
ing. When asked, he says that he needs to have surgery
generally speaking intentional acts require “planning,”
because of his sick intestines, and that he understands
although not necessarily reflective thought or strategy.
that he could get cancer if he does not have the opera-
We do many things intentionally but without thought,
tion. He also hopes that the surgery will reduce his pain
such as reaching for a glass of water in order to drink,
and diarrhea. He does not fear anesthesia; he has been
scratching an itch, or turning a page in a book.
through several operations before without problems.
Unintentional acts can result from accidents or
Because of his religious beliefs he does not fear death.
habitual behavior, or even as a byproduct of an inten-
Allen appears to be an autonomous person with capac-
tional act. Imagine that Mary presents with flank pain
ity to decide – or at least participate to a great degree –
suggestive of a kidney stone. Her physician orders an
in decisions about his care, and should be given a
intravenous pyelogram (IVP). After administration
complete description of his options in language aimed
of the contrast agent and IV fluid, increased urine
at his level of understanding.
output washes the stone into the bladder. The IVP is
negative, but Mary’s pain is resolved. The physician
Temporary incapacity intended to run the test to diagnose the cause of her
Many common clinical factors, both temporary and pain and he intended to appropriately treat the condi-
permanent, can impair the capacity to make medical tion responsible for it. Both things happened. The test
7
 Section 1. Consent and refusal

was run according to plan, but pain relief occurred A physician owes to his patient the duty to disclose in a
because of an unintended side effect of the test. Mary’s reasonable manner all significant medical information
pain relief was the result of an accident and not a result that the physician possesses or reasonably should possess
of intention, even though the outcome of the accident that is material to an intelligent decision by the patient
whether to undergo a proposed procedure.9 [italics
and the intended outcome of the physician’s plan are
added]
the same.
Patients are asked explicitly and implicitly to con- Without knowing exactly what information is “mate-
sent to both intentional and unintentional acts by rial” to a patient, one potential strategy could be to sim-
physicians. Intentional acts are broadly categorized ply recite as many relevant medical facts as possible to
as those acts that result in the expected outcomes. obtain consent and avoid liability later on. With regard
Unintentional acts are those acts that result in out- to patient decision-making, however, it is important to
comes that are not expected or not desired, such as side understand that not all medical facts are material ones
effects, accidents, and medical catastrophes. When and not all material facts are medical ones. Patients
autonomous patients consent following adequate base decisions on a number of matters, only some of
information about both the known and intended, and which are medical facts. They also consider the poten-
known possible-but-unintended outcomes of treatment tial medical and nonmedical outcomes of the treat-
(and they are not manipulated or coerced), then they ment in the context of their lives, personal values, and
can be said to have intended to consent to the poten- personal experiences, as in the following scenario:
tial unintended consequences of treatment. It would Ann and Sarah, each 39 years old, have a 1.5 cm
be difficult to assert that a patient intended to consent breast  cancer. Both are weighing the same options:
to outcomes about which they were not informed. A lumpectomy with adjunctive chemotherapy, or mas-
patient who is inadequately informed is therefore not tectomy with chemotherapy. Each treatment is associ-
making an autonomous choice because intention is a ated with similar cure rates. Ann decides to undergo
requirement for autonomous choice. Adequate infor- lumpectomy based on her priorities of minimizing
mation is key to promoting patient autonomy, but what surgical recovery and disfigurement, as well as her
constitutes “adequate information”? confidence that the chance of recurrent cancer is
small. Sarah also worries about disfigurement, but is
more concerned about cancer recurrence because her
What the physician must disclose mother died of breast cancer after protracted treat-
It was not until the mid twentieth century that a legal ment and significant suffering. She requests bilateral
obligation to inform patients prior to obtaining con- mastectomies to ease her fears of experiencing bilateral
sent was established. In Salgo v Trustees of Leland cancer. Relatively few of the medical facts are actually
Stanford Hospital7 it was found that physicians must material to either woman’s decision – and even thought
discuss risks and alternatives to treatment, as well as the facts are the same in each case, the decision is not.
describe the procedures and their consequences. This The presence of cancer, recurrence rates, and the
finding was reinforced in Canterbury v Spence in 1972, potential cure rates of each type of proposed surgery
which determined: are material to both women. Potential disfigurement
… it is evident that it is normally impossible to obtain from the surgery is also material to both – and this
a consent worthy of the name unless the physician first becomes decisive for Ann. But for Sarah, other non-
elucidates the options and the perils for the patient’s medical issues, such as her experience of her mother’s
edification.8
death and how it affected her perceptions and fears
Physicians argued that the courts had imposed an about breast cancer and cancer treatment, are both
impossible burden: explaining all of the possible risks material and decisive.
and outcomes of procedures would be tantamount An exhaustive presentation of nonmaterial medi-
to providing the patient with a medical education. cal information not only dilutes medical informa-
Patients were neither knowledgeable, nor educable to tion that is essential to a patient’s decision, but also
the level of detail needed to make “competent” medi- potentially neglects “non-medical” information that
cal decisions. Subsequent court findings disagreed. In is also critical to the patient’s decision. Physicians
Harnish v Children’s Hospital Medical Center, the duty are expected to discuss the proposed treatment and
to inform patients was further clarified: reasonable alternatives. Common risks should be

8
 Chapter 1. Informed consent

discussed because they are likely to occur and the coerce almost any persons, while others are selective
patient should be given a chance to consider those enough to only coerce a few. Furthermore, circum-
possibilities. Nausea and vomiting, pain, dental dam- stances that restrict personal choice are not “coercive,”
age, sore throat, and adverse drug reactions are exam- because circumstances are not persons and cannot
ples of some common risks that might be discussed. have intentions. A patient who requires surgery to
Serious risks, even if rare, should be disclosed because relieve a bowel obstruction is confronted with few
such serious harm may be material to the patient’s viable choices and therefore is not entirely “free”, but
decision. Stroke, blindness, major cardiac events, a choice to undergo surgery can still be autonomous,
cardiac arrests, and death are examples of serious because within the framework of the circumstances
risks that could be addressed. Physicians should also the person can act with intention, with understand-
attempt to discover what other issues are germane to ing, and without being controlled by the will of other
the patient: asking the patient about their questions, persons.
fears and special concerns may uncover other ques- Coercion is not uncommon in anesthesia and
tions that are important to clarify. surgical practice. Consider Mr. Forrest, an 85-year-
old man with metastatic colon cancer, who has a
large bowel obstruction, severe pain and discomfort,
Autonomous choice: the effects of coercion, and requires palliative surgery. He has requested a
manipulation, and persuasion do-not-­resuscitate (DNR) order because of his ter-
Even when acting with intention and understand- minal disease. Mr. Smith sincerely hopes to sur-
ing, autonomous persons can make nonautonomous vive his surgery, but he understands that death is
choices. The bank teller who is forced at gunpoint to a risk. He knows that both his age and his diagno-
hand over money is an autonomous person, but she is sis make his prospects of surviving a cardiac arrest
being forced by the robber to make a choice against her grim. Furthermore, he believes that death under
will – to give up the money or risk being killed. She is anesthesia, while not his intended goal, would be
autonomous, but her choice is not. She acts both with an acceptable and possibly humane outcome, and
intention and understanding, but is under the irresist- he consents to it. But the anesthesiologist refuses to
ible power of a controlling influence. In the informed proceed unless Mr. Smith rescinds his DNR order,
consent process, physicians have ethical obligations to even though cardiopulmonary resuscitation (CPR)
avoid controlling influences that invalidate autono- is not integral to treating bowel obstruction per se.
mous choice. The anesthesiologist is presenting Mr. Smith with a
credible threat of harm, and she certainly is capable
of carrying out that threat by preventing surgery that
Coercion will relieve Mr. Smith’s pain. The threat is sufficiently
Coercion occurs if one person both intentionally and severe that Mr. Smith ultimately is controlled by it
successfully influences another by making a believ- and agrees to rescind his DNR status. The anesthesi-
able threat of harm that is sufficiently severe such that ologist has intentionally and unethically coerced him
the other person is unable to resist acting to avoid it. into accepting a treatment he does not want (CPR)
Because it controls the other person’s actions and and likely will not need, in order to obtain treatment
usurps autonomy, coercion is unethical. Even if it is that he both wants and does need (bowel resection).
not successful, attempting to coerce someone dem- (For a more detailed discussion of DNR orders in the
onstrates a lack of respect for patient autonomy and is operating room, see Chapter 2.)
unethical.
Not all threats are coercive. For a threat to be coer-
cive, the threatened person must understand it, believe Persuasion
that it will be carried out, and be unable to resist it. Persuasion is a noncontrolling (resistible) form of
Threatened harms can include physical, psychologi- influence in which one person intentionally and suc-
cal, social, legal, and financial harms, among others. cessfully uses reason to induce another person to
Perceptions about what constitutes a believable threat freely and willingly accept the beliefs, intentions,
and sufficient harm are subjective and vary from per- and actions of the persuader. Persuasion is an inte-
son to person – some threats are universal enough to gral part of informed consent as, for example, when

9
 Section 1. Consent and refusal

the anesthesiologist recommends epidural anesthesia Now, suppose instead that a patient who is a heavy
over general anesthesia for an elective Cesarean sec- smoker presents for total knee arthroplasty. The
tion, due to the advantages of maternal–infant bond- anesthesiologist wants to do a subarachnoid block
ing immediately after birth, the possibility of epidural (SAB). She does discuss both general anesthesia and
narcotic analgesia for postoperative pain relief and a SAB. However, she states that “spinal anesthesia is
perception of decreased risks to mother from pulmon- much safer in for knee replacements,” and “spinal
ary aspiration. For such a recommendation to qualify anesthesia is much safer in smokers.” This is an exam-
as persuasion and not manipulation, it must present ple of manipulation by creating a false perspective of
accurate and balanced information, and must be the patient’s choices. There is no strong evidence that
resistible by the patient (that is, the patient can choose SAB is safer for most surgeries or safer in smokers,
not to follow the recommendation). and the statement inaccurately portrays the compara-
Persuasion is entirely ethical. Patients expect tive risks and benefits of these two anesthetic options.
physicians to make rational recommendations about Once again, this anesthesiologist has attempted to
medical treatments and alternatives. In fact, physi- manipulate the patient, and has disrespected the
cians may even be held legally liable and morally culp- patient’s autonomy.
able if they do not at least attempt to persuade their
patients to consent to treatments that are medically
indicated. Therapeutic privilege and waiver of
informed consent
Two exceptions may exist to the rule that competent
Manipulation patients must have risks disclosed to them: the concept
Between persuasion and coercion lies a group of influ- of therapeutic privilege and the idea that competent
ential behaviors included under the broad definition of patients may waive their rights to be informed.
“manipulation,” including indoctrination, seduction, In evoking therapeutic privilege, physicians
deception, omissions, and lies. In general, manipula- argue that it is ethical to withhold material informa-
tion strategies work by either altering actual choices tion from patients in whom such disclosures would
provided to patients, or by altering patient’s percep- cause unacceptable harm, thus causing the physician
tions of their choices. to violate the ethical principle of nonmaleficence
The degree of control exerted by manipulation (and (avoiding harm). Accepting this general argument
therefore the degree to which manipulation interferes without restriction, however, is a prescription for
with patient autonomy) ranges from inconsequential to paternalism. If the definition of “unacceptable harm”
completely controlling. Not all attempts at manipula- is framed too broadly, then physicians could con-
tion succeed, but many if not all manipulative strategies ceivably justify withholding almost any information,
involve deception, either through false or misleading because such disclosures are laden with at least some
information or omission of key facts. Manipulation stress for most patients. Physicians even could use it as
is therefore unethical whether it is successful or not, an excuse to “control” the decisions of patients whom
because it both violates ethical obligations of verac- they feel might refuse therapy after a full disclosure.
ity (telling patients the truth) and disrespects patient If unacceptable harm is defined very narrowly as
autonomy. harm that causes the patient to become emotionally,
In the case introducing this chapter, the anesthesi- psychologically, or intellectually incapable of making
ologist has engaged in manipulation by not describing a decision, then therapeutic privilege does not tech-
the benefits and risks of epidural anesthesia and anal- nically violate the principle of respect for autonomy
gesia, even though it is a common anesthetic alterna- because full disclosure would render the patient non-
tive. Had she discussed this option, she would have autonomous anyway. The courts have recognized the
discovered that Allen in fact had opted for an epidural risk of physician paternalism, and have reinforced
for previous bowel surgery, and had done well. By the legal emphasis on respect for autonomy:
omitting the discussion in order to meet her own goals, The physician’s privilege to withhold information for
she has altered Allen’s actual choice, since Allen would therapeutic reasons must be carefully circumscribed …
probably have chosen to have an epidural if he knew it for otherwise it might devour the disclosure rule itself.
were possible. The privilege does not accept the paternalistic notion

10
 Chapter 1. Informed consent

that the physician may remain silent simply because • Persuasion does not manipulate or control
divulgence might prompt the patient to forego therapy patient choice, and is consistent with ethical
the physician feels the patient really needs. That attitude physician behavior.
presumes instability or perversity for even the normal
patient, and runs counter to the foundation principle that
• Therapeutic privilege and waiver of consent
the patient should and ordinarily can make the choice for are possible exceptions to informed consent,
himself.10 but only under very restricted circumstances.

Waiver of disclosure by the patient is conspicuously

different from therapeutic privilege. An autonomous
patient may decide intentionally, with understand-
References
ing, and without controlling influences by others, 1* Moumjid, N. and Callu, M.F. (2003). Informed
consent and risk communication in France. BMJ,
to waive their rights to have medical information,
327(7417),734–5.
or may decide to have the facts disclosed to some-
2  Schloendorff v. Society of New York Hospital, 211 N.Y.
one else, such as a family member. Because their
125, 105 N.E. 92 (1914).
choice is an autonomous one, respecting such deci-
3  Chalmers, J. (2008). Capacity. In The Cambridge
sions respects patient autonomy, and is consistent
Textbook of Bioethics, ed. Singer P. Cambridge,
with ethical practice. Legal ramifications of patient UK: Cambridge University Press, pp. 17–23.
waiver have not, however, been clearly resolved in
4  Mebane, A.H. and Rouch, H.B. (1990). When
case law. do physicians request competency evaluations?
Psychosomatics, 31, 40–6.
Key points 5  Ibrahim, S.A., Kwoh, C.K., and Krishnan, E.
(2007). Factors associated with patients
• The ethical principle of respect for patient
who leave acute-care hospitals against
autonomy is firmly grounded in western medical advice. Am J Public Health, 97(12),
ethical principles valuing individual freedoms. 2204–8.
• Capacity, or competence, is a threshold 6  van Kleffens, T. and van Leeuwen, E. (2005) Physicians’
element necessary to being an autonomous evaluations of patients’ decisions to refuse oncological
person: patients have capacity to make treatment. J Med Ethics, 31,131–6.
decisions if they can communicate a choice, 7  Salgo v Leland Stanford, etc. Bd. Trustees, 154 Cal.
understand the relevant information, App.2d 560.
appreciate the consequences of the decision 8   Canterbury v Spence, 1972, 464 F.2d 772 (DC Cir. 1972).
and can reason about their decision. 9  Harnish V Children’s Hospital Medical Center (1982).
• Physicians have ethical obligations to respect 387 Mass. 152, 429 N.E.240.
patient autonomy, and to promote autonomy 10   Canterbury v. Spence., 464 F.2d 772 (D.C. Cir.
when competence can be restored in a time 1972).
frame that still renders the medical treatment 11  Health Care Consent Act, 1996. S.O. 1996, Chapter 2,
meaningful. Schedule A. Canada. (last amended 2009).
• Disclosure is not required to be 12  Cote, A. (2000). Telling the truth? Disclosure,
comprehensive: rather, ethical and legal therapeutic privilege and intersexuality in children.
disclosure discusses the treatment, reasonable Health Law J, 8, 199–216.
alternatives, common risks and serious risks, 13   Israel Patient Right’s Act, 1996.
as well as anything the physician knows or 14  Akabayashi, A. and Slingsby, B.T. (2006). Informed
reasonably should know is material to the consent revisited: Japan and the US. Am J Bioethics,
patient in making their decision. 6(1), 9–14.
• Coercion and manipulation are unethical 15  Information and Consent. Medical Council of New
because they violate the principle of Zealand. 2002. www.mcnz.org.nz.
respect for patient autonomy, and because 16* General Medical Council Guidance for doctors.
manipulation often involves deception and Consent: patients and doctors making decisions
violates physician obligations of veracity. together. 2008 GMC, UK.
17   US case law; see chapter text.

11
 Section 1. Consent and refusal

Faden, R. and Beauchamp, T.L. (1986). A History and Theory

Further reading of Informed Consent. Oxford, UK: Oxford University
Appelbaum, P.S. (2007). Assessment of patients’ competence Press Inc.
to consent to treatment. New Eng J Med, 357, 1834–40.
General Medical Council Guidance for doctors.
Badcott, D. (2005). The expert patient: valid recognition or Consent: patients and doctors making decisions
false hope? Med Health Care Philos, 8(2), 173–8. together. 2008 GMC, UK. http://www.gmc-ul.rg/static/
Bird, S. (2004). Does my patient have capacity to consent to documents/consent/Consent_2008.pdf
treatment? Aust Fam Physician, 33(8), 638–9. Green, D. and MacKenzie, C.R. (2007). Nuances of
Council of Europe. Convention for the protection informed consent: the paradigm of regional anesthesia.
of human rights and dignity of the human being HSS J, 3(1), 115–18.
with regard to the application of biology and Hedayat, K.M. (2007). The possibility of a universal
medicine: Convention on human rights and declaration of biomedical ethics. J Med Ethics, 33,
biomedicine. CETS no.: 164. Full text available 17–20.
at: http://conventions.coe.int/Treaty/Commun/ McLaughlin, L.A. and Braun, K.L. (1998). Asian and
QueVoulezVous.asp?NT=164&CL=ENG. pacific islander cultural values: considerations for
Earle, M. (1999). The future of informed consent in British health care decision making. Health and Soc Work,
common law. Eur J Health Law, 6, 235–48. 23(2), 116–26.

12
 Section 1 Consent and refusal
Chapter

2
Informed refusal – DNR orders in the patient
undergoing anesthesia and surgery and at
the end-of-life
David M. Rothenberg

The Case subjected to uterine surgery. Justice Cardozo of the

New York Court of Appeals described the wrong
A 67-year-old male with oxygen-dependent COPD
committed as a “trespass,” emphatically stating
requires a series of electroconvulsive therapies (ECT) for
severe depression refractory to medical therapy. The patient “Every human being of adult years and sound mind
has consented to general anesthesia with mask ventilation has a right to determine what shall be done with his
for these procedures, but refuses endotracheal intubation own body.” A competent patient’s refusal of treat-
irrespective if it might be life-sustaining in the event of ment, including the request to refuse potentially
respiratory or circulatory arrest. As such, he requests that a life-sustaining therapy, must be honored. However,
do-not-resuscitate (DNR) order be enacted and remain in individual autonomy is not a legal or moral absolute
place during the perioperative period and throughout the and can be superceded by the state’s rights to protect
entirety of his hospitalization. innocent third parties (e.g., minors), prevent sui-
In 1960, cardiopulmonary resuscitation (CPR) was cide, and maintain the integrity of the medical pro-
introduced to clinical practice and was intended to fession. Concerns about maintaining the integrity of
apply to those patients in whom their hearts were con- the medical profession and the individual integrity of
sidered “too good to die.” Unfortunately, the more lib- physicians are often invoked in discussions of futility
eral use of CPR in patients with hearts essentially “too as it applies to a patient’s DNR order.
poor to live” prompted ethical consideration of when The theory of medical futility originated in the
CPR should be withheld, thus averting the situation ancient philosophical teachings of Plato and was later
whereby death, rather than life, was delayed. espoused by Hippocrates, who stated that, in general, the
The DNR order is founded on the ethical principle role of medicine “is to do away with the sufferings of the
of respect for individual autonomy and the legal doc- sick, to lessen the violence of the diseases, and to refuse
trine of informed consent. Autonomy to make one’s to treat those who are over-mastered by their diseases,
own decisions regarding medical therapy is not a mod- realizing that in such cases medicine is powerless.”3
ern day concept. Indeed, John Stuart Mill proposed this The Council on Ethical and Judicial Affairs of
idea in his 1869 treatise On Liberty in which he stated, the American Medical Association simply affirms
“Considerations to aid his judgment, exhortations to Hippocratic dogma in stating: “When efforts to resus-
strengthen his will, may be offered to him, even obtruded citate a patient are judged by the treating physician to
on him, by others; but he himself is the final judge. All be futile, even if previously requested by the patient,
errors which he is likely to commit against advice and CPR may be withheld.”4Although the predominance
warning, are far outweighed by the evil of allowing oth- of medical opinion continues to be that physicians
ers to constrain him to what they deem his good.”1 are not and should not be required to provide futile
The doctrine of informed consent was defined by treatment, defining futility may be a more difficult
Justice Benjamin Cardozo in the case of Schloendorff and critical task. It has been implied that medical
v Society of N.Y. Hospital.2 In this case a young woman, futility should apply when there is an absence of at
who consented only to a gynecological examin- least a modicum of medical benefit or, in the setting of
ation under ether anesthesia, was instead ­furtively cardiac arrest, when the patient predictably has near

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
13
 Section 1. Consent and refusal

0% survival after CPR. For patients with diseases such defining futility as a treatment that fails to achieve
as metastatic cancer, acute stroke, sepsis, or multilo- the goals of medicine. Social and medical acceptance
bar pneumonia, CPR should probably not be offered of futility as it pertains to CPR can then hopefully be
in the event of a cardiac arrest. Schneiderman et al. attained by using this definition in formal outcome
suggested that, in terms of probability, futile therapy studies.
be defined as a chance of success being less than 1 in DNR orders may be written based on physician
100.5 Although isolated cases of long-term survival in assessment of futility, or based on patient request. The
these instances may exist, if these occurrences are so majority of patients who request DNR orders do so
rare as to be unexplainable and therefore have little not because they wish to die, but rather as a reflec-
predictive value, then this definition of futility would tion of how they perceive their quality of life before
still apply. or after the resuscitation. Diminished quality of life
In discussing futility, it is imperative to differentiate has been defined as diminished capacity to resume
“physiologic” or “quantitative” definitions of futility – work and/or impaired cognitive function specifically
based on scientific data that suggest that CPR will not as it applies to awareness of one’s environment. It has
be effective – from more value-laden or “qualitative” been shown that, in patients who survive critical ill-
definitions of futility, in which physicians may impart nesses, quality of life is worse if the patient requires
their own beliefs on what they perceive as the patient’s CPR. Physical or mental impairment, chronic disabil-
preference, and suggest in this context that CPR is not ity, or persistent vegetative states are additional rea-
worth attempting. sons patients or their surrogates may request a DNR
Within the framework of “physiologic” futility, a order. Patients also express desires for DNR orders
DNR order should be written and CPR should be with- when they believe that CPR will merely prolong the
held when an arrest occurs. Patients and/or their fam- dying process. Irrespective of the reasons behind
ilies should be informed of this decision, although to the decision, the individual patient’s values are more
suggest that a choice exists could imply that there may relevant than those of the physician in determining
be a potential benefit from CPR, inadvertently send- resuscitation status when quality of life is the issue in
ing a mixed message. Respect for patient autonomy question.
does not mean that patients have a right to demand Physician insecurity in applying a DNR order has
nonbeneficial and potentially harmful treatment. sometimes led to the ethically and medically inappro-
Physicians who agree to such demands act purely on priate practice of the “slow-code” or “show code.”
behalf of the patient’s psychological welfare rather than Additionally, a DNR order should not be misinter-
on the patient’s rights. Brody reiterates “that there are preted as an order to withhold or withdraw other vital
some questions of professional ethics that physicians therapies. Indeed, the misconception of this order to
are entitled to decide among themselves unilaterally. mean “do-not-round” has led to the suggestion that
Regarding those matters, the society is entitled to decree the order be renamed no-CPR, or do-not-attempt
that the profession of medicine will not be practiced in resuscitation, to convey the idea that even if CPR were
that way … But the society is not entitled to dictate to to be initiated, the likelihood of success would be
the profession the contents of professional integrity.”6 extremely low. A DNR order does not preclude the use
In protecting the integrity of the medical profession, of other life support therapies including, in selected
however, public trust must not be compromised. DNR instances, surgery or intensive care. Most recently
policies founded on the premise of cost containment a call for renaming these orders to “allow natural
tend to be value laden and, if implemented, are likely to death” (AND) has been suggested in order to eschew
foster a paternalistic approach to patient care, as well as the negative connotation of do-not-resuscitate.7 The
to erode patient confidence that physicians are acting problem with this term is that it may inappropriately
with their best interests in mind. lead to the withholding of all other forms of therapy
Guidelines for establishing standards of medical exclusive of CPR.
futility have been suggested in an effort to create an Our patient is justified in requesting a DNR order
open dialogue with society, in general, and the medi- in advance of ECT as he perceives his life to be insuf-
cal community. These guidelines include (1) acknowl- ferable should he require prolonged mechanical venti-
edging that the word futility is widely used and (2) latory support. An argument for a physician-initiated

14
 Chapter 2. Informal refusal – DNR orders

DNR or AND order based on medical futility does not criminal immunity for EMS technicians who termi-
apply because of a lack of scientific evidence citing sur- nated resuscitative efforts in good faith in the field. At
vivability if this type of patient suffers a respiratory or that time, other states restricted the use of pre-hos-
cardiac arrest. pital DNR orders to only hospice programs, patients
Combinations of both medical and social factors being transferred between institutions or terminally
have led to the more frequent application of the DNR ill patients. Difficulty was felt to arise in establishing
order both in a pre-hospital and in-hospital setting. An the validity of an advance directive or the competency
aging population with end-stage malignancies, stroke of a conscious patient who refused such therapies as
syndromes, multiple organ failure, and Alzheimer’s endotracheal intubation or intravenous vasopressors.
dementia contributes to the growing use of the DNR As of 2002, however, 42 US states had enacted
order. They are also major social factors related to out-of-hospital DNR protocols based on scientifi-
the enactment of patient’s Self-Determination Act cally ­validated studies assessing the futility of CPR in
of 1990,8 which mandated that all hospitals receiv- the field. Futility in a pre-hospital setting needs to be
ing Medicare reimbursements provide patients with determined completely on a physiologic basis (as was
information that would aid in their decisions regard- previously discussed), and without value-laden qual-
ing end-of-life issues such as a DNR order. As DNR ity of life judgments. Outcome data in these multiple,
orders continue to be written, it is inevitable that large studies indicate a near 0% survival if there is no
new ethical dilemmas will arise. Such dilemmas are return of spontaneous circulation in the field, espe-
increasingly common in the pre-hospital and pre- cially in the setting of blunt trauma.9 Although studies
surgical settings. of these types seem to validate the definition of physi-
ologic futility as it relates to CPR in the field, appli-
cation of “termination of resuscitation rules” based
Pre-hospital DNR orders solely on futility are not absolute. Significant variabil-
Pre-hospital DNR policies have emerged recently and ity regarding the timing of termination of resuscita-
serve three primary purposes: (1) to provide continued tive efforts and the pronouncement of death has been
respect for patient autonomy following hospital dis- noted despite having defined rules, especially in large
charge, (2) to prevent futile resuscitation efforts in the cities where many different base hospitals provide on-
field, and (3) to protect the well-being of emergency med- line medical control of EMS personnel during out-of-
ical service (EMS) personnel. Patients who maintain a hospital cardiac arrest.
DNR order following discharge from the hospital should Finally, concern regarding the health of both EMS
have this order honored in a pre-hospital setting should personnel and innocent bystanders during high-speed
an arrest occur at home or at a chronic care facility. ambulance transports, the increase of risks of HIV and
Attempts to clarify whether a patient has a pre- hepatitis B exposure during resuscitation, economic
existing DNR order based on quality of life in an constraints in terms of use of limited resources (espe-
out-of-hospital setting may be difficult and time con- cially in small communities), and costs of futile resus-
suming. Therefore recommendations have been made citation have all been offered as additional reasons to
to identify such patients preemptively, and include establish pre-hospital DNR policies. Although fear of
a DNR identification bracelet or “no-code” tattoo, medical liability, in concert with the public’s expecta-
or a central, computerized file system allowing EMS tions that EMS personnel will initiate and continue
personnel to access and verify resuscitation status at CPR, may have limited the use of pre-hospital DNR
the scene. In the event that the patient’s wishes are orders in the past, federal and/or widespread state
unclear, full resuscitative measures often are instituted adoption of such preset rules of out-of hospital termin-
by medical rescue technicians irrespective of the prob- ation of basic and advanced cardiac life support appear
ability of successful resuscitation. Emergency depart- imminent.
ment physicians and ethicists have thus considered the
need for a pre-hospital DNR policy based on medical
futility. As of 1991 when the US Federal Patient Self- Pre-anesthesia DNR orders
Determination Act was mandated, Montana was the Patients with preexisting DNR orders often require
only US state to have a policy that provided civil and anesthesia for surgical procedures necessitated by

15
 Section 1. Consent and refusal

the need to improve quality of life. Common surgical “exhortations,” it is hoped that most patients or their
procedures that are often performed as a means of pal- surrogates would opt to have the surgery performed
liation or comfort of care in patients with DNR orders with the DNR order temporarily suspended. Patients
include the following: should be reassured that resuscitation measures
• Tracheostomy would be employed only if necessary, and any form
• Indwelling central line access of life support would be discontinued if no longer
required or no longer beneficial in reversing the
• Feeding gastrostomy/jejunostomy
patient’s underlying condition. This approach also
• Emergency surgery (hemorrhage, bowel
allows distinguishing between, and treatment of
obstruction, peritonitis.
those arrests that are readily reversible and those in
In addition, it is not uncommon for patients with which resuscitation is physiologically futile.
DNR orders to require an anesthetic for nonsurgi- Within the context of this “informed consent”
cal procedures such as electroconvulsive therapy as discussion, the patient or surrogate is entitled to cer-
described for our patient. Given that the practice of tain options as they relate to the pre-anesthesia DNR
anesthesiology is inseparable from the process of order. The patient may: agree to undergo the surgery
intraoperative resuscitation, an ethical dilemma may with the DNR order temporarily suspended; undergo
occur when a patient with a DNR order presents for surgery but may stipulate that only specific resuscita-
surgery. In this setting automatic resuscitation may tive measures be used (e.g., vasopressors but no CPR
violate patient autonomy and give rise to a situation or mask ventilation but no endotracheal intubation);
directly prohibited by the DNR order, whereas auto- refuse surgery unless the DNR order is maintained
matic withholding of life-support may mean ignoring throughout the procedure, thus accepting the risk of
a reversible complication, thus violating the spirit of potentially reversible causes of death. If the patient
patient’s wishes. demands the last option, both surgeon (or in our
Although arguments have been made in favor patient’s case, psychiatrist) and anesthesiologist must
of maintaining the DNR order at the time of sur- decide if it is proper to proceed without the ability to
gery, the majority of medical and ethical opinion institute life-support measures should a complication
favors a policy that has been best termed “required occur. Although physicians are not obligated on moral
reconsideration.” or legal grounds to operate under these constraints,
In keeping with the philosophy of Mills, the anes- they do have a duty to try to secure other physicians to
thesiologist should stress to the patient that to have care for the patient, so as to avoid potential charges of
the greatest likelihood of surgical success, simple patient abandonment.
intraoperative interventions and/or resuscitation The American Society of Anesthesiologists10 and
may be necessary. These may include pharmacologic the American College of Surgeons11 have drafted
reversal of residual anesthetic agents (e.g., naloxone guidelines for the management of the patient with
for the respiratory depressant effects of opiates, or a presurgical DNR order. Although both societies
flumazenil for similar effects of benzodiazepines), have adopted a policy of “required reconsideration,”
antiarrhythmic therapy for iatrogenically induced neither offers recommendations for either postop-
arrhythmias (e.g., ventricular tachycardia second- erative resumption of the DNR order or discontinu-
ary to either an accidental intravascular injection ation of life support should intraoperative CPR be
of a local anesthetic or direct myocardial irritation necessary. Recommendations for weaning or termi-
from a central venous catheter placement), or cor- nating life support in this setting have been proposed
rection of hypoxemia due to accidental esophageal or by Franklin and Rothenberg.12 Should resuscitation
unilateral bronchial intubation. The contention that be required in the operating room, necessitating life
these mishaps are more likely to result in an intra- support either in the form of mechanical ventila-
operative arrest in a patient with a preexisting DNR tion, inotropic agents or vasopressors, then post-
order has not been substantiated. Indeed patients operatively, the patient should be transferred to an
should understand that survival following resuscita- appropriate care area such as the intensive care unit,
tion, specifically CPR, has been shown to be consid- and an attempt to wean the patient from support
erably improved if the arrest occurs in an operating should commence. This type of management should
room versus the general hospital ward. With these probably not take place in a post-anesthesia care

16
 Chapter 2. Informal refusal – DNR orders

unit where the discussion and enactment of possi- increasingly common and are likely to be
ble termination of life support may be distressing to widely inacted.
other recovering patients. Weaning should ideally
• DNR orders in the setting of anesthesia
be achieved within a reasonably short period (i.e.,
and surgery should undergo “required
24 hours) should the etiology of the arrest be iatro-
consideration” in which the risks and benefits
genic or unrelated to the patient’s underlying disease.
of resuscitation in the OR are reviewed and
If successful, the DNR order may be reinstated and
patient desires determined.
the patient transferred to an appropriate care area.
• When a patient desires that a DNR order be
Should the weaning process fail, then provisions
maintained during anesthesia and surgery,
for  terminating life support should be considered.
providers who feel they cannot proceed
Prior preoperative discussions in this regard are
nevertheless have an obligation to try to
essential so that patients and their families may be
secure alternative physicians who are willing
assuaged of their fears of being left on life support
to respect the DNR order.
systems indefinitely. Appropriate medical consulta-
tion to ensure that the patient’s condition is irrevers- • Plans should be formulated for postoperative
ible and to support the decision to withdraw support resumption of the DNR order, if suspended,
is encouraged. Constant communication with the or for discontinuation of life support after
patient and/or surrogates and documentation of these intraoperative CPR if appropriate.
discussions in the medical record is also mandatory.
The actual termination of life support should be
done in accordance with well-established guidelines
References
1*  Mills, J.S. (1978) On Liberty. Indianapolis, IN; Hackett
and be conducted with the sole purpose of minimizing
Publishing, p. 75.
patient suffering.
2  Schloendorff v Society of NY Hospital, 105 N.E. 92,
1914.
Case resolution 3*  Chadwick J, Mann WN (eds). The Medical Works of
Hippocrates. (1950). Boston, MA: Blackwell Scientific.
Our patient agreed to undergo ECT and suspend his 4*  Council on Ethical and Judicial Affairs, American
DNR order during the time surrounding his treatment Medical Association (1991). Guidelines for the
and the immediate recovery period with the stipula- appropriate use of do-not-resuscitate orders. JAMA,
tion that should he require endotracheal intubation 265, 1868–71.
and mechanical ventilation, these supportive modal- 5*  Schneiderman, L.J., Jecker, N.S., and Jonsen, A.R.
ities would be discontinued in an expeditious fashion (1990). Medical futility: Its meaning and ethical
(24 hours). Appropriate sedative/analgesic therapies complications. Ann Intern Med, 112:949–53.
would be instituted if tracheal extubation would likely 6*  Brody, H. (1994). The physician’s role in determining
lead to respiratory and subsequent circulatory arrest, futility. J Am Geriatr Soc, 42, 875–8.
assuring comfort at the end-of-life and in keeping with 7*  Venneman, S.S., Narnor-Harris, P., Perish, M., and
the principle of the “double effect”. The patient was able Hamilton, M. (2008). “Allow natural death” versus “do
to successfully complete a series of eight treatments not resuscitate”: three words that can change a life. J
and was discharged from the hospital with a DNR to be Med Ethic, 34, 2–6.
maintained at his chronic care facility. 8  Omnibus Budget Reconciliation Act of 1990, Public
Law 101–508, Section 4751.
9* Vayrynen, T., Kuisma, M., Maatta, T., et al. (2007).
Key points Medical futility in asystolic out-of-hospital cardiac
arrest. Acta Anaesthesiol Scand, 52, 81–6.
• DNR orders may be written if CPR would
10* Committee on Ethics, American Society of
be physiologically futile, or at the request of
Anesthesiologists: Ethical guidelines for the anesthesia
patients who feel that CPR would result in care of patients with do not resuscitate orders or other
poorer quality of life. directives that limit treatment. American Society of
• Pre-hospital DNR orders to prevent futile Anesthesiologist Directory Members, Park Ridge, IL,
or unwanted CPR in the field are becoming ASA, 1994, pp. 746–7.

17
 Section 1. Consent and refusal

11  Committee on Ethics. (1994). American College

of Surgeons: Statement on advance directives by
Further reading
patients: Do not resuscitate in the operating room. Am Bishop, J.P, Brothers, K.B., Perry, J.E. and Ahmad, A. (2010).
Coll Surg Bull, 79, 29. Reviving the conversation around CPR/DNR. Am J
Bioeth, 10(1), 61–7.
12*  Franklin, C.M. and Rothenberg, D.M. (1992). Do-not-
resuscitate orders in the presurgical patient. J Clin
Anesth, 4,181–4.

18
 Section 1 Consent and refusal
Chapter

3
Informed refusal – the Jehovah’s
Witness patient
James M. West

The Case Leviticus 17:10–16 - … I will set my face against the

soul that eateth any manner of blood, and will cut him off
A 41-year-old female with hepatitis C cirrhosis compli- from among his people. … no soul of you shall eat blood,
cated by hepato-pulmonary syndrome is listed for liver neither shall any stranger that sojourneth among you eat
transplant. She has high priority status due to the severity blood. … Ye shall eat the blood of no manner of flesh; for
of her pulmonary disease, which is usually reversible with the life of all flesh is the blood thereof; whosoever eateth it
liver transplant. Pertinent lab results are: hemoglobin 12, shall be cut off.
INR 1.1, bilirubin 1.0, creatinine 1.0 and platelet count 75 Acts 15:28–29 - … that ye abstain from things sacri-
000. Her situation is further complicated by the fact that ficed to idols, and from blood, and from things strangled,
she is one of Jehovah’s Witnesses and will not accept blood and from fornication; from which if ye keep yourselves, it
transfusions. shall be well with you. Fare ye well.
Should this patient be a candidate for a liver transplant,
given the relatively common need for blood transfusion dur- A 1951 article in Watchtower, a publication of the JW
ing the operation? What are the anesthesiologists’ obligations governing body, explained the ban:
to the patient, to themselves and even to other patients on “ … when sugar solutions are given intravenously, it is
the transplant recipient list? Is the decision to follow through called intravenous feeding. … the transfusion is feeding
with this case different from any other major surgeries, such the patient blood and …(the patient) is eating it (blood)
as coronary artery bypass surgery or liver resection? through his veins.” [Bold type added]
Over the years, adaptation has been required to keep
Jehovah’s Witnesses up with advances in medicine. Guidelines have been
Jehovah’s Witnesses (JWs) began as a Bible study group developed to help members deal with renal dialysis,
formed in 1870 by C.T. Russell in Allegheny, PA. They cardiopulmonary bypass, blood harvesting includ-
believe that God’s name is Jehovah, which is an English ing cell saver, acute normovolemic hemodilution, and
translation of the name that appears in Hebrew texts. autologous blood donation as well as organ transplant.
They also believe in the literal interpretation of the See Table 3.1 for a timeline of significant events in the
bible, except in cases in which it is obvious that it is alle- Jehovah’s Witness faith.
gorical. JWs believe that only one government is owed
allegiance – God’s Kingdom. They do not salute flags, Ethical principles
serve in the military, or vote in political elections. They Ethical dilemmas can be examined in the context of
also believe we are living in the “last days” of the pre- the four basic principles of medical ethics defined by
sent system.1 Beauchamp and Childress: (1) respect for ­autonomy –
Like many religions, JW beliefs and teachings have a norm of respecting the decision-making capacities
evolved as society has evolved. In 1945 there was a ban of autonomous persons, (2) beneficence  – a group
placed on blood transfusions based on three quotes of norms for balancing benefits against risks, (3)
from scripture:2 ­nonmaleficence - a norm of avoiding harm, and (4) jus-
Genesis 9:3 - Every moving thing that liveth shall be meat tice – a group of norms for distributing benefits, risks,
for you; even as the green herb have I given you all things. and costs fairly.3 In the US, the principle of respect for
But flesh with the life thereof, which is the blood thereof, patient autonomy is usually the most heavily weighted
shall ye not eat. of the four, while in many European countries, the

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
19
 Section 1. Consent and refusal

Table 3.1. Events in the history of the Jehovah’s Witness church prevented her from consenting to a transfusion, not
and transfusion from receiving one” and a transfusion was ordered. In
1870 Study group formed Raleigh Fitkin Memorial Hospital v. Anderson, a preg-
1879 First Issue of Watchtower published nant Jehovah’s Witness was not permitted to refuse a
necessary transfusion.5
1901 Discovery of ABO blood groups
Over the last 40 years, US courts have rejected
1914 First blood bank transfusion these cases and consistently upheld the rights of adult
1931 Changed name to Jehovah’s Witnesses Jehovah’s Witnesses to refuse blood even when a trans-
1945 Ban placed on transfusions fusion would be life saving – and even when others,
2008 7.1 million members worldwide and 1.1 such as dependent children, may be indirectly affected.
million members in US On the other hand, when the patient is a minor child
and hospitals have sought court orders to give blood
principle of beneficence may weigh more heavily than believed to be absolutely necessary to preserve life,
respecting individual autonomy. such orders have usually been granted. Exceptions
Adults with appropriate decision-making capacity have sometimes been made when an older teenager is
express their autonomy through the informed con- committed to his/her religion and seems to fully under-
sent process. Physicians demonstrate respect for the stand the scope and consequences of his/her decision.
autonomy of competent patients by accepting their Legal precedents in many European countries have
informed decisions, whether or not they consent to paralleled those in the US.6
medical treatment. It seems self-evident that without
respect for informed refusal, the concept of informed Specific issues to consider in this case
consent is invalidated: “consent” would then merely be Key questions arise in most cases involving Jehovah’s
acquiescence of the patient to the physician’s recom- Witnesses and others who refuse certain types of treat-
mendations. Adults are therefore even allowed to make ment on religious or other grounds.
what doctors may sometimes consider unwise or fool-
ish decisions. The physician does not have to agree with Does the patient have appropriate decision-making
the patient, but neither can a physician be compelled to capacity?
give inappropriate, bizarre, or substandard care. (For All patients over the age of majority are assumed to
more on informed consent, please see Chapter 1.) have adequate decision-making capacity unless proven
In order to give informed consent, a patient must otherwise. Anesthesiologists can usually tell whether
have appropriate decision-making capacity, be able patients have decision-making capacity, which is gen-
to understand the nature of the procedure, the risks, erally present if the patient understands the nature of
benefits and alternatives including that of doing noth- his/her illness/condition, the nature of the proposed
ing, and the probable outcomes of both acceptance and procedure and its inherent risks and benefits and alter-
refusal of the proposed procedure. In addition the deci- natives, and the consequences of refusing treatment.
sion must be made free of coercion. Coercion is present In doubtful cases, evaluation by a psychiatrist may be
if the patient feels threatened, bullied or subjected to helpful.
irresistible pressure to make a decision he or she would
otherwise not make. Have all appropriate risks, benefits and alternatives
been explained?
Legal precedents There are other important issues in this case that need
Although legal decisions are not always synonymous to be addressed, aside from the usual explanation of
with “ethical” ones, a review of some legal precedents anesthesia and surgical risks. These include assur-
regarding JWs and how they have changed provides ing that the patient understands that there are some
some insights into how medical ethics has shifted in blood cells in solid organs; explaining the specifics
the US from a paternalistic and/or beneficence-based of blood conservation techniques; and clarifying the
emphasis, to one of respect for autonomy. risks of not accepting blood in the face of massive
In 1964, two US courts compelled transfusion for hemorrhage.
adult patients. In Georgetown College v. Jones4 the In nonemergent cases such as these, there is also
court of appeals ruled that the “patient’s religion merely often time to plan. Patients should be encouraged to
20
 Chapter 3. Informed refusal – the Jehovah’s Witness

discuss their options not only with the surgical team, Sometimes the decisions JW patients express in
but also with the local hospital liaisons from their the presence of family and church members are dif-
church (who can be a resource for physicians as well). ferent from those they later express in private. In the
Preoperative treatments with erythropoietin, iron author’s experience, this is extremely rare. However,
supplements, or other methods to improve baseline it is important that at some point prior to surgery and
hematocrit should be discussed. Consideration should anesthesia, patients have an opportunity to express
also be given to intraoperative use of DDAVP and any their transfusion preferences to the anesthesiolo-
other measures that will minimize blood loss during gist in private.7 This might be done in a preoperative
the procedure. holding area after the family and/or church members
have been sent to the waiting room. The intent should
Can a surrogate decision-maker refuse transfusion not be to talk the patient into receiving blood, which
for an incompetent patient? would be itself coercive, but to insure that his/her
All JWs are encouraged to carry a durable power of true wishes are known and followed. If the patient
attorney that explains in detail what their beliefs are does recant, it is then important to determine what,
concerning blood and blood products (see Fig. 3.1). If if anything can/should be told to family members
this is not available and it cannot be verified that the about whether blood products were given. Principles
patient is a practicing JW, then physicians generally err of patient confidentiality demand that specifics of
on the side of transfusion. Consultation with hospital treatment such as this only be discussed with the
legal affairs or an organization’s ethics committee may patient unless there is an agreement with them to do
be helpful if the appropriate action remains unclear. otherwise.

Can a surrogate decision-maker change a plan made Which blood products will and will not be acceptable?
by a previously competent patient? It is not a given that a patient professing to be a JW
A surrogate decision-maker’s task is to make decisions will not accept any blood products. In one study, for
for the patient when the patient cannot make them example, up to 10% of pregnant JW patients indi-
for himself. Ideally, surrogates are not supposed to cated they would accept blood in an emergency.8
express their own wishes, but are supposed to make Nevertheless, in general, few if any baptized Jehovah’s
the same decision that a patient would make if he/she Witnesses will accept whole blood, packed red blood
were able to do so. Once the patient’s decisions are cells, plasma, platelet concentrates, or white blood
known, whether physicians agree or not, those deci- cell transfusions.9 Stored autologous blood is also
sions should stand unless new information becomes not acceptable because it is out of contact with the
available that brings the previous decision into ques- body for an extended period. Fractionated products
tion. This can be particularly difficult if the patient has such as albumin, cryoprecipitate, cryo-poor plasma,
refused a treatment that the physician thinks is life sav- and individual factors are left to the “discretion of the
ing, and the physician knows, believes, or even hopes practicing Christian,” as are organ and bone marrow
that the surrogate would capitulate and allow the pro- transplantation.
hibited treatment. That is when physicians discover if Other “gray areas” include, but are not limited to,
they truly believe in patient autonomy. (For more on cell saver, acute normovolemic hemodilution (ANH),
surrogate decision-making, see Chapter 4.) cardiopulmonary bypass, and renal dialysis. In these
situations, The Watchtower has stated that if the blood
Is the patient making a decision that is free of coercion? is kept in continuous circuit with the body and not
Patients should be free of coercion from healthcare stored for any length of time, then accepting its trans-
providers and feel safe that regardless of their per- fusion is a personal decision.
sonal choices their doctors will not abandon them. Cardiopulmonary bypass and dialysis would
Additionally, providers must also strive to ensure that almost always involve a continuous circuit. Cell saver
the choices a patient makes are truly his/her own. It is and ANH do not necessarily involve a continuous cir-
not unusual for members of the JW church commu- cuit, but one can be created by flushing the cell saver
nity, as well as family members, to flock to the bedside bag and tubing with crystalloid and connecting the
of a JW patient, both to support their loved one and circuit to the patient’s IV prior to blood collection.
also to protect him/her from receiving blood. If, after collecting blood for ANH, the line to the
21
 Section 1. Consent and refusal

(a)

Figure 3.1  Sample form for Jehovah’s Witness Patients Refusing Blood Transfusions. www.watchtower.org

22
 Chapter 3. Informed refusal – the Jehovah’s Witness

(b)

Figure 3.1  (Cont.)

23
 Section 1. Consent and refusal

Table 3.2. Blood product guidelines for Jehovah’s Witness patients

Accept/refuse/personal
Type of blood product or procedure decision (PD) Specific concerns
Whole blood Refuse
PRBCs Refuse
Plasma Refuse
Platelets Refuse
White cells Refuse
Cryoprecipitate PD
Cryo-poor plasma PD
Fractionated factors PD
Albumin PD
Erythropoetin PD Most erythropoietin is albumin coated
and is a PD. Darbepoetin contains no
albumin
Recombinant Factor VII Accept Not made from blood, though some
may still object
Cell saver PD If kept in continuous circuit
Acute normovolemic hemodilution PD If kept in continuous circuit
Cardiopulmonary or veno-venous bypass PD Continuous circuit rule
Renal dialysis PD Continuous circuit rule
Stored autologous blood Refuse Not in continuous circuit
Organ and bone marrow transplant PD

collection bags remains connected to the patient then Is it appropriate to undertake liver transplantation or
it, too, is considered to be a continuous circuit. (See other major surgery in a JW patient?
Table 3.2)
In many routine surgical and anesthesia cases, dis-
tributive justice (fair allocation of scarce resources)
What are the capabilities of the surgical team? is not a large consideration in the decision-making
When large surgical procedures are planned that process. However, except in the case of a living related
may involved significant hemorrhage, it is impor- donor, solid organ transplantation involves use of a
tant to assess whether the surgical and anesthesia very limited resource. Even centers that specialize in
team have the skills, experience, and resources nec- organ transplants in Jehovah’s Witnesses have strict
essary to perform this procedure on a patient who criteria for selecting the proper candidates for organ
has limited their ability to care for him/her by refus- transplantation. If there is relative certainty that the
ing blood. The principle of nonmaleficence, doing preoperative status of the patient will mandate the use
no harm, might suggest refusing to do the surgery if of blood products during the transplantation, then a
the team does not have sufficient experience, modi- Jehovah’s Witness patient should not be a candidate
fying the surgical plan, or referring the patient to if they would refuse such transfusions. On the other
another center with more experience in “bloodless” hand, many potential candidates for liver transplant
surgery techniques. There are centers in the US, for are not in severe failure but are at the top of the recipi-
example, that have created a niche in caring for high- ent list due to other complicating factors such as hepa-
risk Jehovah’s Witness patients. They can be found to-pulmonary syndrome, hepatocellular carcinoma,
by contacting the official Jehovah’s Witness web- or hepato-renal syndrome. Many of these patients
site.10 Consultation with, or referral to, such centers have normal coagulation and hemo­globins and have a
may be useful. reasonable chance of receiving a liver transplantation
24
 Chapter 3. Informed refusal – the Jehovah’s Witness

without transfusion, whether they are one of Jehovah’s

Witnesses or not. Such patients may be appropriate
Case resolution
In this case, the patient had been advanced on the
candidates for organ transplantation.
recipient list due to her hepato-pulmonary syndrome,
the only cure for which was a liver transplant. In add-
What are the anesthesiologist’s rights and obligations? ition, her pulmonary status was worsening and it was
Many anesthesia providers feel that refusal of stand- felt that she soon would not be a candidate at all. Though
ard care in the operating room, such as blood transfu- the transplant team did not have extensive experience
sions, places them in an untenable position in which in transplanting Jehovah’s Witnesses, the most experi-
a seemingly irrational patient choice prevents them enced surgeon did have a track record of operating on
from fulfilling their professional obligations to pro- patients such as this with minimal blood loss and min-
vide life-saving therapy. The American Society of imal use of blood products. The lead anesthesiologist
Anesthesiologists has developed guidelines for the had extensive experience with Jehovah’s Witnesses in
anesthesia care of patients with do-not-resuscitate other major surgeries such as cardiac surgery. Both of
orders or other directives that limit treatment11 that these individuals committed to being involved in this
specify the following: case, whether on call or not, at the time a liver became
When an anesthesiologist finds the patient’s or surgeon’s available for this patient.
limitations of intervention decisions to be irreconcilable The patient agreed to acute normovolemic hemodi-
with one’s own moral views, then the anesthesiologist lution and cell saver as long as a continuous circuit was
should withdraw in a nonjudgmental fashion, providing an maintained. She also agreed to albumin and recom-
alternative for care in a timely fashion.
binant factor VII if necessary. At the time of surgery
[if such] alternatives are not feasible within the time
three units of blood was drawn off and left in circuit
frame necessary to prevent further morbidity or suffering,
then in accordance with the American Medical Association’s with the patient. The surgery went smoothly and the
Principles of Medical Ethics, care should proceed with rea- patient received the three units of blood and two units
sonable adherence to the patient’s directives, being mindful of cell saver after the new liver had been revascular-
of the patient’s goals and values. ized. DDAVP was also administered. She tolerated the
surgery and was discharged ten days later, having had
In nonemergent situations, anesthesiologists have a slightly extended postoperative ICU stay due to her
the right to excuse themselves from a patient’s care, as pulmonary status.
long as they are willing to refer the patient to another
provider. This referral could even be to another med-
ical center that has developed expertise in caring for Key points
Jehovah’s Witness patients, and may be desirable in
• Due to strongly held beliefs, most practicing
certain situations even if the anesthesiologist would
Jehovah’s Witness patients will refuse
personally be willing to care for the patient.
transfusion of blood and many blood
If the situation is a life-or-death emergency with
products.
no time to make a referral, then the anesthesiologist is
• Respect for patient autonomy is the primary
obligated to care for the patient, trying as much as pos-
ethical principle applied in the United States,
sible to adhere to the patient’s wishes.
while the principle of beneficence is more
These guidelines are similar to the Guidelines on
strongly held in many other countries.
Clinical Management of Jehovah’s Witnesses published
by the National Health Service in Great Britain in • Respect for autonomy supports the concept
2005.12 European countries vary somewhat in the depth that adult, competent patients have the right to
of obligation a physician has to honor a patient’s wishes refuse blood transfusions, as well as any other
to not be transfused. In France, for example, an autono- therapy.
mous patient’s wishes are generally respected, but the • Commitment to principles of beneficence
law gives leeway to physicians acting in the course of an and nonmaleficence require anesthesiologists
emergency. In Germany, transfusion even to save a life to offer the best care available within the
would be in direct conflict with constitutional guaran- constraints of the patient’s wishes – this
tees of autonomy – although it is uncertain how this includes appropriate preoperative planning
would play out in court if challenged. for adjunctive therapies, and even referring

25
 Section 1. Consent and refusal

de Cruz, P. Comparative Health Care Law. Page 295.

JW patients to other providers if they are
Cavendish Publishing Ltd, London UK. 2001.
more experienced, and likely to accomplish
procedures with less blood loss. Loriau, J., Manaoulli, C., Montpellier, D., et al. (2004).
Surgery and transfusion in Jahovah’s witness patient.
• Many other Western countries follow laws and
Medical legal review. Ann Chir, 129(5), 263–8.
practices similar to that of the United States –
*  Honig, J.F., Lilie, H, Merten, H.A., and Braun, U.
the wishes of competent patients to forgo
(1992). The refusal to consent to blood transfusion.
transfusions are generally respected, although
Legal and medical aspects using Jehovah’s Witnesses as
individual countries may differ in whether an example. Anaesthesist, 41(7), 396–8.
and how strongly they penalize doctors who
7* Muramoto, O. (2000). Medical confidentiality and the
choose to transfuse rather than lose a patient’s
protection of Jehovah’s Witnesses; autonomous refusal
life in the operating room. of blood. J Med Ethics, 26(5), 381–6.
8* Gyamfi, C. and Berkowitz, R.L. (2004). Responses by
References pregnant Jehovah’s Witnesses on health care proxies.
1*  Jehovah’s Witnesses – Who are they? What do they Obstet Gynecol, 104(3), 541–4.
believe? (2006). Watch Tower Bible and Tract Society 9*  Jehovah’s Witnesses – religious and ethical position
of Pennsylvania. http://www.watchtower.org/e/jt/ on medical therapy, child care, and related matters.
index.htm. (2001) Watch Tower Bible and Tract Society of
2   New Revised Standard Bible. Pennsylvania
3*  Beauchamp T.L. and Childress, J.F. (2001). Principles 10   www.watchtower.org
of Biomedical Ethics, 4th edn. Oxford, UK: Oxford 11* Ethical Guidelines for the Anesthesia Care of
University Press, p. 12. Patients with Do-Not-Resuscitate Orders or Other
4   Georgetown College v Jones. 118 U.S. App. D.C. 80 Directives that Limit Treatment. American Society
(1964). of Anesthesiologists. Park Ridge, Il. Approved
5   Raleigh Fitkin–Paul Morgan Memorial Hospital v. by HOD, October 2008. http://www.asahq.org/
Anderson, 42 N.J. 421 (1964). publicationsAndServices/standards/09.pdf.
6   Re T (Adult: Refusal of Medical Treatment). Great 12* Guidelines on Clinical Management of Jehovah’s
Britain Court of Appeal, Civil Division. All Engl Law Witnesses. January 2005. Maidstone and Tunbridge
Rep 1992; 30[1992]4:649–70. Wells NHS Trust. London, UK.

26
 Section 1 Consent and refusal
Chapter

4
Surrogate decision-making
Elizabeth K. Vig, Allen Gustin, and Kelly Fryer-Edwards

The Case – Part 1 Many European countries have autonomy-based

models of decision-making for competent patients,
Ethel Smith, an 80 year-old widowed woman, is admit-
and hierarchies for surrogate decision-making for
ted for elective total hip replacement. She has a history of
well-controlled diabetes and hypertension, but is other-
incapacitated patients that are similar to that in the
wise healthy. Her functional status has declined because US. A recent review of laws of eight European coun-
of hip pain. Preoperatively, she is cognitively intact. Her tries (Belgium, Denmark, England, France, Germany,
surgery proceeds uneventfully; however, she develops the Netherlands, Spain and Switzerland) showed that
postoperative delirium in the recovery room. Her medical all recognize the autonomy of competent patients to
team decides that she should be transferred to an inten- make medical decisions. All except France recognize
sive care unit for support and monitoring. They schedule the legally binding power of written advance direct-
a meeting with her three children to discuss her condition. ives. Decisional powers of family members, close
During this meeting, her family states that she never desig- friends, and family doctors vary from country to
nated any family member to act as her decision-maker. country. Similarities and differences are summarized
in Table 4.1.1
Who is the legal decision-maker? A Durable Power of Attorney for Healthcare is a
As long as Mrs. Smith has decision-making capacity, legal document in which individuals can designate one
she can make her own medical decisions. Surrogates or more individuals whom they want to make decisions
do not become legal decision makers until a patient on their behalf if they lose decision-making capacity.
loses decision-making capacity. Many places (includ- There are some exceptions to this, such as some docu-
ing 44 of the United States) have laws identifying a ments from the State of California that allow the DPOA
hierarchy of legal surrogates. Different states vary in to make decisions even if the patient retains decision-
who is included in the hierarchy, but the order is often making capacity.
as follows: Court appointed guardian, Durable Power Patients usually want their families to make deci-
of Attorney for Healthcare (DPOA), spouse, adult chil- sions for them if they lose the ability to make their
dren, parents, and adult siblings. Five states include own decisions. In one study, older patients explained
attending physicians in this hierarchy. In Mississippi, that the reason they chose a given surrogate decision
the “owner, operator, or employee of a residential long maker was because that person was the person they
term care institution” is included in the hierarchy. In felt closest to (33%), the person who understood them
Texas, a “member of the clergy” is included. the best (26%) and the person who was geographically
If there are multiple people within a category, such the closest (17%).2
as Mrs. Smith’s three children, in the US they all have A living will is a type of advance directive in
equal legal standing as decision-makers. The legal which an individual expresses his/her preferences for
­decision-maker is not automatically the oldest, smart- care in future health states. Most of these documents
est, or most involved child. When there is not agree- are not very specific, but can be used by the family
ment between the surrogates within a category, some and the patient’s healthcare team in order to guide
states require consensus, while others only require a decisions when the patient can no longer express
majority opinion. preferences.

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
27
 Section 1. Consent and refusal

Table 4.1. Surrogacy in medical decisions for incapacitated patients in eight European countries, 2009

Patient has AD Patient has No AD but has a Patient has No AD and no

designated Surrogate designated Surrogate
Belgium AD has decisional power Surrogate has decisional Family member has
power but must show it is decisional power: order is
consistent with pt wishes spouse; child; parent; sibling
Denmark AD has decisional power Surrogate has decisional Family member or close
only for end-of-life power friend has decisional power
England AD has decisional power Surrogate has decisional Family member has
Treatment refusal must be power consultative role
expressed unequivocally for Only a power of attorney Physicians have decisional
the physician to comply can refuse life-sustaining power
treatment
France AD has consultative role Surrogate has Family member has
consultative role consultative role
Germany AD has decisional power Surrogate has decisional Family member and family
but Surrogate may power doctor have consultative
challenge Court approval is required roles
to refuse life-sustaining
treatment or there is
disagreement with the
physician
The AD has decisional power Surrogate has decisional Family member has
Netherlands power consultative role
Family order is spouse;
parents, children, siblings
Spain AD has decisional power; Surrogate has decisional Family member or close
there is a National Directory power friend have decisional
of ADs power
Switzerland AD has decisional power Surrogate has decisional Family member or close
If not sufficiently specific, power friend has decisional power
AD has a consultative role The order is spouse;
decendents; parents;
siblings
AD: Advance Directive

When is a surrogate decision-maker does not automatically indicate that an individual is

incapable of making his/her own decisions. An eval-
needed? uation of a patient’s decision-­making capacity (dis-
Patients who are at risk of losing decision-making cussed later in this chapter) can determine whether
capacity include hospitalized patients, patients with a patient can make a specific decision. Patients with
some types of psychiatric illness (such as depres- decision-making capacity sometimes voluntar-
sion and schizophrenia) and cognitive impairment ily defer decision-making to loved ones. This is an
(such as dementia, delirium, and strokes), resi- ethically and legally acceptable action. The literature
dents of nursing homes or assisted living facilities, has identified that patients from certain ethnic and
and patients who are approaching the end of life. immigrant groups and older patients are more apt to
However, merely being in one of these categories delegate decision-making.

28
 Chapter 4. Surrogate decision-making

What are the limits of surrogate How do surrogates make decisions?

decision-making? Although surrogates are expected to make decisions
based on substituted judgment or best interests, there
Regional differences exist with regard to the decisions
is evidence in the literature that surrogates factor their
that surrogates are allowed to make. In California,
own beliefs and preferences into the medical decisions
surrogates cannot make decisions about whether or
they make for loved ones. One study of experienced
not a patient receives electro-convulsive therapy. In
surrogate decision makers found that surrogates make
North Dakota, surrogates cannot make decisions
decisions in different ways.4 Most surrogates relied, in
about sterilization or abortion. In New York State,
part, on the substituted judgment standard and made
surrogates cannot make decisions about stopping
decisions based on their knowledge of their loved one’s
artificial nutrition and hydration unless there is “clear
preferences or thresholds of “living versus existing;”
and convincing evidence” of a patient’s preferences.3
and a small percentage (10%) of the surrogates relied
States are variable regarding the descriptions of the
on written documents, such as the patient’s living will.
abilities of surrogate decision makers; these specifi-
Another small group (18%), deferred decision-mak-
cations can be found in the state codes and laws, often
ing to someone more experienced, such as a clinician
searchable online. Clinicians also can contact the
family member. The third group based decisions on
risk manager of their facility to obtain guidance on
a sense of shared values with their loved one, which
the specifics of each state’s surrogate decision-maker
they believed obviated the need to formally discuss
statutes.
care preferences with their loved one. The final group
was made up of 28% of surrogates who made decisions
The Case – Part 2 based on their own personal values and/or prefer-
Mrs. Smith’s children understand the need for transfer of ences, not necessarily those of their loved one.
her care to an intensive care unit and initially agree to There is not clear consensus amongst ethics experts
continue medical care with the goal of getting her back to as to whether it is ethically permissible for family mem-
her pre-operative state. Four days later, she is still in the bers to incorporate their personal values and prefer-
intensive care unit with delirium. She is unable to partici- ences into decisions they make for their loved ones.
pate in her own care, and she develops aspiration pneu- Some ethics experts have espoused the principle of
monitis. At this time, she is supported with supplemental relational autonomy which recognizes that the patient
oxygen, however the family is told that she may need to is not the only stakeholder in a medical decision.5
be intubated. The orthopedic surgeon also notes purulent
In favor of relational autonomy is evidence that
drainage from the wound and feels the need to re-explore
the wound in the operating room. The patient’s family
patients are concerned about burdening loved ones
begins to disagree about what to do. They do not agree on and surrogates will often be the ones most affected
whether she would want to be reintubated. by decisions made for incapacitated patients.6 For
example, if Mrs. Smith’s children decide that she would
not want to be reintubated and she dies as a result of
How should surrogates make decisions? this decision, they then have to live with the emotional
and psychological implications of this decision. On
As determined by law, surrogate decision-makers
the other hand, if they decide that she would want to
can make their decisions on two bases:  substituted
be reintubated and hospital care continued, she might
judgment or best interests. The preferred is the sub-
have a prolonged hospital course and recovery period
stituted judgment standard, in which the surrogate
that might have financial implications for her children.
makes the decision s/he believes the patient would
While no one would condone making these decisions
have made. If the surrogate does not have enough
on the basis of personal gain or loss, relational auton-
familiarity with the patient’s care preferences, s/he
omy asks surrogates and clinicians to consider a broad
then makes a decision using the best interests stand-
interpretation of what decision is best.
ard, that is, making the decision that is in the patient’s
best interests. Both of these standards are intended
to be used based on the surrogate’s knowledge and The Case – Part 3
understanding of the patient’s interests, values, and After much discussion, Mrs. Smith’s older son convinces her
preferences. two daughters that she would want life-sustaining treatment

29
 Section 1. Consent and refusal

continued. He argues that she opted for the hip replacement In these studies, patients fill out a questionnaire iden-
to improve her quality of life and that she was not ready to tifying their care preferences in numerous health
die. Her daughters assert that she would not want prolonged states, and their preferred surrogate decision-makers
mechanical ventilation, and would not want to be depend- estimate their care preferences in these same states.
ent on others indefinitely, but eventually agree to a time-
Surrogates’ accuracy in estimating patient preferences
limited trial of continued care in the intensive care unit.
is then calculated. A review of these studies found that
surrogates correctly estimated their loved ones’ pref-
What if the surrogate isn’t making decisions erences 68% of the time. Of note, clinicians are less
accurate than family members in estimating patient
that appear to be what the patient would preferences.
have wanted?
When a surrogate’s decision seems to diverge from a The Case – Part 4
patient’s known preferences, medical teams may find After 9 days, Mrs. Smith remains unable to recognize her
it challenging to decipher whether the decision stems children, appears delirious, and is still intubated in the
from family beliefs/needs or from more dubious intensive care unit. Mrs. Smith’s son remarks to the ICU
motives. In most cases, deviations from patient’s pref- nurse, “I realize that there’s not much we can do but wait,
erences result from surrogates’ authentic love for the and I hate to see her suffer, but I think we need to keep things
patient, not malice. For example, family members may going for now because I need to have something that I can
live with.”
opt for more aggressive care for a terminally ill loved
one than the patient would have wanted because they
have not yet come to terms with their loved one’s grim
prognosis. However, some family members may have
What are the burdens of decision-making
ulterior motives behind their decisions. Asking family on surrogates?
members to explain the reasons for their decisions may Patients recognize how their illness, caregiving needs,
help. Ethics and palliative care consultants can also and need for decision-making may impose stress on
help evaluate these difficult situations. their loved ones. In previous research, many different
If there is clear evidence of a patient’s preferences, types of patients have expressed concern about bur-
such as in a living will, which the surrogate isn’t hon- dening their loved ones with their illness and needs.
oring, and the medical team doesn’t believe that the In order to lessen the burden on loved ones, many
surrogate’s reasons for disregarding the patient’s pref- patients allow their loved ones some degree of leeway
erences are acceptable, then the medical team may con- in how strictly to follow their preferences. For example,
sider taking the case to court. At least three cases have a patient may prefer not to remain on a ventilator for
involved discordance between the patient’s preferences an extended period of time, but also may recognize that
in their living will and the opinions of the patient’s legal his/her surrogate decision-maker may need time to get
decision-maker (the cases of Dorothy Livadas in New comfortable with making the decision to withdraw
York in 2008, Hanford Pinette in Florida in 2004, and care. Patients may recognize this and agree to remain
Doris Smith in Louisiana in 2004). In all cases, the liv- on the ventilator temporarily.
ing will trumped the legal decision-maker. Prior to tak- Additionally, it is stressful both to have a loved one
ing a potential case to court, the medical team and/or who is seriously ill and to make life or death decisions
ethics consultants should consider whether the patient for that loved one. The literature on the after-effects of
would have allowed the surrogate leeway in imple- caregiving and surrogate decision-making is becom-
menting his/her preferences and whether taking the ing more extensive. In studies from France8 and the
case to court might have serious adverse effects on the US9, families who made decisions for a loved one in an
surrogate(s) and/or patient’s family. intensive care unit were found to have anxiety, depres-
sion, and even symptoms of PTSD up to six months
after their loved one was discharged from that unit.
How accurate are surrogate estimates of There are some data from the perspective of sur-
patient preferences? rogate decision-makers on what clinicians could have
Numerous studies have investigated the accuracy of done to make decision-making easier for them. In one
surrogates’ estimates of their loved ones’ preferences.7 study, surrogates reported that decision-making was
30
 Chapter 4. Surrogate decision-making

easier when clinicians were available to answer their condition and the decision at hand. The team should
questions, gave them frank information about chances review her condition, the need for a tracheostomy, and
of recovery and prognosis, made treatment recom- the risks, benefits, and alternatives to the procedure.
mendations, and treated them with respect.10 When They might ask Mrs. Smith to repeat this information
too many clinicians were involved, decision-making back in her own words – by writing, or indicating her
was harder for surrogates. When the medical team can preference on a tablet or computer screen, for exam-
frame their recommendations in terms of the patient’s ple. Next, her appreciation should be assessed. Does
known values and preferences, such a recommen- she realize that the decision will affect her body? For
dation can be a strong guide and support for the sur- example, if she is in denial about how sick she has been
rogate. That is, the team can help shift the burden of and her continued need for mechanical ventilation at
owning the decision from the surrogate to the patient night, she might not appreciate why a tracheostomy is
(e.g., just enacting his/her wishes for him/her) or to the needed. The team next would want to ask Mrs. Smith
disease state (e.g., there is little more we can offer that to indicate her treatment choice and the reasons for
will help her). that choice. Her reasons should be consistent with
her beliefs and values. Her choice should follow this
The Case – Part 5 reasoning and be stable over time. If she changes her
mind when she is more confused, but then reverts to
After 2 weeks, Mrs. Smith’s aspiration pneumonitis and her
delirium show signs of improvement. She is still intubated,
her previous choice when less confused, the choice
but her confusion begins to wane. She now recognizes her voiced when she is less confused should be honored.
children. She has periods where she is quite lucid and other After assessing a patient’s decision-making abil-
periods where she is still quite confused. She probably would ities, the clinician uses his/her judgment to determine
benefit from a tracheostomy in the operating room, but her if the patient has decision-making capacity. Patients do
clinicians don’t know if they should ask Mrs. Smith or her not need to have all four abilities present to have deci-
family to make this decision. sional capacity. The clinician determines how much
of each ability needs to be present for capacity to be
present, and may vary the requirements depending on
How do we determine if a patient can make the decision at hand. In other words, when assessing a
his/her own medical decisions? patient’s decision-making capacity, the evaluation will
be more stringent if the consequences of the decision
The team needs to assess Mrs. Smith’s decision-making
are more serious and irreversible, such as the decision
capacity. Unlike competence, which is determined in a
to withdraw life-sustaining treatment.
court of law, decision-making capacity is determined
by a clinician. Psychiatrists and psychologists aren’t the
only clinicians who can evaluate decision-making cap- Key points
acity – any physician can determine whether a patient • It may be possible to prevent confusion
has decisional capacity. about the appropriate surrogate by asking all
Decision-making capacity is made up of four hospitalized and preoperative patients with
­decision-making abilities:  understanding, appreci- decision-making capacity to identify their
ating, reasoning, and choosing. Though she may be preferred surrogate decision maker(s) early in
intermittently delirious, Mrs. Smith may still be cap- their hospital stay.
able of making some decisions, especially when her
• Most patients are concerned about burdening
mental status is clearest. For example, Mrs. Smith may
loved ones and allow their surrogates some
be able to designate one of her children as her Durable
leeway in interpreting and implementing their
Power of Attorney for Healthcare, but at the same time,
care preferences.
she may not be able to make more complex decisions
• Surrogates estimate loved one’s preferences
such as whether or not to undergo an additional surgi-
with moderate accuracy. When they choose
cal procedure.
treatment plans that seem to be contrary to a
When assessing whether Mrs. Smith can make the
patient’s preferences, it is more often because
decision about a tracheostomy, her medical team would
of love than malice. Ethics and palliative
want to talk to her when she is most alert and lucid. They
first would want to assess her understanding of her
31
 Section 1. Consent and refusal

end-of-life decision-making. J Am Geriatr Soc,

care consultants can help evaluate apparent
54(11), 1688–93.
discrepancies.
5*  Verkerk, M.A. (2001). The care perspective and
• Disagreement between surrogates about the
autonomy. Med Health Care Philos, 4(3) 289–94.
“best” plan of care happens often. Although
6*  Stewart, A.L., Teno, J., Patrick, D.L., and Lynn, J. (1999).
surrogates are expected to interpret a patient’s
The concept of quality of life of dying persons in the
preferences, they may have trouble putting context of health care. J Pain Symptom Managem, 17(2),
their own preferences aside. Clinicians 93–108.
may need to investigate the reasons for 7*  Shalowitz, D.I., Garrett-Mayer, E., and Wendler, D.
each surrogate’s opinion when there is (2006). The accuracy of surrogate decision makers: a
disagreement and try to refocus the discussion systematic review. Arch Intern Med, 166(5), 493–7.
from each party’s interest to a general 8*  Azoulay, E., Pochard, F., Kentish-Barnes, N., et al.
discussion of the patient’s life and values. (2005). Risk of post-traumatic stress symptoms in
• Decision-making capacity is assessed by family members of intensive care unit patients. Am J
evaluating patients’ abilities to (1) understand Respir Crit Care Med, 171(9), 987–94.
information about their condition and 9*  Anderson, W.G., Arnold, R.M., Angus, D.C., and Bryce,
treatment options; (2) appreciate that the C.L. (2008). Posttraumatic stress and complicated grief
decision at hand will affect them; (3) explain in family members of patients in the intensive care unit.
their reasoning; and (4) arrive at a choice J Gen Intern Med, 23(11), 1871–6.
consistent with their values and beliefs or a 10* Vig, E.K., Starks, H., Taylor, J.S., et al. (2007).
discussion of the patient’s life and values. Surviving surrogate decision-making: what helps
and hampers the experience of making medical
decisions for others. J Gen Intern Med, 22(9),
References 1274–9.
1*  Lautrette, A., Peigne, V., Watts, J., et al. (2008). Surrogate
decision makers for incompetent ICU patients: a Further reading
European perspective. Curr Opin Crit Care, 14(6), 714–19. Beauchamp, T.L. and Childress, J.F. (1994). Principles
2   Cohen-Mansfield, J., Rabinovich, B.A., Lipson, S., of Biomedical Ethics. 4th edn. Oxford, UK: Oxford
et al. (1991). The decision to execute a durable power University Press.
of attorney for health care and preferences regarding Buchanan, A.E. and Brock, D.W. (1990). Deciding for Others:
the utilization of life-sustaining treatments in nursing The Ethics of Surrogate Decision Making. Cambridge,
home residents. Arch Intern Med, 151(2), 289–94. UK: Cambridge University Press.
3   In re Westchester County Medical Center, 72 NY 2d Grisso, T. and Appelbaum, P. S. (1998). Assessing Competence
517 (1988) to Consent to Treatment. A Guide for Physicians and Other
4*  Vig, E.K., Taylor, J.S., Starks, H., et al. (2006). Beyond Health Care Professionals. New York: Oxford University
substituted judgment: how surrogates navigate ­ Press.

32
 Section 1 Consent and refusal
Chapter

5
Informed consent and the pediatric patient
David Clendenin and David B. Waisel

The Case unlikely to have complete decision-making capac-

ity but are able to voice preferences about increas-
During the preanesthetic discussion for resection of
ingly complex questions. Children older than 14 are
­pulmonary metastases of osteosarcoma, the anesthesiologist
advises the 14-year-old boy and his parents that a thoracic considered to have decision-making capacity unless
epidural catheter would be the best way to manage post- proven otherwise.
thoracotomy pain. The anesthesiologist initiates a discussion This chapter will discuss the issues raised by incor-
commensurate to the adolescent’s age, experiences and porating the ethical concept of pediatric patient assent
cognitive ability. The patient immediately refuses the into the traditional process of parental (surrogate)
thoracic epidural stating, “I don’t want a needle in my back informed consent.
while I’m awake.” Despite reassurance by the anesthesiologist
and parents of adequate sedation and analgesia, the patient Competency and decision-making
still refuses. The parents, frustrated, scared and wanting the
best for their child still ask the anesthesiologist to insert the capacity
epidural. In discussing pediatric decision-making, it is
important to distinguish between competency and
The child’s role in medical decision-making ­decision-making capacity. In the US, competency
is a legal status determined by the judicial system
The American Academy of Pediatrics Committee on
and is not determined by clinicians, although the
Bioethics 1995 recommended integration of children
judicial system relies on clinical specialists such as
into the informed consent process1 (Table 5.1), and this
psychiatrists when determining competency. By law,
has been reaffirmed both nationally and internation-
except under specific circumstances, children are
ally.2 Indeed, the ASA has incorporated the principle
not legally competent to authorize medical care for
of pediatric assent into its Guidelines for the Ethical
themselves.
Practice of Anesthesiology (Section I.2):
Distinct from competency, decision-making capac-
Anesthesiologists respect the right of every patient to self-
determination [and] should include patients, including
ity is the ability to make specific decisions at ­specific
minors, in medical decision-making that is appropriate times.a Clinicians determine decision-making capac-
to their developmental capacity and the medical issues ity. Children exhibit ranges of decision-making
involved.3 capacity, depending on age, risks and benefits of the
decision, emotional and cognitive maturity, and tem-
Anesthesiologists should choose to involve children in porary (e.g., sedation) and permanent limitations on
medical decision-making with the ethical objective of cognitive function.
enhancing the child’s self-determination, while keep-
ing the child engaged in their care. Developmental progression of pediatric
Anesthesiologists can use the patient’s age as
a first approximation of a patient’s cognitive and assent
emotional development. Children under the age of For children younger than 7 years old, anesthesiolo-
7 generally do not have decision-making capacity. gists should focus on obtaining parentalb informed per-
Children between ages 7 and 14 years are considered mission or “assent.” (Table 5.1) “Informed permission”

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
33
 Section 1. Consent and refusal

Table 5.1. Elements of consent and assent as defined by the American Academy of Pediatrics Committee on Bioethics

Consent
(1) Adequate provision of information including the nature of the ailment or condition, the nature of the proposed
diagnostic steps or treatment and the probability of their success; the existence and nature of the risks involved;
and the existence, potential benefits, and risks of recommended alternative treatments (including the choice of no
treatment)
(2)  Assessment of the patient’s understanding of the above information
(3)  Assessment, if only tacit, of the capacity of the patient or surrogate to make the necessary decisions
(4) Assurance, insofar as it is possible, that the patient has the freedom to choose among the medial alternatives
without coercion or manipulation
Assent
(1)  Helping the patient achieve a developmentally appropriate awareness of the nature of his or her condition
(2)  Telling the patient what he or she can expect with tests and treatment
(3) Making a clinical assessment of the patient’s understanding of the situation and the factors influencing how he or
she is responding (including whether there is inappropriate pressure to accept testing or therapy)
(4)  Soliciting an expression of the patient’s willingness to accept the proposed care

is used instead of informed “consent” because “con- As children increase in age from 7 to 14 years,
sent” implies that the patient is providing the legal they  are beginning to seek independence and are
consent. The implication of “informed permission” is progressively capable of assimilating, analyzing, and
that, although clinicians nearly always honor paren- using complex information. As a result, anesthesi-
tal decision-making, parental decision-making does ologists should begin seeking both age-appropriate
have boundaries. Physicians honor parental decision- assent and parental informed permission from these
making because they assume that parents desire the children. Age-appropriate assent varies by age and
best for their children, parents have to live with the the complexity of the decision, with particular focus
consequences of that decision, and parental values on the potential risks of the decision. It ranges from
and goals often approximate their child’s future values involving a 7-year-old in determining whether to use
and goals. preoperative premedication, to discussing preop-
Boundaries of parental decision-making are erative intravenous placement with a 10-year-old, to
informed by the “best interests” standard, which seeking assent from a 12-year-old for placement of
requires that parents and clinicians choose their deci- a peripheral nerve block. More important than the
sions from within a range of reasonable options. This specifics is that anesthesiologists make an effort to
standard does not require clinicians to dogmatically integrated children into the decision-making process
insist on what they think is best for the child. However, based on their maturity. As these children approach
if the parents are making a decision that is unacceptably adolescence, they become increasingly able to under-
outside the boundaries of reasonable decision-making stand parental and physician motives. For example,
options, then clinicians are expected to intervene in an a 13-year-old child fearful of an awake intubation
escalating manner as necessary to protect the child.4 may recognize the importance of a sound medical
For example, if the child in the introductory case were decision and assent to the process. Anesthesiologists
9 years old, then it is acceptable, if perhaps suboptimal, who involve children in decisions related to their
for the parents to choose intravenous pain manage- care frequently cite patient autonomy, education and
ment instead of epidural analgesia. If, however, the the protection of a child’s rights as the focus of the
parents wanted to forgo all pain management out of involvement.
fear of exacerbating a known family risk of narcotic Adolescents older than age 14 prioritize inde-
addiction, then that decision would be an unaccept- pendence and have fully developed abstract thought
able treatment option and would require intervention and complex reasoning. Anesthesiologists must
by the anesthesiologist. engage these adolescents in decision-making.

34
 Chapter 5. Informed consent and pediatric patient

However, fully developed cognitive abilities do not Anesthesiologists can minimize the harm of lim-
necessarily translate into good decision-making iting a child’s decision-making authority by overtly
skills. Adolescents do not fully develop impulse con- honoring their authority about more negotiable deci-
trol and consideration for long-term consequences sions. For example, while a 12-year-old girl may not
until their early twenties. For this reason, deci- be permitted to choose whether to have an anterior
sions of significant risk and consequences (such as cruciate ligament reconstruction because of potential
refusal of potentially life-saving transfusion therapy long-term harm, it would be reasonable to permit a
in the child of a Jehovah’s Witness) must undergo healthy adolescent to choose between a peripheral
greater scrutiny and require significant evidence nerve block or intravenous narcotics to provide post-
of ­decision-making capacity. Evidence of decision operative analgesia. The anesthesiologist still should
making capacity includes internally coherent rea- explain to the patient that a nerve block may provide
soning, appreciation of cause and effect, apprecia- superior pain management, but should respect the
tion of the range of outcomes and the effects that patient’s wishes should she choose the alternative.
the different possibilities would have on loved ones, This approach helps balance the sometimes unaligned
and the ability to imagine what circumstances would goals of self-determination and safe and quality care
have to be different for them to choose an alternate for the adolescent.
path. Determining the extent of risk includes con-
sidering the amount of potential harm to the child
by the intervention or its absence, the likelihood of Medical decisions: who ultimately
occurrence for each of the likely outcomes, and the chooses?
overall risk-to-benefit ratio.
Disagreements about the appropriate clinical plan
occur in any combination within the patient–­parent–
Engaging children in decision-making clinician triad. As with all disagreements about
The American Academy of Pediatrics emphasizes that patient care plans, clinicians should focus on con-
“no one should solicit a patient’s views without intend- tinued communication and transparent exchanges
ing to weigh them seriously.”1 Pro forma and insincere among the parties. Divining misunderstandings
engagement of children is easily recognized and brings may resolve disagreements. Unfortunately, clini-
harms to current and future patient-doctor relation- cians tend to avoid patients and family members that
ships. A common mistake is well-intentioned vague- are complicated or are considered to be “difficult.”
ness in explaining options to children, leading the child Avoidance appears to be the easier option, but in the
to choose untenable options. long term, it entrenches opinions and exacerbates
In non-emergent care, anesthesiologists should discord.
honor a child’s refusal of care. Some suggest the abil- When the preferences of the parent and patient
ity to refuse elective procedures begins around the diverge, clinicians should attempt to define the reason
age of 10, although in practice is seems to be older, for the disagreement. Parental and adolescent disagree-
perhaps around age 12.5 Clinicians should explore ment often is rooted in the dynamic of the adolescent
the child’s refusal in the hopes of addressing specific establishing independence from the parent. Clarifying
concern. Short delays, a change of location, changing the merits of the options, offering an objective opin-
into street clothes, or using pediatric mental health ion based on stated values, and improving intra-family
professionals often help address most refusals. Given communication can help resolve these challenging
the harm of ignoring a child’s preferences, clinicians problems.
should disregard pressures to proceed forthwith from When differences persist within the patient–­
operating room administrators, physicians or parents. parent–clinician triad, clinicians may want to consult
Strategies such as using the operating room for other multidisciplinary conflict resolution experts such as
cases may help ameliorate these production pressures. social workers, ethics consultants, and chaplains. The
To minimize the harm of pro forma solicitation of a enhanced communication that often results from third
child’s opinion, children should never be offered ille- party consultation may increase decision-makers’
gitimate choices. Moreover, they should be directly appreciation of the shared interest in the child’s well-
informed when they will undergo procedures despite being. Improved communication may also enable cli-
their objections. nicians to recognize previously unappreciated fears or
35
 Section 1. Consent and refusal

misunderstandings. Legal counsel may be necessary in explain to the parents why it is more important to
the rare instances of impasse. Even when legal inter- honor their child’s requests than to insert a thoracic
vention is necessary, clinicians should continue to seek epidural catheter.
common ground and a functional patient–parent–­
clinician relationship.
Requests for non-disclosure to children
Case resolution Parental non-disclosure requests range from “do not
tell him he is having surgery” to “details will only
In the situation of the 14-year-old with pulmonary
scare him” to “she doesn’t know the diagnosis and
metastases of osteosarcoma, the parents and the
we want to keep it that way.” Thoughtful considera-
patient disagree about whether to have a thoracic
tion of parental nondisclosure requests should serve
epidural catheter placed. This patient’s fear of an
solely the goal of patient benefit. Although dishon-
epidural needle does not obviate the risks of insert-
esty jeopardizes the physician–patient relationship,
ing a thoracic epidural placement in an anesthetized
frightening children for the sake of a principle is often
patient. Exploration of his refusal reveals that his
unwise. A pragmatic approach is to disclose issues
fear is based on “ward gossip’ that getting an epi-
that the child will find out in the imminent future and
dural really hurts, despite what the anesthesiologist
is within the domain of anesthesiology, but to defer
says. Such gossip is formidable. Extensive conversa-
disclosure about issues that would be better served
tions emphasizing the differences among patients
by discussions with other experts. For the most part,
and their situations and the promise to stop if the
children should be told in age-appropriate terms that
procedure became too uncomfortable do not amel-
they are having surgery and anesthesia, but it would
iorate his concerns.
be inappropriate for the anesthesiologist to insist that
Four options present themselves:  (1) insert the
the child be told that he has been diagnosed with can-
thoracic epidural catheter after inducing anesthesia;
cer. Anesthesiologists who believe that information
(2) insert the thoracic epidural catheter after heav-
is being inappropriately withheld from the patient
ily sedating the patient, either surreptitiously or after
should approach the primary physicians to discuss
informing the patient he did not have a choice about
their ethical concerns.
the epidural; (3) insert a lumbar epidural catheter after
inducing anesthesia, although a lumbar epidural may
be less effective; or (4) use intravenous postoperative Emancipated minors and mature
pain management.
The decision rests heavily on the relative benefits minors status
of placing a thoracic epidural. If he would strongly Emancipated minors can legally give informed consent
benefit from the attributes of a functional thoracic for their medical decisions. Emancipated minor status
epidural (such as pain control enhancing pulmonary is determined by state statuted, and varies from state
hygiene in a patient with pulmonary disease or mini- to state, but commonly included determinants are
mizing intravenous narcotics in a patient at risk for pregnancy, marriage, military service, or being self-
apnea), then with appropriate parental informed per- supporting. Mature minor status differs from eman-
mission (consent), it may make sense to risk insert- cipated minor status. Mature minor status is awarded
ing the epidural catheter after inducing anesthesia or by a judge and permits minors to be an autonomous
to inform him that his preference is being overrid- decision-maker for specific decisions (such as refus-
den in his best interest. Lying to the patient might be ing transfusion therapy for the perioperative period).
devastating in a child who will continue to undergo These minors tend to be near the age of consent and
extensive therapy. On the other hand, if the clinically are more likely to be granted mature minor status in
significant benefits of using a thoracic epidural for decisions of lesser risk.
postoperative analgesic are minimal, then the benefits
of not inserting a thoracic epidural catheter outweigh
the risks of inserting the thoracic epidural catheter in Emergency care
an anesthetized, surreptitiously sedated, or coerced Consistent with the idea that nearly all people want
patient. In the example case, it is ethically proper to emergency therapy to preserve life and functional

36
 Chapter 5. Informed consent and pediatric patient

status, emergency treatment should be initiated in Key points

children even if their parents are unavailable to pro-
vide consent.6 This unambiguous presumed consent • Pediatric patients should be integrated into
wilts when unaccompanied adolescents refuse emer- the process of informed consent.
gency care or when adolescents and parents differ in • Competency is a legal term while decision-
their preferences. Honoring an adolescent’s prefer- making capacity is the ability to make a
ences in an emergency medical situation depends specific decision at a specific time.
on the adolescent’s rationale and the extent of poten- • Children exhibit ranges of decision-making
tial harm. If there is considerable risk in honoring capacity, and there is a developmental
the adolescent’s desires and the adolescent cannot progression of the capacity of a child to
exhibit substantial decision-making capacity, then it assent.
is appropriate to supersede the adolescent’s prefer- • Insincere engagement of children is harmful.
ences and use the “best interests” standard. Indeed, • It is important to resolve disagreements
in emergencies, it is rare for an adolescent to dem- among the pediatric patient–parent–physician
onstrate sufficient decision-making capacity to con- triad about the appropriate clinical plan.
vince other decision-makers to override standard • Response to requests for nondisclosure by
medical practices. parents must weigh the goal of the “best
interests” of the patient.
• Emancipated minor and mature minor status
Confidentiality pose distinct ethical and practical issues.
Physicians are obligated to protect patient infor- • Confidentiality must be honored, and failure
mation from unauthorized disclosure. Breeches of to do so may be harmful to the patient.
confidentiality often cause adolescents to eschew
future medical care.7 Clinicians should only consider
breeching confidentially if they believe that main- Notes
taining confidentiality exposes the patient to serious a
 Editor’s note: in the UK, the terms “competency” and “capacity” are
reversed from the US. “Competency” generally refers to functional
risk. If the risk of non-disclosure is not significant,
ability, and “capacity” to legal status.
then clinicians may wish to encourage adolescents to b
 The term “parental” will be used in this chapter to refer to the adult
confide in their parents, but clinicians should respect decision-maker(s) and should be considered inclusive of all other
decisions not to confide. Emancipated and mature adult surrogate decision-makers.
minors have a right to complete confidentiality.
Given the principles of confidentiality, it is nearly
always ethically appropriate to inform only the ado- References
lescent of a positive pregnancy test. Similarly, most 1*  Committee on Bioethics, American Academy of
states have statutes that limit disclosure of a positive Pediatrics. (1995). Informed consent, parental
permission, and assent in pediatric practice. Pediatrics,
pregnancy test only to the adolescent.8 When an ado-
95, 314–17.
lescent has a positive preoperative pregnancy test, the
2*  De Lourdes Levy, M., Larcher, V., and Kurz, R. (2003).
anesthesiologist should seek consultation with experts
Informed consent/assent in children. Statement of
such as pediatricians, gynecologists and social workers
the Ethics Working Group of the Confederation of
as to how best to proceed. Informing parents or other European Specialists in Paediatrics (CESP). Eur J
family members may expose the minor to other serious Pediatr, 162, 629–33.
risks, in part because family incest is not an uncom- 3   Guidelines for the Ethical Practice of Anesthesiology
mon etiology. If the adolescent, anesthesiologist, and (2003). American Society of Anesthesiologists. Park
surgeon were to postpone surgery, and the adolescent Ridge, IL. (last amended 2008) http://www.asahq.org/
chooses not to tell her parents of the pregnancy, then publicationsAndServices/standards/10.pdf.
the physicians must be careful not to inadvertently 4*  Edwards, S. D. (2008). The Ashley treatment: a step too
breech confidentiality when informing the parents far, or not far enough? J Med Ethics, 34, 341–3.
about postponing surgery. (For more on pregnancy 5*  Diekema, D.S. Boldt v. Boldt: a pediatric ethics
testing, see Chapter 14) perspective. (2009). J Clin Ethics, 20, 251–7.

37
 Section 1. Consent and refusal

6   Committee on Pediatric Emergency Medicine. (2003).

Consent for emergency medical services for children
Further reading
and adolescents. Pediatrics, 111, 703–6. Committee on Adolescence, American Academy
of Pediatrics. (1996). The adolescent’s right to
7*  Council on Scientific Affairs, American Medical
confidential care when considering abortion.
Association. (1993). Confidential health services for
Pediatrics, 97, 746–51.
adolescents. JAMA, 269, 1420–4.
8*  American Academy of Pediatrics. Committee on Hagger, L.E. (2004). The Human Rights Act 1998 and
Adolescence. (1998). Counseling the adolescent about medical treatment: time for re-examination. Arch Dis
pregnancy options. Pediatrics, 101, 938–40. Child, 89, 460–3.

38
 Section 1 Consent and refusal
Chapter

6
Do not resuscitate decisions in pediatric
patients
Kelly N. Michelson and Joel E. Frader

The Case indiscriminate use of CPR, particularly with termi-

nally ill patients for whom resuscitations seemed to
A 4-year-old boy with metastatic neuroblastoma undergoes
stem cell transplantation following intensive chemother- provide no benefit and who might experience suffer-
apy and radiation. 17 days post-transplant, with the suc- ing related to CPR. In some circumstances, profes-
cess of anti-cancer treatment and stem cell rescue unclear, sionals began to decide, albeit arbitrarily and without
he develops an acute bowel obstruction. His parents feel input from patients or their loved ones, who should
that, after many months of therapy, especially over the last or should not have CPR. Language such as “show
few weeks, their son should not have to endure “heroic” code,” “Hollywood code,” or “slow code” emerged to
treatment. They do not want him to have cardiopulmonary describe sham resuscitations when healthcare pro-
resuscitation (CPR) and the oncologists have agreed to a viders chose not to make serious efforts to revive
“do not resuscitate” (DNR) order, given the boy’s overall patients.
poor prognosis. The parents would like him to have pallia-
In 1974, the American Medical Association (AMA)
tive surgery to relieve the bowel obstruction. The anesthesi-
described CPR as a procedure meant to prevent sud-
ologists and surgeons request suspension of the DNR order
for the surgery. The parents do not understand why it is den, unexpected death that has no valid use in patients
acceptable to forgo resuscitation on the oncology unit, but with terminal, irreversible illnesses. They stated,
not in the operating room. “Resuscitation in these circumstances may represent
a positive violation of an individual’s right to die with
Attempts to resuscitate a person from an apparently dignity,” and proposed that actual orders be written in
“lifeless” state date back to at least biblical times: the patient’s chart when a physician determines that
When Elisha came into the house, he saw the child lying CPR is not indicated.3 In response, hospitals developed
dead on his bed. So he went in and closed the door on specific DNR order policies.
the two of them, and prayed to the Lord. Then he got up
Arguments about the patients’ right to self-
on the bed and lay upon the child, putting his mouth
­determination ensued. Some felt practitioners should
upon his mouth, his eyes upon his eyes, and his hands
upon his hands; and while he lay bent over him, the flesh assume that all patients prefer resuscitation unless
of the child became warm.(2 Kings 4:32–34)1 they or their valid surrogates have clearly stated oth-
erwise. Others argued for only offering CPR when
In 1878, Boehm described closed chest cardiac massage “medically indicated.” A 1983 report of the President’s
in cats, the basis for current CPR. The first successful Commission for the Study of Ethical Problems in
resuscitation in humans using CPR, reported in 1960, Medicine and Biomedical and Behavioral established
involved five patients who experienced in-­hospital a standard whereby consent for CPR was presumed
­cardiac arrests.2 unless specifically withdrawn following discussion
The use of CPR spread and in 1966 the National between the patient or surrogate and the involved
Academy of Sciences’ National Research Council physicians.4
recommended all health care providers obtain CPR
training. CPR became a nearly ubiquitous final
procedure for all hospitalized patients experienc- Terminology
ing cardiopulmonary arrest, regardless of circum- The original term, DNR, persists at many institu-
stances. Later, healthcare providers questioned the tions. Some institutions use “DNAR” (“do not attempt

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
39
 Section 1. Consent and refusal

resuscitation”), arguing it better recognizes that CPR adolescents have some capacity to make, or assist in
often does not succeed. Recently, some have advo- making medical decisions. The American Academy
cated using “AND” (allow natural death) noting that of Pediatrics recommends that the pediatric patients
it focuses attention on improving the dying process, contribute to decisions to the extent of their ability.6
rather than on withdrawing therapies. (More in-depth discussions of pediatric informed
Simple DNR orders do not convey information consent and the rights of minors can be found in
about a patient’s goals for care and views about life- Chapter 5)
­prolonging technology. Resuscitation goals do not
always fit into a “yes” or “no” response. Patients may DNR in the OR
prefer to make specific decisions about multiple thera-
The Federal Patient Self-Determination Act of 1990
pies, including intubation, vasoactive medication,
requires hospitals and healthcare organizations
defibrillation, chest compression, antibiotics, and lab-
to advise patients during every admission of their
oratory testing. A patient might want intubation in the
right to create advance directives and to inquire if
event of respiratory decompensation, for example, but
the patient has completed one. The law refocused
prefer not to undergo chest compression or defibrilla-
attention on limits of resuscitation and intensive
tion for cardiac arrest. Which interventions make sense
care. Professionals noticed that many advance direc-
depends on patient/surrogate goals and the specifics of
tives provided inadequate clarity and specificity for
the clinical situation.
clinical decision-making. Ambiguities included
whether limits on resuscitation applied in the oper-
DNR orders in adults vs. children ating room. Even at end-of-life, surgical interven-
In the US competent adults have the legal right to tions may be undertaken to ease continuing care
refuse unwanted medical therapies, provided they (e.g.  placement of tracheostomy or gastrostomy
understand the consequences of refusal. A compe- tubes or ports for IV medications), or to surgically
tent adult can refuse therapies based on: (1) religious palliate acute problems (e.g., relief of pain from a
or moral views, (2) views about what constitutes a pathologic fracture or nerve root interruption to
good quality of life, or (3) a determination that a par- prevent pain transmission).
ticular therapy is inappropriate for medical or other Many surgeons and anesthesiologists argue that
reasons. Often adults lack decision-making capacity providing general anesthesia is similar to providing
at the time when a decision is required. Anticipating continuous resuscitation. During surgery patients are
such a possibility, some adults have written or oral under continuous close observation that differs fun-
instructions, known as “advance directives,” that damentally from care outside the OR. Most patients
communicate their wishes should they lose deci- dying on hospital units die from causes directly
sional capacity. Alternatively, adults may identify a related to their underlying conditions, such as cancer,
decision-maker and confer on them a “durable power congestive heart failure, and degenerative neurologi-
of attorney for healthcare decisions” for situations cal disease. By contrast, in the OR cardiopulmonary
when the patient cannot make or communicate their collapse can occur as a direct result of anesthesia or
own decisions about care. The law generally expects surgical manipulation (e.g. hemorrhage). Moreover,
alternative decision-makers to choose based on what resuscitative efforts under the well-monitored and
the patient would have wanted. This is called substi- expectant conditions of the OR have higher success
tuted judgment. in returning patients to their baseline functioning
Pediatric patients often lack the capacity to make than do resuscitations outside the OR. Finally, some
medical decisions, either because of their neuro­ argue that the OR provides a poor environment for
developmental status or their medical conditions. end-of-life care. OR personnel typically do not deal
Principles of law and ethics rely on parents to make with terminal situations and the OR has no readily
medical decisions on behalf of their children, based available space to accommodate grieving families
on the best interest of the child.5 The best interest and clergy.7
standard requires that the decision-maker deter- In the early 1990s, institutional policies honor-
mine the net benefit for the patient of each option, ing patients’ or surrogates’ DNR wishes, as reflected
and the appropriate course of action is the one with in physicians’ orders, typically permitted automatic
the greatest overall patient benefit. Older children or suspension of DNR orders for surgical procedures
40
 Chapter 6. DNR decisions in pediatric patients

and during the immediate post-operative period. hypoxemia, hemorrhage, arrhythmia, etc.) differ
Such policies did not sufficiently reflect respect for fundamentally from events that may happen else-
patients’ autonomy. Over time, there has been more where. The assumption is that iatrogenic death, or
general acknowledgment of the rights of patients and near death, deserves a different response from other
their valid surrogates to authorize or reject available events. This claim has some merit in that instabil-
treatments, particularly at emotionally and reli- ity in the OR is often easily reversed with a small
giously sensitive periods, such as the end of life.8 A likelihood of major adverse effects. But it does not
shift occurred from paternalistic ­physician-centered explain why one would not have a similar responsi-
decisions, to shared decision-making between bility to attempt to reverse all potentially fatal events
patients or surrogates, and healthcare profession- that could be “blamed” on medical interventions.
als. Mirroring guidelines from the American Society For example, a patient may experience cardiac arrest
of Anesthesiologists, the American College of as a result of severe sepsis, a known complication in
Surgeons, and the Association of OR Nurses, some immunocompromised patients who have received
hospitals have adopted “required reconsideration,” anti-neoplastic agents. Few would insist on revers-
whereby a review of existing directives limiting ing DNR orders for every event whose etiology
treatments occurs before a procedure is undertaken. could possibly be traced to a medical intervention.
Discussion of perioperative DNR orders should A patient, parent, or other surrogate might well ask
involve the patient or surrogates, the anesthesiolo- why acceptance of death in one circumstance (on the
gist, the surgeon, and other professionals involved nursing unit) should not apply in the OR, especially
in the patient’s care.9 It should include the following in a setting where the patient is mercifully uncon-
points: scious and will likely not suffer. The temporal and
(1)  Careful review of the goals of the procedure(s); causal relationship between anesthetic delivery or
(2)  Discussion of the meaning of the treatment limits surgery and death may well affect how physicians
and how proscriptions on interventions might and surgeons feel about what happens, but does not
compromise or complicate the anesthetic and/or necessarily make an important moral or psychologi-
the operation; cal difference to the patient or loved-one who accepts
(3)  Discussion of the likelihood of successful the inevitability of the patient’s death.
reversal of any anesthesia- or surgery-related This points to potential conflicts in the goals of care
complication; for patients and loved-ones, versus those of the pro-
fessionals. All parties need to clarify these goals and
(4)  Agreement on what, if any, limits on resuscitation
develop practical guides that all parties can accept.
will remain during the procedure;
In many cases, everyone will agree on preserving life
(5)  Establishment of time boundaries for reinstituting
if temporary instability develops in the OR, so that
the DNR orders if they are suspended;
remaining expected weeks or months pass with greater
(6)  Assurance that suspension of treatment comfort or even function. In others, patients or sur-
limitations will not inhibit sound decision- rogates may feel that some measures, such as chest
making – including a decision to withdraw life compressions, electroshock, or even mechanical ven-
support – should the patient’s evolving condition tilation beyond the surgical suite or recovery room
alter the expected clinical course. imply a level of personal invasion or indignity which
The anesthesiologist and/or surgeon should provide is unacceptable, given the patient’s overall condition
clear and comprehensive documentation of the agree- and prognosis. In those cases, there are few ethical
ment in the medical record and ensure that all those arguments that support the idea that the preference of
involved with the proposed surgery understand and anesthesiologists or surgeons for life extension should
accept the agreement. simply override the feelings and beliefs of patients and
family members.
Is the cause of cardiac arrest relevant?
Reluctance of OR personnel to accept DNR orders Case resolution
rests to a great extent on the notion that actions by The fact that the bowel obstruction occurs so soon after
surgeons or anesthesiologists which cause or appear transplantation makes this case especially problem-
to cause life-threatening events (e.g. hypotension, atic, because there is likely little reliable information
41
 Section 1. Consent and refusal

regarding prognosis. Decision making with such all patients, particularly those with terminal
uncertainty makes physicians uncomfortable. The illness and otherwise dismal prognosis.
oncologists may well favor “aggressive” treatment,
• The patient’s/surrogates’ goals should
hoping the patient will remain free of neuroblastoma
determine the appropriateness of
and have marrow recovery. The surgeons and anesthe-
resuscitative interventions in and outside of
siologists, also hoping for a good medical outcome,
the OR.
may view relief of bowel obstruction as relatively
• Pediatric patients may or may not have the
simple and limits on trying to sustain the boy’s life as
capacity to participate in medical decision-
wrongheaded.
making, depending on age and medical
The child’s parents see this picture quite differently.
condition. They should be involved in
Their son has already endured the rigors of initial can-
decision-making to the degree they are
cer surgery and chemotherapy that failed to eliminate
capable. In general, parents function as
the disease. He has also experienced considerable dis-
surrogate decision-makers, acting in the
comfort and distress related to “conditioning” prior
overall “best interest” of the child.
to the stem cell transplant, felt the difficulties of post-
transplant, pre-engraftment treatment, and faces a very • Automatic suspension of DNR orders in the
uncertain outcome. Bowel obstruction represents “one setting of anesthesia and surgery does not
more blow” and while they accept an attempt at sur- sufficiently recognize patients’ rights to self-
gical correction, they feel “heroic” attempts to revive determination.
him from a cardiac arrest in the OR would only impose • DNR orders in pediatric patients undergoing
additional burdens on their son and on them. anesthesia and surgery, as in adults, should
Extensive conversations between professionals and undergo “required reconsideration” in
parents may or may not overcome their concerns about which the involved parties review treatment
cardio-pulmonary arrest and CPR. They may accept limitations in light of their benefits and risks,
a time-limited reversal of a standing DNR order. Or and agree upon and document changes in
they may persist in their view that CPR and mechani- orders, if any.
cal ventilation beyond the OR represent unacceptable • When patients or their surrogate decision-
invasiveness, given the boy’s overall prognosis. Should makers, such as parents, do not wish to
they refuse to accept a temporary suspension of the suspend DNR orders in the setting of surgery,
DNR order, few ethical theories could justify ignoring few ethical arguments support ignoring their
their wishes. wishes.
A somewhat thornier ethical issue concerns
whether professionals have an obligation to proceed References
with surgery if they voice “conscientious objection” to 1   The Holy Bible. The New Revised Standard Version.
providing care without authorization to resuscitate. In (1989). New York: Oxford University Press.
the absence of finding substitute physicians who could 2   Kouenhoven, W.B., Jude, J.R, and Knickerbocker, G.G.
willingly respect the parents’ wishes, simply refusing to (1960). Closed-chest cardiac massage. JAMA, 173,
give the anesthetic may be regarded as “abandoning” 1064–7.
the patient and/or exerting coercive power over the 3*  Standards for cardiopulmonary resuscitation (CPR) and
patient/surrogates. Such willful expressions of power emergency cardiac care (ECC). (1974). JAMA, 227(7),
over patients raise questions about what it means to Suppl:837–68.
accept the mantle of “professional” as one who puts 4*  Burns, J.P., Edwards, J., Johnson, J., et al. (2003). Do-not-
the interests of patients ahead of self-regarding con- resuscitate order after 25 years. Crit Care Med, 31(5),
siderations. (For more on physician conscientious 1543–50.
objection see Chapter 43.) 5*  American Academy of Pediatrics Committee on
Bioethics. (1994). Guidelines on foregoing life-
sustaining medical treatment. Pediatrics, 93(3),
Key points 532–6.
• DNR orders developed in response to the 6*  Committee on Bioethics, American Academy of
realization that CPR is not appropriate for Pediatrics. (1995). Informed consent, parental

42
 Chapter 6. DNR decisions in pediatric patients

permission, and assent in pediatric practice. Pediatrics, 8*  Waisel, D.B., Burns, J.P., Johnson, J.A., et al. (2002).
95(2), 314–17. Guidelines for perioperative do-not-resuscitate policies.
7*  Ewanchuk, M. and Brindley, P.G. (2006). J Clin Anesth, 14(6), 467–73.
Perioperative do-not-resuscitate orders – doing 9*  Fallat, M.E. and Deshpande, J.K. (2004). Do-not-
‘nothing’ when ‘something’ can be done. Crit Care, resuscitate orders for pediatric patients who require
10(4), 219. anesthesia and surgery. Pediatrics, 114(6),1686–92.

43
 Section 1 Consent and refusal
Chapter

7
Consent in laboring patients
Joanna M. Davies

Case 1 fully informed consent from them.1 Seventy percent

­considered active labor a barrier to the ability of a
Sarah is a 32-year-old, gravida 1, para 0 in active labor at
woman to give consent. However, a Society of Obstetric
4 cm cervical dilatation. She is experiencing considerable
pain and requests an epidural for analgesia. However, as
Anesthesia and Perinatology Anesthesiologists (SOAP)
the anesthesiologist arrives, the patient’s husband, Tom, is survey, published the same year (2006), found that 68%
telling the nurse that, prior to labor, his wife specifically told of 448 anesthesiologists thought that women in active
him that she did not want an epidural for pain, even if she labor are able to give informed consent.2 Scott has gone
begged for one, and he should not let her change her mind. so far as to say “the only time when consent to an epi-
This information is also written in her birth plan. Sarah is dural to relieve the pain of labor is truly informed is in
now screaming with each contraction and, despite receiving labor itself … when the person concerned knows what
a total of 150 mcg of intravenous fentanyl, is adamant that the pain is like.”3
she wants an epidural “now.” Several studies of the patient’s perspective of
Principle-based medical ethics focuses on the four informed consent during labor show that the pain of
concepts of autonomy, beneficence, nonmaleficence labor does not appear to interfere with the patient’s
and justice. Over time, there has been movement from ability to hear and comprehend the information rel-
the beneficence driven paternalism of “doctor knows evant to consent.4 Furthermore, a woman’s ability to
best” towards increasing patient autonomy. Authentic understand epidural risks does not correlate with level
patient autonomy requires that the patients make their of labor pain, anxiety, duration of pain, opioid medi-
own decisions after they have received all of the rele- cation, previous epidural experience or the desire for
vant information pertinent to their situation and are an epidural.5 In fact, the ability to recall the risks has
therefore fully informed. Informed consent requires been found to be similar in both laboring and non-
several elements: (1) capacity of the patient to make a laboring, nonobstetric patients.6 Ideally, written or
decision, (2) freedom or voluntariness of the patient in visual information about labor analgesia should be
decision-making, (3) disclosure of adequate informa- provided or at least available during prenatal visits
tion to the patient, (4) understanding of that informa- to the obstetrician’s office in the antenatal period or
tion by the patient, and (5) consent by the patient to during early labor allowing time for consideration of
the procedure. Ensuring that these elements have been the available options and any questions.
addressed and obtaining consent for procedures in Is Sarah’s consent impeded by the fentanyl she has
laboring patients can be extremely challenging. received? In general the answer is poorly addressed in
the literature. There are no US legal precedents regard-
ing this issue and most institutions have inconsistent
Can informed consent be obtained during policies. Anesthesiologists can and do routinely make
the pain of labor? judgments about a patient’s capacity for informed con-
There are conflicting views on whether informed sent based on the elements described above. There is
consent is even possible during active labor. Black normally no need to contact a psychiatrist or obtain
and Cyna, analyzed responses from 291 anesthesi- legal advice. Sarah must have the mental capacity to
ologists surveyed about the risks they discussed with comprehend and participate in the consent process
laboring patients, and whether it was possible to gain and analgesia may allow her to do this. Withholding

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
44
 Chapter 7. Consent in laboring patients

appropriate analgesia, particularly if there is a delay in rather than the ethical debate that cause anesthesi-
the anesthesiologist obtaining consent, may in itself ologists the most concern. As a woman with capac-
put the anesthesiologist in an unsupportable ethical ity, Sarah can legally overrule her birth plan at any
position. point. However, there is a risk after delivery, when
the pain is long gone, that Sarah might feel she some-
Ulysses directives how “failed” during the birthing process by agree-
ing to have an epidural and see the anesthesiologist
At this stage in her care, the literature supports that
as an accomplice in this failure. This could result in
Sarah, despite being in severe pain and having received
an accusation of assault, or unconsented touching of
fentanyl, should be able to provide fully informed con-
the patient.
sent for epidural placement. However, an additional
The anesthesiologist should be encouraged to see
ethical dilemma has developed. Sarah’s husband, Tom,
the patient and her family postpartum. At that time the
is insistent that Sarah does not really want an epidural
anesthesiologist can discuss the events and reassure
and produces a written birthing plan which includes
the patient that her decision was the correct one for
a statement that Sarah does not want to be permitted
the circumstances in which she found herself. It may
to deviate from this plan or her wishes concerning
help to inform the patient that relief of pain and stress
an epidural. Such a document is known as a “Ulysses
during labor has benefits for the fetus and the course of
directive” and brings into conflict the anesthesiolo-
labor. It is also wise to document the ­decision-making
gist’s beneficent desire to provide Sarah with analgesia,
process that occurred. An example chart note might
and the wish to respect Sarah’s autonomous decision to
read:
have a “natural” delivery.
After an appropriate consent process, the patient has
However, autonomous decision-making brings
decided to withdraw her previous refusal of epidural
with it the privilege for a woman to change her analgesia for labor. I will proceed based on her currently
mind, especially if she has never experienced the stated request for epidural analgesia.
pain of childbirth before. One might argue that
Sarah’s directive be considered invalid because it was In this particular case the ethical tension was resolved
made at a time when the she was not fully informed. when the anesthesiologist conducted a patient and
Antenatally, she may have been determined not to lengthy discussion with both Tom and Sarah. They
have an epidural. However, she may not have received agreed that they may not have appreciated how painful
appropriate information regarding the risks and the labor would be, that an epidural would allow Sarah
benefits of epidurals, nor had she experienced labor to enjoy the birth more, and that perhaps they had been
pain previously. Information and valid experience naïve in her inexperience to completely refuse to con-
are critical prerequisites for autonomous decision- sider all of her analgesic options.
­making. While Scott considers it unethical “to with-
hold pain relief from a greatly distressed woman …
solely because of a statement written in her birth How much information is enough?
plan..”, Thornton and Moore have argued that this How much information is too much and how long
“… does not respect her long-term preferences”, and a discussion is too long during the throws of active
hence her autonomy.”7 Other authors have even pos- labor? The amount of information given to Sarah
tulated that the duty of beneficence (in this case to regarding the risks and benefits of an epidural needs
relieve pain) may allow an intervention to proceed to be balanced against her level of pain and urgency
in the absence of informed consent until evidence of to proceed. If possible, discussions should be held
patient refusal is forthcoming.8 In this instance there between contractions when the woman can focus on
is no unequivocal ethical ground upon which to stand what she is being told. It is prudent to have this con-
and it has been suggested that the anesthesiologist be versation with the patient’s support person present.
guided by the circumstances.9 Tom, in this case, will be able to ask questions and
Sarah is a primiparous woman at 4 cm cervi- witness that the information has been provided.
cal dilatation and is likely to be in labor for many Every anesthesiologist has their own routine when
more hours. Placing an epidural for analgesia is cer- providing information to a patient during the con-
tainly an ethically defensible decision in this case. sent process. Brooks and Sullivan have aided the
Interestingly, frequently it is the legal ramifications practitioner by developing a list of recommended
45
 Section 1. Consent and refusal

issues that should be discussed with the patient.10 In every instance the cases were found in favor of the
This list includes: defending anesthesiologist because the courts felt there
(1)  benefits of the epidural to the mother, i.e., was not only evidence of “reasonable” information hav-
excellent pain relief; ing been provided to the patients but also, the patients
(2)  potential beneficial effects of an epidural on the had not objected to, and in fact, had actively cooper-
baby and labor; ated with the procedure.12
(3)  risks of epidurals, such as epidural failure, side
effects, and rare but serious risks; Case 2: Refusal to consent to
(4)  information relevant to the individual patient, e.g.,
the effect of an epidural on preexisting medical treatment
conditions she may already have, e.g., chronic back Fatima is a non-English speaking, 19-year-old, gravida
pain or neurological disease; 2, para 1, Somalian Muslim married to 40-year-old
(5)  alternatives for analgesia and any further Mohammed. It is 3:00 am. Because of the hour there is no
formal Somali interpreter available so Mohammed has
information requested by the patient.
been providing interpretation. Fatima has been in labor
for more than 20 hours with slow progress. She is at 9 cm
cervical dilatation and the fetus is showing signs of distress
Which risks should be disclosed? with severe variable heart rate decelerations into the 60s.
The obstetricians want to perform an urgent cesarean sec-
As is frequently the case, Sarah does not wish to hear a
tion but Mohammed is refusing, despite being told that the
lot of details about the procedure and urges the anesthe-
baby could die if surgery is delayed. In spite of his refusal
siologist to “just get on with it.” While being flexible for surgery Fatima continues to say that she wants her baby
in the approach to providing information under these to be delivered safely. There is concern that Mohammed is
conditions, it is imperative that the anesthesiologist not giving his wife the correct information or providing the
cover the risks of the procedure. There is no univer- practitioners with an adequate representation of Fatima’s
sal standard of care when disclosing risks associated wishes.
with an epidural to obtain informed consent, although
Frequently, such dilemmas are resolved by further dis-
different rules have been proposed. Several studies
cussion regarding the risks and benefits of the Cesarean
have found that the majority of women want to hear
section, understanding the fears of surgery that the
all the risks associated with regional anesthesia, par-
patient brings to the table, and gentle persuasion as to
ticularly those that occur commonly but are less severe,
the best course of action to gain the consent of the hus-
and those which are rare but could be serious or life-
band to proceed. However, that is not always the result.
threatening.11
There are several ethical issues that must be considered
in this situation. The first is that of “maternal–fetal con-
flict,” also discussed in Chapter 8, under “CDMR from
Should informed consent be written or the Fetus’s Perspective.”
verbal?
There is no consensus about whether it is better to have
patients sign consents or, simply verbally consent: both Maternal–fetal conflict
are ethically and legally acceptable in many states. This case demonstrates how two fundamental ethical
Documentation of this discussion can include either a principles, autonomy and beneficence, can come into
separate anesthesia consent form signed by the patient conflict. A competent pregnant woman such as Fatima,
or a detailed note in the patient’s chart verifying verbal has the autonomous right to refuse medical interven-
consent. tion, even if that decision may adversely affect her fetus.
This can be distressing to the obstetrician who is advis-
Is informed consent during labor a liability ing a cesarean section in accordance with the ethical
principle of beneficence to ensure the best outcome for
issue? both Fatima and her baby.
Knapp examined three legal cases that addressed the Some physicians may feel that the obvious solu-
issue of adequacy of informed consent during labor. tion in this case would be to obtain a court order to

46
 Chapter 7. Consent in laboring patients

perform the cesarean section and save Fatima’s baby. It there is no guarantee that she has not been influ-
has long been debated as to whether the fetus should enced by others. In this case, while respecting the
be considered as a patient, with its own rights, sepa- cultural and religious basis upon which Mohammed
rate from the mother. This stance does consider the is operating – and thereby potentially manipulating
fact that the fetus is dependent on the mother for its Fatima’s care – we also want Fatima to understand
existence. While delivery of the fetus may respect the the situation, so that she could at least discuss it with
right to life of the fetus, it compromises Fatima’s right her husband.
to autonomy. There some is concern that critical information
There has been much discussion in the literature is not being conveyed accurately to Fatima. Muslim
regarding forced medical intervention and its possi- women are allowed to voice their opinion but, like any-
ble justification in certain situations. The American one, they need all the facts before making their deci-
College of Obstetricians and Gynecologists (ACOG) sion. The absence of an interpreter is a problem. One
has provided clear guidance on this, stating that in solution is to use a telephone interpreter service, to
cases of maternal refusal of treatment for the sake which many hospitals subscribe. Such services provide
of the fetus, “court-ordered intervention against access to most languages at any time of day. This serv-
the wishes of a pregnant woman is rarely, if ever ice was unfortunately not available on that particular
acceptable.”13 The American Medical Association night. Interpreter help in urgent situations can also be
(AMA) considers forced intervention to be sought from hospital employees, religious community
­counter-productive, stating that “women may with- members, or relatives of the patients who might be
hold information from the physician … Or they may reachable by phone.
reject medical or prenatal care altogether.”14 A com- Ultimately, Mohammed and Fatima stood by their
pounding issue is whether the obstetrician’s progno- decision, despite prolonged discussions with the obste-
sis regarding the fetal outcome without intervention tricians. Fatima’s baby was still-born several hours later.
is correct. There have been cases where the woman Although distressed by their loss, they were comforted
has refused emergency cesarean section on religious by their belief that this was Allah’s will. The obstetri-
grounds, only to deliver a healthy baby vaginally.15 cians were devastated.
When court orders have been sought in the US, dif- Could this case have been managed differently?
ferent states and judges have come to different judg- Ethically, the obstetricians behaved correctly by
ments in these difficult cases. The risk to the primary respecting Mohammed’s autonomous decision
patient, the mother, may often decide these cases. to refuse a cesarean section for Fatima. There will
Specifically, there is a foreseeable risk for a mother always be concerns that Fatima was not given all the
with a complete placenta previa, not just a threat to facts about the fetal condition and may have been
her undelivered fetus. able to persuade her husband to allow a Cesarean
delivery.
Ethical considerations are of primary importance
Cultural and religious beliefs in cases such as these, but there are also legal issues
that need to be considered and managed. Whenever a
Some cultures and religions place constraints on
patient refuses medical care, the American College of
medical care. Physicians must have respect for differ-
Obstetricians and Gyencologists suggest that following
ent belief systems and work with laboring patients to
information should be documented:16
achieve the best outcome for both mother and baby.
In Western culture, Fatima’s autonomy regard- (1) The patient’s refusal to consent to a medical
ing her medical care is paramount and we would treatment, surgical procedure, or diagnostic test
expect her to decide whether she is willing to con- (2) Confirmation that the need for this treatment,
sent to a Cesarean section only after receiving all procedure, or test has been explained
the pertinent information. According to the Islamic (3) The reasons stated by the patient for refusal of
faith, Mohammed has the right to make decisions treatment
for his wife. This is seen as a positive, caring aspect (4) Confirmation that the consequences of the
of their marriage. Personal autonomy is not consid- refusal, including possible jeopardy to health or
ered important. Even if Fatima is asked her decision, life, have been described to the patient.

47
 Section 1. Consent and refusal

anesthesiologists from the United States. IJOA, 15,

Key points 98–103.
• Although many anesthesiologists believe 3*  Scott, W.E. (1996). Ethics in obstetric anaesthesia.
that laboring women may not be able Anaesthesia, 51, 717–18.
to give informed consent, most studies 4*  Pattee, C., Ballantyne, M. and Milne, B. (1997).
indicate that laboring women are similarly Epidural analgesia for labour and delivery: informed
capable to nonlaboring patients of hearing consent issues. Can J Anaesth, 44, 918–23.
and remembering the risks involved and 5*  Jackson, A., Henry, R., Avery, N., et al. (2000). Informed
consenting to treatment. consent for labour epidurals: what labouring women
want to know. Can J Anaesth, 47, 1068–73.
• The informed consent process in laboring
patients has requirements to disclose risks, 6*  Affleck, P.J., Waisel, D.B., Cusick, J.M., et al. (1998).
Recall of risks following labor epidural analgesia. J Clin
benefits, and alternatives to anesthesia care
Anesth, 10, 141–4.
that are similar to that in nonlaboring patients.
7*  Brooks, H. and Sullivan, W.J. (2002). The importance of
• Ulysses directives – advance directives
patient autonomy at birth. IJOA, 11, 196–203.
that include irrevocable instructions – are
8*  Hoehner, P.J. (2003). Ethical aspects of informed
sometimes included in birth plans, but are
consent in obstetric anesthesia – new challenges and
ethically problematic in laboring women solutions. J Clin Anesth, 15, 587–600.
who retain personal autonomy during labor.
9   Brooks, H. and Sullivan, W.J. (2002). The importance of
Women have the right to change plans and patient autonomy at birth. IJOA, 11, 196–203.
may do so in light of valid new experience.
10  Brooks, H. and Sullivan, W.J. (2002). The importance of
It is questionable whether such directives patient autonomy at birth. IJOA, 11, 196–203.
are ethically or legally binding in most cases.
11  Jackson, A., Henry, R., Avery, N., et al. (2000).
Deviation from Ulysses directives requires Informed consent for labour epidurals: what labouring
appropriate discussion and documentation. women want to know. Can J Anaesth, 47, 1068–73.
• Every labor carries the risk of maternal–fetal 12* Knapp, R.M. (1990). Legal view of informed consent
conflicts. ACOG and AMA guidelines for anesthesia during labor. Anesthesiology, 72, 211.
discourage forced intervention in all but rare 13* Patient choice in the maternal–fetal relationship. In
cases, and recognize that respect for maternal Ethics in Obstetrics and Gynecology. 2nd edn. (2004).
autonomy is usually the dominant ethical Washington, DC: American College of Obstetricians
principle to follow. and Gynecologists, pp. 34–6.
• Cultural and religious beliefs may complicate 14  Hoehner, P.J. (2003). Ethical aspects of informed
care of the laboring patient and require consent in obstetric anesthesia – new challenges and
consideration in managing ethical conflicts. solutions. J Clin Anesth, 15, 587–600.
• When a laboring woman refuses critical 15* Weiniger, C.F., Elchalal, U., Sprung, C.L., et al. (2006).
intervention, all efforts should be made to Holy consent – a dilemma for medical staff when
inform her of the risks and benefits of refusal maternal consent is withheld for emergency caesarean
section. IJOA, 15, 145–8.
of treatment, including the use of interpreter
services if needed to a conduct careful and 16* Informed refusal. In Ethics in Obstetrics and
Gynecology. 2nd edn. Washington, DC: American
complete discussion.
College of Obstetricians and Gynecologists, pp.
105–6.
References
1  Black, J. and Cyna, A.M. (2006). Issues of consent Further reading
for regional analgesia in labour: a survey of obstetric Beauchamp, T.L. and Childress, J.F. (2001). Principles
anaesthetists. Anaesth Intens Care, 34, 254–60. of Biomedical Ethics, 5th edn. Oxford, UK: Oxford
2  Saunders, T.A., Stein, D.J. and Dilger, J.P. (2006). University Press Inc.
Informed consent for labor epidurals: a survey of Walton, S. (2003). Birth plans and fallacy of the Ulysses
Society for Obstetric Anesthesia and Perinatology directive, I5OA, 12, 138–45.

48
 Section 1 Consent and refusal
Chapter

8
Maternal–fetal conflicts: Cesarean
delivery on maternal request
Ruth Landau and Steve Yentis

The Case previous Cesarean delivery, a decline in vaginal breech

deliveries, and a reluctance among many obstetricians
Jane and Jim, successful lawyers in their mid-forties, are
expecting their first child. Immediately after they learned
to “risk” a vaginal delivery when labor is not straight-
that their 4th in-vitro fertilization attempt was successful, forward. The number of Cesarean deliveries at maternal
they decided to request a Cesarean delivery. At 36 weeks, request (CDMR) – i.e., in the absence of any medical or
Jane and Jim confirm again their desire to have a ‘maternal obstetrical indications – has been increasing, account-
request’ Cesarean section and ask for the Cesarean delivery ing for 48–18% of all Cesarean deliveries.1 An inde-
to be performed the following week at 37 weeks’ gestation to pendent panel of the National Institute of Child Health
accommodate Jim’s busy agenda. In addition, Jane is adam- and Human Development and the Office of Medical
ant she wants to have a general anesthetic due to her fear Applications of Research of the National Institutes of
of experiencing any kind of discomfort or pain during the Health (NIH) reviewed CDMR in 20062 and drew the
Cesarean section. following conclusions.
Until recently, debate around the indications for and (1)  The incidence of cesarean delivery without
choice of Cesarean section have focused on rights of medical or obstetrical indications is increasing in
women to refuse a Cesarean section when urgent deliv- the US, one component of which is CDMR.
ery is medically indicated. In terms of the “principlism” (2)  There is insufficient evidence to fully evaluate
(four principles) approach to ethical analysis, this the benefits and risks of CDMR compared to
debate has highlighted the balance between the obliga- planned vaginal delivery. More research is
tions of the obstetrician to both the mother and fetus needed.
and obligations of the mother to the fetus, based on ben- (3)  Until evidence becomes available, the decision
eficence and non-maleficence, and the duty to respect the to perform CDMR should be individualized and
mother’s autonomy. Legally, many courts recognize an consistent with ethical principles.
absolute right of women with capacity to refuse medical (4)  The risks of placenta previa and accreta rise
treatment even when that decision may result in their with each Cesarean delivery, and CDMR is
death or the death of their baby. Doctors have duties to not recommended for women desiring several
respect a woman’s autonomy and obligations to inform children.
fully, counsel honestly, and avoid coercion.
(5)  CDMR should not be performed before 39 weeks’
Recently, a new phenomenon has emerged in which
gestation or without verification of lung maturity
patients demand a cesarean section. More women are
because of the significant danger of neonatal
switching their birth plan from a “natural childbirth/no
respiratory complications.
epidural” perspective towards a more “controlled”, med-
(6)  Unavailability of effective labor pain options should
icalized or surgical childbirth. What ethical implications
not influence the decision to perform CDMR.
does this growing phenomenon have for clinicians?
Ethical considerations for CDMR go beyond the
Cesarean section upon maternal request principles of respect for autonomy and beneficence/
Cesarean section rates are rising in developed coun- non-maleficence. They include issues of resource
tries. Reasons include a decline in vaginal births after allocation and the impact of CDMR on healthcare

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
49
 Section 1. Consent and refusal

costs (i.e., the principle of justice) as well as ideal- most common motivations cited by women request-
istic and philosophical reflections on future soci- ing CDMR.4
etal implications if Cesarean deliveries become the Autonomy of decision-making implies that the
norm. benefits and risks are known, disclosed and discussed.
In the case of CDMR, this may not be entirely possible.
Evidence on the risks and benefits of CDMR in low
CDMR from the mother’s perspective risk pregnant women has never been entirely assessed,
Common reasons reported by women requesting leading the NIH to call for more randomized clinical
a cesarean delivery are fear of labor pain and stress; trials.
uncertainty of outcome; fear of emergency interven-
tion such as forceps; fear of fetal distress during labor;
fear of future sexual dysfunction, stress incontinence CDMR from the fetus’s perspective
or pelvic prolapse; and convenience. Ultimately, The concept of “fetal rights” contributes to a notion
women may invoke a right to have their autonomy that the pregnant woman and her fetus are potential
respected, and to participate in all decisions related adversaries. Much of the debate around “fetal rights”
to their healthcare; in other words, if an informed has been in the context of abortion, an area of great
woman wants a cesarean delivery, she should have the political, ethical, and legal controversy. The fetus is in
right to request a cesarean delivery regardless of any an intermediate ethical, and legal position. Lacking
medical risk that her decision may inflict on her or capacity, it cannot have autonomy. Furthermore, the
her baby. fetus is dependent for its well-being on the choices
Respect for patient autonomy requires that a made by the mother. In UK and Canadian common
patient be fully informed about the benefits and the law “the fetus does not have legal rights until it is born
risks of a recommended treatment, and then has the alive and with complete delivery from the body of the
right either to consent to the treatment or refuse it. pregnant woman.”5 If a competent woman refuses
But broadening this principle to create an obligation medical advice, her decision must be respected even if
to respect a patient request for treatment that is not the doctor believes that her fetus will suffer as a result.
recommended and might even be harmful stretches According to the ACOG Committee on Ethics6:
the concept of patient autonomy to a point that many Pregnant women’s autonomous decisions should be
ethicists and lawyers believe goes beyond what is rea- respected. Concerns about the impact of maternal deci-
sonably acceptable within the usual doctor–patient sions on fetal well-being should be discussed in the context
relationship. In the UK, non-obstetrical patient of medical evidence and understood within the context of
treatment requests have been tested in the courts, each woman’s broad social network, cultural beliefs, and
which have confirmed that doctors are not legally values. In the absence of extraordinary circumstances,
or ethically obliged to provide treatment requested circumstances that, in fact, the Committee on Ethics can-
by a patient if they consider it not in his/her best not currently imagine, judicial authority should not be
interests.3 used to implement treatment regimens aimed at protect-
ing the fetus, for such actions violate the pregnant woman’s
With CDMR, the situation is further complicated
autonomy.
by the involvement of a third party  – the fetus. A
woman may desire CDMR to avoid a complicated vag- Regarding CDMR, the fetus’s best interests are usu-
inal delivery that may be harmful not only to herself ally considered in terms of the risks of prematurity
but also to her baby. Furthermore, the risk of a primi- and trauma if delivered by elective cesarean section,
gravidae requiring an urgent unplanned cesarean weighed against the risks of injury arising from dif-
delivery during labor are significant – approximately ficult delivery, emergency intervention, or post-
10%–20%. Cesarean section following a prolonged maturity.
trial of labor involves higher maternal morbidity In the case of Jane and Jim, CDMR is particularly
than a scheduled Cesarean, due to increased risk of controversial because they request it at 37 weeks’ ges-
uterine atony and hemorrhage. For the baby, a sched- tation. Compelling evidence concludes that neonatal
uled Cesarean delivery may reduce risks, such as outcomes are improved if Cesarean delivery is delayed
reduced availability of neonatal resuscitative meas- until 39 weeks.7 The risks should clearly be presented to
ures, associated with a possible “out of office hours” Jane and Jim as well as the option to perform fetal lung
delivery. Indeed, concern for the baby is one of the tests prior to scheduling the surgery.
50
 Chapter 8. Maternal–fetal conflicts

CDMR from the doctor’s perspective obstetricians would either choose CDMR for themselves
or their partners and/or would comply with women’s
Do doctors have the choice whether or not requests. Their reasons include fears of complications
to perform a CDMR ? of vaginal delivery, desires to avoid medicolegal conse-
quences if such complications develop after refusing to
Principles of beneficence and nonmaleficence are par-
perform CDMR, and desires to respect women’s auton-
ticularly challenging with CDMR, since they must bal-
omy. In a survey involving eight European countries
ance benefits and harms for both mother and baby in a
and over 1500 obstetricians, wide differences in cul-
situation where (1) there is a lack of reliable authorita-
ture and case law appeared to account for variation in
tive data, (2) physicians’ own personal views may vary
compliance with a woman’s request for CDMR, which
widely, and (3) there is heated political as well as medi-
ranged from 15% (Spain) to 79% (UK).10 A survey of
cal debate.
ACOG members found that of 699 respondents, just
The most compelling arguments against perform-
over half believed that women had the right to CDMR
ing an elective Cesarean section relate to complica-
and a similar proportion had complied with such a
tions. To reduce fetal morbidity, CDMR should at
request.11
least not be performed before fetal lung maturation
has been established, and therefore should not be
scheduled before 39 weeks’ gestation. Data regarding CDMR from a public health perspective
maternal morbidity are generally based on nonsched- In a world of finite resources, we might question
uled procedures in women with medical and obstet- the ethics (distributive justice) of promoting CDMR
rical conditions that both increase risks and may as a standard of care to endorse women’s autonomy
require general rather than regional anesthesia. Data when millions of citizens do not have access to even
for maternal morbidity following scheduled proce- basic health coverage. If healthcare resources are
dures are few. In addition, maternal risks are known diverted to increased Cesarean deliveries, theoret-
to increase with successive Cesarean sections. From a ically such resources will not be available to others.
nonmaleficence perspective, therefore, CDMR risks Should individual women therefore bear financial
to future pregnancies must be thoroughly examined responsibility for their CDMR just as they do for
and discussed. other “non-­medically” indicated procedures such as
Should obstetricians ever be compelled to provide cosmetic surgery? Limiting CDMR to women able
a Cesarean delivery they do not believe to be medic- to afford the extra cost of surgery, however, creates
ally necessary? Most doctors believe that professional another inequality in healthcare access. How would
autonomy protects them from providing such ther- this model take into account the percentage of women
apy, and ensures their “clinical freedom.” There are who ended up with an urgent, complicated, and costly
cases (e.g., abortion) in which doctors are excused unplanned Cesarean delivery after a failed trial of
from obligations to provide treatment to which they labor and delivery?
have a moral or religious objection. Obstetricians Finally, how do we anticipate the true cost of CDMR
might argue it is against their moral integrity to when most studies assessing such costs compare vagi-
perform a nonindicated surgical procedure such as nal deliveries with all cesarean sections, including
a CDMR. However, as reinforced in the UK by the those with sicker women and/or babies? Taken to an
Burke ruling,8 a much stronger argument may be one extreme, if all women who wanted CDMR obtained
based on risks and benefits and the interests of the it, the need for labor and delivery rooms, and the inci-
patient(s), rather than one based on physicians’ per- dence of lengthy failed labors, urgent instrumental or
sonal morals. In the UK, National Institute for Health cesarean deliveries would significantly decline, poten-
and Clinical Excellence (NICE) guidelines suggest tially being replaced by a less costly obstetrical prac-
that doctors have the right to “decline a request for tice. Although cesarean section without labor would
a caesarean section in the absence of an identifiable seem to be more expensive than uncomplicated vagi-
reason.”9 nal delivery, studies attempting to compare such costs
are often methodologically flawed, involve few rand-
What do obstetricians believe? omized trials, are plagued by inadequate power, and
Surveys show disagreement among obstetricians often omit important considerations including costs
regarding CDMR, and that a significant proportion of accruing to patients.
51
 Section 1. Consent and refusal

Other societal issues not directly related to costs Fetal risks of general anesthesia
include the medicalization of childbirth and a para- A recent study in a cohort of very preterm infants com-
doxical transfer of power from women to the medical paring neonatal mortality after epidural, spinal and
profession if CDMR becomes the norm. general anesthesia for cesarean reported no increased
risk after general anesthesia when controlling for
CDMR from the anesthesiologist’s gestational age.13 However, a large population-based
study reported higher neonatal risks with general
perspective anesthesia even in scheduled cesarean sections.14
The anesthesiologist probably would not have been Women therefore need to be informed that the risk for
directly involved in the patient’s and obstetrician’s neonatal resuscitation and intubation are potentially
decisions regarding mode of delivery. However, one higher after general anesthesia than after regional
of the reasons cited by women choosing CDMR is fear anesthesia.
of pain during labor and delivery, and adequate infor- Long-term effects of general anesthesia on the
mation and access to optimal labor analgesia may be developing brain have been of growing concern,15 but
crucial in shaping this discussion. Anesthesiologists further studies are necessary before firm conclusions
are obliged to inform women that early neuraxial anal- can be drawn regarding the adverse effect of short peri-
gesia is safe and available. For women who fear loss of natal exposure to general anesthetics.
control, access to low-dose neuraxial labor analgesics
with patient-controlled epidural analgesia (PCEA) Alternative regional anesthesia
may be one way to “avoid” a CDMR. Pain during and In order to make an informed choice the risks of alter-
after Cesarean section is a major concern for women, natives, including regional anesthesia must also be
and these issues also need to be addressed. discussed, including hypotension, inadequate anesthe-
At minimum, the following information regard- sia requiring conversion to general anesthesia, severe
ing general anesthesia should be discussed with Jane headache, nerve damage, epidural abscess or menin-
and Jim: gitis, epidural hematoma, and severe injury including
paralysis. Benefits such as being awake to bond with
Maternal risks of general anesthesia the baby, and the opportunity for postoperative neu-
Anesthesia-related maternal mortality, though low, raxial analgesia should also be presented.
has been associated with difficult airway management
and aspiration during induction of anesthesia and
recovery.12 However, these risks are clearly increased
Can the anesthesiologist refuse to
when patients are obese and surgery is unplanned and participate in CDMR?
urgent, mitigating this concern when it is applied to Examples of refusal by physicians to provide anesthe-
elective surgery. sia when it conflicts with their personal beliefs include
abortions and care of Jehovah’s Witnesses undergoing
Risk of pain after Cesarean delivery scheduled surgery. The NICE guidelines give doctors
A woman who requests a general anesthetic to avoid all the right to decline a request for a Cesarean section
pain and discomfort during Cesarean section should in the absence of an identifiable reason. However,
be informed that the gold standard for post-Cesarean Camman argues that unlike terminations of preg-
analgesia, neuraxial opioids, cannot be administered. nancies or refusal of blood transfusion by Jehovah’s
The clear association of severe acute post-delivery witnesses, elective Cesarean sections do not have a
pain, post-partum depression, and chronic pain must religious or moral component, since Cesarean sec-
also be disclosed. tion is an accepted medical intervention that does not
intentionally result in harm or loss of life.16 Refusal to
Risk of awareness during general anesthesia provide anesthesia based on beneficence and nonma-
Although the risk of awareness is low, this potentially leficence arguments are therefore stronger than those
traumatic and devastating outcome must be disclosed based on moral objection, although Gass, in a counter
to women who are seeking the utmost comfort and to Camman, has argued that there are moral grounds
stress-free experience when choosing a CDMR under for refusal to participate in CDMR based on the utili-
general anesthesia. tarian need to maximize societal benefit.17

52
 Chapter 8. Maternal–fetal conflicts

Conscientious objections could be applied to

such refusal may be detrimental to her or to
any treatment where the doctor might have personal
her fetus. Physicians generally are ethically
beliefs that conflict with the patient’s. But rights of phy-
obliged to honor these rights.
sicians to invoke conscientious objection is limited by
• The obligations of physicians to accede to
the (usually) overriding duties to provide patient care.
requests for nonrecommended treatments are
In the UK, the General Medical Council has stated the
less straight forward.
following18:
• Principles of beneficence and nonmaleficence
You must make the care of your patient your first concern.
You must treat your patients with respect, whatever
require that consideration be given to the
their life choices and beliefs. maternal benefits against the maternal harms,
You must not unfairly discriminate against patients by as well as benefits and harms for the fetus.
allowing your personal views to affect adversely your pro- • When patients request unnecessary
fessional relationship with them or the treatment you pro- interventions, additional ethical considerations
vide or arrange. include issues of distributive justice (does
If carrying out a particular procedure or giving advice CDMR divert healthcare resources away from
about it conflicts with your religious or moral beliefs, and more basic needs to fulfill the wishes of a few
this conflict might affect the treatment or advice you pro- privileged persons, or does it have the potential
vide, you must explain this to the patient and tell them
to reduce health care costs overall by avoiding
they have the right to see another doctor. You must be sat-
isfied that the patient has sufficient information to enable
the costs of complications of more traditional
them to exercise that right. If it is not practical for a patient care?).
to arrange to see another doctor, you must ensure that • Some patient care situations allow physicians
arrangements are made for another suitably qualified col- to withdraw out of conscientious objection
league to take over your role.You must not express to your based in personal religious or moral beliefs,
patients your personal beliefs, including political, religious but refusing to provide requested and
or moral beliefs, in ways that exploit their vulnerability or accepted (albeit unnecessary) therapies
that are likely to cause them distress. are better supported by arguments using
(For more on physician conscientious objection, see principles of beneficence and nonmaleficence.
Chapter 43.) • When a physician objects to providing
medical services that are acceptable within
With regards to the choice of anesthetic, there is no dif- the standard of care, they have obligations to
ference between CDMR and any other Cesarean sec- transfer the care of such patients to a suitably
tion. It is generally accepted that regional anesthesia is qualified colleague who can provide such care.
safer and better than general anesthesia. However, there
may be cases, such as when the parturient’s anxiety and
fear are so great – even if irrational – that her interests References
are best served by undergoing a general anesthetic. 1  ACOG Committee Opinion No. 394, December 2007.
The authors would personally be agreeable to Jane Cesarean delivery on maternal request. Obstet Gynecol
and Jim’s request to perform a Cesarean section as 110, 1501.
soon as fetal lung maturity has been established (or 2  NIH State-of-the-Science Conference Statement on
at 39 weeks), preferably under regional anesthesia. cesarean delivery on maternal request. NIH (2006).
When the desires of a pregnant woman are in conflict Consens State Sci Statements, 23, 1–29.
with usual medical indications for treatment or with 3  R (Burke) v General Medical Council and Disability
the best interests of the baby, the following key points Rights Commission (interested party) & The Official
should be kept in mind: Solicitor (Intervener) [2004]. EWHC 1879
4  Wiklund, I., Edman, G., and Andolf, E. (2007).
Cesarean section on maternal request: reasons for the
Key points request, self-estimated health, expectations, experience
• The principle of respect for patient autonomy of birth and signs of depression among first-time
supports a pregnant woman’s rights to refuse mothers. Acta Obstet Gynecol Scand, 86, 451–6.
recommended medical treatments, even if 5  Flagler, E., Baylis, F., and Rogers, S. (1997). Bioethics
for clinicians: 12. Ethical dilemmas that arise in the

53
 Section 1. Consent and refusal

care of pregnant women: rethinking :maternal-fetal 17* Gass, C.W. (2006). It is the right of every anaesthetist
conflicts. CMAJ, 156, 1729–32. to refuse to participate in a maternal-request caesarean
6* ACOG Committee Opinion N. 321. Maternal section. Int J Obstet Anesth, 15, 33–5.
decision making, ethics, and the law. November 2005. 18  General Medical Council. (2008). Consent: patients
American College of Obstetrics and Gynecology. and doctors making decisions together www.gmc-uk.
Washington DC. org/guidance.
7  Tita, A.T., Landon, M.B., Spong, C.Y., et al. (2009) N
Engl J Med, 360, 111–20.
8  R (Burke) v General Medical Council and Disability
Rights Commission (interested party) & The Official
Further reading
ACOG Committee Opinion No. 385. (2007). The limits
Solicitor (Intervener) [2004]. EWHC 1879
on conscientious refusal in reproductive medicine.
9  (NHS) NIfCE: Caesarean section. www.nice.org.uk/
American College of Obstetrics and Gynecology.
CG013NICEguideline 2004.
Washington DC.
10  Habiba, M., Kaminski, M., Da Fre, M., et al. (2006).
Caesarean section on request: a comparison of Bergeron, V. (2007) The ethics of cesarean section on
obstetricians’ attitudes in eight European countries. maternal request: a feminist critique of the American
BJOG, 113, 647–56. College of Obstetricians and Gynecologists’ position on
patient-choice surgery. Bioethics, 21, 478–87.
11  Bettes, B.A., Coleman, V.H., Zinber, S., et al. (2007).
Cesarean delivery on maternal request: obstetrician- Hawkins, J.L. (2007). American Society of Anesthesiologists’
gynecologists’ knowledge, perception, and practice Practice Guidelines for Obstetric Anesthesia: update
patterns. Obstet Gynecol, 109, 57–66. 2006. Int J Obstet Anesth, 16, 103–5.
12  American Society of Anesthesiologists’ Practice Kukla, R., Kuppermann, M., Little, M., et al. (2009). Finding
Guidelines for Obstetric Anesthesia: update 2006. autonomy in birth. Bioethics, 23, 1–8.
American Society of Anesthesiologists. Park Ridge, Il. Maclean, A.R. Caesarean Sections, Competence and the
http://www.asahq.org. Illusion of Autonomy (St George’s Healthcare NHS
13  Laudenbach, V. Mercier, F.J., Roze, J.C., et al. Trust v S; R v Collins and others, ex parte S [1998] 3
(2009). Anaesthesia mode for caesarean section and All ER 673, [1998]). Web Journal of Current Legal Issues
mortality in very preterm infants: an epidemiologic 1999.
study in the EPIPAGE cohort. Int J Obstet Anesth,
Minkoff, H. and Paltrow, L.M. (2004). Melissa Rowland
18, 142–9.
and the rights of pregnant women. Obstet Gynecol, 104,
14  Algert, C. S., Bowen, J.R., Giles, W.B., et al. (2009). 1234–6.
Regional block versus general anaesthesia for caesarean
section and neonatal outcomes: a population-based Nilstun, T., Habiba, M., Lingman, G., et al. (2008). Cesarean
study. BMC Med, 7: 20. delivery on maternal request: can the ethical problem
be solved by the principlist approach? BMC Med Ethics,
15  Loepke, A.W. and Soriano, S.G. (2008). An assessment
9, 11.
of the effects of general anesthetics on developing brain
structure and neurocognitive function. Anesth Analg, Samanta, A. and Samanta, J. (2005). End of life decisions.
106, 1681–707. BMJ, 331, 1284–5.
16* Camann, W. (2006). It is the right of every anaesthetist Weiniger, C.F. (2007). Cesarean delivery on maternal
to refuse to participate in a maternal-request caesarean request: implications for anesthesia providers. Int J
section. Int J Obstet Anesth, 15, 35–7. Obstet Anesth, 16, 186–7.

54
 Section 1 Consent and refusal
Chapter

9
Consent for anesthesia for procedures with
special societal implications: psychosurgery
and electroconvulsive therapy
Sadek Beloucif

The Case patient’s personality and their emotional experience of

the world. Caregivers described them as listless, dull,
A 20-year-old patient suffers from severe psychiatric
apathetic, without drive or initiative, passive, preoccu-
disorders (agitation, hetero-aggressivity, threatened self-
pied and dependent. A horror among the public devel-
mutilation) for which he had been hospitalized almost
continuously for 7 years. His condition is refractory to oped that the operation actually excised free will.
the usual psychiatric medication, and psychosurgery In 1948, Norbert Wiener remarked,
may reduce his potential for violence and make him less Prefrontal lobotomy … has been recently been having a
dangerous to himself and to others. The health care team certain vogue, probably not unconnected with the fact
thus hopes the intervention will provide more humane that it makes the custodial care of many patients easier.
treatment than the prison-like incarceration to which Let me remark in passing that killing them makes their
he is currently subjected. However, given the history and custodial care still easier.2
grim connotation of lobotomy as well as its irreversibilty,
it raises major issues of appropriate consultation and In 1950, physicians in the Soviet Union banned lob-
informed consent more than for any other treatment. otomy, concluding that it was “contrary to the prin-
These concerns continue to be at the forefront of ethical ciples of humanity,” and that it “turned an insane
considerations in psychosurgical techniques and other person into an idiot.”3 Notorious outcomes involving
functional psychiatric interventions, such as electrocon- lobotomy, both in real life (e.g. Rosemary Kennedy
vulsive therapy (ECT). and Rose Williams, sister of Tennessee Williams), as
well as in fiction (e.g. Ken Kesey’s One Flew Over the
Cuckoo’s Nest) perpetuated a horror of psychosurgical
Historical perspective techniques.
Psychosurgery has a controversial history, in which After neuroleptics and chlorpromazine were dis-
medical, moral, social, and political considerations covered in the 1950s, psychosurgery declined rapidly,
intermingle. First described in 1936, and defined as although it continued to be used in cases viewed as
a surgical ablation or destruction of nerve transmis- otherwise refractory to treatment. Following spirited
sion pathways with the aim of modifying behavior, social controversy in the US, a Federal commission
the conventional “lobotomy” of the 1940s and 1950s was convened in 1977, which discredited growing pub-
flourished. There was a strong desire to relieve over- lic allegations claiming that psychosurgery was used to
population in asylums and hospitals, and lobotomy control minorities, restrict individual rights, and that
came to be seen as a means for calming down and even its undesirable effects were nonethical. The Chairman
discharging an appreciable proportion of committed of National Committee for the Protection of Human
patients,1 or of at least of making caring for them easier. Subjects of Biomedical and Behavioral Research, even
Little attention was paid to patient selection and con- went so far as to declare:
sent. The unrestrained application of lobotomy makes We have looked at the data and they did not support our
it difficult to this day to gain an objective evaluation of prejudices. I, for one, did not expect to come out in favor
its true efficacy. of psychosurgery. But we saw that some very sick peo-
Almost immediately after its introduction, lobot- ple had been helped by it … The operation should not
omy was noted to have severe collateral effects on the be banned.4

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
55
 Section 1. Consent and refusal

Nevertheless, lobotomy was subsequently prohibited to be comparatively free of complications, as there is

in a number of states in the US and in other countries no permanent cerebral damage. They achieve psycho-
such as Germany or Japan. Psychosurgery continues to modulation, even the equivalent of a reversible anterior
be performed, but is strictly regulated and controlled capsulotomy, by inducing radiofrquency stimulation
in the US, Finland, Sweden, the UK, Spain, India, to the brain in specific locations of the cerebral paren-
Belgium, and the Netherlands1. chyma via implanted electrodes. Although very differ-
ent from surgery mutilating the cerebral parenchyma,
these stimulation techniques will probably always
Psychosurgery techniques remain less psychologically and socially acceptable
Conventional lobotomy than, for instance, cardiac electrical pacing. However,
because the patient is free to interrupt the neurostimu-
Prefrontal leucotomy – or “standard” prefrontal lob-
lation, the voluntariness of the patient’s submission to
otomy  – and transorbital leucotomy destroyed parts
treatment is preserved. In fact, these new treatments
of the frontal lobes or their connections to the limbic
share many points in common with behavioral modifi-
system. Significant “frontal lobe” syndrome was a com-
cation induced by pharmaceutical treatment.
mon complication, characterized by permanent apathy
or euphoria, inconsistency, puerility, boorishness,
impaired judgment, and chaotic behavior. Harmful side Ethical issues
effects included epileptic seizures or aggressiveness. The present indications for psychosurgery, although
exceptional, have not entirely disappeared. In 2001, a
Functional neurosurgery
prominent specialist stated:
Earlier techniques have since been abandoned in favor “However, despite the plethora of pharmacological
of much more limited  – although still ­destructive – agents that are available today, there remains a small but
procedures. Grouped under the heading of “psycho- significant proportion of patients who suffer horribly
surgery,” these procedures based on a “functional” from severe, disabling, intractable psychiatric illness. It
neurosurgical approach are: is in these patients that surgery might still be appropriate
(1) anterior capsulotomy – interrupting fronto­ if intervention is safe, reasonably effective, and without
thalamic connections in the internal capsule significant morbidity.”5
(2) cingulotomy – partial destruction of the cingulate The main ethical issues connected to these interven-
gyrus, altering certain connections within the tions involve the scientific validity of the therapy and
limbic system its evaluation, the validity of patient consent, and
(3) subcaudate tractotomy – acting on the lower the possibility of conflict between the interests of the
portion of the frontal cortex to destroy the fibres patient and those of society – particularly in the case of
which connect it to the hypothalamus and the dangerous or violent individuals.
head of the caudate nucleus and Accordingly, many questions remain to be
(4) bilimbic leucotomy – combining cingulotomy answered. What are the indications? How are these
and subcaudate tractotomy. techniques being evaluated and researched? What are
Results are generally considered effective, although this the limits of informed consent? Are patients able to
is on the basis of small case series due to the paucity of consent who have, in essence, lost a significant aspect
acceptable indications. The severe cognitive behavioral of their freedom of judgment?
disorders experienced by early lobotomy patients are no
longer observed. More recently, the administration of Current indications
highly focused gamma radiation (“gamma-knife”) has A primary indication for psychosurgery is obsessive-
produced clinical results similar to functional neuro- compulsive disorder (OCD). Treatment-refractory
surgical techniques, while being minimally invasive. OCD is both tormenting and disabling. About 70% of
psychosurgical procedures are currently performed
Cerebral stimulation techniques for OCD, with notable objective improvement. Patient
New hopes are arising for new, nondestructive tech- consent is not usually an issue, since patients are fre-
niques based on stereotaxic neurostimulation. Initially quently aware of their disability, competent, and eager
used to treat severe Parkinson’s disease, they appear to pursue treatment.

56
 Chapter 9. Consent for psychosurgery and ECT

Other possible indications include severe depres- In the case of severe obsessive psychoses and OCD
sion refractory to extreme pharmacologic therapy and patients are fully conscious of the torment they endure
sismotherapy (ECT), selected affective disorders such and are often the first to call for the intervention. In
as treatment-refractory schizophrenic psychosis, and the presence of this desire, physicians need to recog-
selected cases of aggressiveness to self or others. nize the anguish created by the pathology, and con-
In practical terms, pre-surgical evaluation to enable sider whether they should accede to such requests.
medical selection of patients applies solely to patients Understanding and sensitivity to the reality and inten-
suffering from OCD. Selection criteria that are consid- sity of the patient’s distress may bring the conviction
ered are: (1) an established diagnosis for at least 5 years; that it non-ethical to deny such treatment to patients
(2) significant suffering evidenced by validated clin- suffering from a disabling, chronic, and intractable dis-
ical and social function scores; (3) failure of the usual ease. Furthermore, the risk of social, somatic and men-
medications to control the disorder, either singly or in tal complications of non-treatment, including the risk
combination when administered for at least 5 years, or of suicide cannot be discounted.
inability to continue medication due to intolerable side Consent may be easy to secure because some
effects; (4) appropriate treatment of an associated co- patients endure such suffering that they may be ready
morbid disorder, and (5) a poor prognosis for the dis- to accept, or for that matter demand, intrepid action. It
order in question. In all cases, it is necessary to inform is precisely this ease of securing consent that paradox-
the patient of the risks, prefer less intrusive stereotaxic ically raises ethical concerns. But an alternate, equally
techniques, and obtain patient consent. legitimate question is how long a patient can ethically
be left to suffer medical therapeutic failure before offer-
The relationship between therapy and research ing the option of neurostimulation.
procedures For patients suffering from aggressive delusional
For all other indications, the scientific demand for conditions (who may be dangerous for themselves
research is dominant, in view of the uncertainties veil- or others), the question of consent is much more
ing both the pathology and its presumed treatment. problematic. It is wishful thinking to imagine that
Although a degree of tension emerges whenever poten- the validity of consent (“free and informed”) does
tially irreversible cerebral manipulation is considered, not bear scrutiny in cases where judgment is severely
obviously the actual reversibility of new techniques impaired. Nevertheless, all efforts must be made to
can only be formally established through research. It secure the patient’s assent, even though this “consent”
therefore seems ethically improper to oppose research may be dubious in legal terms. Cerebral neurostimu-
which aims to examine reversibility of the effects pro- lation techniques may be appropriate in some par-
duced. According to a report of the French Bioethics ticularly disabling treatment-refractory psychiatric
Advisory Commission on the subject of consent6: pathologies. However, because neurostimulation
The intricacy of the care and research relationship has for such patients is not established standard therapy
become a major characteristic of “scientific medicine”. and therefore is inextricably involved with research,
This should be a subject of pride. When it engages in a very specific concept of consent, validated by exter-
research, medicine questions its own principles, corrects nal appraisal, must be provided. For further discus-
its mistakes, and progresses. Good research is not suf- sion of consent for human subjects in research, see
ficient in itself to ensure quality health care, but it does Chapter 27.
contribute. In situations where both therapy and research are
involved, consent takes on a new dimension. A phys-
Consent ician must inform his patient of the consequences of
The concept of consent has very different implica- the expected therapeutic effects, and also of the value
tions depending on whether the perspective is med- of the research activity. Although it is clear that consent
ical, legal, philosophical, or ethical; whether it only may be defective for patients suffering from psychi-
concerns the individual in question; or whether it is atric disorders, every effort must nevertheless be made
given for the benefit of a third party. Consent remains to obtain agreement prior to treatment. Even though a
a crucial issue in psychiatry, more than for any other particular patient’s “intervals of lucidity” may be very
medical discipline, and particularly so when psycho- rare, assent should still be sought persistently to try
surgery is one of the options. to assure whenever possible that the patient has been

57
 Section 1. Consent and refusal

able to understand, at least to some degree, the med- and ECT. In some of the US, such treatments can be
ical expectations and their consequences. obtained for decisionally incompetent patients only by
Confronted with a mentally disabled individ- court order.
ual whose condition may risk violence to self or to In many cases, a casuistic approach, based on a
others, society has a duty to protect the vulnerable, case-by-case discussion, is needed. In fact, the Madrid
but while doing so, must also respect and protect the Declaration of the World Psychiatric Association states:
sick ­individual – who is also vulnerable. In the clinical Ethical behavior is based on the psychiatrist’s individ-
setting as well as in biomedical research, pains should ual sense of responsibility towards the patient and their
always be taken to do as much good and as little harm judgment in determining what is correct and appropri-
as possible, while respecting the freedom of decision ate conduct. External standards and influences such as
of those one seeks to help. Even though duty calls for professional codes of conduct, the study of ethics, or the
rule of law by themselves will not guarantee the ethical
a constant effort to combine and reconcile these two
practice of medicine.9
principles, there often conflict between beneficence
and autonomy. For example, the French Code of Ethics One solution might be the formation of a formal
of the medical profession states:7 committee tasked with establishing decision-making
Consent from the person under examination or care procedures for the purpose of providing support and
must always be sought …. when the patient is in a fit protection to such patients. In the presence of severe
state to express his/her wishes, and rejects the investiga- psychotic conditions, it may not be best to accept a sur-
tion or treatment offered, the physician must respect that rogate consent between the attending physician, the
rejection, after having informed the patient of the conse- expert, and the family or legal representative. Rather,
quences. If the patient is unable to express his/her wishes,
a committee including non-medical personnel as well
the physician may not take action unless next of kin have
as individuals capable of evaluating both the handicaps
been warned or informed, unless that is an impossibility
or urgent action is required. and misery endured by the patient, the family, and the
entourage, might attenuate the pain and anxiety of
Therefore, the issue of “being or not being fit to express making such decisions.
a wish” is the crux of the matter. Further detailed For procedures that involve considerations of
instruction in the Code of Ethics on this difficult mat- research and care, every protocol should be approved
ter is unambiguous: by a special committee, according to criteria which
Consent from a mentally sick patient to treatment offered define: (1) conditions for approaching potential candi-
is most advisable and, if necessary, attempts to secure it dates; (2) criteria for patient selection such as severity,
may be insistent ; however, in case of refusal, the physician chronicity, gravity and failures of prior medical treat-
and the family must, in certain cases, ignore the patient’s
ment; (3) validity of consent; and (4) mode of evalu-
wishes. When mental aberration is clearly established,
ation of results.
or if the patient is dangerous, commitment by certifi-
cation or voluntarily to a mental hospital or institution In view of new issues arising out of the emergence
becomes necessary. The law dated June 27, 19908 on the of experimental therapy, the committee’s task would
commitment of the mentally ill, allows for the wishes of be to preserve the integrity of suffering human beings
the patient to be ignored in certain cases, both as regards and safeguard respect for their autonomy, as well as to
admission to a public hospital and administering treat- consider what alternative objective help can be given
ment. When neurotic disorders or affective disturbances, to them. On the subject of psychosurgery, a working
even of a spectacular nature, do not alter the patient’s per- group of the Steering Committee on Bioethics of the
sonality nor prevent reasonable decision, no treatment Council of Europe stated:
may be applied without the patient’s consent. where States continue to sanction the use of it, the con-
While the advisory and, in some cases, authoritative sent of the patient should be an absolute prerequisite for
role of family members in providing consent for men- its use. Furthermore, the decision to use psychosurgery
should in every case be confirmed by a committee which
tally disabled patients is recognized in Europe, such is
is not exclusively composed of psychiatric experts.10
not universally true elsewhere. In the US, where psy-
chosurgical techniques and psychiatric interventions
have been associated in public perception with manipu- Electroconvulsive therapy
lation or obliteration of free will, restrictions have Electroconvulsive therapy (ECT) is a procedure
been placed on consent for psychosurgical procedures performed under general anesthesia during which

58
 Chapter 9. Consent for psychosurgery and ECT

a seizure is induced by application of electricity Key points

through electrodes applied on the head. After its
introduction in the 1940s, as with psychosurgery, • Special societal implications of psychosurgery
excesses involving its use in the 1960s and 1970s led and ECT lead us to reconsider the hierarchy of
to sharp criticisms questioning its very necessity. As cardinal ethical principles.
with psychosurgery, negative associations of its use • Because of the investigational nature of more
in public perceptions, both real (e.g., Frances Farmer recent, less invasive and potentially reversible
and Ernest Hemingway) and fictional (e.g., Robert techniques, research and patient care cannot
Pirsig’s Zen and the Art of Motorcycle Maintenance) always be disengaged from one another.
perpetuate suspicion regarding ECT. It neverthe- • When considering Autonomy, Beneficence,
less remains widely used throughout the world. Non-Maleficence and Distributive Justice, the
Current indications for ECT are severe psychiatric physician has a moral obligation to respect the
disorders (severe depressions, melancholia) with a common good, with a fair balance between
tangible risk of suicide. It is also used in cases of doc- beneficence and the autonomy of the patient.
umented resistance to medical therapies for severe • Psychosurgery raises fundamental questions,
depressions and in selected patients suffering from such as those linked to the definition of person
maniac-depressive psychosis or severe schizophrenic and free will, concepts of dignity, integrity,
disorders. and the validity of true consent.
General anesthesia including muscle relaxants is • In the quest for authentic harmony in the
mandatory to prevent musculoskeletal complications relationships between the health care provider
of seizures. Preoperative clinical evaluation allows and the patient, tensions between means
recognitions of classic contraindications such as cer- and ends should be recognized, as well as the
tain arrhythmias, or intracranial hypertension compli- understanding of contextual influences, such
cating some neurological disorders. ECT might even, as economic, political, scientific, and social
in selected patients, have less morbidity than certain perceptions, that may alter the consent process.
antidepressants. • Ultimately, decisions regarding
The main controversy surrounding ECT involves psychosurgical interventions and ECT must
the fear of psychiatric pathologies and their therapies. be made on a case-by-case basis, taking into
An important symbolic question also raised by ECT is account patient suffering and disability, and
the issue of dignity, which is deeply embedded in the balancing these considerations with patient
concept of free will. Accordingly, the aim of safeguard- autonomy.
ing the patient’s freedom is central to the official dec- • Decisions regarding involuntary treatments
larations of psychiatric associations regarding patient may benefit from the input of established
rights. The World Health Organization recently con- committees including non-medical personnel
demned the abuses and violation of the human rights and representatives of the patient and their
of people with mental disorders and Dr Jong-Wook entourage.
Lee, former Director General of WHO urged:
countries, international organizations, academia, the
healthcare and legal sectors and others to take a hard
look at the conditions of people with mental disorders References
and take action to promote and protect their rights.11
1*  Feldman, R.P. and Goodrich, J.T. (2001). Psycho­
The question of how to best preserve the interests of surgery: a historical overview. Neurosurgery,
the patient while having effecting human behavior, 48, 647–59.
is key to this subject. The use of ECT should be per- 2   Wiener, N. (1948). Cybernetics, The MIT Press.
formed in a non-passionate and dramatic way, and in 3   Laurence, W.L. (1953). Lobotomy banned in soviet as
cooperation with the patient. When obtaining con- cruel. New York Times, p. 13.
sent, the clinician must believe that the treatment is 4   Cullinton, B.J. (1976). Psychosurgery; National
performed in what he/she thinks is in the patient’s Commission issues surprisingly favorable report – news
best interests, yet always keep open the possibility of and comment. Science, 194, 299–301.
patient refusal. 5   Cosgrove, G.R. (2001). Neurosurgery, 48, 657–8.

59
 Section 1. Consent and refusal

6  CCNE, Opinion n° 58, Informed consent of and 11  News Release WHO/68, 7 December 2005 : “End
information provided to persons accepting care or Human Rights violations against people with mental
research procedures. Text available at http://www. health disorders”. Text available at http://whqlibdoc.
comite-ethique.fr. who.int/press_release/2005/PR_68.pdf.
7  Article 36 of the Code de Déontologie.
8  Law n° 90–527 June 27 1990 (J.O. June 30, 1990) ; art. Further reading
L.326 – L.355 of the code de la santé publique. Bell, E., Mathieu, G., and Racine, E. (2009). Preparing the
9  Madrid Declaration of World Psychiatric Association, ethical future of deep brain stimulation. Surg Neurol,
Approved by the General Assembly on August 25, 1996. 72(6), 577–86.
Text available at http://www.wpanet.org/generalinfo/ Comité Consultatif National d’Éthique. CCNE, Opinion
ethic1.html. n° 71, Functional neurosurgery for severe psychiatric
10  “White paper” on the protection of the human rights disorders. Text available at http://www.comite-ethique.fr.
and dignity of people suffering from mental disorder, Walter G, and McDonald A. (2004) About to have ECT?
in particular those placed as involuntary patients in a Fine, but don’t watch it in the movies: the sorry
psychiatric establishment. Council of Europe, January portrayal of ECT in film. Psychiatric Times; 21(7)
3, 2000. http://www.psychiatrictimes.com/.

60
 Section 1 Consent and refusal
Chapter

10
Ethical use of restraints
Joan G. Quaine and David B. Waisel

The Cases by law enforcement to constrain individuals. Medical

care should not be hindered by forensic restraints.
Case 1 Medical immobilization to accomplish a procedure is
not considered restraint therapy. Examples of medical
A muscular 25-year-old requires post-operative mechan-
immobilization including placing a baby in a papoose
ical ventilation following laryngospasm-induced negative
pressure pulmonary edema. The nurse applies restraints to perform a frenulectomy and holding down a toddler
prior to lightening his sedation and calls the intensivist for to perform a mask induction of anesthesia.
an order, explaining that he is concerned that the patient Restraint therapy should be used thoughtfully.
will extubate himself as he wakes up. Comprehensive, individualized assessments should
be performed before and throughout restraint ther-
Case 2 apy. Clinicians should obtain informed consent from
available decision-makers before instituting restraint
After a stroke, a 76-year-old man is intermittently commu- therapy. If there are no available decision-makers, the
nicative, occasionally aware of self and place. He is being
decision to use restraints should be based solely on
physically restrained with wrist restraints to minimize
the likelihood of dislodging his intravenous and arterial
beneficence, the obligation to do good, or nonmalefi-
catheters. The wrist restraints occasionally agitate him for cence, the obligation not to harm. It is assumed that
short periods. His non-medical daughter is extremely dis- appropriate use of restraint therapy is consistent with
turbed by the use of restraints and repeatedly requests their the desires of patients to receive safe and quality med-
removal. His son, a physician, does not object. ical care. Restraints should not be used for clinician
convenience, as a solution for insufficient staffing, or as
Restraint therapy is instituted to prevent injuries to
a substitute for adequate medical care.
patients or others by restricting a patient’s move-
Common physical restraints include wrist, chest
ment. If used improperly, restraint can cause acciden-
and waist restraints. Wrapping the hands in bandages
tal injury or even death. In order to reduce associated
is used to prevent patients from using fingers. Chemical
risks and protect a patient’s health, safety and well-be-
restraint is the use of drugs to control behavior and limit
ing, while concomitantly preserving a patient’s dignity
movement. Medication is not considered a restraint
and rights, physicians are ethically obliged to limit the
when used to treat a clinical condition such as pain.
use of restraints to clinically and adequately justified
situations.
Principles
What is medical restraint? Restraint therapy should maintain the patient’s dig-
Intent, not mechanism, determines whether movement nity and comfort by using the least restrictive restraint
restriction is considered restraint. Medically necessary possible (Table 10.1). Determining the least restric-
restraints are designed to avoid harms from unplanned tive restraint involves determining both the extent of
interruption of therapy, such as self-extubation, restraint needed to accomplish the goals and the spe-
removal of catheters, or interruptions to operative sites. cific benefits ostensibly obtained by restraint therapy.
Behavioral restraints are used to maintain safety for the To decrease the need for restraint therapy to treat
patient and others. Forensic restraints are those used agitation, clinicians should sooth patients through

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
61
 Section 1. Consent and refusal

Table 10.1. Principles of restraint use

•  Create the least restrictive but safest environment for patients.

•  Restraintsshould only be considered after determining whether treatment of irritants or other problems would
minimize the need for restraint therapy. Alternatives to restraints should be sought.
•  Restrainingtherapies should only be used when the risk of harm from treatment interference outweighs the physical,
psychological and ethical risks of restraint use.
•  The rationale for restraints must be documented in the medical record.
•  Orders for restraint therapy should be time-limited to encourage formal reassessment.
•  Patients and significant others should receive education as to the need for, and nature of, the restraining therapies.
•  Patients receiving neuromuscular blockade should receive adequate sedation and analgesia.
•  Theneed for restraint therapy should be frequently reassessed and restraint therapy should be discontinued at the
earliest possible time.

diversion, music, reorientation, enhanced comfort, and decreasing access to the limited resource of intensive
reduction of light and noise stimulation. At the same care unit beds. Longer intensive care unit stays expose
time, clinicians should treat potential medical sources patients to more bacterial infection, muscle wast-
of agitation such as hypoxemia, hypercarbia, electro- ing, and critical illness polyneuropathy, among other
lyte disorders, drug withdrawal and pain. Ventilation problems.2
settings, endotracheal tube position and the fit of masks Lengthy withdrawal of sedation can be minimized
used for noninvasive ventilation should be optimized. by either conversion to physical restraints or use of
Better methods of securing the endotracheal tube may multimodal therapy at the appropriate time. A 2004
also reduce the need to use restraint therapy. editorial stated that in the UK, while “physical restraint
Physicians should consider whether the benefits of patients is considered unacceptable in the [UK] …
of restraint therapy are worth the harms. In certain the importance of the timely withdrawal of sedation
situations, clinicians may consider removal of certain cannot be overemphasized, and the judicious use of
therapies, such as endotracheal tubes and extracorpor- physical restraints may legitimately be built into an
eal membrane oxygenation lines in the very ill, to have overall treatment plan …”2
potentially devastating consequences. Other times,
however, maintenance of the therapy may be easily
reinstituted, or the loss of the therapy may not be con- Case discussion
sidered harmful. Between 63% and 89% of self-extu- We can apply these principles to both of the example
bated patients do not require reintubation, suggesting cases. In the muscular 25-year-old man with nega-
that, for these patients, unplanned extubation was not tive pressure pulmonary edema, the desire for the
harmful.1 restraints may be misguided. The nurse may worry
Potential risks of restraint therapy include regurgi- that he will miss the onset of agitation because other
tation and aspiration in the supine patient, skin break- nursing responsibilities keep him from the bedside,
down, dehydration and accidental death. Straining or that inadequate in-house coverage may mean that
against restraints may cause muscle injury and may an unplanned extubation would have a devastating
increase agitation. It is unclear if restraints affect the effect (note that unplanned extubation might well not
extent of posttraumatic stress disorder that occurs in be harmful). Unquestioned acceptance of the nurse’s
ICU patients. request for restraint therapy may lead to inappropri-
Chemical restraints may be seen as kinder and ate therapy as well as a missed opportunity to high-
less invasive than physical restraints and frequently light an institutional system-level problem. On the
are used without the requisite oversight and continual other hand, avoidance of restraint therapy may lead
reassessment of physical restraints. However, use of to the use of chemical restraints, which may increase
chemical restraints in lieu of using other measures has the duration of mechanical ventilation and intensive
individual and societal costs. Deep sedation used for care unit time. This complexity is best addressed by
restraint may increase intensive care unit stay, perhaps adopting well-considered protocols to help ensure

62
 Chapter 10. Ethical use of restraints

appropriate use of restraint therapy in order to best • The ethical principles of respect for patient
achieve the desired goals. self-determination (including informed
The second case exhibits the effects of restraint consent obtained from surrogate decision-
therapy on the family. While restraints minimize the makers), beneficence and nonmaleficence
likelihood of catheter dislodgement (possibly neces- should weigh heavily in the decision to
sitating replacement), they occasionally appear to employ restraint as a mode of treatment.
agitate the patient. Wrapping the arterial line such
that it could not be removed may be inconvenient for
the nurses, who have to document the appearance of References
the arterial line site at specific intervals. The family’s 1*  Maccioli, G.A., Dorman, T., Brown, B.R., et al. (2003).
reaction to the restraints was perhaps indicative of Clinical practice guidelines for the maintenance of
the public’s perception. The nonmedical adult daugh- patient physical safety in the intensive care unit: use of
ter was horrified and campaigned daily for removal restraining therapies – American College of Critical
of the restraints. The physician-son recognized the Care Medicine Task Force 2001–2002. Crit Care Med, 31,
benefits of the restraints, and was capable of assess- 2665–76.
ing the appropriateness and possible consequences 2*  Nirmalan, M., Dark, P.M., Nightingale, P., and Harris, J.
of restraint therapy. He may also have been inured to (2004). Editorial IV: physical and pharmacological
the use of restraints after years of working in intensive restraint of critically ill patients: clinical facts and ethical
care units. Despite the son’s explanation to his sister considerations. Br J Anaesth, 9, 789–92.
that there was no treatable cause of their father’s agita-
tion, that he appears to tolerate the restraints well, and Further reading
that the loss of the arterial line would require painful Council on Ethical and Judicial Affairs, American Medical
reinsertion, the daughter continued to focus on the Association. Opinion 8.17 Use of Restraints. Code of
restrains. Following additional strokes, the patient Medical Ethics.
had fluid and nutrition therapy withdrawn. Yet, sev- http://www.ama-assn.org/ama/pub/physician-resources/
eral years after her father’s death, the daughter’s nar- medical-ethics/code-medical-ethics/opinion817.shtml.
rative of her father’s death focused on the restraint Hine K. (2007). The use of physical restraint in critical care.
therapy. Nurs Crit Care, 12, 6–11.
The Joint Commission. (2010). Hospital Standards
Key points Manual: PC.03.02, 03.02,03.05. 3.
• Used appropriately, restraint therapy reduces http://www.jointcommission.org/.
patient risk and improves outcome. Kunken, F.R., McGee, E.M., and Stell, L.K. (2001). Strap him
down. Hastings Cent Rep, 31, 24; discussion -6.
• The general impression by oversight bodies is
that physical restraint therapy is overused in Ofoegbu, B.N. and Playfor, S.D. (2005). The use of physical
restraints on paediatric intensive care units. Paediatr
the US, but may be underused in the UK and
Anaesth, 15, 407–11.
elsewhere.
Van Norman, G. and Palmer, S. (2001). The ethical bound­
• By considering the use of restraints as a
aries of coercion and restraint of patients in clinical
therapy, clinicians will go through the natural anesthesia practice. Int Anesth Clin, 39(3), 131–43.
process of seeking a thorough understanding
Zun, L.S. (2003). A prospective study of the complication
of indications, risks, and benefits, and will rate of use of patient restraint in the emergency
likely use restraint therapy appropriately. department. J Emerg Med, 24, 119–24.

63
 Section
Section11 Consent and refusal
Chapter

11
The use of ethics consultation regarding
consent and refusal
Susan K. Palmer

The Case Religious freedom and state interests

A 63-year-old female unconscious patient involved in an In the US there is a complex history of the relation-
MVA was brought urgently to the O.R for repair of bilateral ship of the state to religious groups. Even though the
femur fractures. The anesthesiologist administered a gen- framers of the Constitution were adamant that there
eral endotracheal anesthetic for a 6-hour operation during should be a separation of church and state, such that
which the patient received six units of packed red cells and the state could make no laws favoring any church,
other blood products. She was transferred to the intensive
there have been times when religious groups were
care unit (ICU) still intubated and ventilated. The following
day the anesthesiologist visited the patient, who was now
given special privileges or permission to indulge in
awake but still dependent on mechanical ventilation. She what would otherwise be illegal conduct. Recently,
signaled that she wanted to write something given a pad religious groups and their followers are more com-
and pencil. She wrote, “I am Christian Scientist, I want to monly being held to the same standards as other
go home NOW.” members of society with their religious stand-
ing or preferences not allowed to excuse harmful
Mary Baker Eddy founded Christian Science in about
conduct just because it conforms with religious pref-
1866. Her textbook entitled Science and Health with
erences. For example, the tradition of churches pro-
Key to the Scriptures became the primary source for the
viding “sanctuary” for people wanted by the civil
Christian Science philosophy, which has unique beliefs
authorities was abolished with the ecclesiastical
concerning illness and healing. There are approximately
courts in ­sixteenth-century England. But the idea that
500 000 members of this group, found mostly in the US.
churches can still provide protection from civil prose-
A foundational belief of the Christian Science
cution for their own clergy and some church members
church is that illness is an illusion and that an ill person
­lingers. Recent revelations that many Roman Catholic
can simply change their perception to alter or elimi-
Churches in America and Europe failed to report the
nate their illusory illness. All drugs, surgery, or other
repeated criminal activities of its clergy are potent evi-
conventional medical treatments are unneeded and
dence that some churches still do not wholly submit to
ultimately ineffective. Prayer is the only effective way
the authority of the state.
to change the course of illness, by revealing the noncor-
poreal nature of all existence, including the nonphysi-
cal nature of the human body. A body that is spiritual is
not in need of physical treatment.
The Christian Scientist church and
Christian Science theology describes the corpor- the state
eal world as a kind of shared illusion. In this sense, Among the many aspects of her Christian Science phi-
Christian Science bears a resemblance to the funda- losophy, Mary Eddy was explicit in her direction that
mental Buddhist idea that the world of the senses is believers should be obedient to the authority of the
illusory. Christian Scientists believe that immortality law and of states, including state health laws. She was
is actually and only achievable by the perfection of the a progressive regarding the treatment of women and
spiritual mind. Disease is an imperfection of the spirit children, and was also a believer in civil liberties and
perceived as a physical problem. individual freedom.

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
64
 Chapter 11. Use of the Ethics Consultation Service

However, the American tradition of “freedom of

religious belief ” is not identical with a right to freely
Case discussion
practice religious behavior that may be harmful to
others or to society. At times, Christian Scientists
How should the anesthesiologist respond
have come to public attention because a member or to this patient?
members have denied standard healthcare for their After reassuring the patient, the anesthesiologist
children. Rejection of vaccination for Christian decided to consult with several colleagues and hospital
Scientist children may lead not only to the suffering officials, with the following results:
and complications of common childhood diseases for (1) The attending orthopedic surgeon was called and
the unvaccinated children, but may also lead to the suggested that his patient be sedated indefinitely
propagation of diseases like measles within the whole so that she does not harm herself or disturb the
population, thus harming others. The state, however, surgical repairs.
has an enduring interest in the health of its children (2) The Chief of Staff (COS), who was also a surgeon,
and its general population. agreed with the attending surgeon.
The majority of the US still has specific legisla- (3) The hospital Chief Executive Officer (CEO)
tion that protects parents from charges of child abuse decided to call the hospital system lawyers.
or neglect when they deny their children certain (4) Anesthesiology colleagues at the state university
resources, including some medical care, for religious suggested calling the chair of their hospital ethics
reasons. The 1972 case Yoder v. Wisconsin allowed committee, and provided a name and phone
Amish to be exempt from the duty to educate or to number.
send their children to school.1 The decision was justi-
(5) An attempt was made to contact local elders/
fied on the basis that it was necessary for preservation
readers from the Church of Christ, Scientist, but
of the Amish way of life. There are numerous examples
there was no phone registered to the local church.
of religion-based exceptions to public health require-
ments such as rules that children be vaccinated to Can the advice of the orthopedic surgeon or the COS be
attend public school. justified by reference to ethical principles or ethical rea-
However, there are no legislative protections for soning? Neither the orthopedic surgeon nor the COS
religious citizens accused of more serious crimes and suggested that their advice to chemically restrain the
felonious harms. In August, 1990 the New York Times patient could be justified on any but practical grounds.
reported on several cases of parents charged with fel- Federal laws regarding physical and chemical restraint
onies after deaths of their children occurred as a direct now require that the use of any restraint must be re-
result of the parents’ failure to seek medical care for evaluated frequently. The patient was cooperative, so
them.2 Although the majority of such cases resulted chemical restraint beyond appropriate analgesia was
only in civil penalties such as fines or sentences not needed.
requiring public service and promises to seek med- The hospital CEO was advised by the hospital sys-
ical care for their remaining children, there are now tem lawyers that legally it would be safest to follow the
some cases in which parents have been sentenced to patient’s requests if she was considered to have med-
prison time. A more recent example occurred in 2008 ical decisional capacity. The lawyers were perplexed as
in Wisconsin wherein parents allowed their 11-year- to whether the patient had the ability to command the
old daughter to die of diabetes.3 The child deterio- removal of her own ventilatory support if the physi-
rated while her parents and other couples treated her cians thought that death would ensue shortly.
only with prayer. The father and mother were accused When the anesthesiologist returned to the patient’s
of reckless homicide and were sentenced to some bedside, she was conscious but dependent on ventila-
prison time every year for 6 years and probation for tory support. The anesthesiologist assured the patient
10 years. that her requests were being seriously considered. He
In our case, the patient is an adult who appears also indicated that her statement was tantamount to
to be decisionally competent and the complexities of requesting euthanasia because she predictably would not
dealing with minor or incompetent patients are (for- survive extubation or cessation of intravenous support
tunately) not involved. at that time. He explained that, when she was delivered

65
 Section 1. Consent and refusal

to the hospital, treatment was started in the good faith insufficiency had not been definitively diagnosed.
assumption that she would want to survive her inju- The differential list included fat emboli, pulmonary
ries. He told her that he could not in good conscience capillary leak syndrome, and transfusion reaction,
stop her medical support at this time, and certainly all of which could have produced her current severe
her metallic femoral implants could not be removed to decrease in oxygenation and impairment of ventila-
satisfy her now stated wish not to receive medical care. tion. However, the impairment was starting to resolve
He indicated to the patient that he was actively seeking and she was expected to fully recover to her baseline
advice about her situation and requests. ventilatory function. With standard medical care, she
was expected to be able to be discharged from the ICU
within 48 hours. She would normally need contin-
Advice from the Ethics Committee chair ued observation, wound care treatment for her inci-
During telephone consultation with the university sions, and in-hospital physical therapy for return to
Ethics Committee chair, she suggested a formal eth- ambulation.
ics consultation involving an in-person evaluation of
the patient’s situation by a member of the university’s
clinical ethics consultation team, who would travel to What are the legal considerations?
his hospital. Alternatively, the university clinical ethics The patient was on a ventilator, but able to commu-
consultation team could participate in a consultation by nicate by writing. She was originally brought to the
conferencing telephone. Finally, the Ethics Committee hospital for emergency care and treatment was under-
chair encouraged the anesthesiologist to lead an infor- taken without specific consent from the patient or any
mal ethical consultation about the patient’s situation. spokesperson. Now she was requesting that her med-
A local ethics consultation process was initiated, ical treatment be stopped and that she be discharged
with the invitation of all interested parties including from the hospital. She was on medications for anal-
the surgeon, the anesthesiologist, the hospital CEO, the gesia and sedation while being weaned from mech-
patient and her choice of supportive relatives or advo- anical ventilatory support. The orthopedic surgeon
cates, and a representative from the patient’s nurses. believed that the patient was incompetent because she
The patient’s consent for the consultation was obtained failed to understand that the course of treatment he
and all the participants agreed that the consultation was prescribing should be followed. He believed that
would be treated with the same respect and confidenti- she may have had cerebral fat emboli as a basis for her
ality afforded the rest of the patient’s medical care. With apparent inability to understand her current medical
the guidance of the university Ethics Committee chair, difficulties. None of the other physicians or the nurses
the anesthesiologist planned the consultation accord- who had spoken to the patient and seen her consistent
ing to the following outline: written responses believed that the patient was men-
(1)  What is the current medical situation? tally impaired. Although a judge could be summoned
(2)  What are the legal considerations? to investigate and evaluate the patient’s degree of legal
competency, the majority of her health care providers
(3)  What are the medical ethical considerations?
already believed she was decisionally competent, but
(4) What is included in the range of acceptable/
misguided by her religious beliefs.
justifiable ethical and professional responses

What are the ethical considerations?

What is the current medical situation? Respect for each patient’s autonomy is a highly valued
All medical ethical consultations begin with explica- principle of the medical ethics of the patient−physician
tion of the patient’s current medical condition and the relationship. This is a particularly strong ethic in the
range of recovery or therapeutic responses expected. in the United States. European principles emphasize
The patient’s attending physician explained what autonomy, but may temper autonomy considerations
the normal course of planned treatments would be. with principles of beneficence (“doing good”) and non-
This patient was stable and expected to recover back maleficence (“avoiding harm”).
to her baseline ambulatory condition. She had signifi- It is justifiable to continue standard medical care
cant risks for continuing pain and for serious seque- while doubts about the patient’s understanding of
lae from her long bones fractures. Her ventilatory her own medical situation are resolved. However,
66
 Chapter 11. Use of the Ethics Consultation Service

physicians are generally not free to define a patient as (3) Do what the patient requests as soon as it is
incompetent primarily because the patient disagrees compatible with important aspects of medical
with their physicians’ recommendations. Capacity professionalism and the deeply held personal
for medical decision-making is not identical with beliefs of the physicians and nurses who are
complete legal competence. A patient who is able to caring for the patient (even if this requires that
appreciate their medical condition, consider their the care of the patient be transferred to other
alternative choices for treatment or refusal of treat- physicians and nurses).
ment, and express a consistent choice with supporting (4) Compromise to the point that both the patient
reasons has decisional capacity. Physicians have a duty and the medical personnel get to do some of what
to place such a patient’s interests above their own med- they consider most important.
ical preferences.

Case resolution
What is included in the range of acceptable The patient and her advocate listened and participated
ethical and professional responses? thoughtfully in the ethics discussion. The patient rec-
The integrity of the medical profession is a soci- ognized that it was not her right to command a physi-
etal good which should not be easily ignored or cian, a nurse, or a hospital to do something that was
thwarted by an individual patient. Physicians are clearly against their medical professional ethics. She
obligated to treat all their patients with respect, agreed to request discharge from the hospital against
but are also bound by the limits of professional medical advice (AMA) as soon as her physicians and
integrity, which would not currently allow eutha- nurses could in good conscience allow her release. The
nasia in the US, even if the patient requests it. Even physicians and nurses were unhappy that they were
in countries where euthanasia is discussed, it is in unable to convince the patient to remain longer under
the context of terminally ill patients or those with their care as they recommended. Everyone agreed to
unrelievable suffering, neither of which applies to the compromise that as soon as the patient’s survival
the patient in this case. The orthopedic surgeon was more likely than not likely, she would be allowed
was taken aback by the patient’s request for cessa- to arrange for her own discharge from the hospital. The
tion of orthopedic care and discharge from the hos- patient was released AMA but without malice or disre-
pital. His definition of his professional obligations spect at a time much sooner than the surgeon’s custom,
to this patient included supervising her recovery but at a time when death was not likely to immediately
from his surgery and starting her on the physical result from cessation of hospital care.
therapy required for her complete recovery. The
anesthesiologist supervising her pulmonary care Did they do the right thing?
did not believe the patient would survive removal Finding an ethically acceptable course of action is
of her endotracheal tube at this time, and on that not the same as calculating a single correct answer to
basis he could not accept the patient’s requests for a simple mathematical problem. The multiplicity of
discharge. ethically justifiable resolutions to a clinical scenario are
The patient has a “right” to expect that her requests often bewildering to scientifically trained physicians
will be honored, but no one has an absolute right to who would normally prefer to find a single most cor-
command the actions of a physician when they con- rect answer to any dilemma. In this case, they did the
flict with the physician’s deeply held personal beliefs or right thing by trying to balance the ethical principles
involve transgression of important elements of profes- of respect for the patient’s autonomy with the impor-
sional medical integrity. If/when the patient’s request tant principle that medical professionals should avoid
for discharge is not tantamount to a request for eutha- doing harm.
nasia, her request may have more power to change her Ethical behavior can seldom be described as
physician’s actions. acting “perfectly” or in such a way as to provide a
Possible courses of action in this case include the paradigm for all future actions by people in similar
following: circumstances. Acting in a way that currently seemed
(1)  Do exactly what the patient requests. thoughtfully ethical, but is later found to be less ethical
(2)  Do only what the orthopedic surgeon advises. than an alternative is not shameful. Difficult situations
67
 Section 1. Consent and refusal

inspire thoughtful reconsideration of previous deci- actions with a goal of better understanding
sions and actions. Contemplating future situations and preparing for future conflicts.
so that future actions can be even more ethical is the
• Respectful physician behavior is key not
response expected from medical professionals who
only to caring for the present patient, but to
are dedicated to serving their patients in ways that
assuring future patients that their concerns
are consistent with each patient’s consent and within
will be dealt with in a just manner.
the boundaries of acceptable professional behaviors.
Respectful professional behavior will not only serve
the patient at hand but it will also inspire respect for References
the medical profession by making future patients con- 1   Wisconsin v. Yoder, 406 US 205 (1972).
fident that their concerns will always be dealt with in a 2*  Margolick. D. (1990). In child deaths, a test for Christian
just manner. Science. The New York Times, Aug 6. The New York
Times.com http://www.nytimes.com/1990/08/06/
Key points us/in-child-deaths-a-test-for-christian-science.
html?pagewanted=1.
• Religious freedom does not guarantee the 3  Guzder, D. (2009) When parent call God instead of the
free practice of religious behaviors if such doctor. Time. Feb 5. Time.com. http://www.time.com/
behavior is harmful to others or to society. At time/nation/article/0,8599,1877352,00.html.
times, conflicts between religious behavior
and societal interests occur in the setting of
medical care. Further reading
• Ethics consultation services can be useful Burton, R.A. (2008). On Being Certain. Believing You are
when unusual or seemingly irresolvable Right Even When You’re Not. New York: St. Martin’s
Griffin.
conflicts between patient wishes and physician
professional standards arise. Code of Medical Ethics of the American Medical
Association. (2006). Council on Ethical and Judicial
• An ethics consultation requires the
Affairs, Current Opinions with annotations 2006–2007
participation of all interested parties, edition. AMA, USA.
including the patient, patient’s caregivers,
Etzioni, A. (1996). The New Golden Rule: Community and
family, and religious support if available, the Morality in a Democratic Society. New York, NY: Basic
physicians, and hospital representatives. Books.
• Ethics consultation includes a process Hamilton, M.A. (2005). God vs. the Gavel. Religion and the
of outlining the medical situation, legal Rule of Law. New York: Cambridge University Press.
considerations, ethical concerns, a range of Luce, J.M. (2010). End-of-life decision-making in the
acceptable ethical and medical outcomes. intensive care unit. Am J Respir Crit Care Med, Mar 1
• Ethical issues may not lend themselves to a [epub ahead of print]
single correct answer; a number of solutions Thaler, R.H. and Sunstein, C.R. (2008). Nudge: Improving
are usually possible, and none may ideally Decisions about Health, Wealth, and Happiness.
meet the desires of all parties. New York: Penguin Books.
• Difficult ethical problems should inspire Waisel, D.B. and Truog, R.D. (1997). How an
thoughtful reconsideration of previous anesthesiologist can use the ethics consultation service.
Anesthesiology, 87(5), 1231–8.

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 Section 1 Consent and refusal
Chapter

12 Consent and cultural conflicts: ethical issues

in pediatric anesthesiologists’ participation
in female genital cutting
Maliha A. Darugar, Rebecca M. Harris, and Joel E. Frader

The Case continued debate about the best term. Some object to
“circumcision’ as suggesting an inaccurate parallel with
A healthy 5-year-old female patient is scheduled for
male circumcision. The WHO adopted female geni-
­“surgical correction of clitoral phimosis.” The patient’s
Somali parents explain their custom of “circumcising”
tal mutilation as the term for this practice.1 However,
girls; a surgeon has agreed to perform the procedure. The many researchers believe “mutilation” alienates the
anesthesiologist doubts the medical indications for the cultures practicing it, resulting in unproductive back-
procedure. The parents assert the need to circumcise their lash. We use FGC as descriptive and as distinguished
daughter so she will be accepted in their community. They from male circumcision, while withholding judgment
tell the anesthesiologist that if they cannot find a US phys- about the practice.
ician to perform the procedure, they will go to Somalia FGC is prevalent globally and not limited to any
where a village elder will do it, without benefit of anesthe- religious or ethnic group. Its highest prevalence occurs
sia or aseptic conditions. in western and eastern Africa where an estimated
Female genital cutting (FGC) refers to procedures 90%–100% of females undergo some form of the
involving partial or total removal of external genitalia practice in Egypt, Guinea, Mali, Somalia, and north-
or other alteration of female genitals for nonmedical ern Sudan. Between 100 and 140 million girls and
reasons. The World Health Organization (WHO) women have experienced FCG worldwide and three
defines four types of FGC.1 Type I (clitoridectomy) million girls may undergo the practice each year.1 In
involves partial or total removal of the clitoris and/or an effort to preserve ethnic identity, immigrants from
the prepuce. Type II (excision) involves partial or total these countries have brought the practice to the West,
removal of the clitoris and the labia minora, with or including Europe and the US. Thus, first world phy-
without excision of the labia majora. Type III (infibu- sicians can no longer regard FGC as exotic and must
lation) involves cutting and appositioning the labia confront requests for participation, especially where
minora and/or the labia majora to create a covering seal large concentrations of immigrants regard FGC as
narrowing the vaginal orifice. Infibulation may or may expected and routine.
not involve excision of the clitoris. Type IV involves all FGC is deeply entrenched in cultures that prac-
other procedures to the female genitalia for nonmedical tice it and persists despite large-scale international
purposes, including pricking, piercing, incising, scrap- campaigns, including medical and health organi-
ing, or cauterization. Despite this categorization, sig- zations condemning it. The WHO, the American
nificant overlap and ambiguity exist in the practice Medical Association (AMA) and the International
within and between the cultures that practice it. The Federation of Gynecology and Obstetrics (FIGO) all
procedure is most often performed between birth and oppose the practice and urge health professionals to
15 years of age, depending on tribal or regional custom. abstain from participating. Ten international health
Adults occasionally undergo the procedure for the first and human rights organizations have created a con-
time or request reinfibulation after childbirth. sensus statement summarizing the international
Many different terms have been used to describe fight to end FGC.2
FGC, including female genital mutilation, female geni- Commentators and analysts differ regarding
tal cutting/mutilation, and female circumcision, with the underlying influences promoting FGC. Many

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
69
 Section 1. Consent and refusal

believe that patrilineal social, economic, and political ­long-term consequences occur regardless of the condi-
values drive the practice of FGC. Some anthropolo- tions under which the cutting occurred.
gists think that women perpetuate the practice as a Immediate adverse outcomes of FGC include pain,
form of African cultural rebellion against encroach- post-operative infection, shock, tetanus, hemorrhage,
ing Western societies. From the latter perspective, and death. Long-term physical complications include
FGC has virtue, promoting female empowerment, urinary problems, dysmenorrhea, inflammation,
strength, cleanliness, and purity. While some assert keloids, introital and vaginal stenosis, painful vul-
that FGC follows Islamic principles, the practice pre- var masses, and fistulae. Long-term sexual dysfunc-
dates the beginning of Islam, is not practiced by the tion includes dyspareunia, loss of libido, inability to
majority of Muslims, and is not universally endorsed achieve orgasm, and partner dissatisfaction. Adult
by Islamic scholars and theologians. Some supporters women may require defibulation procedures to allow
believe FGC curbs sexual desire in women, preserv- for intercourse and childbirth. Subsequent obstetric
ing virginity prior to marriage.3 Others consider FGC complications include prolonged labor from mechan-
to enhance the appearance of female genitalia. Many ical obstruction, hemorrhage from perineal tears, and
women consider FGC part of a coming-of-age ritual perinatal complications including fetal death. Studies
inducting young girls as members of a community. In suggest FGC can increase the risk of human immuno-
any case, women who reject the practice endure stig- deficiency virus (HIV) infection from unsterilized
matization and ostracism. Females without FGC are instruments.4
often considered unsuitable for marriage within their No literature demonstrates specific health ben-
community, creating practical dilemmas, as marriage efits of FGC, though no well-controlled, unbiased
grounds economic and social stability. All of these fac- studies consistently show the physical harms of FGC.
tors contribute to perpetuating FGC.3 Existing studies do not adequately distinguish the
Community elders and birth attendants trad- adverse consequences associated with subtypes of
itionally performed FGC. Campaigns from the West FGC. A systemic review of the adverse consequences
highlighting severe medical consequences of FGC of FGC concluded that most studies had inad-
performed under unhygienic conditions have back- equate power or failed to show statistically signifi-
fired. Rather than halting the procedure, the efforts cant increased risk of many complications, including
have shifted the practice to the medical sector. Women urinary problems and infertility among women
from cultures practicing FGC now ask physicians from with FGC compared to uncut women. Data do not
many specialties, including obstetrics/gynecology, unequivocally demonstrate differences in frequency
surgery, and family practice, to perform the procedure of intercourse, orgasm, and sexual desire in women
using sterile technique with analgesic agents to minim- who have undergone FGC compared to women who
ize pain and adverse medical outcomes. have not. Finally, the psychosocial and cultural value
Patients or other medical professionals may request of the practice to women who practice it cannot be
the help of anesthesiologists for female genital surger- readily tallied.
ies. This may put an anesthesiologist in a difficult pos-
ition, as s/he must consider the patients’ wishes, the
professional’s relationships with and obligations to
Ethical issues
other members of the medical team, and the ethical Whether an anesthesiologist should participate in FGC
implications of participating in a procedure with a cul- depends on his or her interpretation of ethical consid-
tural, rather than medical, justification. erations. Primary among these is the weight to give
cultural values, beliefs, and practices of a particular
community, compared with claims of universal human
Medical sequelae of FGC rights, a concept known as cultural or moral relativ-
Physicians must understand the potential medical ity. Should Western concerns about gender equality,
sequelae of FGC to make reasoned decisions about treatment of children as a protected vulnerable group,
whether or not to participate in the procedure. Both patient autonomy, avoiding paternalism, the need to
immediate and long-term medical complications arise stress nonmaleficence (prevention of harm), and the
from FGC. Most of the immediate adverse outcomes primacy of beneficence trump an ethnic or other com-
result from nonhygienic practices outside of med- munity’s belief that FGC preserves important and valid
ical settings by lay midwives or shamans. Some of the traditions?
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 Chapter 12. Consent and cultural conflicts

Cultural/moral relativism poor outcomes for males who have penile circumci-
Cultural or moral relativism refers to the notion that sion. Furthermore, harms to women from FGC stem
moral or ethical norms must be understood in the from more than the medical consequences of the pro-
context of particular circumstances rather than as cedure; any violation of rights is embedded in broad
universal moral standards. A cultural/moral relativist social structures supporting and perpetuating FGC,
may argue that Westerners have no moral authority including male supremacy in education, political free-
over those practicing FGC. The relativist would note dom, and economic opportunity. In this light, phys-
widespread variation in what communities consider ician participation in FGC, while possibly reducing
acceptable human activity, for example, polygamy harm to the individual patient, legitimizes the practice
vs. monogamy, proscriptions on vs. permissibility as medically and socially acceptable, maintaining gen-
of pregnancy termination, allowing or prohibiting der inequalities.
physical punishment for civil transgressions and so Medical decisions involving children have unique
on, as well as a lack of a generally agreed upon system ethical considerations. The American Academy of
for resolving philosophical disputes. Others support Pediatrics Committee on Bioethics advises that chil-
a notion of universal, absolute human rights. From dren should be given age-appropriate information
this perspective all humans have a right to live free about medical decisions and the opportunity to pro-
of institutionalized suffering, meaning that policies vide assent for medical interventions.6 Children also
or practices that systematically promote harms to a have a right to dissent to medical interventions when
group of people are unethical. Further, minority and/ not urgently necessary to preserve the health or well-
or politically and economically marginalized persons being of the child. FGC is a non-urgent procedure that
deserve protection from injustice. Some see FGC as has significant risks. The child will have to live with
part of a long-practiced set of honored traditions that any complications or consequences of the procedure.
are common and widely accepted in Somalia. Others Under such circumstances, the informed child should
condemn FGC as unethical in the US as imposing have the right to refuse the procedure and physicians
physical and sexual harm on girls and women, per- should respect this right. When a young child does not
petuating a social system that oppresses and disen- have the capacity to make decisions about her medical
franchises females. care, the parents must make medical decisions accord-
ing to the best interest of the child. In FGC, parents typ-
Human rights, children’s rights and gender equality ically request the procedure on the grounds that FGC
will preserves the girl’s chances of obtaining a good
Physicians must balance their duty to respect patient,
marriage. Whether such social interests outweigh the
or in the case of children, parental autonomy with their
medical and psychological harms of the practice com-
duty to respect and protect human rights. FGC chal-
prises the ethical problem in FGC. Physicians have
lenges women’s rights to gender equality and the WHO
independent moral responsibilities toward their child
considers FGC a violation of women’s rights. FGC
patients and cannot rely solely on the views of parents.
also violates the rights of children in the view of many
The risks and benefits (including the socio-cultural
nongovernmental organizations such as Amnesty
benefits) specifically for the child deserve careful con-
International and UNICEF, necessitating action to
sideration before physicians decide whether to partici-
protect especially vulnerable young girls.
pate in FGC.
The United Nations Declaration on the Elimination
of Violence Against Women classifies FGC as a type of
violence against women, impinging on a woman’s right Patient autonomy, conscientious objection,
to, “equality, security, liberty, integrity and dignity.”5 and paternalism
Proponents of FGC defend the custom as parallel Patient autonomy is a fundamental principle of bioeth-
to male circumcision. Some consider prohibition of ics, underlying patients’ rights to make informed and
FGC as a violation of equal rights in that it prevents voluntary decisions about their medical care. It does not,
women from participating in a custom in which men however, mean that patients must receive any requested
participate. However, women do not experience health medical intervention. Two broad types of interven-
benefits from FGC that parallel males benefits from tion that patients do not have an unequivocal right to
circumcision (e.g., reducing HIV transmission); the receive from a given physician include:  (a) interven-
adverse health effects of FGC have no similar set of tions without medical indications and (b) interventions
71
 Section 1. Consent and refusal

that violate the physician’s ethics. In the former case, surgeon cannot find another anesthesiologist willing
one often finds dispute about what constitutes a med- to provide the requested care, the anesthesiologist
ical indication. For example, some individuals may feel, will face a dilemma. She or he must compromise
and courts have upheld, the right of a parent to request personal values and provide the requested service or
and receive mechanical ventilation for recurrent apnea continue to refuse to participate. The latter decision
in an infant with anencephaly despite medical claims implies a philosophically problematic belief that his
that artificial respiration served no medical purpose. In or her values are “better” than those of the family and
the latter case, individual physicians may decline par- should prevail.
ticipation in pregnancy termination, removal of feed-
ing tubes, or palliative sedation, though they may have Nonmaleficence and beneficence
obligations to explain legally available options and refer Although most professional and advocacy organiza-
patients or families to other professionals willing and tions in the West strongly condemn FGC, anesthesiol-
able to provide the requested service. ogists may feel conflicted because patients may end up
Of course, medical professionals routinely per- having it done in unsanitary nonmedical settings with
form procedures without clear medical necessity, inadequate analgesia. FGC performed in the hands of
such as cosmetic surgery. Assuming an informed medical professionals can reduce harms by decreasing
patient with adequate capacity to consent, FGC adverse outcomes through sterile technique, increas-
seems similar to elective female genital cosmetic sur- ing the skill level of the cutter, and providing appro-
gery: no medical indication exists and each alters the priate pre- and post-operative care. Medical FGC may
shape of the genitals. Just as women request labia- allow professionals some control over the type and
plasty and vaginoplasty to alter their bodies to meet severity of procedure performed. However, FGC vio-
Western standards of beauty, women requesting FGC lates the principle of nonmaleficence, the duty to do no
aim to meet cultural standards of beauty and gain harm. Nevertheless, physician participation may pro-
social acceptance. The interventions may differ, how- mote beneficence by reducing the harm patients would
ever, with respect to the likelihood of negative con- otherwise suffer in untrained hands. The case exem-
sequences, such as diminished sexual pleasure, risk plifies the complexity of medical decisions we cannot
of fistula formation, and complications of pregnancy, reduce simply to “do no harm.” The goal of harm reduc-
labor, and delivery. tion may override the physician’s duty to do no harm.
Highly contentious procedures like FGC can
challenge physicians’ values to the extent that they
feel they cannot reconcile participation and must Case analysis
refrain from any involvement. Conscientious objec- The anesthesiologist must consider the medical and
tion involves the refusal to participate in activities social risks and benefits of FGC to the patient. If he or
on religious, moral, or ethical grounds. Frader and she chooses to participate, the child may experience
Bosk argue that invoking conscientious objection for long-term adverse outcomes associated with FGC.
medical interventions acceptable to society and to However, the anesthesiologist will help the child’s
the medical profession generally undermines patient acceptance in her culture. The anesthesiologist must
autonomy, professional ethics, and trades on the balance her or his feelings about the procedure with
imbalance of power in the patient-physician relation- the parents’ authority to raise their children according
ship.7 They oppose opting out of any interaction with to their beliefs.
the patient or surrogate about an objected-to inter- If the physician chooses not to participate, the child
vention and suggest physicians must warn prospect- may have much greater risk for long-term adverse out-
ive patients or family members about their objections comes when performed in Somalia. Furthermore, the
before solidifying a physician–patient relationship child will likely suffer greater procedure-associated
or explain the objections to those with an established pain. However, the anesthesiologist will be refusing to
relationship and provide appropriate referrals. In the participate in a procedure contributing to the oppres-
case of FGC, assuming various forms of the practice sion of women and the rights of women to control their
remain legal, anesthesiologists may have to decide if own bodies. The anesthesiologist may have a right to
they can ethically agree to participate despite their refuse to participate if he or she feels that the procedure
strong moral opposition. If the anesthesiologist or contravenes his or her moral standards.

72
 Chapter 12. Consent and cultural conflicts

3*  Nour NM. (2008). Female genital cutting: a persistent

Key points
practice. Rev Obstet Gynecol, 1, 135–9.
• FGC has wide acceptance in many cultures 4   Brewer, D.D., Potterat, J.J., Roberst, J.M. Jr., and Brody,
across the globe despite gender-related and S. (2007). Male and female circumcisn associated with
more general human rights concerns raised by prevalent HIV infection in virgins and adolescents
the practice. in Kenya, Lesotho, and Tanzania. Ann Epidemiol, 17,
• FGC produces adverse health outcomes, 217–26.
especially those arising from performance of 5   United Nations General Assembly. Declaration on the
the procedures by non-medical professionals. Elimination of Violence against Women. 1993. http://
• Physician participation in FGC may www.un.org/documents/ga/res/48/a48r104.htm.
prevent some health consequences but also 6   American Academy of Pediatrics Committee
perpetuates objectionable social practices. on Bioethics (1995). Informed consent, parental
• FGC is particularly problematic when it permission, and assent in pediatric practice. Pediatrics,
95, 314–17.
involves a request from a parent for the
procedure on a child, who will have to live 7   Frader, J. and Bosk, C.L. (2009). The personal is
with the long-term consequences of FGC. political, the professional is not: conscientious
objection to obtaining/providing/acting on genetic
• While some medical organizations, e.g., the information. Am J Med Genet C Semin Med Genet,
AMA, have created guidelines for FGC, most 151C(1), 62–7.
professional societies provide only guidance,
without a binding effect on members.
• Physicians’ decisions to participate in FGC Further reading
currently rely on personal judgments, Cantor, J.D. (2006). When an adult female seeks ritual
weighing adverse medical and psychological genital alteration: ethics, law, and the parameters
consequences against potential cultural of participation. Plast Reconstr Surg, 117, 1158–64;
benefits and harms. discussion 1165–6.
Nour, N.M. (2004). Female genital cutting: clinical and
cultural guidelines. Obstet Gynecol Surv, 59, 272–9.
References Obermeyer, C.M. (2005). The consequences of female
1   World Health Organization. (2009). Female Genital circumcision for health and sexuality: an update on the
Mutilation. http://www.who.int/mediacentre/factsheets/ evidence. Cult Health Sex, 7, 443–61.
fs241/en/. Schreiber, M., Schott, G.E., Rasher, W. and Bender, A.W.
2*  United Nations Interagency Group. (2008). Eliminating (2009). Legal aspects of ritual circumcision. Klin
Female Genital Mutilation. An Interagency Statement. Padiatr, 221(7), 409–14
www.unfpa.org/webdav/site/global/shared/ Serour, G. I. (2010). The issue of reinfibulation. Int J
documents/publications/2008/eliminating_fgm.pdf. Gynaecol Obstet, Feb 5 [epub ahead of print]

73
 Section 1 Consent and refusal
Chapter

13
Communitarian values in medical
decision-making: Native Americans
Susan K. Palmer

The Case these states would be well served to acquaint them-

selves with the customs and cultural understandings
An anesthesiologist approaches the bedside of a young
that nearby Native Americans share. The cultural
Native American woman to complete a pre-anesthetic
evaluation. The woman is scheduled for a lumpectomy
effects of Native American beliefs in the medical
and appears anxious. The anesthesiologist introduces workplace serve to illustrate problems common to
herself and begins asking questions. “How long have the care of patients whose cultural beliefs are signifi-
you had diabetes? Do you measure your blood sugar at cantly different from that of the traditional “health-
home? Why does it say here that you haven’t eaten for care” culture with regard to autonomy, beneficence
48 hours?” The patient does not look at the anesthesi- and informed consent.
ologist nor does she immediately reply to the series of Native Americans have populated the North
questions. She seems to be looking around the room for American continent for at least 10 000–20 000 years –
someone else. Three people approach the bedside. The
indeed, some archeologists believe it has been much
patient looks directly at them and seems relieved, but
longer. There is ample evidence that the tribal cultures
still does not answer the anesthesiologist’s questions. The
three visitors stand quietly. The anesthesiologist begins of North America were from early times advanced in
again: “Have you had any surgery before today?” She is their languages, kinship systems, sacred histories, and
frustrated, not knowing to whom to address her ques- sophisticated methods of living in sustainable ways on
tions, or when to expect answers. the land. Native Americans should not be confused with
There are more than 500 “tribal entities” in the US, depictions of pre-historic “early man” found in many
with over 200 in Alaska alone. There are thought museum dioramas, which are intended to illustrate
to be about three million Native Americans and very early use of animal skins for clothing, early pos-
Native Canadians. No more than 30%–40% of these sible social structures, group hunting, survival behav-
­individuals live on reservations or associated land iors, and early forms of tool-making. Confusing Native
trust areas. Americans with African and European evidence of early
The Indian Health Service (IHS) is a US govern- humans does a distinct disservice to Native Americans,
mental agency charged with providing preventive, whose history is much more recent and whose cultures
curative, and community healthcare for US Native are far more sophisticated than that of early man before
American populations throughout the US. Many the development of cultural identities.
Native Americans will be cared for outside of Indian
Health Service (IHS) hospitals, and therefore may Principles of respect for autonomy,
need care from anesthesiologists not employed by the
IHS. Although most states have less than 2% of their respect for community, and the principle
population identified as Native Americans, some of beneficence
states have significant Native American populations,
such as Alaska 19.0%, Arizona 5.7%, Montana 7.4%, Communitarian values
New Mexico 10.5%, Oklahoma 11.4%, and South Native American cultures are far more communitarian
Dakota 9%.1 Anesthesiologists who practice in one of than mainstream American cultures. Communitarian

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
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 Chapter 13. Communitarian values: Native Americans

cultures are based on the fundamental premise that to the homeland earth and climate. To restore health
the “community” is the most valued entity, with part of or “beautiful” living, the sick person may want to
each individual’s worth being measured by the degree consult a tribal elder or a tribal member with medici-
to which they are able to contribute to the community’s nal powers. Western medical treatments may also be
well-being. Individual members of a community have needed. Western medicine can be respectfully com-
an obligation to put the community’s interests before bined with tribal beliefs about restoring “right rela-
their own personal interests. In such “utilitarian” value tionships” to achieve successful health outcomes for
systems, the principle of “beneficence” may therefore Native Americans.
be practiced less in the context of individual benefi- Respect for the tribal homeland and designat-
cence, than in one of beneficence to the community. ing landforms and its local flora and fauna features as
Competitive white American culture often assigns sacred is part of the interrelatedness which native cul-
social status to individuals based on their accumulation tures value. The earth is often spoken of as a “mother”
of money and possessions. Native Americans, instead, who nourishes and cares for the people. Traditional
often value their ability to distribute what abundance creation stories in many native tribes reveal that a spir-
they have to make sure that no one in their community itual being, the Great Mystery, preceded and then cre-
is without necessary food, shelter, and means to care ated mankind. The earth, the sun, the forces of weather,
for their families. These fundamentally different value the cardinal directions, and the “brotherness” of other
systems may lead people to make quite decisions with living creatures make everyday interactions “sacred”
regard to their healthcare. activities. Natives developed sustainable relationships
with the flora and fauna of their homelands because
Native American views on illness they knew that the existence of their community
depended on this.
There are over 550 federally recognized Native
The recent worldwide attention to “sustainable”
American tribes in the US. Defining what constitutes a
living has renewed interest in the tribal ways of Native
“tribe” would be academically difficult, but we know in
Americans. They recognized and valued sustainable
general that the requirements for a distinct tribal com-
living thousands of years before the emergence of the
munity include: (1) having a common homeland; (2)
current interest in conservation of resources, preser-
speaking a common language; (3) having an agreed kin-
vation of species, and the development of renewable
ship system; and (4) sharing a sacred history. It would
resources.
be impossible to describe the tribal customs or beliefs
regarding illness and healing for each of the hundreds
of federally recognized “tribal entities.” There are, how- Navajo culture and informed consent
ever, common themes among many tribes that are use- An important way in which the differences between
ful for anesthesiologists to appreciate when caring for Western and Native American values in healthcare eth-
Native American patients. What follows is a descrip- ics can be illustrated is through the process of informed
tion of some features of a belief system surrounding consent. Western medical ethics place great value in
illness and healing of one of the largest tribes in the “authentic” or autonomous choices of patients. In order
US – the Navaho, or Dine. for choices to be truly autonomous, this value system
Southwestern pueblo cultures, particularly the holds that a patient must be sufficiently informed and
Navaho, value being in correct relationship with oth- able to choose without coercion. Such information
ers in the community, with the Great Mystery, with includes the nature of the treatment, risks, chances of
other living creatures, with even with the features of success or failure, and alternatives to the recommended
the homeland landscapes which are thought to be treatment.
part of the birthright of the tribal community. When Traditional Navajo culture, on the other hand,
a Navaho person becomes ill, the root cause of the ill- holds that words can change reality. A discussion of bad
ness is thought to be the loss of a “correct” relation- events, or even the possibility of them, is unwelcome,
ship. Relationships must be in balance to avoid or since it may actually bring the unwanted outcomes to
terminate illness. Each tribal member must strive to pass. The anesthesiologist may be faced with an ethical
maintain a correct relationship to other tribal mem- dilemma – respect the patient’s culture and withhold
bers, the right relationship with spiritual forces in information out of cultural sensitivity, or fully inform
other life forms, and maintain respect and gratitude the patient and reject their cultural values.
75
 Section 1. Consent and refusal

In such a dilemma, it is important to recognize

that autonomy is not inextricably linked to informa-
Why should an anesthesiologist be
tion. In fact, patients can make completely authentic concerned about a patient’s cultural or
and autonomous choices by asking not to be informed, spiritual preferences?
or by assigning the power over health care decisions to Apart from the humane aspect of concern for the
another, such as their relatives, or even the physician comfort of others, scientific evidence supports the
themselves. Furthermore, it is not the amount of infor- premise that a patient’s psychological state affects
mation that is significant to autonomy, but rather what healing, ­immunity, and the course of disease. Psycho­
information the patient considers most important to neuroimmunolgy is the name used for the 20-year-old
their well-being. Therefore, we can respect autonomy, field of scientific study that acknowledges the effects
even if we do not have all of the objective information that a patient’s state of mind has on their neurologi-
on the table, so long as we have respected the patient’s cal and immunological systems. Complex interactions
values with regard to how much and what kind of infor- between the immune system and the central nervous
mation they desire and need to feel comfortable with system, including the effects of positive and negative
their health care decision. The easiest way to deter- emotions on immunology and infection, have long
mine this is to ask the patient what is important to her been recognized and studied. Anesthesiologists have
in the context of her values, choices and culture. also long known that it is better to anesthetize a patient
who is already calm, than to rapidly induce general
Ethical responsibilities of anesthesiologists anesthesia in a patient who is distraught or nearly out
caring for Native American patients (or any of control. Pre-medication can produce the picture
of calmness, but may or may not produce actual psy-
patient with a cultural background chological calm. The old saying that “patients wake
different from their own) up exactly as they go to sleep,” is indicative of the fact
Anesthesiologists share with all other physicians the that general anesthesia interrupts, but does not resolve,
duty to be respectful to patients and their families and strong emotions. Every anesthesiologist has probably
to put the patient’s interests before their own. Learning had the experience of putting a weeping patient to sleep
about their culture and views on medical care is one and have them wake to continue their crying.
way to demonstrate respect for our patients as individ- Cardiac rhythm, blood pressure, resistance to
uals. Physicians are expected to act with sincere respect infection, secretion of stress hormones, and activation
for our patients’ beliefs, especially when we do not of endothelial reactivity are just some of the things we
share similar beliefs. It would be impossible to know now know are related to patients’ emotional state during
the cultural etiquette of all other cultures. However, it emergence from general anesthesia. The phenomenon
would be possible for anesthesiologists to learn some of of wakefulness during apparent general anesthesia, for
the predominant cultural beliefs and traditional ways example, is thought to be correlated with the patient’s
of Native American patients or other ethnic groups pre-induction state of arousal.
who live in their area and are likely to fall under their
care. All patients are benefited by the acknowledgment
of their spiritual needs. Patients who are confident that
Learning more about Native American
their anesthesia care is personalized are likely to be beliefs and healthcare
more satisfied with their care. A list of valuable readings regarding Native American
Further, it can be argued that physicians have a duty culture and healthcare follows this chapter. Probably
to examine their own background cultural influences the single most helpful book for physicians is The
and work to avoid de-valuing the beliefs or lifeways of Scalpel and the Silver Bear, by Lori Alviso Alvord. It is
patients who have a completely different value system. the story of a Navaho woman raised with traditional
Negative stereotypes of those who are different need tribal values, who decides to pursue higher education
examination and revision so as not to interfere with and eventually becomes a general surgeon. Her jour-
respectful and thorough medical care. Better medical ney away from tribal and reservation life and into the
care and outcomes occur for patients, and more job sat- general American culture and later adoption of the
isfaction results when anesthesiologists can sincerely prejudices which are a normal part of medical surgical
respect their patients. training makes it clear what stresses may be affecting
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 Chapter 13. Communitarian values: Native Americans

any of our Native American patients. Dr. Alvord’s jour- pre-operative questions, one could add a question such
ney also illustrates a way of understanding how the as “What else should I know about you in order to pro-
strengths of Native American spiritual understandings vide comfortable care for you? Is there anything which
and mainstream American views of illness and healing you are concerned about in the treatment I have rec-
can be combined in a synergistic way. ommended for you?”
Navaho people have a concept called “Hozhone It is important to recognize that, for some cultures,
haazdlii”, Walking in Beauty, but it isn’t the beauty that the nature and quantity of information discussed dur-
most people think of. Beauty to Navahos means living ing consent for medical care may vary. Patients have
in balance and harmony with yourself  – mind, body, autonomous rights to limit the amount of specific
spirit  – and having the right relationships with your information they wish to receive, and/or to designate
family, community, the animal world, the environ-
someone other than themselves to receive informa-
ment – earth, air, and water – our planet and universe.
tion and make decisions for them. When a patient
Lori Arviso Alvord, M.D.
desires limited risk disclosure, the anesthesiologist
should document this as part of their informed con-
sent discussion.
Case discussion Some Native Americans may wish to carry sym-
The patient and her family were enrolled members bolic items with them during anesthesia and surgery.
of the Navaho nation. This family valued tribal sup- Provisions for safe accompaniment of symbolic items
port, restraint in conversation, and honored the “old can usually be made to accommodate the patient’s
ways.” Their understanding of disease and its treatment wishes, just as most American hospitals and most physi-
included respect for their tribal beliefs about the origin cians allow patients and their family/pastor to complete
of disease. traditional Christian prayers before whisking them off
Like many physicians, anesthesiologists are often to the OR. Making time and space for tribal members
unaware of the social effects and implications of their and ceremonies is in the same category of respect for the
approach to patients. For example, in the interest of healing power of Native American tribal customs.
efficiency, anesthesiologists often begin their conver-
sations with patients by asking questions. This has
become commonplace in the hurried atmosphere of Key points
a healthcare setting, but would be considered rude
in normal social situations among even non-Native • Native Americans have views on health
Americans. It may be especially offensive and anxiety or strong spiritual beliefs that should
provoking for patients who come from cultures that be acknowledged, respected, and safely
value restraint in conversation. integrated into the plan for anesthesia care.
Most patients, including Native Americans, appre- • Native Americans have sophisticated
ciate it when their physicians begin a conversation by historical spiritual belief systems that should
introducing themselves first, and then stating what not be confused with our understandings
their role will be in the patient’s care. Many cultures, about pre-historic early human social
including those of Native Americans, prefer that the organization.
next part of the conversation includes the recognition • Scientific research supports the connections
of the patient as a unique person with important rela- between spiritual and mental states and the
tionships. Recognizing and speaking to the patient’s outcomes of stressful healthcare procedures.
bedside relatives and friends is a first step in showing • Verbalizing respect for the concerns and
that the physician understands that the patient is part spiritual needs of our Native American
of an important social network, and that they and their patients and their families should be a normal
family will be cared for in a respectful way. part of ethical anesthesia care for these
The anesthesiologist should try to identify very patients.
early in the pre-anesthetic conversation what effect her • Patients of all cultures have a right to
conversation is having on the patient and her family. determine how much and what type of
Asking the patient for guidance as to what information information is essential to them in making
is important to them can be helpful when physician and healthcare decisions. Accordingly, they may
patient values/beliefs diverge. Instead of the routine
77
 Section 1. Consent and refusal

D’Souza, R. (2007). The importance of spirituality in

choose to limit discussion of risks, or to
medicine and its application to clinical practice. Med J
designate someone else to make healthcare Aust, 21, 186(10 Suppl): S57–9.
decisions for them. Fixico, D. (2003). The American Indian Mind in a Linear
• Anesthesiologists could benefit all their World. New York, NY: Routledge.
patients by beginning their conversation Hall, A. (2002). What the Navajo culture teaches us about
with an introduction of themselves and their informed consent. HEC Forum, 14(3), 241–6.
role for the patient. Adjusting the tempo Kelly, L. and Brown, J. Listening to Native Patients. (2002).
and intimacy of pre-operative questions Can Fam Phys 48, 1645–52.
may be necessary to accommodate social Mann, B.A. (2008). Make a Beautiful Way. The Wisdom of
expectations and prevent anxiety for some of Native American Women. Lincoln, NE: University of
our patients. Nebraska Press.
Martinez, D. (2009). Dakota Philosopher: Charles Eastman
And American Indian Thought. St Paul, MN: Minnesota
Historical Society Press.
References McLaughlin, L.A. and Braun, K.L. (1998). Asian and
1  Census Brief 2000. The American Indian and Alaska pacific islander cultural values: considerations for
native popultion 2000. US Census Bureau, Washington health care decision making. Health and Soc Work,
DC. February 2002. http://www.census.gov/prod/ 23(2), 116–26.
2002pubs/c2kbr01–15.pdf. Nerburn, K. (1999). The Wisdom of the Native Americans.
Novato, CA: New World Library.
Turner, N.J. (2005). The Earth’s Blanket. Traditional
Further reading Teachings For Sustainable Living. Seattle: University of
Alvord, L.A. and Van Pelt, E.C. (1999). The Scalpel And The Washington Press.
Silver Bear. The First Navaho Woman Surgeon Combines Utter, J. (2002). American Indians: Answers To Today’s
Western Medicine And Traditional Healing. New York: Questions. 2nd edn. Norman, OK: University of
Bantam Books. Oklahoma Press.

78
 Section 1 Consent and refusal
Chapter

14
Informed consent for preoperative
testing: pregnancy testing and other tests
involving sensitive patient issues
Gail A. Van Norman

The Case having a condition they do not have; the risk of a false-
negative test falsely reassuring a patient that they do
A healthy 15-year-old girl presents for elective ­diagnostic
not have a condition which they in fact do; the risk that
ankle arthroscopy for ankle pain and swelling. She is
accompanied by her mother. During the preoperative
erroneous results might lead to inappropriate therapy
interview, she appears acutely uncomfortable with ques- with its attendant complications; the risk that errone-
tions about whether she is sexually active (she denies it) ous test results might deprive a patient of important
and the timing of her last menstrual period. The anes- therapy they would otherwise get; and the complica-
thesiologist informs her that she will need to get a urine tions of performing the test itself, and monetary cost,
sample for a pregnancy test. The test is required by the to name a few.
anesthesia group’s policy of pregnancy testing female Are all preoperative tests ethically equivalent? Some
patients, and members of the group will not perform elect- of the ethical problems that face the anesthesiologist in
ive anesthesia on pregnant patients. The patient’s mother the case introducing this chapter may be obvious, and
questions the necessity of the test, stating with confidence some may not. But is there really an ethical problem
that “my daughter has never had sex.” The urine preg-
with obtaining an ECG, for example? This discussion
nancy test, however, is positive. State law prevents the
anesthesiologist from informing anyone but the patient
will focus on issues related to common, routine pre-
of her positive test, although the mother will surely guess operative tests, and also examine two preoperative tests
the test results if the case is cancelled. Furthermore, the with special social implications: HIV and pregnancy
patient is below her state’s age of consent for sexual inter- testing.
course, and her pregnancy is therefore by legal definition
the result of statutory rape according to state law – which
also requires any doctor who suspects child abuse to General ethical principles regarding
notify state authorities. medical testing
While physicians often consider ethical issues con- Physicians have ethical obligations based in principles
cerning medical therapies, it is easy to overlook ethical of beneficence and nonmaleficence to make respon-
issues regarding something as routine as a preopera- sible and knowledgeable decisions about whether a
tive laboratory testing. Yet principles of beneficence preoperative test is even warranted. Principles of good
(doing good) and nonmaleficence (avoiding harm) medical practice require that physicians balance the
suggest that anytime we prescribe a medical test, eth- cost of testing against the likelihood that testing will
ical considerations may be relevant, since we doing produce more benefits than harms. Physicians are
such testing precisely because we hope to benefit also bound by an ethical principle of fidelity to their
patients and/or avoiding harm. Preoperative testing patients. Fidelity is the concept that physicians should
presumably benefits patients by identifying unrec- be faithful and committed in providing good medi-
ognized or disguised conditions that might adversely cal care, and not compromise that care in the inter-
affect anesthetic risk. But harms can also result from ests of anyone else, not even for physicians’ personal
preoperative testing. Some harms include the risk of interests.. This principle respects the vulnerability of
a false-positive test erroneously labeling a patient as patients in the doctor–patient relationship. Not only

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
79
 Section 1. Consent and refusal

does the doctor have special medical knowledge and serves us best when it spurs systematic investigation
skills in which the patient must place their trust, but that results in sound, evidence-based decision sup-
also the physician determines to a great degree how port for physicians., Once evidence-based algorithms
expensive medical testing and therapy will be. are available, they should guide most decisions and
The principle of nonmaleficence requires physi- replace “routine” or traditional patterns of ordering
cians to consider, in addition to the monetary costs tests.
of a test, both the medical and social harms that may
result from unnecessary or poorly conceived testing.
Medical harms include the discomfort and incon- Preoperative HIV and pregnancy screening
venience of the test and the potential for false-pos- Social risks associated with preoperative testing may
itive or false-­negative results that misdirect medical not be as obvious as medical risks, but can be the
therapy in ways that create greater harms than ben- source significant harm. Two examples of tests that
efits. Such misdirection can occur even with a simple can produce social harm but are of limited preopera-
ECG. Take, for example, a 40-year-old healthy man tive utility are HIV and pregnancy testing.
with no medical complaints who presents for knee Adverse social consequences known to be asso-
arthromenisectomy. His surgeon orders a routine ciated with HIV seropositivity include employment
preoperative ECG as he has for the last few decades discrimination, loss of insurance, and social isola-
on all of his patients scheduled for surgery. The ECG tion. Studies demonstrate that seropositive women
demonstrates concerning but nonspecific ST seg- experience high rates of marital break-up, abandon-
ment changes, so the surgeon consults a cardiologist ment, and verbal and physical violence when their
who orders stress cardiac imaging for further clarifi- HIV status is disclosed.1 Compulsory preoperative
cation. Imaging reveals a significant area of decreased HIV testing is known to prevent some patients from
apical uptake compatible with myocardial ischemia seeking medical care. Recognition of these harms
or possible attenuation artifact, so a cardiac catheter- has led in the US to the inclusion of AIDS patients
ization is undertaken – which reveals normal coron- in the protections afforded under the Americans
ary arteries. Ultimately, the patient suffers a femoral with Disabilities Act, and has resulted in legislation
artery tear during catheterization and has to undergo specifically protecting the privacy of a patient’s HIV
emergency vascular surgery. The physical and finan- status.
cial cost to the patient is very high, although no med- Revealing a positive pregnancy test may likewise
ical decisions concerning the original surgery were have negative, even life-threatening consequences for
ultimately altered and no surgical risks reduced as a vulnerable patients in social environments where their
result. In fact, this healthy patient’s risk of a major pregnancy is not accepted. Studies show that female
adverse event increased with each test his doctor patients and their fetuses are in some situations at risk
ordered. The most recent guidelines for perioperative of physical violence. Further, adolescent pregnancies
cardiac workup now indicate questionable utility of a are sometimes the result of child abuse, incest, and
preoperative ECG in this case. The subsequent stress rape. Communication of a positive pregnancy test
test was also not indicated because it was unlikely to result to the parents of a pregnant minor can place
reveal anything that would favorably alter outcomes the child in jeopardy of further physical harm, since
for a low risk surgery. it may be evidence of criminal behavior on the part of
Good medical practice, both from ethical and med- a family member, or family friend or acquaintance.
ical standpoints, includes applying evidence-based Many states have statutory requirements for phy-
guidelines in determining if a test should be done, sicians to report evidence of child abuse, and some
rather than on individual experience and beliefs. authorities recommend reporting pregnant minors to
Individual experiences suffer from bias, unique con- Child Protective Services for investigation of possible
founding factors, and situational conflicts of interest. abuse.
Anecdotes may be useful when no systematic inves- In much of the US, a female patient of any age has
tigation has been undertaken that can advise physi- the legal right to absolute privacy regarding reproduc-
cians about the course of action most likely to lead tive matters. To reveal or even imply the results of a
to the best overall outcomes. But anecdotal experi- pregnancy test to a third party, even a parent or spouse,
ence, albeit a strong tradition in medical education, without the woman’s consent, would represent an overt

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 Chapter 14. Ethical issues in preoperative testing

violation of law. The anesthesiologist who discovers a vigilance regarding universal precautions, such tests
pregnancy is therefore left with few comfortable legal may paradoxically increase actual risk or exposure.
options if they have not first obtained the patient’s vol- In any case, preoperative HIV testing does not bene-
untary informed consent for pregnancy testing and fit the patient, although they will bear the monetary
discussed both how the test results will be used and to and social costs of the test. It is therefore difficult
whom they can be revealed. to justify routine unconsented preoperative HIV
Given that there are risks of both social and med- screening on either ethical or medical grounds.
ical harms associated with HIV or pregnancy testing,
is there evidence that routine preoperative testing for
HIV or pregnancy alters outcomes in a sufficiently Routine Preoperative pregnancy screening
favorable way to justify risking such harms? Anesthesiologists often cite three reasons for screening
pregnancy tests: (1) a desire to avoid unnecessary anes-
thesia exposure that may affect fetal development and/
HIV testing or increase the risk of spontaneous miscarriage; (2) a
HIV testing is usually ordered by the surgeon or anes- desire to avoid litigation for fetal anomalies or miscar-
thesiologist to determine which patients may pose riages that might occur following elective anesthesia
a risk to members of the operating room team, and exposure, and (3) a belief that female patients may lie
therefore with which patients they should be particu- to them about their pregnancy status. Are any of these
larly careful to avoid possible exposure. Studies show fears well founded?
that most surgeons and anesthesiologists erroneously Despite widespread belief to the contrary, large
believe that:  (1) compulsory routine HIV screening population-based studies have failed to show defini-
will reduce their personal risk of exposure; (2) order- tive differences in the rates of fetal anomalies or spon-
ing such tests is the prerogative of the physician; and taneous miscarriage following anesthetic exposure
(3) that such tests can be done without the patient’s during the first trimester of pregnancy. Exposure of
consent. the fetus to anesthetic agents in early pregnancy does
The effort to protect fellow members of the operat- appear to  be associated with lower birth weight.2,3
ing room team may be laudable. The doctrine of self- More  recently, concerns have been raised about the
interest, however, is not an ethical principle, and carries effects in primates of later fetal exposure to anesthetic
little or no weight ethically when balanced against agents and its possible effects on subsequent neuro-
issues that affect the patient and his or her rights. This cognitive development. However, no studies have been
is especially true when the risk to the physician is low, done to test whether neurocognitive development in
and the primary method of reducing risk is applied to humans is adversely affected after fetal exposure to
all patients anyway (e.g., universal precautions). anesthetic agents.4
HIV testing has not been demonstrated to Preoperative pregnancy testing also does not con-
improve operating room safety. When applied to a stitute a “standard of care.” In one study, only about
low-­prevalence population, positive screening tests one-third of anesthesia practices required preopera-
are more likely to represent false-positive results tive pregnancy testing.5 In 2003 the American Society
than if testing is selectively applied to a high-risk of Anesthesiologists Task Force on Perioperative
population. False-positive results are harmful to Testing and the American Society of Anesthesiologist
the patient, who is unnecessarily labeled with a Committee on Ethics issued a joint statement that
serious illness and may undergo further testing or anesthesiologists should offer preoperative preg-
treatment related to the false result. Physicians, can nancy testing to any female patient who might desire
be harmed by false-negative test results if they are one, but that medical evidence for requiring preg-
falsely reassured by the result. Furthermore, true nancy screening prior to anesthesia and surgery was
negative tests can occur early in the course of HIV lacking.6
infection when viral titers (and infectious risks) are Is preoperative pregnancy testing even necessary?
actually at their highest. Even a true negative test No study has directly tested how accurate female
may therefore falsely reassure the operating room patients are in reporting their pregnancy status in
team that a patient represents lower risk when the elective conditions when patient privacy is strictly
opposite is actually true. If the outcome is relaxed protected. A study of preoperative pregnancy testing

81
 Section 1. Consent and refusal

in adolescent female patients revealed the patients highly correlated with a woman’s decision to postpone
were accurate in reporting if they could possibly surgery, indicating that the test results represented
be pregnant, and no unexpected pregnancies were important information most of the women consid-
detected in over 500 instances.7 In one recent study ered relevant in deciding whether to have surgery.
of female patients presenting for elective surgery at Anesthesiologists therefore have an ethical duty to
a facility that performed routine pregnancy test- explain what is known and what is not known about
ing, the rate of “unexpected” positive pregnancy the risks of anesthesia and surgery in early pregnancy,
test results was < 0.2%, although one of those posi- and to offer pregnancy testing to women, in case their
tive tests was actually a false positive.8 Other studies decision to have surgery would be affected by the
have put the rate of positive preoperative pregnancy information. An autonomous woman who is prop-
tests at between 0.9%.9 Studies that report the results erly informed of these largely theoretical risks has the
of preoperative pregnancy testing fail to distinguish right to refuse testing, both by law and ethical princi-
between positive test results that occurred in women ples. Coercing such a patient into having a test against
who claimed they were not pregnant versus those her wishes violates patient autonomy, and in general,
who simply didn’t know and requested testing. The refusal to have a test should not result in a cancellation
accuracy of urine pregnancy testing is estimated at of anesthesia or surgical care.
97%–99%. To put it another way, conducting a urine
pregnancy test will result in a false negative in up to
1%–3% of cases. Asking a female patient present- Case discussion
ing for elective surgery if she is pregnant results in The anesthesiologist in our case presentation faces
a false-negative response < 1% of the time. It seems several serious ethical and legal problems:  (1) The
somewhat questionable whether a urine pregnancy laws of her state afford an absolute right to privacy
test is actually superior to simply asking the patient for females of any age with regard to reproductive
whether she is pregnant. There is no evidence what- status. To reveal, or even imply to anyone other than
soever that exploring a female patient’s sexual and the patient that she is pregnant is an explicit violation
menstrual history has any influence on pregnancy of state law and the patient’s rights. (2) It is impos-
test outcomes, much less anesthesia and surgical out- sible for the anesthesiologist to know if revealing the
comes, despite the bizarre invasion of privacy these information will expose the patient or her fetus to
questions represent. risk of serious physical harm from others. (3) The
Is undetected pregnancy a major litigation issue anesthesiologist has no practical way to discuss the
in the practice of anesthesiology? As of 2003, two results without the mother’s knowledge, and simply
cases had been described in the ASA Closed Claims canceling the surgery will certainly clue the patient’s
database related to spontaneous miscarriage of a mother in to the test results. (4) To make matters
previously undetected pregnancy following elective worse, state law also requires the anesthesiologist to
anesthesia.10 In one case, the patient prevailed against report her findings to Child Protective Services as
her surgeon when it was determined that the patient evidence of sex with a minor, which is illegal under
should have had a pregnancy test prior to deciding to child abuse statutes. (5) Failure to obtain informed
proceed to surgery, since a positive test would have consent for the test is also a separately actionable legal
explained her medical condition and eliminated the claim in that state, even if no medical harm occurs.
need to operate. In the second, the anesthesiologist Instead of reducing the possibility of litigation, the
prevailed against the patient, because the patient anesthesiologist’s management of this case has actu-
failed to demonstrate that anesthesia was the cause ally opened an entirely separate avenue of litigation
of a later miscarriage, or even that preoperative preg- against her.
nancy testing by anesthesiologists was a standard of As is often the case when a situation gets off to
care. such a bad start, there is no simple way to easily extri-
The ethical principle of respect for patient auton- cate our anesthesiologist from the ethical and legal
omy requires physicians to respect the decisions of mess in which she finds herself. But this situation
competent patients once they have been properly might easily have been avoided if ethical principles
informed of the risks. In most studies of preoperative had been followed from the outset. In the first place,
pregnancy testing, the finding of a positive test was a policy of requiring routine preoperative pregnancy

82
 Chapter 14. Ethical issues in preoperative testing

testing is questionable at best and based on little or evidence-based guidelines in determining if a

no supportive medical evidence. It creates ethical preoperative test should be done.
and legal dilemmas and potential social harm, while • Social risks associated with preoperative
failing to provide proven improved outcomes to testing may not be as obvious as medical
patients. Because not everything is known, or likely risks, but can be the source significant
will ever be known, about the effects of anesthesia harm – and may well outweigh any potential
on a developing fetus, patients should be privately medical benefit.
informed of the theoretical concern that pregnancy • Pregnancy testing and HIV testing are
outcomes could be affected by surgical stresses and examples of two tests with significant social
anesthetic exposure. They should also be informed implications, but little proven medical
that true risks are unknown, and they should be benefit as screening tests. Policies requiring
offered pregnancy testing if they desire it. The prac- such tests should be reconsidered in light
titioner should also determine how the patient of the ethical principles respecting patient
wishes test results to be handled, whether positive autonomy and striving for beneficence and
or negative. The informed consent process requires nonmaleficence.
respect for informed refusal, and with rare excep- • Patients should be informed of the risks and
tions patients should not be coerced into undergoing benefits of preoperative testing; informed
screening pregnancy testing by threatening to cancel refusals should in general be honored.
the case if they refuse. • If socially sensitive preoperative tests are
Whether or not routine pregnancy testing is mandated by policy, patients should be
mandated by group policy, preoperative pregnancy informed at the time of scheduling of surgery
testing requires informed consent. The anesthesia and anesthesia that these tests are required, so
practice should have policies and procedures that that they can make a determination whether,
at minimum assure the following; (1) reproduct- in the interest of their own privacy, they wish
ive information will be elicited in private; (2) if the to have care elsewhere.
patient refuses testing, the anesthesiologist will have
a response to third parties (such as parents) that
respects the patient’s right to privacy; and (3) the
consent process includes a private discussion with
the patient about to whom she wants test results to be
References
1* Lester, P., Partridge, J.C., Cheesny, M.A., and Cooke, M.
revealed. Anesthesiologists need to be aware of the
(1995). The consequences of a positive prenatal HIV
social and legal consequences of discovering a preg-
antibody test for women. J Acquir Immune Defic Syndr
nancy in a minor female patient, and group practices Hum Retrovirol, 10, 341–9.
should have a process in place to refer appropriate
2* Mazze, R.I. and Kallen, B. (1989). Reproductive
patients for counseling and prenatal care. In some outcomes after anesthesia and operation during
cases, if the patient is a minor, Child Protective pregnancy: A registry study of 5405 cases. Am J Obstet
Services may need to be involved if a test returns Gynecol, 161, 1178–85.
positive. Finally, if a group practice does decide des- 3  Reedy, M.B., Kallen, B. and Kuehl, T.J. (1997)
pite these difficulties to mandate pregnancy testing, Laparoscopy during pregnancy: A study of five fetal
it would be wise to provide that information prior outcome parameters with use of the Swedish Health
to the day of surgery to all female patients contem- Registry. Am J Obstet Gynecol, 177, 673–9.
plating anesthesia with that practice, so that patients 4* Loepke, A.W. and Soriano, S.G. (2008). An assessment
can incorporate this information in their decision of of the effects of general anesthetics on developing brain
whether to have the surgery done at their institution, structure and neurocognitive function. Anesth Analg,
or go elsewhere. 106(6), 1681–707.
5* Kempen, P.M. (1997). Preoperative pregnancy testing: a
survey of current practice. J Clin Anesth, 9, 546–5.
Key points
6* Practice Advisory for PreAnesthesia Evaluation. (2003)
• Good medical practice, both from ethical ASA Task Force on Preanesthesia Evaluation, Revised.
and medical standpoints, includes applying American Society of Anesthesiologists, Park Ridge, IL.

83
 Section 1. Consent and refusal

7* Malviya, S., D’Errico, C., Renolds, P., et al. (1996). 10 Personal communication to the author from ASA
Should pregnancy testing be routine in adolescent Closed Claims Database analyst.
patients? Anesth Analg, 83(4), 854–8.
8   Kahn, R.L., Stanton, M.A., Tong-Ngork, S., et al. (2008). Further reading
One-year experience with day-of-surgery pregnancy Lawerence, V.A., Gafni,, A., and Kroenke, K. (1992).
testing before elective orthopedic procedures. Anesth Preoperative HIV-testing: is it less expensive than
Analg, 106(4), 1127–31. universal precautions? J Clin Epidemiol, 46, 1219–27.
9   Hennrikus, W.L., Shaw, B.A., and Gerardi, J.A. (2001). Nyrhinen, T. and Leino-Kilpi, H. (2000). Ethics in the
Prevalence of positive pregnancy testing in teenagers for laboratory examination of patients. J Med Ethics, 26(1),
orthopedic surgery. J Pediatr Orthop, 21(5), 677–9. 54–60.

84
Section End-of-life issues

2
 Section 2
1 End-of-life issues
Chapter

15
The principle of double effect in palliative
care: euthanasia by another name?
Denise M. Dudzinski

The Case undertaken only with the intention of achieving the possible
good effect, without intending the possible bad effect even
Mrs. Ryan was a 58-year-old woman with widely meta- though it may be foreseen; (3) does not bring about the pos-
static breast cancer. She entered a hospice a month prior to sible good effect by means of the possible bad effect; and (4)
this hospital admission. A Do Not Attempt Resuscitation is undertaken for a proportionately grave reason.2
(DNAR) order had been written 2 months ago at her request.
Per her living will, she was willing to forgo artificial nutri- In the context of caring for a terminally ill patient, DE
tion and hydration when she was no longer able to take food allows healthcare providers to:  (1) provide adequate
and water by mouth. Her pain and symptoms were well con- pharmacological pain and symptom management (a
trolled on an outpatient regimen of celecoxib, amitriptyline, good action) knowing that (2) the foreseen but unin­
lorazepam, oxycodone hydrochloride, and morphine sulfate. tended consequence is that the medications may sup­
After 2 weeks on this regimen, she was admitted to the hospi- press respirations and hasten death. The provider
tal due to unbearable pain in her back, pelvis, and shoulders must intend only good pain management. She may
(presumed due to bone metastases). In order to relieve pain
not hope to save the patient from suffering by causing
and symptoms, intravenous fentanyl and lorazepam were
administered and titrated up when Mrs. Ryan exhibited ver-
the patient’s death, as this would constitute euthana­
bal or physical signs of distress or pain. She was receiving 700 sia which is illicit in this moral framework. (3) Death
mcg/h of fentanyl with 100 mcg boluses every hour for break- (the bad effect) is not a means to alleviate suffering (the
through pain. In keeping with Mrs. Ryan’s wishes, her physi- good effect). (4) Pain and suffering at the end of life is
cians achieved their therapeutic goal of relieving her pain and a “proportionately grave reason” to justify the use of
symptoms, but they knew there may be a “double effect.” The opioids, but the risk of hastening death is only ethically
medications could suppress respiration and hasten her death. justified if the patient is terminally ill.
What is the ethical rationale for allowing physicians to
take this risk?
Preconditions and components of DE
Certain virtues and prohibitions are taken for granted
The principle of double effect (DE) in the employment of DE. For example, alleviating
St. Thomas Aquinas first used the term “double effect” to pain at the end of life is morally virtuous, and inten­
refer to “the duality of results of a single human action” tionally killing or assisting in the death of another
in discussing killing in self-defense.1 If one attempts to person is always prohibited. Physicians need not
defend oneself, and the assailant is killed, it does not hold these beliefs. There are a myriad of other ethical
mean that death was the defender’s intention. Catholic frameworks that may inform moral behavior, such as
moral theology distinguishes what someone intends maximizing benefit and minimizing harm (utility) or
and the side effect (“foreseen but unintended conse­ acting according to duty (deontology). For example, if
quences”), suggesting that people remain responsible a competent, terminally ill patient requested euthan­
for, but are less culpable for, such double effects. asia by means of high doses of opioids, one could argue
A modern formulation of DE is: this is morally permissible because it is consistent with
(T)he traditional rule of double effect specifies that an action the patient’s wishes, the patient is dying, and euthan­
with two possible effects, one good and one bad, is morally asia will mercifully end her suffering in the manner she
permitted if the action: (1) is not in itself immoral; (2) is chooses. This is a legitimate ethical argument, but it is

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
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 Section 2. End-of-life issues

not an argument based in DE. Ultimately, each physi­ intention of the act and the intention of the actor. The
cian must decide if he finds DE reasoning persuasive, intention of the act is the goal of an action and should
and to do so he should understand both the precon­ be discernible by looking at the drugs and dosage
ditions necessary for an appeal to DE and its specific increments as well as the way pain and symptoms are
components. assessed. For example, lorazepam, oxycodone hydro­
chloride, morphine sulfate, and fentanyl effectively
Proportionality alleviate pain and anxiety. However, the adminis­
Prior to invoking DE, the patient must be dying and there tration of potassium chloride, under the auspices of
must be evidence that the patient’s pain and suffering analgesia, would be impermissible because, under the
cannot be managed using less risky means, which always principle of DE, therapy must still be governed by the
include non-pharmacological management such as standard of care, and potassium chloride cannot alle­
spiritual and social support. The expert management of viate pain.
pharmacological and non-pharmacological treatments In the interest of good palliative care, pain and
is essential to the concept of proportionality. Jansen and symptoms should be assessed frequently so that the
Sulmasy describe proportionality: “A physician’s thera­ patient can receive additional medication if she needs
peutic response to terminal suffering is justified, even if it and so that the dosage can be maintained if pain relief
it imposes a high risk of hastening the patient’s death, if has been achieved. When physicians use appropriate
and only if (1) the measures implemented are directly analgesics and write orders to titrate medication based
proportionate to the intensity of the patient’s suffering; on evidence of pain and suffering, such as groaning,
[and] (2) the measures implemented are appropriate for agitation, verbal complaints, diaphoresis, hyperten­
the type of suffering the patient is experiencing …”3 In sion, or unexplained tachycardia, they demonstrate
addition, we must exhaust all “equally efficacious alterna­ that the intention of the act is geared toward alleviat­
tives with fewer side-effects.”4 For example, if Mrs. Ryan ing pain. Unmonitored continuous infusions or orders
was receiving moderate doses of narcotics and anxiolyt­ to titrate up irrespective of signs of pain, anxiety, or
ics but was still in pain and her doctor chose to suddenly dyspnea may suggest poor clinical management or a
administer an extremely high dose of fentanyl, DE could covert intention to hasten death. Neither is acceptable
not legitimately be invoked. There is no medical or ethi­ under DE. Expert clinical management and exhaustive
cal justification to leap to such a high dose of fentanyl efforts to avoid risks of respiratory depression are pre-
without first testing accelerated but intermediate doses, conditions of DE. Pre-emptive dosing in anticipation of
and therefore no “proportionately grave reason” (e.g., signs and symptoms of suffering is not forbidden under
unremitting pain despite carefully titrated analgesia). An DE, provided it meets all DE criteria, is proportional,
appeal to DE can only be made after the patient is receiving incremental, and in keeping with expert clinical man­
expert pain and symptom management. One cannot rely agement and monitoring.
on DE to justify poor clinical care. The motives and intentions of the actor (the phy­
sician ordering medication, nurse administering the
The principle of DE does not address medication, etc.) are more difficult to ascertain. The
physician should aim only to alleviate the patient’s
the issue of consent suffering, not to hasten death. DE asks physicians to
In cultures where respect for autonomy is a legal and carefully examine their motives and assumes that one’s
ethical priority, the patient or legal surrogate should private moral intentions are morally relevant, even
understand and accept the risks of pain management. though we can never be certain of another’s intentions.
Patients and surrogates consent to all medical inter­ Put simply, we trust the stated goals and motivations of
ventions, so palliative care should be no exception. providers, unless there is good reason or evidence to
However, we respect patient autonomy due to obliga­ question them.
tions that are independent of DE. DE is silent on con­
sent. Instead, DE revolves around intention. DE permits extremely high opioid doses
DE places no upper limit on opioid or other medication
Intention dosages. The patient’s narcotic tolerance, age, underly­
Doctors who want to appeal to or better under­ ing diseases and organ dysfunction, current level of
stand DE should be able to distinguish between the sedation, and previous alcohol or drug use account for
88
 Chapter 15. Double effect

pronounced variations in narcotic and benzodiazepine drip” without adjusting medications for targeted
requirements. An experienced anesthesiologist might symptoms.7 Because the dying process tends to be
be astounded by the dosages a patient requires and slower, those involved might feel that death is simply
may continue to titrate up, provided she doses based the DE of aggressive comfort care measures, however
on ongoing clinical assessments to alleviate targeted the interval between treatment and death is irrele­
distressing symptoms such as dyspnea, agitation, and vant in DE. One can intend to hasten death slowly or
pain, and provided narcotics are not increased after quickly. For reasons already outlined, DE does not
symptoms are relieved. DE unquestionably supports support hanging the morphine drip, failing to moni­
this clinical approach, because it meets the proportion­ tor the patient’s symptoms, and succumbing to pres­
ality condition. sures from family or providers to end the anguishing
experience of witnessing a longer-than-anticipated
dying process. These pressures should be addressed
Double effect reasoning, physician aid- in other ways such as educating the family and pro­
in-dying and euthanasia viding emotional and spiritual support to the family
DE is invoked when physician aid-in-dying (a.k.a. and providers.
physician-assisted suicide) and euthanasia are illegal
and/or deemed immoral. Washington and Oregon
Death with Dignity Acts allow competent adults
Legal and professional appeals to
residing in those states who “have been determined double effect reasoning
by the attending physician and consulting physician In the interest of good anesthesia practice, phy­
to be suffering from a terminal disease, and who … sicians widely hold dual commitments to relieve
voluntarily expressed their wish to die, may make a pain at the end of life and to minimize respira­
written request for medication that the patient may tory depression and other undesired side-effects
self-administer to end his or her life in a humane and of analgesia. This professional obligation does not
dignified manner.”5 These Acts describe physician aid- rely on the principle of DE. However, when this
in-dying (PAD) as practiced in the US. Even outside balancing act is no longer sustainable, both medi­
the specific provisions of state Death with Dignity cal societies and courts seem to support DE reason­
Acts, physician aid-in-dying occurs when the physi­ ing. The American Medical Association states that
cian complies with a competent patient’s request for a “physicians have an obligation to relieve pain and
prescription for lethal medication and the physician suffering and to promote the dignity and autonomy
understands that the patient intends to self-administer of dying patients in their care. This includes pro­
the medication for the purpose of ending his or her viding effective palliative treatment even though
life. It is not PAD when a patient hoards medications it may foreseeably hasten death.” 8 Similarly, laws
prescribed for therapeutic purposes and overdoses, distinguish intended versus unintended action.
provided the physician was not aware of the patient’s For example mens rea crimes, crimes of direct
intention. intent, result in stricter punishments than crimes
In contrast, “euthanasia occurs when a third party of neglect. Intention is relevant to culpability,
administers medication or acts directly to end a per­ because “we can refuse to cause harm intention­
son’s life.”6 It is the action of another person that causes ally, but can’t avoid all harm that occurs as a side
the patient’s death, and he acts out of mercy to end effect.” 9
the patient’s suffering. Physicians may feel they are on In Vacco v. Quill, the United States Supreme Court
the cusp of euthanasia when treating pain and symp­ responded to the argument that ending or refusing life­
toms in dying patients. Granted, in some cases, the saving medical treatment is “nothing more nor less than
line between the two may not be clear, but certainty is assisted suicide.”10 Chief Justice William Rehnquist
not required, even were it possible. DE addresses this wrote that that the distinction between withdrawing
concern and helps to distinguish “slow euthanasia” or withholding medical interventions and assisted
from the DE of effectively treating terminal pain and suicide “comports with fundamental legal principles
suffering. of causation and intent.” “When a patient refuses life-
Billings and Block describe one example of slow sustaining medical treatment, he dies from an underly­
euthanasia as the practice of “hanging the morphine ing fatal disease or pathology; but if a patient ingests
89
 Section 2. End-of-life issues

lethal medication prescribed by a physician, he is killed Key points

by that medication.”10 Indeed, it is precisely uncer­
tainty concerning cause of death that raises the ethical • Until relatively recently, dying patients were
dilemma: Am I hastening death by adequately treating routinely undertreated for pain because
pain? DE permits death as a side effect not because we physicians feared that the treatment would
assert, without proof, that the underlying disease was hasten death.
the cause of death, but because the physician is not cul­ • The principle of double effect permits
pable even if the medications he administered were the aggressive treatment of pain when death may
cause of death. be an unintended effect of that treatment.
The Supreme Court seems to concur. “(I)n some • DE requires that the therapy in question be
cases, painkilling drugs may hasten a patient’s death, within the standard of care for treating the
but the physician’s purpose and intent is, or may be, targeted symptoms.
only to ease his patient’s pain. A doctor who assists a • DE does not provide moral justification for
suicide, however, “must necessarily and indubitably, poor clinical care.
intend primarily that the patient be made dead.”11 In
Vacco v. Quill, Justice Rehnquist wrote “Just as the
State may prohibit assisting suicide while permitting
patients to refuse unwanted lifesaving treatment, it References
may permit palliative care related to that refusal, which 1   Summa Theologica of St. Thomas Aquinas, I–II.
may have the foreseen but unintended ‘double effect’ of 2*  Sulmasy, D.P. and Pellegrino, E.D. (1999). The rule of
hastening the patient’s death.”10 double effect: clearing up the double talk. Arch Intern
Med, 159(6), 545–50.
3*  Jansen, L.A. and Sulmasy, D.P. (2002). Proportionality,
Criticisms of DE terminal suffering and the restorative goals of
DE’s emphasis on intention invites criticism. Timothy medicine. Theoret Med Bioeth, 23(4), 321–37.
Quill, Rebecca Dresser, and Daniel Brock write, “(A) 4*  Young, R. (2007). Medically Assisted Death. Cambridge,
ccording to modern psychology, human intention is UK: Cambridge University Press. p. 251.
multilayered, ambiguous, subjective, and often con­ 5   Revised Code of Washington, 70.245.020.
tradictory. The rule of double effect does not acknowl­ 6*  Braddock, C. and Tonelli, M.R. (2009). Physician Aid
edge this complexity; instead, intention is judged in Dying. Ethics in Medicine Website, University of
according to the presence or absence of a clear pur­ Washington, Seattle WA. http://depts.washington.edu/
bioethx/topics/pas.html
pose. Clinicians familiar with the requirements of the
rule may learn to express their intentions in perform­ 7*  Billings, J.A. and Block, S.D. (1996). Slow euthanasia.
J Palliative Care, 12(4), 21–30.
ing ambiguous acts … in terms of foreseen but unin­
tended consequences …”12 On the contrary, DE does 8*  Council of Ethical and Judicial Affairs. (1992).
Decisions Near the End of Life. Chicago, IL: American
acknowledge the complexity of human intention, but
Medical Association.
still requires moral honesty and integrity, not perfec­
9*  Hawryluck, L.A. and Harvey, W.R. (2000). Analgesia,
tion, in examining private intentions. Under virtue-
virtue, and the principle of double effect. J Palliative
based traditions, the fact that human psychology Care, 16 Supplement, S24–30.
and motivation is complex and sometimes ambigu­
10   Vacco v. Quill, 521 US793 (1997).
ous – that we often have mixed intentions – does not
11   Washington v. Glucksverg. 521 U.W. 702 (1997).
exempt one from setting morally appropriate goals,
12* Quill, T.E., Dresser, R. and Brock, D.W. (1997). The
examining mixed intentions, and acting in good faith.
rule of double effect – a critique of its role in end-of-life
Certainly, a physician can appeal to DE to justify his
decision making. N Engl J Med, 337(24), 1768–71.
intention to hasten death and none may be the wiser.
DE does not “let him off the hook” simply because it
has no mechanism to objectively test for dishonesty. Further reading
Rather, his intentions never met criteria for DE despite Battin, M. (2008). Terminal sedation: pulling the sheet over
his claim. our eyes. Hastings Ctr Rep, 38(5), 27–30.

90
 Chapter 15. Double effect

Boyle, J. (2004). Medical ethics and double effect: the case of and sedation in dying intensive care unit patients. BMC
terminal sedation. Theoret Med Bioeth. 25(1), 51–60. Med Ethics, 3(3): E3.
Hawryluck, L.A., Harvey, W.R., Lemieux-Charles, L, and Jansen, L.A. (2010). Disambiguating clinical intentions: the
Singer, P.A. (2002). Consensus guidelines on analgesia ethics of palliative sedation. J Med Philos, 35(1), 19–31.

91
 Section 2
1 End-of-life issues
Chapter

16
Surgical interventions near the
end of life:  “therapeutic trials”
Carl C. Hug, Jr.

The Case Ethical considerations: should the operation

An 86-year-old retired accountant was experiencing have been offered?
­worsening symptoms and signs of congestive heart failure.
He was particularly frustrated by generalized fatigue and
The patient clearly understood and accepted the
dyspnea on excretion, which severely limited his functional- balance of benefits versus risks, and gave informed
ity. Cardiac catherization and echocardiography revealed consent to the procedure. Offering the operation is
calcific aortic stenosis (0.8 cm2), significant occlusions of respectful of the ethical principle of autonomy. On
his coronary arteries (>95% LAD, >75% circumflex and the other hand, a surgeon might consider the bal-
RCA), global hypokinesis (EF 0.25), 2+ mitral regurgita- ance of the principles of beneficence and nonma-
tion, dilated left ventricle, and pulmonary artery hyperten- leficence to be unacceptable, and as an independent
sion (70/35 mmH)g. Co-morbidities included non-insulin moral agent, could justifiably refuse to perform the
diabetes mellitus and right ocular blindness. The cardiac operation.1
surgeon estimated a 20%–30% operative mortality and Patients should carefully consider three specific
a 30%–40% chance of reducing his debilitating symp-
questions before undergoing an intervention with sub-
toms. The patient declined surgery initially, but returned
3 months later stating he would “rather die than go on in his
stantial risks of bad outcomes:
present condition.” (1)  What are my goals for the intervention?
He underwent aortic valve replacement and coronary (2)  What disabilities are unacceptable to me?
artery bypass grafting during 3 hours of cardiopulmon- (3)  What are my alternative options?
ary bypass after which an intraaortic balloon pump and
multiple inotropic drugs were required to sustain mar- The patient’s primary goals were to improve his func-
ginal cardiac function. Platelets were required to treat his tionality and to reduce his symptoms even in the face
coagulopathy. of a substantial risk of dying. It is not clear that he fully
His 26-day stay in the intensive care unit required understood that he might incur disabilities beyond
treatment for bacteremia and pneumonia, tracheotomy, those he was experiencing preoperatively. It is almost
and peritoneal dialysis. Fluctuating mentation, per- certain that the alternative option to surgery was pal-
sistent low-grade fever, and two failed attempts of tra- liative care and hospice either at home or in a hospice
cheal extubation indicated insertion of a percutaneous facility.
endoscopic gastric (PEG) feeding tube and a percutan-
eous intravenous central catheter. On the 27th post-
operative day he was transferred to a long-term acute Interventional trials
care facility.
Medicine has been described as the science of uncer-
On the 33rd postoperative day he suffered a mas-
tainty and the art of probability. There is never 0% or
sive GI bleed and systolic blood pressures in the 50’s. He
was transferred to the hospital ER, then to the ICU with 100% benefit or risk. Sir William Osler said, “Every
continuing requirements for transfusions, inotropic vaso- treatment is an experiment.”2 An interventional trial
pressors, and mechanical ventilation to stabilize his vital with both potential benefits and recognizable risks of
functions. Two days later, profuse bleeding recurred and death is neither euthanasia nor physician-assisted sui-
after 45 minutes of cardiopulmonary resuscitation (CPR) cide. Statements by ethicists include: “only after start-
death was declared. ing treatments will it be possible in many cases … to

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
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 Chapter 16. Surgical interventions near end of life

balance prospective benefits and burdens”;3 “… trial ­suspending his living will and the timing of reinstating
interventions, coupled with hard-nosed clinical real- it were ever discussed.
ism, may appropriately balance the possibilities for Several questions need to be addressed when the
good or ill …”;4 “… The moral burden of proof often outcome of the intervention is poor and the possibil-
should be heavier when the decision is to withhold ities of achieving the patient’s stated goals are virtu-
than it is to withdraw treatments.”3 ally nil:
However, an interventional trial has important (1) When should the primary emphasis of care be
requirements in the case of surgical operations with changed from restorative to palliative? Both are
substantial risks of serious disabilities and death. Some intimately part of patient care throughout the
time will be required to allow recovery from the oper- intervention,5 but the restorative measures may
ation. With evidence of progressive improvement over become ineffective and burdensome to the patient
days (with transient ups and downs) support of vital and even to his family and friends. The burdens
functions should be continued. But there should also may include pain and discomfort as analgesic
be an understanding and willingness to discontinue and sedative drug doses are reduced in attempts
vital function support if: to wean the patient from mechanical ventilation.
(a) It is unlikely that the patient’s goals will be Examples of burdens to his family and friends
achieved, include perceiving the patient as suffering, the
(b) There is worsening of the patient’s condition uncertainty about the degree and duration of his
despite continuing or even increased supportive dependency on continuing interventions and life
therapy, and most assuredly, supporting measures, the escalation of continuing
(c)  If multiple organ systems fail. costs of care, and the possibility that the patient
would never be able to return to his home.
Ideally, all these possibilities should be discussed with
(2) What are the options for decelerating vital
the patient and his/her family well in advance of under-
function support? First of all, the family should
taking the operation.
receive regular and realistic updates on the
patient’s progress, or lack thereof, toward
Does this case represent surgical “euthanasia?” achieving the patient’s stated goals for the
On the basis of the principle of double effect, the operation. The focus should be on the overall
answer to that question depends on the intentions of trend and not the minor ups and downs of vital
the patient and the surgeon.3 Although the patient and signs, drug infusion rates, ventilatory settings,
the surgeon recognized death as a possible outcome of etc. It is important to recognize that it will take
surgery, it is clear that they accepted this possibility and time, perhaps days, for the family to grasp the lack
had the intention of improving the patient’s status. The of improvement or deterioration in the patient’s
patient never stated a wish for euthanasia or assisted condition.
suicide.

What roles should the patient’s living will and durable Decelerating and discontinuing vital
power of attorney for healthcare (DPAHC) decisions function support 6
have played? When it becomes clear to the physicians that the patient
The restrictions on interventions expressed in his liv- is failing to respond to maximum therapy, and deteri-
ing will (dated several years earlier) would have to be oration of one or more vital organ functions is occur-
suspended for any patient undergoing cardiac sur- ring, it is appropriate to approach the patient (if able
gery, because resuscitation measures such as mech- to comprehend) and family members on the issues of
anical ventilation, defibrillation, etc. are routinely decelerating vital function support while continuing to
used in the conduct of cardiac operations. His specific keep the patient comfortable. Never say: “There is noth-
instructions to his primary (wife) and secondary (son ing more we can do.” Rather, assure the family that “we
who is an obstetrian/gynecologist) surrogates, if any, can keep the patient comfortable.”
are unknown. Both were supportative of his decision Recognizing the family’s need for time to accept
to have the operation. It is doubtful that the issues of and adjust to the circumstances, deceleration may take

93
 Section 2. End-of-life issues

a stepwise course. Often, the first step is to establish a especially if that burden will fall primarily on one
do-not-resuscitate (DNR) order, while reassuring the ­person.7
family that all other therapies will be continued for
the present time. Assure the family that the patient’s Dealing with demands that  “everything”
needs will not be ignored. The patient will not be aban-
doned. To the author, DNR has two meanings: Do Not be done
Resuscitate. Do Not Relax! This case is typical of the cases most commonly brought
Subsequent discussions may include discontinu- to an ethics committee of an acute care hospital today.
ation of one or more vital function supporting meas- Acute care hospitals are primarily involved with surgi-
ures (e.g., dialysis). Sometimes a family will agree to cal and other types of invasive interventions sometimes
discontinue all vital function supports with the excep- followed by intensive care. Fortunately, most patients
tion of one particular measure which may be symbolic are successfully discharged from the hospital in stable
to them. When the ultimate decision is to discontinue condition, but some have varying degrees of disability
all vital function supports, the family should be reas- and continuing requirements for assistance with their
sured that the patient will not be allowed to suffer. For convalescence.
that reason, an intravenous infusion of fluids should Aging draws on physiologic reserves (see Fig 16.1)
be continued, and drugs administered to prevent ago- to maintain independent function, and for some, the
nal respiration, which is most distressful to the fam- functional level is amazingly good as they compensate
ily (e.g., morphine infusion at 2–5 mg per hour), and for accumulating chronic diseases. But when a signifi-
a drying agent (e.g. scopolamine 0.2 mg iv) along with cant hurdle is imposed, even apparently very fit patients
oral pharyngeal and tracheal suction to prevent the may have too little additional reserves to clear the hur-
“death ­rattle.” Intensivists differ on the maintenance dle.8 This fact of life is not recognized or accepted by
or removal of the endotracheal tube to prevent these the general public in the US, especially by those “baby
distressing signs. boomers” who strive to live “forever.” And discussions
of death are taboo in most families and among friends.
In addition, the ideas of “medical miracles” in the
Transferring the patient from the ICU news media coupled with television situations in which
If the patient is stable but in need of continuing life- resuscitation virtually never fails, the common expec-
supporting measures, discussions with the family tations are that “doing everything” will successfully
about transferring the patient from the ICU to another restore any patient. Obviously, the truth is otherwise
facility (e.g., long-term acute care) should be outlined for many cases.
in some detail and assurances given that there will Suggestions of what physicians and nurses can do
continuity of care by virture of direct communication when faced with a family who demands that everything
with the physicians and nurses at that facility. be done to save their loved one who is deteriorating
Social Services can be very helpful in locating the include:
appropriate facility that is satisfactory to the family. (1)  Consistently state the truth about the patient’s
Most importantly, there should be assurances that condition in a compassionate manner and
communications with the physicians in that facility do not suggest there is hope based on
will include specific information about any limitations minor, usually transient, changes in vital
on further interventions (e.g., DNR order) to which the functions.
patient and family have agreed. (2)  Ideally, agree to have a single physician
If the patient requires only moderate assistance with communicate with the family to avoid their
the activities of daily living, adhering to the prescribed impressions that the care team is divided because
schedule of medications, and a proper diet, the transfer different physicians use different words and have
sequence may be from the ICU to a private room in the different body language that are interpreted as
hospital and then to a rehabilitation facility and then to different conclusions.
a nursing home-type facility. (3)  Constantly refer to what the goals of the patient
Given the stress of caring for such a patient in a were in consenting to the intervention. Of course
private home the family should think long and hard it is important to have the goals explicitly stated
about the burdens of providing 24/7 continuous care, and recorded in advance.

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 Chapter 16. Surgical interventions near end of life

Organ System Functional Reserve Figure 16.1  Functional reserve is

needed when a person faces a stressful
situation. As persons age, they draw
Physiologically
100 on their functional reserve to maintain
“Young”
relatively normal function, and as a
%Maximal organ function

­consequence, they have less reserve to

80 meet a new, stressful challenge such
as a major surgical operation and the
demands of recovery.
60
Average
Functional
40 reserve
Physiologically
20 “Old”

Basal
0
20 30 40 50 60 70 80 90
Age (Years)

(4)  Remind all involved that it is one thing to keep

a heart beating, but quite another to restore a • Be willing to discontinue aggressive care if the
meaningful life as defined by the patient’s previous goals cannot be achieved.
statements. • Recognize that “comfort care” is an important
(5)  Distinguish prolonging death from extending life. and continuous form of caring.
(6)  Involve pastoral services to help the family deal • Deal with the demand that “everything be
with their dread and grief. For many people, done” sympathetically but realistically.
there is belief that death is a transition to another
(better) existence.

Case resolution References

1*  Code of Medical Ethics. Termination of the physician–
As a therapeutic trial, the lengthy and complex opera-
patient relationship. American Medical Association,
tion initially had limited success in so far as the patient Chicago, IL 2008–2009 edition, Section 8.115, p. 261–263;
made slow progress. When it became evident that his Section 8.20, p. 289, and Section 10.05, p. 354.
situation remained tentative with virtually no chance 2*  Jonsen, A.R. (2000). A Short History of Medical Ethics.
that the patient could tolerate any major set back, con- New York: Oxford University Press, p. 89.
sideration of initiating DNR would have been appropri- 3*  Beauchamp, T.L. and Childress, J.F. (2001). Non-
ate for two purposes: (a) it was in line with the patient’s maleficence. In Principles of Biomedical Ethics, 5th edn,
advance directives; and (b) it would have been a clear New York: Oxford University Press, pp. 113–64.
signal to his surrogate-family members that expecta- 4*  McCullough, L.B., Jones, J.W., and Brody, B.A. (1998).
tions for reaching his stated goals were diminishing Surgical Ethics. New York: Oxford University Press,
day by day. pp. 152–70.
Most importantly, the failure to have a DNR order 5*  Statement on clinical practice guidelines for quality
in place at the outside facility resulted in an inappropri- palliative care. (2006). American Academy of
ate transfer back to the hospital and futile attempts to Hospice and Palliative Care. Glenview, IL. www.
salvage what clearly was a fatal event given his already nationalconsensusproject.org.
extremely limited reserves. 6*  Truog, R.D., Cist, A.F.M., Brackett, S.E. et al. (2001).
Recommendations for end-of-life care in the intensive
Key points care unit: the Ethics Committee of the Society of
Critical Care Medicine. Crit Care Med, 29(12),
• In end-of-life care, focus on the patient’s 2232–48.
goals, not merely the individual procedures 7*  Mittelman, M. (2005). Taking care of the caregivers. Curr
involved. Opin Psychiatry, 18 (6), 633–9.

95
 Section 2. End-of-life issues

8*  Muravchick S: (2000). Anesthesia for the elderly. In http://www.asahq.org/publications and services/
Anesthesia 5th edn. Miller, R.D., ed. Philadelphia, sgstoc.htm
PA: Churchill Livingstone, p. 2141. McCullough, L.B., Jones, J.W., and Brody, B.A. (1998).
Surgical Ethics. New York: Oxford University Press,
Further reading p. 182.
Ethical guidelines for the anesthesia care of patients with Troug, R.D., Campbell M.L, Curtis J.R. et al. (2008)
do-not-resuscitate orders or other directives that limit Recommendations for end-of-life care in the intensive
treatment (2008). ASA Standards, Guidelines and care unit: a consensus statement by the American
Statements, American Society of Anesthesiologists. College of Critical Care Medicine. Crit Care Med, 36(3),
Park Ridge, IL. 953–63.

96
 Section 2
1 End-of-life issues
Chapter

17
Withholding and withdrawing life support
in the intensive care unit
Mark D. Siegel and Stanley H. Rosenbaum

The Case and physician in charge rather than to the patient’s

wishes or disease. In many cases, treatment is exceed-
Mrs. Jones is an 88-year-old woman with a history of
ingly unlikely to confer benefit and resources expended
­diabetes, stable coronary artery disease, and hypertension.
She lives independently in her own home, with weekly visits could be better directed elsewhere. Dying patients
from a housekeeper. Three grown children live nearby, and often endure needless pain and suffering, while fam-
one of her children (a son, age 54) lives out of state. ily members experience severe psychiatric symptoms.
The housekeeper discovers Mrs. Jones unconscious Families participating in end-of-life decisions often
in the hallway of her home after an obvious fall that is describe conflict with the medical team, a potential
believed to have occurred sometime in the preceding sev- source of dissatisfaction.2
eral days. Mrs. Jones is intubated, and admitted to the ICU. Several comprehensive reviews offer guidance to
She has a broken hip, severe dehydration, and aspiration physicians and other caregivers seeking to optimize
pneumonitis. Shortly after admission, she is diagnosed end-of-life care and are included in the “Further read-
with a subdural hematoma and proceeds to surgery for
ing” at the end of this chapter. This chapter will con-
emergency evacuation of the subdural. She never regains
sider an ethical framework to guide decision making,
consciousness.
Postoperatively, she remains ventilator dependent with to explore frequently encountered obstacles, and to
significant hypoxemia requiring 100% oxygen and PEEP. offer practical suggestions to enhance care for patients
She develops sepsis, with hypotension, tachycardia, and dying in the ICU.
myocardial ischemia. After resuscitation from a cardiac
arrest due to ventricular tachycardia, she develops acute
renal failure that requires hemodialysis. Liver function tests
Ethical framework for end-of-life
demonstrate elevated transaminases. decision-making
Discussions with the family about withdrawing life Four basic ethical principles should guide end-of-
supporting therapy begin. While the three local children are
life decision-making in the ICU:  (1) respect for the
in favor of limiting treatment to comfort care, the son from
patient’s autonomy; (2) the duty of beneficence; (3)
out-of-state wants to continue invasive treatments.
the duty of nonmaleficence; and (4) the obligation to
More than one-fifth of deaths in the US follow intensive ensure just distribution of care. Day-to-day dilemmas
care unit (ICU) admission, usually after decisions to in the ICU frequently bring these principles into ten-
forgo life support.1 Each day, intensivists must decide sion. Patients may exercise their autonomy by refus-
whether to start or continue life sustaining therapies ing recommended care or requesting treatments that
such as cardiopulmonary resuscitation, mechanical physicians believe they should forgo. Alternatively,
ventilation, or hemodialysis. Often, the decision to resource limitations may force caregivers to deny care,
forgo treatment may protect a dying patient from inef- even if desired or potentially beneficial. Negotiating
fective care and suffering, but sometimes the decision these tensions is a challenge for physicians seeking to
may determine if a patient lives or dies. providing ethically appropriate care.
End-of-life care in the ICU has many shortcom- End-of-life decisions fall broadly into two cat-
ings. For example, patients with similar illnesses egories depending on the degree to which available
receive highly variable care and end-of-life decisions choices are constrained. Constrained choices include
may be more closely related to the country, hospital, those affected by triage or futility considerations. For

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
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 Section 2. End-of-life issues

Table 17.1. An example of a triage scoring system* The goal of triage is to maximize utilization of the
Level 1 – Patient requiring life support and with potential ICU by patients most likely to benefit (Table 17.1).
to benefit In choosing among patients, two key factors to con-
Level 2 – Patient requiring close monitoring with
sider are severity of illness and potential to benefit.
potential to benefit Patients requiring life support technology such as
intubation and mechanical ventilation, continuous
Level 3 – Patient requiring life support with minimal
potential to benefit
renal replacement therapy, or left ventricular sup-
port devices generally have a more compelling need
Level 4 – Patient requiring close monitoring with
for ICU care than those requiring monitoring alone.
minimal potential to benefit
At the same time, factors such as severity of the acute
Level 5 – Patient does not meet standard ICU criteria illness and chronic comorbidities strongly influence
* Adapted by Medical Triage Policy, Yale–New Haven Hospital. the likelihood of benefit. Patients who are moribund
and unlikely to survive despite aggressive care are
example, when the demand for ICU beds exceeds often less likely to benefit than those that are less ill.
capacity, physicians may have to deny admission to The same holds for patients with severe underlying
patients who might benefit.3 Similarly, physicians may illnesses, like advanced cancer, in whom the progno-
not be able to provide requested care because desired sis is likely to be poor regardless of the intervention
outcomes cannot be achieved, which, by definition, provided.
limits options.4 Most end-of-life decisions in the ICU, Basic principles of fairness should govern triage.
however, are less constrained, leaving patients or sur- It is inappropriate to discriminate on the basis of race,
rogates with treatment options to consider. gender, sexual orientation, ability to pay, or political
connections. Whether to discriminate on the basis
Triage of age or functional status is controversial. Objective
With increasing frequency, physicians are forced to scoring systems should be used to maximize fairness.
choose among multiple patients vying for a limited To minimize conflicts of interest, triage responsibility
number of ICU beds. Contributing factors include should be delegated to physicians not directly involved
growth in the critically ill population, increasing rec- in patient care. Physicians responsible for triage require
ognition of better outcomes associated with ICU institutional support to support their authority while
admission, and concerns about bioterrorism and pan- the hospital administration, attorneys, and ethics com-
demics. As a result, ICU administrators and physicians mittee should be enlisted to provide oversight and
are obligated to implement effective, fair triage plans to guidance. Finally, when admission is denied, decisions
optimize bed use. must be made to determine if life saving efforts will be
By definition, triage implies that patients who attempted outside the ICU or whether the focus should
might benefit from the ICU may be denied admission. shift to palliation alone.
The decision to deny admission could bring harm,
including death, to the patient. Hospitals should seek Futility
to avoid the need to triage by investing sufficiently in In the context of decision-making, futility refers to care
resources to meet demand by ensuring a sufficient sup- that cannot achieve a desired end point.4 How often
ply of qualified staff, beds, and equipment. In addition, futile care is requested or provided is unknown; how-
steps should be taken to safely decrease ICU length of ever, the frequency undoubtedly depends on the def-
stay by promoting good practices, such as timely wean- inition used. Both quantitative and qualitative criteria
ing from mechanical ventilation, making timely end- for futility have been proposed, although consensus is
of-life decisions, and encouraging efficient throughput lacking. In general, agreement is more easily achieved
by transferring patients out of the ICU as soon as they when situations are extreme, for example, when the
are eligible. Institutions should maximize their abil- patient is moribund.
ity to care for patients outside the unit, for example by At least in theory, identifying futility should trans-
increasing skills and staffing of non-ICU personnel. form decision-making and relieve families from con-
Denying ICU admission should not be equated with sidering treatments that cannot alter outcome, shifting
the decision to forgo life support, although sometimes the focus to those that can. Offering futile care makes
that may be the implication. little ethical sense: it cannot help, it may cause harm,

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 Chapter 17. Withholding / withdrawing life support

and it may waste resources and deny other patients information is available to guide these judgments, sur-
access to care. rogates may be left to choose treatment they believe to
Surrogate decision makers will occasionally request be in the patient’s best interest.
care that physicians consider futile. Professional soci- Several factors are likely to increase the burden
eties have opined that physicians are not obligated to faced by surrogates. Decision-making subjects family
provide care that cannot achieve treatment goals, even members to enormous stress. Many family members
if requested.5 Careful, informative, empathic discus- experience severe anxiety and depression during the
sions will generally resolve most disputes. In the minor- ICU stay, which could interfere with their ability to be
ity that persist, a deliberate approach that incorporates effective surrogates.7 Some may not know the patient
second opinions and opportunities to transfer care may well enough to feel comfortable making decisions.
ultimately lead to unilateral decisions to forgo treat- Although they are probably more accurate than physi-
ment. However, not all physicians agree that unilateral cians, family members may not reliably make the same
decisions are appropriate and some suggest deferring choices the patient would.2 Even if past discussions
to families in the small minority where impasse cannot occurred, patients’ wishes may not be static  – prior
be resolved.4 conversations and advance directives may not accu-
For practical reasons, the futility rationale should rately portray what patients would choose under the
probably be curtailed for all but the most obvious circumstances encountered.
cases. Physicians and nurses are often unable to accu- Certain observations may be helpful. The will-
rately identify futility, raising the possibility of error. ingness of individual patients to endure aggressive
Concerns about self-fulfilling prophecies suggest that therapy should not be underestimated. Many patients
poor outcomes may occur simply because physicians with severe underlying diseases are willing to choose
consider the prognosis poor. Finally, survival appears aggressive ICU care, particularly if there is a chance
to be improving for some patients with traditionally for functional survival. In contrast, patients tend to be
devastating illnesses, such as stem cell transplant recip- less willing to undergo ICU care if the likely outcome is
ients with respiratory failure, suggesting that prior functional or, especially, cognitive impairment.8
beliefs about futility may be obsolete. For these rea-
sons, we believe futility designations should be limited Family meetings
to obvious cases, while favoring traditional approaches The primary purpose of family meetings is to choose
that balance risk, benefit, and patient preferences when treatments best suited to meet the patient’s goals.
there is doubt. Effective family meetings can increase family sat-
isfaction and may mitigate long term psychiatric
Unconstrained decision-making complications during bereavement. At its core,
appropriate family meetings include all the compo-
Surrogate decision-making nents of any other discussion devoted to informed
Most decisions in the ICU are unconstrained by decision making. Physicians must ensure that surro-
triage and futility concerns, leaving physicians and gates are in a position to make decisions most likely
surrogates with options to consider. Respect for the to meet the patient’s goals. Surrogates must have the
patient’s autonomy should dictate most decisions. capacity to make informed decisions and physicians
Unfortunately, most critically ill patients cannot rep- must give them the information required, including
resent themselves due to cognitive impairment result- descriptions of the patient’s illness, available treat-
ing from their acute illness, delirium, sedation, or ments options, and the risks, benefits, and likely
dementia. Surrogate decisions-makers, usually family outcomes of each option. Most surrogates want phy-
members, must speak for them.6 sicians to contribute to ­decision-making9 and physi-
Ideally, surrogates may be able to articulate patients’ cians should provide input to the degree that families
previously documented wishes, for example if relevant desire.
advance directive are available. If no explicit direction Unfortunately, family meetings are often poorly
is available, surrogates may be able to provide sub- run.1 Many are led by physicians with little experience
stituted judgment, indicating what they believe the and tend to emphasize procedural details (e.g., intuba-
patient would choose, for example, on the basis of prior tion and CPR) without adequately discussing likely
discussions or what is known about the patient. If no outcomes, risks, and alternatives. There is often undue

99
 Section 2. End-of-life issues

focus on “code status,” rather than appropriate treat- suffering if there is no reasonable associated treat-
ment goals, which should, in turn, guide decisions. ment benefit.
Families are often asked to decide upon major interven- Most perceived impasses and conflicts between
tions with insufficient information to guide them.10 family members and caregivers are actually due to
Many families have limited understanding of identifiable problems that can be readily addressed
their loved ones’ illnesses and prognoses. Many (Table 17.2). Different perceptions regarding prog-
know relatively little about life-sustaining technolo- nosis may respond to open, patient discussion. Many
gies and often overestimate the likelihood of suc- perceived sources of conflict such as anger, distrust,
cess.10 Many express a fear, not entirely misplaced, and unrealistic expectations may simply be the
that a do not resuscitate (DNR) decision will lead to manifestations of grief associated with the trauma
less aggressive care overall.1 Language barriers when of hearing bad news and may dissipate if caregivers
families do not speak English and also when impre- show empathy. Various cultural barriers may impose
cise terminology and jargon are used may com- obstacles, particularly when physicians and families
promise communication. An undue burden is often are from different racial, religious, ethnic, or cultural
placed on families to make decisions independently, backgrounds or speak different languages.12 Families
even though most would prefer to share responsi- from non-Western backgrounds may not share stand-
bility with physicians.9 Physicians often miss oppor- ard beliefs regarding patient autonomy, delivering
tunities to let families speak or to share emotional bad news, or the family’s appropriate role in deci-
support and empathy, which, in turn, could under- sion-making. Families from traditionally oppressed
mine negotiation.11 groups may be less inclined to trust that physicians
Several reviews have highlighted the features of have the patient’s best interest at heart. Families from
successful family meetings.1,5,11 Key among these are some religious backgrounds may believe in miracles
meeting early in the ICU stay, planning in advance, and may not be inclined to consider the physician’s
following a structured but flexible format, allowing prognostic estimates relevant. Sensitivity to these
time for family members to speak and ask questions, potential sources of conflict and input from allied
avoiding undue pressure to make decisions, and show- personnel such as professional interpreters, chap-
ing empathy. Families show greater satisfaction when lains, and social workers may help identify and over-
they are assured that their loved one will not suffer or come barriers. Finally, it is important to recognize
be abandoned, and when they receive support for their that most families experience anxiety and depres-
decision.11 sion when faced with losing a loved one. Patience,
Under the best of circumstances, physicians and empathy, and willingness to share in the burden of
family members may not be able to agree on deci- decision making may prove valuable. In the setting of
sions. Families may choose treatments that differ from a trusting relationship, physicians should rarely feel
those physicians recommend. Physicians are obliged the need to override families’ choices. Negotiation,
to ensure that families understand treatment options education, and good communication about progno-
and that coherent decisions are made in accord with sis and treatment options should eliminate or min-
the patient’s wishes, if known, or best interest, if not. imize barriers to consensus.
Physicians may choose to gently disagree and negoti-
ate with families. However, in most cases, they should Withholding and withdrawing life support
defer to families, as long as the choices are well consid- If the decision is made to withhold or withdraw life
ered and are limited to options consistent with stand- support, it is generally appropriate to proceed expedi-
ard medical care. tiously, while allowing time for family and other visi-
Families will occasionally request treatment that tors to gather. When appropriate, local organ banks
arouses misgivings among team members. In some should be notified so that donation options are pur-
cases, physicians may feel that the requested care is sued – often local policy may require notification, par-
likely to cause excessive suffering and little good; ticularly in the setting of brain death.
alternatively, physicians may be concerned that fam- The patient’s physical comfort must be assured
ilies are refusing potentially effective care and putting prior to withdrawing life support, particularly when
patients at risk. Ultimately, physicians are obligated intubation and mechanical ventilation are discontin-
by basic ethical principles to avoid causing pain and ued. Families may differ regarding their preference

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 Chapter 17. Withholding / withdrawing life support

Table 17.2. Sources of conflict in end-of-life decision-making and potential solutions

Nature of conflict Potential solutions*

Religious Input from clergy
Unrealistic expectations Teaching, time-limited treatment trials
Lack of trust Build rapport, emphasize mutual desire to help patient
Cultural barriers Input from interpreters or caregivers from similar background
Irrational thinking Consider cognitive impairment and/or psychiatric symptoms, consider input from
social work, take a gentle approach, be patient
Anger Build rapport, redirect emotions
* Suggested solutions are not meant to imply that conflicts raised have easy or predictable solutions, nor that the cause is always
easily identified. The nature of the dispute cited by the family or identified by caregivers may mask deeper conflicts requiring further
exploration.

for removing the endotracheal tube and their wishes transfer to a hospice unit or a floor able to provide con-
should generally be respected as long as the patient’s tinue expert care may be necessary, particularly if ICU
comfort is paramount. Withdrawal of life support is beds are in short supply.
best approached as a procedure with specific, neces-
sary components. Medications should be targeted Case resolution
to ensure comfort. To achieve symptom control, the Mrs. Jones failed to improve. Her physicians saw death
dosing of some medication, particularly opiates, may as inevitable and tried to persuade the family to with-
lead to respiratory depression or even quicken death in draw life support. Three children embraced these rec-
some cases. From an ethical perspective, such dosing ommendations, but the son from out of town did not.
is acceptable (i.e., the principle of “double effect” – see Over the next 2 days, the medical team met frequently
Chapter 15) as long as the primary purpose is to allevi- with the family, accompanied by ICU nurses, a social
ate discomfort and not primarily to suppress respira- worker, and a chaplain. During these meetings, the
tion or hasten death. In most cases, however, opiates son acknowledged a strained relationship with his sib-
do not shorten time to death and sometimes symp- lings and expressed regret that he had not visited his
tom management may lead to a period of temporary mother more often. He ultimately acknowledged that
stabilization. his mother was not improving and came to support
Families require substantial support during and his siblings’ view that she would not want to remain
after withdrawal of life support. Physicians may offer on the ventilator given the poor prognosis. Consensus
reassurance by visiting the patient’s room intermit- was soon reached to switch the focus to palliation. A
tently, answering questions about the dying proc- morphine infusion was started for pain and dyspnea
ess, reinforcing their support for the decision, and and the ventilator was disconnected. Mrs. Jones died
expressing empathy and support. It may be helpful peacefully several minutes later, surrounded by her
to explain the role of medications to treat distress- family and the ICU team.
ing symptoms. Similarly, it may be helpful to explain
the dying process, particularly agonal breathing, and Key points
reassure families that symptoms will continue to be
effectively managed. Recognizing that family mem- • End-of-life care, particularly making
bers, particularly spouses, are at significant risk for decisions to withhold or withdraw life
developing psychiatric disorders during bereave- support, is a fundamental component of
ment, plans for follow-up care and appropriate refer- critical care practice.
rals might be considered. • Appropriate end-of-life decision-making
If the bed is available and death is imminent, hinges on the intensivist’s understanding of
patients should be kept in the ICU and families should key ethical principles. In some cases, decisions
be allowed to spend time with the body afterwards if are constrained by limits in available
they wish. However, if process is likely to be prolonged,
101
 Section 2. End-of-life issues

theory and clinical practice. Ann Intern Med, 149(1),

ICU resources, particularly beds; in other
48–53.
cases, decisions are constrained by limitations
7*  Pochard, F., Azoulay, E., Chevret, S., et al. (2001).
imposed by the patient’s disease.
Symptoms of anxiety and depression in family
• Careful, deliberate, and empathic members of intensive care unit patients: ethical
explanations and negotiation usually lead to hypothesis regarding decision-making capacity. Crit
choices acceptable to both family members Care Med, 29(10), 1893–7.
and the medical team. Impasses may 8*  Fried, T.R., Bradley, E.H., Towle, V.R., and Allore, H.
occasionally arise, although most are likely to (2002). Understanding the treatment preferences of
resolve with patience and identification of the seriously ill patients.[see comment]. N Engl J Med,
barriers preventing agreement. 346(14), 1061–6.
• When life support is discontinued, it is crucial 9*  Heyland, D.K., Cook, D.J., Rocker, G.M., et al. (2003).
to providing ongoing care both to patients and Decision-making in the ICU: perspectives of the
their newly bereaved families. substitute decision-maker. Intensive Care Med, 29(1),
75–82.
10* Heyland, D.K., Frank, C., Groll, D., et al. (2006).
Understanding cardiopulmonary resuscitation
References decision making: perspectives of seriously Ill
1*  Siegel, M.D. (2009). End-of-life decision making in the hospitalized patients and family members. Chest,
ICU. Clin Chest Med, 1, 181–94. 130(2), 419–28.
2*  Way, J., Back, A.L., and Curtis, J.R. (2002). Withdrawing 11* Curtis, J.R. and White, D.B. (2008). Practical Guidance
life support and resolution of conflict with families. for Evidence-Based ICU Family Conferences. Chest,
BMJ, 325, 1342–5. 134(4), 835–43.
3*  Guidelines for intensive care unit admission, discharge, 12* Kagawa-Singer, M. and Blackhall, L.J. (2001). Negoti­
and triage. (1999). Task Force of the American College ating cross-cultural issues at the end of life: “you got to
of Critical Care Medicine, Society of Critical Care go where he lives.” JAMA, 286(23), 2993–3001.
Medicine. Crit Care Med, 27(3), 633–8.
4*  Burns, J.P. and Truog, R.D. (2007). Futility: a concept in Further reading
evolution. Chest, 132(6), 1987–93. Beauchamp, T.L. and Childress, J.F. (2009). Principles of
5*  Truog, R.D., Campbell, M.L., Curtis, J.R., Haas, C.E. Biomedical Ethics. 6th edn. New York: Oxford University
et al. (2008). Recommendations for end-of-life care in Press.
the intensive care unit: a consensus statement by the Medical futility in end-of-life care (1999). Report of the
American College [corrected] of Critical Care Medicine. council on ethical and judicial affairs. JAMA, 281,
[erratum appears in Crit Care Med. 2008 36(5), 1699]. 937–41.
Crit Care Med, 36(3), 953–63.
Ratnapalan, M., Cooper, A.B., Scales, D.C., and Pinto, R.
6*  Berger, J.T., DeRenzo, E.G., and Schwartz, J. (2008). (2010). Documentation of best interest by intensivists: a
Surrogate decision making: reconciling ethical retrospective study in an Ontario critical care unit. BMC
Med Ethics, 11, 1.

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 Section 2
1 End-of-life issues
Chapter

18
Discontinuing pacemakers, ventricular
assist devices, and implanted
cardioverter-defibrillators in
end-of-life care
Cynthiane J. Morgenweck

The Case probably be were the device active. The physician who
writes the order for disabling the device writes an order
Mr. K is a 59-year-old who was diagnosed with idiopathic
that is the potential cause of the patient’s death. A third
ventricular tachycardia at age 50. He had an implant-
able cardioverter defibrillator (ICD) placed at that time.
argument is that disabling a cardiac assist device could
Within a month of placement, Mr. K experienced his be construed as physician-assisted suicide because the
first shock and described it as a ‘sledgehammer to my order to disable the device must be written by a physi-
chest.’ He became afraid of further shocks and limited cian in response to a patient request. What could such
his activities in the hopes of avoiding them. The ICD was an order be but an agreement to help the patient to
reprogrammed, his medications were readjusted and he commit suicide?
underwent cognitive behavioral therapy to lessen his fears In a recent survey of physicians and their attitudes
of the shocks. With these changes in place Mr. K was able towards device deactivation, 46% of respondents
to resume several activities. He now returns requesting believed it was illegal or were unsure if it is illegal to dis-
that his ICD be turned off because he has been diagnosed able a device. Once they were reassured that it is legal,
with unresectable cancer. He had undergone some pallia-
91% of the respondents indicated that they would be
tive chemotherapy but has decided that he does not want
more chemotherapy because it makes him so ill that he
willing to discuss disabling cardiac devices under cer-
cannot focus on getting his affairs in order before he dies. tain circumstances.2

Responses to arguments against

Are there ethical arguments for keeping disabling cardiac devices
the ICD activated? The biofixture analysis is adapted from legal concepts
Some practitioners will not disable any cardiac and is not a fully analogous argument. Devices are
devices  – pacemakers, ICDs or ventricular assist inserted and removed from patients throughout their
devices (VADs), citing several potential ethical argu- lifetimes. For example, intraocular lenses and artifi-
ments for leaving the device intact and functioning. cial joints are implanted in patients and explanted if
One argument is that the device has become part of not functioning properly. The device does not contain
the patient’s physiology. It is a “biofixture” and to dis- the patient’s DNA or other attributes that identify it as
able it is to interfere with the patient’s current physi- uniquely specific to a particular patient. Further, dis­
ologic functioning in a negative manner.1 Physicians abling a cardiac device does not entail its removal, so
should not be a part of actions that diminish patients’ the patient is not at risk for further surgery.
health, because it would violate the principle of non- When it is argued that disabling a cardiac device
maleficence or “do no harm.” A second argument is will harm a patient, it is important to remember that
that dis­abling the device constitutes euthanasia in harm assessments ought to come from the patient,
that without the device, the patient will have a cardiac particularly if the therapy has been ongoing. The phy-
event that is no longer readily reversible, as it would sician must educate the patient about the potential

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
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 Section 2. End-of-life issues

benefits and burdens of disabling the device, but it diseases with less thought to the limits and burdens of
is the patient who decides whether or not to accept the technology.
the benefits and burdens. In this case the patient ini-
tially accepted the benefits and burdens of his ICD;
however, as the patient’s life circumstances changed,
Distinguishing characteristics of current
those benefits no longer outweighed the burdens in cardiac devices
his view. Each of the three types of currently used cardiac
The writing of an order to disable a device should devices has different functions and a different mix of
not be viewed as euthanasia. In general, euthanasia is harms and benefits. These differences may impact the
considered to be an act on the part of a healthcare pro- decision to disable the device. Each device may be disa-
vider that intentionally hastens the death of a patient. bled by simply “deprogramming,” or by battery pack
A physician may believe that the lack of countershock disconnection.
will inevitably hasten the death of the patient; how-
ever, this may also be an overestimate of the value Pacemakers
of the ICD. Not all delivered shocks are appropri- Pacemakers are the oldest of the devices, having been
ate, there are nonfatal arrhythmias, and death may used since the early 1960s. There are risks with implant-
occur from other causes. Also, disabling the device ation. There can be infection, lead fractures, and inabil-
is merely the removal or forgoing of a therapy that is ity to place the leads in a satisfactory manner with a
no longer requested by a patient rather than a further resultant inability to pace. If the patient is able to have
intervention that is designed to hasten the death of the a pacer placed successfully, there appears to be min-
patient. imal downside. It is a small device with little disfigure-
Disabling a device is not physician-assisted suicide. ment of the patient and it performs its function without
The requests for disabling cardiac devices are gener- patient awareness. By maintaining an adequate cardiac
ally made in the context of other life-limiting diseases rhythm, a pacemaker can help a patient to have a nearly
where the benefit of a device that causes the heart to normal life with few restrictions.
function while the rest of the body is failing is no longer When a patient is dying, continued pacing may be
acceptable. If a practitioner is uncertain about the men- seen as a burden. The pacing can be viewed as a manda-
tal health of a patient, it is reasonable to consult with a tory continuation of one physiological system that is
psychiatrist or psychologist. out of sync with the overall condition of the (dying)
The doctrine of “double effect” may help in analysis patient. But exactly what happens if a pacemaker is dis-
of this issue. (For more about Double Effect, refer to continued is of concern. A slower heart rate may cause
Chapter 15). If the intention of the physician is to relieve congestive heart failure with shortness of breath, pul-
suffering that the device is causing, and the death itself monary edema, and an inability of the patient to enjoy
is unintended, then disabling may be ethically per- the last days of life. These symptoms may be amelio-
missible. It is important to remember that disabling rated with good palliative care. It might also be that the
the device does not inherently cause the death of the patient’s intrinsic rate is sufficient to maintain the lim-
patient – there are patients who have devices implanted ited activities of a bedridden, dying patient.
who have never been shocked. Alternatively, shocking There are few stories available for review of what
a dying patient may unnecessarily prolong death and happens to patients when their pacemakers are disa-
cause further discomfort. bled and so it is hard to predict what will happen. If the
The rationale for disabling the device are based on a device is disabled within the context of multiple lethal
fundamental notion of patient autonomy, informed by diseases, there is little reason to fix blame for all of the
patient awareness and acceptance of the consequences patient discomfort on that action alone. It is important
of the choices made. This set of conditions is analogous to remember that good palliative care can ameliorate
to the withdrawal of other medical therapies such as the symptoms that the patient might experience dur-
ventilatory support or dialysis. A debate about disab- ing the dying process when the pacer is disabled. If the
ling cardiac devices has arisen in part because these patient is completely pacer dependent – i.e., there is no
devices are relatively new, because they literally sup- underlying cardiac rhythm  – death will likely occur
port the symbolic organ of life (the beating heart), and shortly after the pacer is disabled. Obviously, specific
because true to the technological imperative, health plans should be made regarding do-not-resuscitate
care providers rush to support those with debilitating orders prior to disabling such a device.
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 Chapter 18. Disabling cardiac devices

Implantable cardioverter defibrillator (ICD) patient was able to either undergo definitive therapy
Today, pacemaker technology is usually enveloped in (cardiac transplantation) or recover from the cardiac
the ICD so that one device functions as a pacemaker or illness. Currently, VADs are being used as destination
ICD or both. This section will focus on the ICD func- devices, i.e., they are implanted with the understanding
tion of the device. The initial placement of the device has that they will remain in place as long as the patient is
the risks of inability to place, infection, and lead frac- alive. Patients who receive a destination VAD are very
ture. Recovery time from the placement is short, if the ill – they have refractory Class IV heart failure and sys-
device is functioning well. It is a relatively small device tolic dysfunction. Even with a properly functioning
with minimal disfigurement. However, once the ICD is VAD, a patient may decide after living with the device
in place and functioning, it may not be as benign as a that the quality of life improvement is not sufficient
simple pacemaker. Patients are frequently aware of the to continue. The patient may experience neurologic
­firing of the device and describe the shock as traumatic. complications, repeat infections, thromboembolic
These experiences create anxiety, depression, and panic complications, and bleeding problems with recur-
states in some patients. They may self-­impose activity rent hospitalizations. When a VAD is disabled, patient
limitations in the hope of avoiding being shocked. Thus, death is likely to occur within a short period of time,
patients may have a greater interest in ICD removal than although this is sometimes hard to predict. Currently
with simple pacemakers in which awareness of function most VADs have external battery packs, and the VAD
is not an issue. If there are other disease states that are can be disabled by simply disconnecting the battery.
not reversible or controllable, the patient may decide Again, plans should be made regarding do-not-resus-
that the burden of ICD shocks added to the incurable citate orders prior to disabling the device.
illness creates a quality of life that is unbearable and ask
for disabling of the device. “Preventive” ethics
Disabling an ICD in a patient with a terminal diag- The decision to disable a cardiac device can be wrench-
nosis creates the potential for a more peaceful death. ing for the patient, for family members and for health-
With no ICD function, death will occur either as the care providers. Preventive ethics may ease some of the
result of a fatal arrhythmia or as a result of the ter- emotions that are experienced when such a request
minal illness. Shocks that would occur if the device is made.3 Physician self-knowledge, communication
were not disabled might prevent a peaceful death that with patients at the time of placement, and anticipation
is being sought by many patients. Patients who accept of points of dispute can diminish some of the anxiety
their imminent death may desire comfort care only about such decisions.
and might actually prefer a sudden cardiac death to a Physicians should reflect on their own responses to
more prolonged dying with its attendant diminution such requests before they are made.4 These responses
of functioning. must be communicated to the patient. If the physician
When discussing ICD disabling with a patient (and/ would never honor such a request, the patient ought
or surrogates), it is necessary to describe the possibil- to be informed at the beginning of the patient/phys-
ity of arrhythmias that do not cause the death of the ician relationship. If the physician is willing to consider
patient, but do create increased disability. Further, it is patient-initiated requests for disabling the device, a
important to point out that disabling the device does great opportunity for conversation is when the device
not guarantee a sudden cardiac death. This may also be is placed. Discussion should include the circumstances
the time to initiate a do-not-resuscitate (DNR) order. under which the physician would recommend disab-
(See Chapter 2.) ling or when the patient might request that the device
be disabled. Patients should be encouraged to fill out
Ventricular assist device (VAD) advance directives if they have not already done so.
VADs are the most recently developed cardiac assist Sometimes the decision to disable a cardiac device
devices, with clinical trials ongoing to determine the may be advocated by all parties involved in the health-
best design and most appropriate candidates for VADs. care of the patient. At other times, there may be dis-
VAD placement is a more invasive surgical procedure putes that will have to be resolved so that the most
with a longer in-hospital recovery time. VADs are more appropriate care of the patient can be rendered with
noticeable than pacers or ICDs. VADs were initially the best possible understanding of the choices made in
viewed as “bridging devices, ” that is, placed until the the treatment plan.
105
 Section 2. End-of-life issues

In the ICU environment, it is perhaps more dif- friends (assuming patient permission) is reasonable.
ficult, but still important to develop as complete Ethics consultation may also be of value. If the phys-
an understanding of the patient’s goals and values ician, as a moral agent, finds herself incapable of hon-
as possible. Knowing the patient’s goals and values oring a valid request, the physician must assist in the
will enable the physician to craft a plan of care that is transfer of care of the patient to another physician who
respectful of the patient’s life views. It is nearly always is willing to honor the request.
helpful to involve the patient’s family to the extent A palliative care consultation may also be helpful
that the patient will permit such involvement. A fam- when a patient requests that their cardiac device be
ily member usually provides a broader understand- disabled. The focus of this consult will be to anticipate
ing of the patient’s life and can become a reflective and alleviate uncomfortable symptoms that may occur
sounding board for decisions. This may minimize when the device is disabled, to describe the timeline of
disputes. the patient’s death as well as the possibility of contin-
ued life, and to prepare the patient, family, and friends
for the death.
What to do if a request is made to disable It is vital to document the conversation and the
a device plan developed for disabling the device. Sometimes,
When a request to disable a cardiac device is made, it is an outside technician is needed to disable the device.
important to assure the patient that the request is being They may seek greater understanding of the physicians
taken seriously, but also to inform the patient that dis- order for disabling the device before carrying out such
abling the device will not occur immediately, because an order. A well-written note will prevent miscom-
the potential irreversibility of the disabling neces- munications. This is also true for all other healthcare
sitates assessment of the request. Conversation with providers who may be cross-covering or coming on
the patient, exploring the reasons for the request is the service shortly after the decision was made.
starting point for the evaluation the request. The dia-
logue may not be long, since there may be obvious rea- Key points
sons that need little explanation. In other cases, review
of the patient’s overall disease state with an emphasis • Refusal of standard medical care, even if
on the prognosis may help to determine if disabling of life threatening, is within a patient’s right to
the device will meet the patient’s real goals. personal autonomy.
It is important to determine if the patient has • Pacemakers, ICDs, and VADS represent forms
“decisional capacity” (the capacity to make decisions). of cardiac-supportive therapies that patients
Elements of “decisionality” include the patient’s abil- may legitimately forgo or discontinue as part
ities to comprehend information, to consider the infor- of end-of-life decision-making.
mation in the context of the patient’s preferences, and • In situations where the benefit vs. burden
to communicate a decision that is consistent over time. balance of medical care does not seem
It is imperative that the physician recognize and accept appropriate to medical personnel, additional
that decisional patients may refuse any and all ther- psychological or ethics team consultation may
apies, even ones that have been instituted years ago. be helpful.
If there are unanswered questions about the patient’s • Discontinuing cardiac device therapy should
decisionality, formal psychiatric or psychologic evalu- be accompanied by thoughtful discussion,
ation will be beneficial. discernment of patient goals, and plans for
The physician should also consider the request in appropriate palliative care.
the context of prior knowledge of the patient. If this
request seems consistent with the patient’s previous
choices in healthcare, then the request is likely to be References
valid. If the patient has an advance directive, the request 1*  Paola, F.A. and Walker, R.M. (2000). Deactivating the
can be evaluated against the choices made in the docu- implantable cardioverter-defibrillator: a biofixture
ment and in conversation with the appointed agent. analysis. So Med J, 93, 20–3.
If the reasons do not appear sound, then discus- 2*  Sherazi, S., Daubert, J.P., Block, R.C., et al. (2008).
sion with colleagues as well as the patient’s family and Physicians’ preferences and attitudes about end-of-life

106
 Chapter 18. Disabling cardiac devices

care in patients with an implantable cardioverter- Goldstein, N.E., Lampert, R., Bradley, E., et al. (2005).
defibrillator. Mayo Clin Proc, 83, 1139–41. Management of implantable cardioverter defibrillators
3*  Wiegand, D.L. and Kalowes, P.G. (2007). Withdrawal of in end-of-life care. Ann Int Med, 141, 835–8.
cardiac medications and devices. AACN Adv Crit Care, Goldstein, N.E., Mehta, D., Siddiqui, S., et al. (2008).
18, 415–25. “That’s like an act of suicide.” Patients’ attitudes toward
4*  Mueller, P.S., Jenkins, S.M., Bamstedt, K.A., and Hayes, deactivation of implantable defibrillators. J Gen Intern
D.L. (2008). Deactivating implanted cardiac devices in Med, 23 Suppl 1, 7–12.
terminally ill patients: practices and attitudes. Pacing Kirkpatrick, J.N., Fedson, S.E., and Verdino, R. (2007).
Clin Electrophysiol, 31, 560–8. Ethical dilemmas in device treatment for advanced
heart failure. Current Opin Support Palliat Care, 1,
Further reading 267–73.
Lewis, W.R., Luebke, D.L, Johnson, N.J., et al. (2006).
Ballentine, J.M. (2005). Pacemaker and defibrillator
Withdrawing implantable defibrillator shock therapy in
deactivation in competent hospice patients: An ethical
terminally ill patients. Am J Med, 119, 892–6.
consideration. Am J Hosp and Pall Med, 22, 14–19.
Manganello, T.D. (2000). Disabling the pacemaker: the
Berger, J.T., Gorski, M., and Cohen, T. (2006). Advance
heart-rending decision every competent patient has a
health planning and treatment preferences among
right to make. Health Care Law Mon, Jan, 3–15.
recipients of implantable cardioverter defibrillators: an
exploratory study. J Clin Ethics, 17, 72–8. Rizzieri, A.G., Verheijde, JL., Rady, M.Y., and McGregor, J.L.
(2008). Ethical challenges with the left ventricular assist
Dudsinski, D.M. . (2006). Ethics guidelines for destination
device as a destination therapy. Phil, Ethics, Humanit
therapy. Ann Thorac Surg, 81, 1185–8.
Med, 3, 20.
England, R., England, T., and Coggon, J. (2007). The ethical
Zellner, R.A., Aulisio, M.P., and Lewis W.R. (2009).
and legal implications of deactivating an implantable
Should implantable cardioverter-defibrillators and
cardioverter-defibrillator in a patient with terminal
permanent pacemakers in patients with terminal
cancer. J Med Ethics, 33, 538–40.
illness be deactivated? Deactivating permanent
Goldstein, N., Carlson, M., Livote, E., and Kutner, J.S. pacemaker in patients with terminal illness. Patient
(2010). Brief communication: management of autonomy is paramount. Circ Arrhythm Electrophysiol,
implantable cardioverter-defibrillators in hospice: a 2(3):340–4.
nationwide survey. Ann Intern Med, 152(5), 296–9.

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 Section 2
1 End-of-life issues
Chapter

19
Brain death
Robert B. Schonberger and Stanley H. Rosenbaum

The Case formalization of cardiopulmonary resuscitation in the

late 1950s and early 1960s. As society was confronted
A 35-year-old patient is comatose following a drowning.
with the possibility of an apparently alive body in an
The treating neurologist has found the patient to be irre-
versibly unconscious with absent brainstem reflexes and irreversibly brain dead patient, medicine was ripe for
no respiratory effort during an apnea test. Because of per- a neurologically based definition of death that could
sistent limb movements thought to be most likely spinal guide the ethical discontinuation of cardiopulmon-
in origin, the primary team elects to get a confirmatory ary support in such patients. In 1959, the concept of
EEG that indicates no brain activity. At the conclusion of irreversible coma was introduced by Mollaret and
EEG testing, the attending neurologist writes in the chart, Goulon in France. However, it may have been the sub-
“3/15/09 20:00. The patient is now deceased.” The next of sequent development of organ transplantation, and
kin decide the following morning not to donate the organs, the accompanying increase in the practical import for
and respiratory support is promptly removed with an determining brain death, that led 10 years later to the
accompanying chart note saying, “3/16/09: The patient has
creation of the first widely accepted standard of brain
died. Time of death 0700.” Two weeks following this inci-
death.
dent, the state medical examiner contacts the care team
and inquires as to the proper time of death. In 1968, 1 year after the first successful heart
transplant, a well-publicized effort in the United
The historical development of a States to reexamine the definition of death in terms
of a neurological standard was conducted by a com-
neurological standard of death mittee at Harvard Medical School.2 This committee,
While the determination of death among many tradi- lead by the chairman of Anesthesiology at Harvard
tions has for thousands of years relied on the cessation Medical School, Henry Beecher, MD, published what
of the pulse or respirations, twentieth-century medical subsequently became known as the Harvard Criteria
care brought about both new possibilities and incen- for determination of brain death which included:
tives for redefining death in terms of a neurological (1)  unreceptivity and unresponsivity; (2) no move-
standard. The possibility of brain death in the presence ments or breathing; and (3) no reflexes (including
of continued cardiovascular function emerged during deep tendon reflexes). The criteria also suggested
the 1950s, largely as a consequence of new develop- checking an electroencephalogram (EEG) when avail-
ments in the medical care of the critically ill. Shortly able for its “great confirmatory value.”2 An isoelec-
thereafter, the incentives for a new definition of brain tric EEG should demonstrate no brain activity, and
death expanded and took on new practical urgency with there should be no muscle movement. The Harvard
the advent of deceased-donor organ transplantation. Criteria mandated these tests be done twice separated
Among the medical developments that led to the by 24-hours. In addition, it was necessary to confirm
possibility of a new concept of brain death was the that the patient was ­neither sedated nor hypother-
improvement in techniques of pulmonary support via mic. While the Harvard criteria would be modified
mechanical ventilation during the polio epidemics of by various authorities over the subsequent four dec-
the 1940s and 1950s.1 Other techniques of cardiovas- ades as described below, these guidelines represented
cular support soon followed, including the develop- the inaugural moment for a neurological standard of
ment of cardiopulmonary bypass in the 1950s and the death into medical practice.

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
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 Chapter 19. Brain death

Current international neurological patients diagnosed as brain dead, both hypothalamic

and pituitary function as well as spinal reflexes are
standards for determination of death commonly found to continue in patients who meet
the current whole brain death criteria.
The whole brain death standard
Protocols for the clinical determination of brain
While the concept of brain death is now well estab- death vary among institutions but must generally be
lished, the specific criteria for its determination vary made by more than one doctor in one of several rele-
among different countries. The legal brain death vant specialties (usually some combination of neur-
standard that has been adopted in the majority of the ology, neurosurgery, trauma, or anesthesiology). In
United States is based on the advice of the National some institutions, most commonly in reference to
Conference of Commissioners on Uniform State pediatric patients, clinical assessment must be repeated
Laws3 which formed a model of brain death legisla- over various intervals of time before the declaration of
tion in 1980 that was subsequently adopted by both death can be properly made.
the American Medical Association and the American
Bar Association as well as a large majority of state leg-
islatures. This standard requires the determination Sufficiency of the clinical diagnosis of brain death
of “irreversible cessation of all functions of the entire versus neurophysiologic testing
brain, including the brain stem.” Similar so-called The majority of the US as well as most European Union
“whole brain death” standards have also been adopted countries have followed the lead of the Harvard com-
in Canada, Australia, and South America, as well as mittee in specifying that the clinical diagnosis of brain
most European countries with the notable exception death in adults is sufficient in itself for the determin-
of the United Kingdom (see below). ation of death, without the need for confirmatory
East Asian countries have seen more recent accept- neurophysiologic testing. In these jurisdictions, neu-
ance of a neurological standard, with brain death rophysiologic assessment is reserved for young pediat-
criteria analogous to the US standards having been ric patients as well as for circumstances in which there
adopted in Japan in 19971 and in South Korea in 2000. is an inability to perform any of the required clinical
A major meeting of Chinese officials to discuss the tests of brain death or where, for whatever reason, some
establishment of neurological standards of brain death doubt exists about the clinical diagnosis of brain death.
occurred in 2008, but no English language summary of For example, a patient too unstable to tolerate an apnea
their findings was located by the present authors. test, may instead undergo alternative neurophysiologic
The determination of whole brain death, when testing. Exceptions to the sufficiency of the clinical
made on clinical grounds, requires the demonstra- standard in adults include France, Italy, Luxembourg,
tion of three things: (1) an irreversible comatose state; and the Netherlands, each of which requires some type
(2) the loss of brainstem reflexes; and (3) brainstem of confirmatory neurophysiologic testing even in the
inactivity leading to apnea. After reversible causes of presence of clinical brain death.4
apparent coma, such as hypothermia, intoxication, Neurophysiologic testing generally falls into
severe metabolic derangement, or residual neuro- two categories that serve either “to confirm the loss
muscular blockade have been ruled out or otherwise of bioelectrical activity of the brain” or to “demon-
corrected, a patient meets the standard by demon- strate cerebral circulatory arrest.”4 Confirmation of
strating the absence of responses to painful stim- brain death via examination of bioelectrical activity
uli including to cranial nerve territories (coma), the can itself be conclusive via the finding of an isoelec-
lack of all cranial nerve reflexes (brainstem areflexia), tric EEG in the absence of other causes for central
and the absence of respiratory efforts in the face of neurological depression. The absence of brainstem
a hypercarbic challenge (brainstem inactivity). Of auditory evoked potentials or somatosensory-evoked
note, the whole brain death standard differs from potentials can also be useful in certain circumstances.
the Harvard criteria in making no mention of spinal These tests have the advantage of being less suscep-
cord function or the total absence of muscle move- tible than EEG to distortion by sedative drugs, but
ments. This standard also requires no documentation evoked potential monitoring, while suggestive, can-
of hypothalamic failure. Although hypothalamic dys- not in isolation conclusively determine whole brain
function including diabetes insipidus is often seen in death.

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 Section 2. End-of-life issues

Neurophysiologic determinations of cerebral

circulatory arrest include four-vessel cerebral angi-
The ethical foundations for a neurological
ography as well as various scintigraphic perfusion standard of death
studies. Angiography demonstrating absence of
blood flow to the brain is widely accepted throughout
Philosophical underpinnings of differing neurological
Europe and the US as a valid standard, while scinti- standards of death
graphic perfusion studies, which may be less sensi- The philosophical question of why brain death should
tive markers for the absence of brain perfusion, are be equated with the death of a patient has been
accepted in some United States institutions as well as answered largely either in terms of sociological tradi-
in Germany and Switzerland.4 Finally, transcranial tions or bio-philosophical arguments. Several argu-
Doppler may be used as a valid confirmatory test of ments have been made in support of a neurological
brain death only in Germany but is not in itself suffi- standard, and they have great import for the resultant
cient for the diagnosis of brain death due to the pos- neurological standard, if any, that is advocated. The
sibility of an insufficient bone window for valid blood current review will focus briefly on three common
flow determinations.4 ethical foundations used in support of a neurological
standard of death.
The brainstem death standard
The UK and India are unique in having a neuro- Formulations of a neurological standard based on a
logical standard of death that specifically focuses on reliance on cultural traditions
brain stem dysfunction. In 2008, the UK’s Academy Defenders of various formulations of the neurological
of Medical Royal Colleges published its “Code of standard of death sometimes reference or explicitly rely
Practice for the Diagnosis and Confirmation of on sociological traditions for their justification of a par-
Death.”5 (UK) The authors reaffirm the UK’s original ticular standard. For example, neurologist Christopher
1976 neurological standard of death which was based Pallis,6 one of the early developers of the UK standard,
on “the irreversible cessation of brainstem func- justified his country’s standard in reference to a trad-
tion.” In India, a similar declaration was part of the ition that equates both breathing and consciousness to
Transplantation of Organs Act of 1994. The Academy the existence of the human soul. The tradition focusing
of Medical Royal Colleges argues that loss of brain- on apnea and unconsciousness does indeed have quite
stem function entails both apnea as well as the loss of a strong history within the Judeo-Christian framework
consciousness and therefore suffices for the determin- of which Pallis was a part.
ation that the “death of the individual” has occurred. Genesis 2:7 recounts “and the Lord God formed
For the exclusively clinical diagnosis of brain death, man of the dust of the ground and breathed into his nos-
there is little practical difference between the UK def- trils the breath of life, and man became a living soul.”7
inition and a whole brain definition of death. If neu- This tying together the idea of breath – albeit a positive
rophysiologic testing is used, however, patients with pressure breath! – with the essence of life has resonated
continued cortical EEG activity or cortical blood flow deeply through Western culture. The Christian doc-
could still be considered dead according to the UK trine that the soul departs the body at the time of death
and Indian standards but not by the other countries has been interpreted by many theologians, Pope Pius
considered in this review. XII among them, as meaning that the soul leaves the
Practitioners involved in brain death determin- body at the time of irreversible loss of consciousness.
ations or engaged in the care of deceased organ It is of interest to note that the sole reference listed in
donors would be well advised to familiarize them- the Harvard committee’s original report was a speech
selves with their own institutional guidelines as by Pius XII.
well as the laws of their particular jurisdiction, as It is, of course, possible to advocate an apnea and
the nuances and procedural requirements for deter- unconsciousness standard on non-religious grounds.
mination of brain death may be critical in deter- In addition, it is possible to advocate for other neuro-
mining the status of suspected brain dead patients. logical standards – or none at all – based on tradition.
Moreover, some jurisdictions give the next-of-kin Any standard thus formulated is subject to all the
the right to deny that a neurological standard of strengths and weaknesses of all arguments from trad-
death be used at all. ition. Some thinkers might argue that all neurological
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 Chapter 19. Brain death

standards share at some level such a philosophical neurological standard of death were truly equivalent to
foundation. a cardiovascular death in the eyes of the legislators who
passed such laws, it would be difficult to imagine that
Formulations of the neurological standard based on they could grant a family the right to consider a dead
“loss of personhood:” patient alive, no matter what the family’s beliefs.
Some justifications for a neurological standard resort
to a “loss of personhood” argument, asserting that the Foundations specific to the whole brain death
absence of a particular set of functions – often perman- neurological standard
ent lack of consciousness and reasoning ability – even So far in this discussion, we have seen that even among
when they occur independently from the death of the people who agree that a neurological standard of death
human organism, may nevertheless suffice for the eth- should exist, the specifics of what such death should
ical and legal determination of death of the person. entail as well as the arguments used in their support
Such a theory finds resonance in the Western can be vastly different. Of the few positions outlined
canon at least as far back as Aristotle who argued above, one relies on an exclusively brainstem-based
that the rational soul was the unique and essential standard while another relies on an exclusively cor-
characteristic of man. Some argue that an individual tical standard. We will now turn to an ethical foun-
who lacks such capability has lost his or her essential dation that may be specific to the whole brain death
claim to personhood. This stance may have provided standard.
the ethical foundation for a decision by the American The bio-philosophical position that was
Medical Association Council on Ethical and Judicial expounded by some members of the United States
Affairs in 1995, that advocated for the use of anen- President’s Council on Bioethics in their 2009 report
cephalic neonates as organ donors.1 Such neonates are advocates for the whole brain death standard. In
born without a brain cortex and could reasonably be contrast to the “loss of personhood” standard, they
assumed to lack the possibility of a meaningfully con- dispute that there can be the death of the person inde-
scious life. pendent from some more fundamental phenomenon
In accord with the AMA council’s philosophical of organismal death.
view of personhood, it might have been reasonable to Specifically, they assert that there is only one
assume (though the council disputed this suggestion) death, and that permanent and total brain failure,
that not only anencephalic newborns, but any persist- including both cortex and brainstem, is its necessary
ently vegetative patients who lacked function beyond harbinger. Underlying their stance is the argument
primitive brainstem activities might reasonably qual- that a living human organism must of essence exhibit
ify to be considered dead-as-people. The council sub- “self-preserving commerce with the world” including
sequently reversed their stance regarding anencephalic some inchoate expression of neediness and actions to
babies,1 presumably concluding that denying person- satisfy those needs. The necessary qualities for human
hood based on an ill-defined threshold of higher order organismal life have been expressed by one author as
brain functions was a hopelessly messy enterprise, “openness to the surrounding environment, ability to
with possibly untoward slippery slope implications. As act upon that environment, and inner experience of
a matter of law, there is no jurisdiction that currently need.”6
equates persistently vegetative states with death. In accord with this philosophical position, the
Loss of personhood arguments, however, can also neurological standard that would warrant a declar-
be used to advocate for other standards, including the ation of death is more stringent than both a “loss of
whole brain death standard. In separating the death of breath and consciousness” standard as well as most
the person from the ultimate death of the patient, such incarnations of a “loss of personhood” standard. This
a formulation resonates with the common desire to call philosophical stance requires that function of the
a person with a beating heart still living. In doing so, entire brain – including cortical and brainstem activ-
however, such arguments shy away from advocating for ity  – cease prior to the determination of death. The
a truly neurological standard of death equivalent to the majority of the Presidential council that delineated this
cardiovascular standard. It may be this argument that standard supported the current United States stand-
has prevailed in some jurisdictions where next-of-kin ard of whole brain death even as they provided a new
may refuse a neurological standard altogether. If the philosophical grounding for it.
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 Section 2. End-of-life issues

They rejected an exclusive reliance on brainstem death criteria should be considered not just dead as
death  – the apnea and unconsciousness standard of a person, but dead as an organism. Such an ethical
England and India – largely based on epistemological standpoint therefore would agree that the neurolo-
grounds. The principal objection was that the inner gist’s original declaration of death was correct and that
state of a person with cortical electrical activity after the subsequent declaration the following day misun-
brain stem death is fundamentally unknowable, and it derstood the essence and practical import of a neuro-
would therefore be problematic to conclude that there logical standard of death.
was a definitive lack of consciousness in cases of con- In this regard, the “loss of personhood” stance
tinued cortical activity. There may be good reason for fundamentally differs from the other philosophical
such doubt, given recent strong evidence for the preser- stances since it maintains a distinction between death
vation of higher-order consciousness in some patients of the person and death of the organism. Although
previously considered to be in persistently vegetative few jurisdictions follow this distinction, an argu-
states.8 ment could be made under the loss of personhood
By their standard, they also would reject a purely standard that both declarations of death in the case
cortical definition of brain death, since in their view above were correct – the neurologist’s declaration of
a spontaneously breathing but unconscious person death was in reference to the death of the person and
would still possess a primitive neediness, openness second declaration was in reference to the death of
to the world, and ability to act and would thus fulfill the organism. Such a distinction is still widely held
the criteria for continued life. It is notable that hypo- in the public and the press as evidenced by frequent
thalamic activity was not addressed in detail by the reports of brain dead patients “being kept alive” on
President’s council in their report, which leads to the life support pending final care decisions. For most
question of why temperature autoregulation (a feature advocates of a neurological standard, such a state-
of hypothalamic activity) would not also qualify as an ment is accurate only in reference to persistently
inchoate self-preserving commerce with the world that vegetative patients.
was worthy of being called life. Whether or not a ventilator remains on or off and
The whole brain death standard  – with slight whether or not there is a blood pressure, most jurisdic-
­variations – has come to be the most widely held inter- tions hold that a brain dead patient is a corpse. This is
national neurological standard of death. While the the essence of the neurological standard of death, and
philosophical foundations underlying the whole brain both doctors and society at large continue to struggle
death standard may include arguments from tradition, with its justification.
loss-of-personhood arguments, or other arguments
not described here, it seems that the “self-preserving Key points
commerce with the world” stance may be most specific • Advances in medical technology and
to a whole brain death standard. transplantation lead to the re-defining of
death to include not only cardiopulmonary
Case resolution death, but death by virtue of “brain death.”
• The medical and legal definitions of brain
Determining the time of death – the essence of the death vary slightly among countries – with
neurological standard some using a “whole brain” definition of
From a legal standpoint, most jurisdictions hold that death in which no cortical activity may be
when the neurological standard of death has been sat- present, and some relying on a “brainstem”
isfied, it is legally equivalent to a declaration of death standard, in which some cortical activity may
based on cessation of cardiovascular function. Such be detectable.
jurisdictions would hold that the neurologist’s first • In all countries where brain death is
declaration of death was the correct one. recognized legally, the diagnosis rests with
From an ethical standpoint, according to the “self- physical examination, at times supported by
preserving commerce with the world” stance, as well further medical testing.
as many arguments based on sociological tradition,
a brain dead patient is fundamentally equivalent to • Philosophical arguments for the integrity
a corpse. As such, a person fulfilling the whole brain of brain death as a definition of death rest

112
 Chapter 19. Brain death

3* Uniform Determination of Death Act. (1980). National

in historic religious and social concepts of
Conference of Commissioners on Uniform State Laws.
what constitutes life, or with ideas that loss
Chicago, IL. http://www.law.upenn.edu/bll/archives/ulc/
of “personhood” may be equivalent to, or fnact99/1980s/udda80.htm
another form of, death.
4*  Haupt, W.F. and Rudolf J. (1999). European brain death
• Because of differences in social, religious codes: a comparison of national guidelines. J Neurol,
and cultural beliefs, “brain death” is by no 246(6), 432–7.
means universally accepted, and continued 5*  A Code of Practice for the Diagnosis and Confirmation
debate can be expected regarding what, if of Death by the Academy of Medical Royal Colleges.
any, neurological standard of death should be (2008). http://www.aomrc.org.uk/aomrc/admin/
recognized. reports/docs/DofD-finalpdf 2008.
6*  Controversies in the Determination of Death: A White
Paper by the President’s Council on Bioethics. (2009)
http://www.bioethics.gov/reports/death/ 2009.
References 7   Holy Bible, King James version.
1* Van Norman, G.A. (1999). A matter of life and
8*  Owen, A.M., Coleman, M.R., Boly, M., et al. (2006).
death: what every anesthesiologist should know about
Detecting awareness in the vegetative state. Science, 313,
the medical, legal, and ethical aspects of declaring brain
1402–3.
death. Anesthesiology, 91(1), 275–87.
2* A definition of irreversible coma: a report of the ad hoc
committee of the Harvard Medical School to examine Further reading
the definition of brain death. (1968). JAMA, 205, Aita, K. (2009). Japan approves brain death to increase
337–40. donors: will it work? Lancet, 374(9699), 1403–4.

113
 Section 2
1 End-of-life issues
Chapter

20
Ethical issues in organ donation after
cardiac death
Richard L. Wolman

The Case The transplantation program in the US is an altruistic

program based on the premise that organ donation is
Mr. Gift is a 59-year-old man who is permanently quadra-
a gift, and relying on ethical principles of autonomy,
plegic and ventilator dependent due to a C2–3 fracture dis-
location following a fall during an equestrian competition
respect for persons (beneficence, nonmaleficence),
8 weeks ago. Since the accident he has undergone several and justice. Public confidence in this system assumes
surgeries, including C-spine stabilization, tracheostomy, obligations of grateful use, grateful conduct, and recip-
jejunostomy tube placement, and intramedullary fixation rocation, and the core shared societal values of volun-
of a femur fracture. He is scheduled for a tracheostomy revi- tarism, respect for family preferences, promotion of a
sion tomorrow, due to intermittent partial obstruction of sense of community through generosity, and improv-
the trachea and tracheal stenosis. ing the quality of life for others.1 The legislative basis
Mr. Gift is awake, alert, and finds life intolerable in his of this system of transplantation is the 1968 Uniform
dependent state. He does not want the scheduled surgery. Anatomical Gift Act (UAGA) that defined the abil-
He views his situation as both emotionally and financially ity of individuals to donate their organs via an opt-in
draining for his family. In the event of a cardiac arrest, he
approach to organ donation that honored the free
has stated he does not want to be resuscitated, and he has
a Do-Not-Resuscitate (DNR) order in his chart. Mr. Gift
“autonomous” choice of individuals to donate their
has further requested that his ventilator support be termi- organs via a “first person consent” or “donor designa-
nated, that he be given comfort measures only to relieve tion” process.
dyspnea and anxiety, and that his organs be donated for Since the early days of organ transplantation, there
transplantation after his death. He has read that sometimes has been general acceptance of the dead donor rule, an
life-supporting therapy can be withdrawn in an operating ethical axiom that states it is unethical for organ pro-
room, and organ procurement carried out immediately curement to cause death or injury and, except in the
after death. In order to provide the greatest possible number case of living donation, it is unethical for organ pro-
of organs, he has talked to an organ procurement organ- curement to precede death. This rule illustrates soci-
ization (OPO) representative, and requests that this be ety’s respect for the donor as a person (autonomy), the
arranged. His family is supportive of the DNR order, but
donor’s interests, and life (nonmaleficence). It was also
unsure about withdrawal of life-supporting therapy and
organ donation.
necessary to safeguard and protect the interests of vul-
While discussions are ongoing, Mr. Gift is accidentally nerable populations, avoid “slippery slope” situations,
extubated while being turned in bed. Attempts to replace and to insure public support for a voluntary system of
the tracheostomy tube fail. By the time the resuscitation organ donation.2 Adherence to the “dead donor rule”
team arrives, Mr. Gift is unconscious, hypoxemic, and presupposes an acceptable, stringent definition of
hypotensive. Physicians are unsure of whether to attempt death.
intubation, given the DNR order. The OPO representative,
who happens to be on the unit when these events unfold,
demands that they continue to attempt to intubate Mr.
Defining death
Gift and initiate cardiopulmonary resuscitation despite his Initially, the only accepted definition of death was car-
DNR order, so that arrangements can be made for a con- diopulmonary death, and organs were only procured
trolled cardiac arrest in the OR followed by organ donation from nonheartbeating donors. This placed practical
per his wishes. limitations on transplantation of many organs, such as

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
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 Chapter 20. Organ donation after cardiac death

hearts, lungs and livers, whose viability declines rap- the first two decisions have been made, a discussion
idly with circulatory arrest. In the meantime, redefin- and decision regarding organ donation can occur.
ing death became important for the ever-increasing Important procedural questions regarding controlled
population of unconscious patients being subjected to DCD may only be discussed after a decision regard-
aggressive and potentially non-beneficial life-support- ing organ donation is made. These include where and
ing medical therapies. Such patients not only presented by whom withdrawal of life-sustaining therapies will
ethical and medical dilemmas (resource utilization, occur and informed consent for premortem proce-
futility, end-of-life care and right to die decisions), but dures to promote organ viability – such as placement of
were also a potential source of organs for transplanta- vascular cannulae to allow premortem administration
tion. In 1968, Henry K. Beecher and the ad hoc com- of medications to enhance organ preservation, and the
mittee of the Harvard Medical School defined clinical infusion of preservative solutions at the time of death.
criteria for “brain death” or death of the whole brain Life-sustaining therapy may be withdrawn in the
and brainstem.3 (See Chapter 19.) intensive care unit or in an operating room with fam-
A legislative “stringent” definition of death in the ily present. After diagnosis of pulmonary and circula-
US was provided by the 1980 Uniform Determination tory arrest, the family, if present, leaves the operating
of Death Act (UDDA), which defined death as either room. A waiting period of 2 to 10 minutes, depend-
cardiopulmonary death (irreversible cessation of cir- ing on institutional protocol and national standards,
culatory and respiratory function) or brain death (irre- is observed prior to declaring death. Organ procure-
versible cessation of all functions of the entire brain and ment can begin once death is declared. In the event
brain stem). Despite this broadening of the definition that cardiopulmonary death does not occur within
of death, the shortage of viable organs has remained a a reasonable period of time, often defined as 1–2
problem, and transplant waiting lists continue to grow.a hours, the patient is returned to the ICU or to a pal-
The shortage of organs for transplantation resulted in liative care unit, and is no longer considered a poten-
renewed interest in vital organ procurement from non- tial donor.
heartbeating donors (donation after cardiac death or It was hoped that DCD would significantly reduce
DCD) in 1992.4 the shortage of viable organs for transplantation, as
well as provide closure and meaning to patients and
their families who wished to donate organs after
Donation after cardiac death (DCD) death. The concept of DCD was supported by the
A non-heart-beating organ donor is “[a] cadaver, Society of Critical Care Medicine,5 Opinion 2.157
whose death was determined by demonstrating of the AMA’s Code of Medical Ethics,6 the Institute
irreversible cessation of cardiopulmonary function of Medicine (IOM),7 and a national conference on
(simultaneous and irreversible unresponsiveness, organ donation after cardiac death.8 However, despite
apnea, and absent circulation) from whom organs increasing annual numbers of DCD donors, they still
are procured.”5 DCD may be “uncontrolled” or “con- represented less than 11% of all deceased donors
trolled.” Uncontrolled DCD may follow, for example, in 2008.9 Attempts to increase the number of DCD
a failed cardiopulmonary resuscitation. Controlled donors have included relaxation of the strict criteria
DCD occurs when organ donation follows death after for donation after cardiac death, and administrative,
a planned withdrawal of life support that is expected legislative, and social changes to the organ donation
to result in rapid death (either in the operating room process. These measures have resulted in ethical and
or intensive care unit). moral controversies and have only increased the pub-
In order for controlled DCD to be ethically accept- lic’s preexisting misperceptions and fears regarding
able, three independent discussions and questions organ procurement and DCD. These fears include
need to be answered by the prospective donor and/or those of physicians’ potential conflicts of interest
surrogates without coercion from conflicted parties. favoring donation over saving the life of a “poten-
Each discussion must be separated from the others tial donor” or over end-of-life care for the “potential
by a functional “firewall”. The first is a discussion and donor”. Other fears include worries that physicians
decision to forgo resuscitation in the event of cardio- will hasten the death of potential donors to facilitate
pulmonary arrest. Then, a discussion and decision to organ transplantation and fears of not being dead at
withdraw life-sustaining therapies with continuation the time of organ donation. Such fears could poten-
of comfort care can be reached. Finally, and only after tially result in a decrease in agreements to sign donor
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 Section 2. End-of-life issues

cards and increased unwillingness to donate under of barriers between the three critical decisions neces-
DCD protocols.10 sary in DCD – to forgo resuscitation, to end life-sus-
taining treatments, and to donate vital organs – raises
Legal precedents the potential for intended or unintended coercion of
the potential donor or their family.
Legislative precedents in the United States are unam-
With the change in COP rules, OPOs began to
biguous, allowing any competent or previously compe-
adopt a “presumptive approach” to organ donation,
tent individual to exercise their autonomous decision
in which it is presumed that patients want to donate
to withdraw what they believe are non-beneficial life-
organs unless proven otherwise. OPOs justified an
sustaining therapies and donate their organs. These
aggressive approach by promulgating the belief that
autonomous rights to have non-beneficial life sus-
everyone should donate organs, since it is the right
taining therapies withdrawn in favor of comfort care
thing to do, and therefore any approach that leads
are supported by the AMA Code of Medical Ethics,11
to increased organ donation may be justified by the
the American Thoracic Society,12 and a Task Force on
beneficent end of more organ availability.16 Since
Ethics of the Society of Critical Care Medicine.13 Some
the “rightness” of organ transplantation is far from a
jurisdictions in the United States do limit the ability to
universally accepted concept, and even in some cases
withdraw care in incompetents without clear (advance)
may violate cultural and religious beliefs of individu-
directive who are not in a persistent vegetative state.14
als, such beliefs by organ transplant agencies are at
the least insensitive, and may at times frankly violate
Ethical controversies ethical principles of respect for individuals. Many
Ethical dilemmas in DCD are confounded by the fact have concluded that this approach is misleading,
that DCD combines two morally complex events  – manipulative and/or coercive, undermines some of
decisions and care of the donor at the end of life, and the core elements of informed consent, and is ethi-
the gift of organ donation. Dilemmas include conflicts cally questionable under the principle of nonmalefi-
of interest in the separation between end-of-life care cence.17, 18 Others point out that the involvement early
and donation, use of the presumptive approach to con- in the process of professionals knowledgeable and
sent (in which the donor is presumed to consent unless involved in organ donation (OPO personnel) may
concrete proof exists to the contrary), possible viola- result in a “dual advocacy” that considers the interests
tions of the donor’s autonomous wishes when consent of both the donor and their family and the transplant
is presumed or obtained from surrogates, supremacy recipient.19
of donation over the donor’s advance directives and Truog compares organ donation with participation
end-of-life care wishes, the determination of who with- in research, involving altruistic gifts, benefits to others,
draws life-sustaining therapies, the appropriateness of potential risk or harm to the patient or family, and oblig­
premortem use of organ protection agents, and the ations of clinicians to support the desires of patients.17, 18
irreversibility of circulatory arrest in the age of cardio- He notes that the meticulous safeguards present
pulmonary resuscitation (CPR). in research consent are absent in the presumptive
The practice of DCD has been even more ethic- approach to consent for organ donation. Clearly, under
ally problematic than the concept of DCD. In 1998, the the principle of nonmaleficence, a potentially coercive,
Department of Health and Human Services, Health conflicted, and presumptive approach would not be
Care Financing Administration (HCFA) changed tolerated in research-informed consent. Ultimately,
the Medicare (Hospital) Conditions of Participation the presumptive approach has the potential to under-
(COP) rules to require that a member of the Organ mine the public’s confidence in the organ procurement
Procurement Organization (OPO) or an OPO trained process and further decrease the donor pool.
“designated requestor” initiate the request for organ Families that revoke a donor’s autonomous inten-
donation.15 This breached the firewall between end-of- tion to donate present additional practical, ethical,
life care and organ donation and presented an extreme and possibly legal challenges to those involved in
conflict of interest, since employees of organizations organ procurement. In 1998, the Center for Organ
whose livelihood is to obtain organs for transplant- Recovery and Education (CORE), an OPO in regions
ation can clearly not be assumed to represent the of New York, Pennsylvania, and West Virginia, began
donor’s interests first and foremost. The breaking down a controversial policy of respecting and acting on the

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 Chapter 20. Organ donation after cardiac death

documented wishes of the patient to donate independ- ­decision-making that were raised by UAGA 2006 are
ent of the family’s consent. This shifted the approach to discussed in detail in Chapter 21.
families from one of seeking consent, to one of inform- Beneficence and nonmaleficence require that to
ing that the individual’s documented decision to avoid even the perception of conflict of interest, the per-
donate would be respected. It rarely resulted in oppos- son withdrawing life-sustaining therapies should not
ition to the donation by the families. As discussed by be involved in the transplantation process. In addition,
May and colleagues,20 there was a firm ethical basis the person withdrawing life-sustaining care should
for this policy shift that was morally permissible and have expertise in palliative care, should participate
morally required. The CORE policy respects: (1) the voluntarily, and have an established patient–physician
autonomous rights of patients to donate their organs relationship with the patient. Withdrawal of life-sus-
(respect for persons) by adhering to a donor directive taining medical therapies is complex, requires special
that is definitive and applicable; (2) patients by having knowledge or training, and lack of knowledge may
their interests survive their death by the fulfillment of result in suffering by patients and their families and
their wishes; (3) the grieving families by relieving them therefore, harm.25 Participation by other physicians,
of a burdenous decision at a time of loss; and (4) the e.g., noncritical care anesthesiologists, is improper
caregivers, by moving them out of a possible conflict and may raise misconceptions regarding the priority
between opposing viewpoints. of care. The involvement of operating room anesthe-
Other attempts to increase the donor pool have not siologists may further foster the misperception that
been so enthusiastically supported in the United States. anesthesia is needed because organs are actually being
Pressure from advocacy groups, such as the Presumed removed prior to death, or that anesthetics are needed
Consent Foundation,21 to shift the national organ trans- for the purpose of killing the donor.
plant system to an opt-out program in which an indi-
vidual would be required to register opposition to avoid
automatically becoming an organ donor upon death, Hastening death and declaring death
is extremely controversial. Although considered by Two of the most controversial questions in the prac-
national organizations such as the American Medical tice of DCD are: (1) whether premortem administra-
Association, the Health and Human Services Advisory tion of organ preservation agents is acceptable, since
Committee on Organ Transplantation, and UNOS as they do not benefit the donor, and may hasten death;
a means of increasing organ donation, well accepted and (2) how long the interval must be between the
as national policy in some European countries, and onset of circulatory arrest and the declaration of
supported by British Prime Minister Gordon Brown, death. A 2005 National Conference on DCD8 sup-
a shift in US national organ donation policy to that of ported both the administration of organ preservation
presumed consent was neither supported by a 1994 US agents and a very short time interval for declaration
survey (71% of those opposed the practice )22 nor a 2006 of death, noting that the intent of the patient and/
IOM report.23 Differences in primary ethical priorities or their family is to donate viable organs and there-
from autonomy and beneficence in the United States to fore, practices to improve this goal are in the best
beneficence and social justice in the European Union interests of the patient’s/family’s goals. However, the
may account for this. Concerns in such an opt-out sys- ethical concerns regarding both practices bear some
tem include the protection of vulnerable populations review.
such as non- or poorly English speaking persons, the
young, elderly, and those who are educationally, eco- Organ preservation and the potential to hasten death
nomically, or socially disadvantaged. Such populations Heparin and phentolamine are examples of two
may neither be aware of the need to actively “opt-out” drugs which might hasten death in violation of the
nor have access to resources to make sure that they can dead donor rule, and are therefore not generally used
exercise such options. in non-donors who suffer from conditions similar to
A more recent legislative attempt to increase those of DCD donors, e.g., intracranial pathology or
the number of organ donors included the 2006 revi- trauma, or other conditions in which enhanced bleed-
sion of the UAGA,24 which had both unintended and ing might be fatal. The argument that the unintended
unacceptable consequences for end-of-life care. The “evil” that might occur is balanced by the potential
ethical and legislative problems for end-of-life medical “good” of increasing organ viability superficially

117
 Section 2. End-of-life issues

sounds like the principle of double effect, which is is therefore difficult to assign when based on the out-
even invoked by some of its proponents. However, comes alone. Under deontological reasoning, the
the principle of double effect refers to a treatment morality of an action is dependent on the intent of the
that is intended to benefit a patient (and does), but actor, as much if not more than the outcome, because
also causes harm as an unintended side effect to that intention is more likely than outcome to be under the
patient. Administration of organ preservation drugs actor’s control.
has no potential benefit for the donor, and there- Inability to reverse a cardiac arrest although one
fore can only have no effect, or will actually harm the intends to do so is not morally the same as never
donor. The principle of double effect therefore does intending and not even attempting to reverse a car-
not apply. Although a utilitarian philosophy might diac arrest even though one might be able to do so if
support administration of such drugs under a prin- they tried. A potential rescuer who fails in their efforts
ciple of beneficence, because it helps the recipient, to save a drowning person is not morally equivalent
the practice would not be supported from a deonto- to someone who might be able to save the victim if
logical perspective, because it clearly treats the donor they try, but intentionally stands by and watches them
as a means rather than an end unto themselves. drown.
(For more on the principle of double effect, see Moreover, a drowning person who is struggling
Chapter 15.) in the water but who will not be rescued is not “dead,”
but rather is “going to die”. Prediction of death must
Declaring death … a matter of timing? not be confused with a diagnosis of death. By such
The timing of the declaration of death in DCD is flawed reasoning, anyone who is ever going to die
extremely controversial, both legally and ethically. For would have to be defined as already dead. The con-
death to be declared, circulatory arrest must be irre- troversial definition of “irreversibility” creates an
versible, in compliance with the UDDA’s definition irresolvable paradox, because death describes a state
of cardiopulmonary death. A primary goal in DCD is that, biologically, socially, or morally, is exclusive of
to minimize warm ischemic time – the time between life in whatever way we might choose to define life.
cessation of circulation and organ reperfusion in the Under the proposed definition in which irreversibil-
recipient. However, the time between circulatory arrest ity is equivalent to “will not be reversed,” an individ-
and declaration of death cannot be so short that irre- ual is at once both living (as an integrated organism)
versibility is not established, lest the patient be killed and dead (because they will not be rescued) immedi-
in the organ donation process. The University of ately preceding and immediately following a cardiac
Pittsburgh decided to set the appropriate duration of arrest, even though they can only be either dead or
asystole at two minutes prior to declaration of death, alive, but not both, at any given time. Clearly, when
based upon controversial evidence from 180 patients the definition of death depends on the intentions and
that autoresuscitation (spontaneous return of pulse motives of a third party and not the physical state of
and circulation) did not occur after that time. However, the person whose heart has stopped, then pronounce-
Adhiyaman and colleagues dispute the claim that there ment of death represents a social construct and not a
is no autoresuscitation after 2 minutes, noting reported biological fact.
survival of patients following much longer periods of The dead donor rule presents major conceptual
cardiac arrest.26 and procedural ethical problems in DCD, and limits
In order to counter concerns that 2 minutes of asys- this method of organ donation. Importantly, how-
tole is not long enough to assure that circulatory arrest ever, society seems willing to accept violations of this
is “irreversible,” some have argued that, for a patient rule without compromising the trust necessary for
who will not be resuscitated, “irreversible” and “will our voluntary system of organ donation. In a survey
not be reversed (or resuscitated)” are ethically identi- of 1351 Ohio residents, 45% of those with consistent
cal. However, these situations are clearly not equiva- answers were willing to violate the dead donor rule
lent ethically, at least under deontological principles. and donate organs of patients they considered to be
In deontological reasoning, actions are determined to alive.27 Furthermore, a survey of terminally ill adult
be “right” or “wrong” independent of their outcomes. cystic fibrosis patients found that one-third desired to
This is because the actor does not have control over all donate their kidneys under anesthesia and be allowed
of the consequences of an action, and accountability to die when admitted for terminal care.28

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 Chapter 20. Organ donation after cardiac death

Solutions to the lack of donor organs are nei- death) then, the patient has made a moral decision.
ther clear nor without political and ethical contro- If the decision results in the most happiness (great-
versy. We must decide whether as a society we should est happiness principle) then it is morally correct
accept the concept that the dead donor rule is a vio- based on utilitarian concepts.31 Here, the only harm
lation of autonomy, or whether we should ignore the is to self and that is morally permissible because “the
dead donor rule and allow donation from patients individual is not accountable to society for actions, in
who have lost personhood (irreversibly neurologic- so far as these concern the interests of no person but
ally impaired but do not reach the definition of brain himself.”30
death) or those who have decided that they wish to On first glance, deontologic (Kantian) ethics would
donate organs prior to their death or submit to other forbid patients to donate organs for the good of society
nontherapeutic procedures  – whether or not these if such donation resulted in their death, as the patients
invasions result in death. Alternatively, society can would be treated as means rather than as ends.32
abandon our strong emphasis on autonomy and However, if a priori, patients decide that their duty is
develop more communitarian principles, a difficult not to burden themselves, their families or society with
political shift in a country founded under concepts continued life, then the decisions are morally correct
espoused by the Enlightenment of individual life, based on Kantian concepts as long as patients treat
­liberty and the pursuit of happiness. The conflict themselves as ends and not means. They are judged
arises when one pits the individual’s rights (auton- by their intentions and not the consequences of their
omy, personal beneficence, nonmaleficence, and decisions. Based upon these concepts, the state or any
justice) against the welfare of society, and utilitarian- other power structure (medical profession, judiciary,
ism cannot solve this conflict. etc.) has no right to interfere. Coercive or paternalis-
tic disruption of the patient’s autonomous decision is
unacceptable to both Kant and Mill. For Kant, refusing
Ethical frameworks to allow the donation might be to treat the patient
(potential donor) as a means and not an end. For Mill,
Individualism: utilitarian and deontological the interference would also be morally unacceptable.
perspectives According to Englehardt, “it is not medicine’s responsi-
Liberal individualism may be supported by both utili- bility to prevent tragedies by denying freedom, for that
tarian and Kantian (deontologic) ethical concepts. would be the greater tragedy.”33
Steinbock, Arras, and London note that “[w]hether In contrast, if patients are incompetent and with-
ethical norms are conceived in terms of enlightened out reason, they cannot be autonomous and Kantian
self-interest, maximized utility, or the recognition of theory is not applicable. Utilitarianism also falls
autonomy and human rights, they are applicable to by the wayside if patients are unable to define what
all times and places.”29 Thus, looking at the most con- grants them the greatest happiness. In this model of
troversial suggestion, the right of a person to donate principlism, decisions based on beneficence, non-
vital organs prior to death (and thus be killed by organ maleficence, and justice (best interests) would trump
donation) or submit to nontherapeutic invasion nonexistent autonomy. Decisions based upon the best
(whether or not these actions result in their death), outcomes (consequences) would pass moral muster,
utilitarianism would support such rights under appro- and controlled paternalism, with interest only for the
priate safeguards. Utilitarian theory, as espoused by patients, would be acceptable.
Mill, would support the ethical right of persons with
decisional capacity as well as those with precedent Communitarianism
autonomy (advance directives) to make this autono- In the situation where there is no autonomy and
mous decision, based on their values, desires, and no precedent autonomous choices, communitari-
wants, irrespective of harm to self.30 Mill values the anism may provide the moral answer. Individual
ability of persons to choose and follow their own life account of a good life will not resolve the problem
plans with little interference. If the decision to donate of what care to give patients who are not and never
vital organs and die as a result is based upon reason were competent. Moving beyond individualism
and rationality (e.g., the patient is terminal and cer- and autonomy, toward an ethic of interdependence,
tain to die and their current suffering is worse than may provide the moral and ethical answers to these

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dilemmas.34 According to Emanuel,35 the principles so long as the individual’s actions are free of harm
of autonomy do not apply in the care of incompe- to others. Respecting the ethical and judicial rights
tent patients because they have no choice, decisions of both donors and recipients in DCD may require
are made by another person (surrogate), the ques- moving beyond the dead donor rule to accommodate
tion of treatment is procedural, and we have avoided the informed wishes of dying patients.
the question of what treatment incompetent patients
should receive. Emanuel recognizes the substantive Key points
standard of best interests and realizes the multi-
factorial ways of determining what is best for the • Organ donation after cardiac death (DCD)
patient. He bases his solution on the development of is controversial because it combines two
democratically determined community consensus ethically complex events: withdrawal of life-
that defines the substantive content of best interests supportive therapies as part of end-of-life care
based on particular conceptions of the good life. In of the dying patient, and the altruistic gift of
contrast, Callahan36 recognizes that there is inher- organ donation.
ent conflict between the individual’s best interests • The dead donor rule presents ethical problems
and what is best for society as a whole. His criteria for expansions of DCD, and some legislative
for deciding on healthcare priorities give priority and practice changes to counteract these
to the good to society over the good to individuals. limitations may have presented even greater
Therefore, Callahan’s version of communitarianism, ethical problems than the dead donor rule
with prohibitions protecting vulnerable groups, itself.
would support the ability of persons to donate their • DCD by its very nature incorporates conflicts
organs, even if the donation resulted in their death. of interest between the care of the donor and
He would also support the changes in Centers for the needs of the recipient.
Medicare and Medicaid Services (CMS) regulations • Firewalls should separate the three key
and presumed approach for obtaining consent for decisions involved in DCD: the decision to
organ donation, concepts of presumed consent, and forgo resuscitation, the decision to withdraw
therefore, the unconsented perfusion of organs fol- life-sustaining therapies, and the decision to
lowing uncontrolled cardiac death. Kantian (deonto- donate organs after death.
logic) and utilitarian theory, while supporting some • Physicians involved in DCD should have
of the 2006 revisions of the UAGA that enforced the expertise and special training in end-
patient’s right to donate over the objections of the of-life care – involvement of general
family, would find most of the other revisions (e.g., anesthesiologists can be harmful, and may
Section 21), as well as the changes in CMS regula- lead to the mistaken belief that donors may
tions, the presumed approach for obtaining consent, be alive and/or suffer during vital organ
presumed consent, and the unconsented perfusion procurement.
of organs following uncontrolled cardiac death mor- • Administration to the donor of drugs for the
ally unacceptable. sole purpose of organ preservation is ethically
We live in a pluralistic liberal society, with no problematic when those drugs may hasten
privileged perspective of the good, where respect death.
for individual autonomy trumps the other princi- • The timing of declaration of death is
ples of beneficence, nonmaleficence, and justice. also controversial, since the point of
These individual positive and negative liberty rights, “irreversibility” of cardiac arrest has not been
imprinted in our Constitution and enforced by statu- defined.
tory and common law, allow self-harm but prohibit • Resolving conflicts in the DCD process may
harm to others, and form the basis of our moral require revisiting the dead donor rule.
thought. Respect for autonomy involves respect for
the legal and moral right to be free of nonconsen-
sual interference. Therefore, it is just as unethical Notes
a
to force a person to become an organ donor as it is  According to data from www.unos.org and www.
not to allow them the opportunity to become one, optn.transplant.hrsa.gov in 2009 there were 14 632

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 Chapter 20. Organ donation after cardiac death

donors (8 021 deceased and 6611 living) resulting in 13   Task Force on Ethics of the Society of Critical Care
28 465 transplants (21 854 from deceased donors and Medicine. (1990). Consensus report on the ethics of
6 611 from living donors). As of June 2010, there were forgoing life-sustaining treatments in the critically ill.
107 970 patients on waiting lists and up to 30% will Crit Care Med, 18(12), 1435–9.
incur significant morbidity or mortality while waiting 14   In re Guardianship of L.W. Wis. Supreme Court, Case
for transplantation. No. 89–1197 (1992) and In re Edna M.F. 210 Wis.2d
557, 563 N.W.2d 485 (1997).
References 15   Medicare and Medicaid programs; hospital
1  Murray, T.H. (1987). Gifts of the body and the needs of conditions of participation; identification of
strangers. Hastings Cent Rep, 17(2), 30–8. potential organ, tissue, and eye donors and
2   Robertson, J.A. (1999). The dead donor rule. Hastings transplant hospitals’ provision of transplant-related
Cent Rep, 29(6), 6–14. data – HCFA. Final rule. (1998). Fed Regist,
63(119), 33856–75 and CFR Section 482.45
3*  A definition of irreversible coma. (1968). Report of the
Medicare and Medicaid Programs:
Ad Hoc Committee of the Harvard Medical School to
Conditions of Participation: Identification of
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Potential Organ, Tissue and Eye Donors and
337–40.
Transplant Hospitals’ Provision of Transplant-
4*  University of Pittsburgh Medical Center policy and Related Data.
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16   Zink, S. and Wertlieb, S. (2006). A study of the
ill patients who may become organ donors after death.
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Kennedy Inst Ethics J, 3, A1–15.
new solution to an old problem. Crit Care Nurs, 26(2),
5  Ethics Committee, American College of Critical 129–36.
Care Medicine, Society of Critical Care Medicine.
17   Truog, R.D. (2008). Consent for organ donation-
(2001). Recommendations for nonheartbeating organ
balancing conflicting ethical obligations. N Engl J
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Med, 358(12), 1209–11.
6    Council on Ethical and Judicial Affairs, American
18  Waisel, D.B. and Truog, R.D. (1997). Informed
Medical Association. (2008). Opinion 2.157: Organ
consent. Anesthesiology 87(4), 968–78.
donation after cardiac death. Code of Medical Ethics of
the American Medical Association: Current Opinions 19   Luskin, R.S., Glazier, A.K., and Delmonico, F.L. (2008).
with Annotations, 2008–2009 Edition. Chicago, IL, Organ donation and dual advocacy (Correspondence).
American Medical Association, p. 71. N Engl J Medicine, 358(12), 1297–8.
7*  Institute of Medicine National Academy of 20*  May, T., Aulisio, M.P., and DeVita, M.A. (2000).
Sciences. Non-Heart-Beating Organ Transplantation: Patients, families, and organ donation: who should
Medical and Ethical Issues in Procurement, 1997 and decide? Milbank Q, 78(2), 323–36.
Non-Heart Beating Organ Transplantation: Practice 21   http://www.presumedconsent.org.
and Protocols, 2000, both Washington, DC, National 22   Seltzer, D.L., Arnold, R.M., and Siminoff, L.A. (2000).
Academy Press. Are non-heart-beating cadaver donors acceptable to
8   Bernat, J.L., D’Alessandro, A.M., Port, F.K., et al. the public? J Clin Ethics, 11(4), 347–57.
(2006). Report of a national conference on donation 23   Childress, J.F. and Liverman, C.T., eds. (2006).
after cardiac death. Am J Transplant, 6(2), 281–91. Committee on Increasing Rates of Organ Donation of
9   www.unos.org. the Institute of Medicine of the National Academies.
10   Sanner, M. (1994). A comparison of public attitudes Organ Donation: Opportunities for Action. Washington,
towards autopsy, organ donation, and anatomic DC: National Academy Press, pp. 1–358, available at
dissection. A Swedish study. JAMA, 271(4), 284–8. http://www.nap.edu.
11   Council on Ethical and Judicial Affairs, American 24   http://www.anatomicalgiftact.org.
Medical Association (2008). Opinion 2.20: 25*  Van Norman, G. (2003). Another matter of life and
Withholding or withdrawing life-sustaining death: what every anesthesiologist should know about
medical treatment. Code of Medical Ethics, Current the ethical, legal, and policy implications of the non-
Opinions with Annotations, 2008–2009 Edition. heart-beating cadaver organ donor. Anesthesiology,
Chicago, American Medical Association, pp. 82–3. 98(3), 763−73.
12   American Thoracic Society. (1991). Withholding and 26   Adhiyaman, V., Adhiyaman, S. and Sundaram, R.
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27   Siminoff, L.A., Burant, C., and Youngner, S.J. (2004). 36*  Callahan, D. (1990).What Kind of Life: The Limits
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attitudes. Kennedy Inst Ethics J, 14(3), 217–34. University Press, pp. 103–34.
28*  Fost, N. (2004). Reconsidering the dead donor rule: is
it important that organ donors be dead? Kennedy Inst Further reading
Ethics J, 14(3), 249–60.
Arnold, R.M. and Youngner, S.J. (1993). The dead donor
29   Steinbock, B., Arras, J.D., and London, A.J. (eds.) rule: should we stretch it, bend it, or abandon it?
(2003). Ethical Issues in Modern Medicine. Boston, MA, Kennedy Inst Ethics J, 3(2), 263–78.
McGraw Hill, p. 26.
Fost, N. (1999). The unimportance of death. In The
30   Mill, J.S. (1986).On Liberty. Amherst, NY, Prometheus Definition of Death: Contemporary Controversies.
Books, pp. 106–129. Youngner, S.J., Arnold, R.M., and Schapiro, R. (eds.).
31  Mill, J.S. (1987). Utilitarianism. Amhurst, NY, Baltimore, MD, Johns Hopkins University Press,
Prometheus Books, pp. 16–7. pp. 161–78.
32  Kant, I. (1988). Fundamental Principles of the Joffe, A.R. (2007). The ethics of donation and transplantation:
Metaphysic of Morals. Amherst, NY, Prometheus are definitions of death being distorted for organ
Books. transplantation? Philos Ethics Humanit Med, 2, 28.
33  Englehardt, H.T. Jr. (2003). Commentary. In Ethical Robertson, J.A. (1988). Relaxing the death standard for
Issues in Modern Medicine. Steinbock, B., Arras, J.D., organ donation in pediatric situations. In Organ
and London, A.J. (eds.). Boston, MA, McGraw Hill, Substitution Technology: Ethical, Legal, and Public Policy
pp. 307–8. Issues. Methieu, D. (ed.). Boulder, CO, Westview Press,
34*  Gaylin, W. and Jennings, B. (2003).The Perversion pp. 69–76.
of Autonomy: Coercion and Constraints in a Liberal Volk, M.L., Warren, G.J., Anspach, R.R., et al. (2010).
Society. Washington DC, Georgetown University Press, Attitudes of the American public toward organ
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35*  Emanuel, E.J. (1991).The Ends of Human Life: Medical Am J Transplant, 10(3), 675–80, Epub 2010 Feb 1.
Ethics in a Liberal Polity. Cambridge, MA, Harvard
University Press.

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 Section 2
1 End-of-life issues
Chapter

21
Revising the Uniform Anatomical Gift
Act – the role of physicians in shaping
legislation
Gail A. Van Norman and Michael DeVita

The Case concerns for vulnerable populations who may experi-

ence either barriers to organ donation or, alternatively,
In Pennsylvania, a man lies in critical condition. He has
become the victims of rules that do not fairly recognize
indicated in his living will that he would not want his life
maintained “on machines.” He has a do-not-resuscitate
their rights and desires to refuse organ donation.
(DNR) order. He has also designated on his driver’s license The original version of the 2006 revision of the
that he wishes to be an organ donor. His physicians are pre- UAGA and its consequences is an object lesson in how
vented from discussing of palliative care options by a new well-meaning experts unintentionally crossed critical
state law based on the new Uniform Anatomical Gift Act ethical boundaries in their desire to improve organ
(2006). The new law prioritizes management of potential donation. It is also a story of how legislative actions can
organ donors to promote organ viability, even if it compro- profoundly affect clinical practice in anesthesiology,
mises palliative care. According to the new law, the family and an illustration that clinical practitioners have
may not intervene when, despite his DNR order, the patient important roles to play in promoting ethical legisla-
is resuscitated from a hypotensive arrest and mechanical tion. A revised version of the UAGA 2006 has now been
ventilation is continued. After evaluation for organ dona-
adopted in most of the US, but the story still serves to
tion, he is taken to an operating room for withdrawal of
life-sustaining treatment. Shortly thereafter he dies and his
remind us that our ethical responsibilities do not end
organs are procured for transplantation. at the hospital doors, but include a duty to help shape
In Washington State, an anesthesiologist who is healthcare legislation.
unaware of these events discovers that adoption of a state The 1987 revision of the original UAGA never
law based on the new UAGA (2006) is about to pass out achieved national ratification and was only adopted by
of committee in the state senate and will likely be signed 26 states.1 Organ donation and transplantation often
by the governor. She is troubled by several problems with transcends state boundaries, and the US needed uni-
the legislation, one of which is that it would permit organ form rules for organ donation and transplantation that
procurement agencies to override a patient’s living will and could be adopted in all 50 states. In addition, despite a
continue or even initiate life-sustaining treatments to pro- seemingly clear mandate in the first UAGA to protect
mote organ viability, without the agreement of the patient
the rights of persons to donate organs, the decisions of
or the patient’s surrogate decision-makers.
donors to make their organs available were often being
The original Uniform Anatomical Gift Act (UAGA) is treated by physicians and families as though they were
model legislation for states to emulate, and to promote merely suggestions rather than formal mandates. It is
uniform laws among states. It was enacted in 1968 still common for donors’ wishes to be countermanded
and revised in 1987, assuring patients of their rights once they have died or can no longer speak for them-
to donate their organs for transplantation after death. selves, because of family objections to organ dona-
More than 40 years later, organ transplantation is a fix- tion.2 Some physicians are reluctant to proceed with
ture in modern health care in developed countries. But organ donation over family objections, even when the
controversies in organ transplantation persist: particu- donor’s wishes are clear – in part out of fear of litiga-
larly those involving rights of donors versus the needs tion, in part due to uncertainty about legal obligations.
of recipients, the balance between end-of-life (EOL) This is occurring while demand for transplantable
care and preservation of transplantable organs, and organs far outstrips supply, and loss of organs from

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
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 Section 2. End-of-life issues

willing donors because of objections of third parties is The UAGA (2006) provided that once a person had
perceived as a barrier to increasing organ availability. designated that they are an organ donor, there were
The UAGA (2006) sought to accomplish several only limited ways in which their wishes could be coun-
explicit goals set forth in the preamble, among them:  termanded. The donor could rescind their agreement
(1) to address the critical organ shortage by providing by executing a new legal document of recission, they
additional ways to make donations; (2) to strengthen could destroy the original document agreeing to organ
language barring others from overriding a donor’s donation, or they could provide verbal rescission of the
decision to donate organs; (3) to broaden opportuni- agreement to donate. Each of these measures required
ties for organ donation by expanding the definition of two witnesses, one of whom “could not be an interested
persons who could agree to donate a patient’s organs party,” such as a family member or transplantation rep-
when the patient could not do so for him or herself to resentative.1 These provisions were intended to pro-
non-family members, such as “an adult who exhibited mote respect for the wishes of donors, but they failed
special care and concern for the decedent;” (4) to pro- to adequately respect the autonomy of persons whose
vide an explicit way for persons who did not wish to wishes regarding organ donation change with time
donate organs to refuse to do so; and (5) to expand the and circumstance. They also failed to take into account
number of transplantable organs by promoting proc- practical aspects of EOL decision-making. Donors
esses biased toward preserving organ viability.1 may lack the opportunity or be unable to execute new
legal documents as EOL approaches and they become
incapacitated. Many depend on family members to
Respect for patient autonomy represent them in medical decision making when they
A major flaw in the UAGA revision was the manner are unable to make or express decisions for themselves.
in which it dealt with conflicts between provisions of Legal and ethical principles in surrogate decision-
living wills and procedures to promote organ dona- making have traditionally recognized the legitimate
tion. UAGA 2006 permitted, even required, institu- role of family, since they presumably share common
tion of measures to “ensure the medical suitability of elements of culture, upbringing, values, and religious
the organ for transplantation,” stating that “therapy beliefs. And there may be no non-family members pre-
may not be withheld or withdrawn from the prospect- sent when a last-minute rescission is expressed by a
ive donor, unless the declaration [of a desire to be an dying patient. Without the presence of such a “disinter-
organ donor] expressly provides to the contrary.”1 The ested party,” late changes of heart would not necessarily
National Conference of Commissioners on Uniform be followed under the new law.
State Laws (NCCUSL) assumed that organ donors Respect for patient autonomy requires that patients
always want to prioritize organ donation over other be fully informed about implications that organ dona-
EOL decisions, although they had no empiric evi- tion may have for other aspects of EOL care. UAGA
dence for this presumption. There is evidence that the 2006 required no such discussion, even though in
major concerns of patients at the EOL are control over its original form, its mandates clearly could be inter-
the timing and location of death, relief of symptoms preted to say that EOL decisions to forgo life-saving
including pain, dyspnea, anxiety and depression, interventions must be rescinded, and measures to pro-
avoidance of a prolonged death, and preservation mote organ viability must be initiated if a patient states
of therapeutic options including withdrawal of life- that they want to be an organ donor. It is reasonable to
sustaining measures and terminal sedation.3 The assume that most patients do not understand that their
lack of basis for prioritizing organ donation ahead EOL preferences and organ donation decisions impact
of other EOL concerns led to criticism of the original each other, although the model law assumed that the
UAGA 2006.4 Critics of the original UAGA 2006 point potential conflict is understood and this prioritization
out that, even if a majority of dying patients would has been made when an organ donor designation is
agree to suspend their living wills in order to become created. A common way in which many people express
donors, the ethical principle of respect for autonomy their interest in becoming organ donors is to sign a
demands that we respect the rights of patients who statement on the back of their driver’s license, where
do not agree, and are seeking EOL care that conforms there is no opportunity for “informed consent” about
with different goals. Thus a more flexible approach how that signature could potentially alter their other
would be warranted. options for EOL care.

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 Chapter 21. Revising the Uniform Anatomical Gift Act

The principle of beneficence for the patient, and not for third parties such as organ
procurement agencies, transplant teams and organ
The NCCUSL intended to assure patients who wished to
recipients.
donate organs that their desires would be carried out at
EOL. By resolving ambiguities in favor or organ dona-
tion, they also hoped to increase the supply of organs The principle of justice; fair distribution of
for transplantation. However their approach fostered burdens and benefits
an either-or process instead of a collaborative decision Principles of justice require that equal persons be
making process. Organ donation is an important part treated equally. The NCCUSL based their resolution of
of EOL planning that should be honored by physicians conflicting EOL decisions in favor of organ donation
and family. on the fact that often donor wishes are ignored even if
Organ donation may provide meaning for patients there is no conflict about EOL management. The most
and families at EOL. On the other hand, unwanted common situation is after death determination using
resuscitation can cause physical suffering for the neurological criteria where the wishes of up to 20%
patient, and has emotional implications for families. of potential donors are ignored.6 Nevertheless, when
The balance of benefits and harms for dying patients there emerges a situation where EOL care and organ
is complex, with highly individual considerations. An donation have to be prioritized, there is not evidence
absolute solution that fits the needs of all patients and to support that most dying patients would prefer one
is of sufficient moral accountability in all cases is prob- or the other priority.
ably impossible to legislate. Instead, it is better for it By not creating clearer processes to firmly estab-
to rest in the dialogue between patients, their families, lish that in the setting of needed EOL care a patient
and their physicians. did or did not want to be an organ donor, the model
law had the potential to disproportionately harm vul-
nerable populations. Economically disadvantaged
The principle of nonmaleficence patients, minority populations, and those who do not
The UAGA (2006) sought to end a potential harm to speak English as a first language are least likely to be
organ donors – the risk that their wishes, even if clear, informed about such procedures, or to have means to
might be rescinded at EOL and their gift not accepted carry them out. Organ distribution in the US is already
or honored. But the model statute failed to recognize known to suffer from imbalance: minority patients are
two important things about dying patients. The first less likely to receive vital organs than Caucasian men,
is that donors can and do sometimes change their for example.7 The concern, accurate or otherwise, is
minds at EOL, when they may be both vulnerable and that the organ donation “system” takes organs from the
have limited capacity to express their change of heart.5 poor, and unfairly benefits the wealthy. It is one of the
Meaningful EOL care involves managing and facili- reasons cited for why organ donation from minority
tating – not hindering – a wide array of decisions to populations remains low.8 Legislation that even has the
meet the changing needs and wishes of dying patients. appearance of unfairly treating vulnerable populations
The second is that patients may truly have conflicting may foster mistrust in the transplant system, and there-
desires as EOL approaches: the desire to donate viable fore could adversely affect future organ donations.
organs, and the desire to forgo life-sustaining inter- Several factors likely contributed to the fact that
ventions that would make such a donation possible. original UAGA 2006 got so far, even being enacted
These seemingly conflicting goals may not be entirely in eighteen states, before the flaws became obvious.
resolvable. We propose that consideration of organ First, of all the numerous “stakeholders” identified by
donation is an important component of good EOL the NCCUSL in its preamble to UAGA 2006 did not
care, but that organ donation does not trump EOL include any physician group traditionally associated
care. Society and physicians have generally chosen in with end of life care in the intensive care unit, such
circumstances where a clear resolution of conflicting as the American Academy of Hospice and Palliative
goals is not obvious, to “err” on the side of asking the Medicine, or the Society of Critical Care Medicine.1
patient or their surrogate decision-makers to clarify Physician specialists in end-of-life have a critical
their priorities, since the goal of care is to promote understanding of complex end-of-life issues, and are
beneficence and nonmaleficence first and foremost arguably the most important physicians to involve in

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 Section 2. End-of-life issues

any discussions surrounding medical issues at end-of-

life. Second, the implementation of the legislation was
The end of the story and Its “morals”
The case summarized at the beginning of this chapter
poorly publicized, both nationally and locally. Many
was reported by Drs DeVita and Caplan in 2007 in the
physicians involved in organ transplantation were
Annals of Internal Medicine.4 It was their intention to
unaware that UAGA was being revised. In Washington
point out the flaws in UAGA 2006 with regard to end-
State there had been no widespread public announce-
of-life care for dying patients, flaws in the NCCUSL
ment of the adoption of the legislation. Indeed, the wit-
process and its consequences, and to promote passage
nesses at Senate hearings were for the most part organ
of significantly amended UAGA model legislation in
transplant recipients and representatives of the local
its place. The “revised” UAGA 2006 (the “New Section
organ procurement network. As a result, the commit-
21”) was proposed by the NCCUSL and contained
tee members were under informed and perhaps not
patient-centered rather than organ-centered resolu-
well positioned to assess unintended consequences of
tion when conflicts between living wills and donation
the wording of the UAGA.
declarations occurred.1 DeVita and Caplan further
suggested that states that had passed the original
Ethical obligations in promoting UAGA 2006 should amend their legislation to include
healthcare legislation this critical change.4
Physician advocacy for patient rights is not only the In Washington State, the anesthesiologist part-
responsibility of a few politically interested parties; nered with a community opinion leader to contact and
patient advocacy is a founding principle in medical inform state legislators about flaws in the legislation
practice, and is a specific duty of every physician in which was based on the original UAGA 2006. They
practice. Such advocacy can take many forms; from placed an editorial in a local leading newspaper, urging
supporting individual patients in their endeavors voters to contact their legislators.12 The anesthesi-
to seek health benefits owed to them, to developing ologist solicited letters to the legislators from national
and advocating for positive changes in health care opinion leaders in anesthesiology and critical care who
legislation. supported amending the legislation. She then met with
Physician professional organizations acknowledge the governor’s legislative aide on healthcare issues and
that ethical obligations of physicians extend beyond urged that the governor not sign the legislation until it
those between individual doctors and patients. The was amended to contain the revised wording of Section
AMA’s “principles of medical ethics” states that, “A phys- 21. Despite strong opposition from the local organ pro-
ician shall respect the law and also recognize a respon- curement agency, the bill was placed on hold for one
sibility to seek changes in those requirements which are year until more informed discussion could occur. A
contrary to the best interests of the patient.”9 The AMA revised UAGA 2006 was ultimately passed, containing
Code of Medical Ethics goes on to say that: “Whenever the critical amendment protecting patient rights and
engaging in advocacy efforts, physicians must ensure options regarding EOL care.
that the health of patients is not jeopardized and that
patient care is not compromised.”10 When doctors Key points
engage in legislative efforts, they are therefore obliged
• Laws can significantly impact individual
to look at all of the benefits and harms that might result
patient care. Without input from physicians
from such rules.
of all involved specialties, including
The AMA Principles of Medical Ethics form a
anesthesiology, legislators may inadvertently
foundation upon which the American Society of
create rules and regulations that lead to
Anesthesiologist basis its own Guidelines for Ethical
unintended negative consequences for
Practice of Anesthesiology, first adopted in 1992, and
patients.
reconfirmed in 2008.11 Anesthesiologists who recog-
nize special concerns in health care legislation and who • Anesthesiologists have ethical duties to
have special knowledge to inform lawmakers should understand legislation that may affect their
step forward when needed to help assure that laws and patients, to publicize concerns, and to press
regulations do not result in unintended negative out- for legislation that adequately and protects the
comes for patients. rights of all patients.

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 Chapter 21. Revising the Uniform Anatomical Gift Act

Anatomical Gift Act (2006). Ann Int Med, 147,

• Decisions regarding organ donation are
876–9.
critical in EOL planning, and when patient
5*  Ditto, P.H., Jacobson, J.A., Smucker, W.D., et al. (2006).
wishes produce contradictory instructions,
Context changes choices: a prospective study of the
physicians have a duty whenever possible
effects of hospitalization on life-sustaining treatment
to discuss and resolve those contradictions preferences. Med Decis Making, 26, 313–22.
with the patient or their legal surrogates.
6*  Barber, K., Falvey, S., Hamilton, C., et al. (2006).
Such resolutions should represent the Potential for organ donation in the United
patient’s priorities with regard to his or her Kingdom: audit of intensive care records. BMJ, 332,
own healthcare, and should not be guided 1124–7.
exclusively by the interests of third parties, 7*  Siminoff, L.A., Burant, C.J. and Ibrahim, S.A. (2006).
such as organ procurement agencies. Racial disparities in preferences and perceptions
• Legislative change requires the actions of regarding organ donation. J Gen Intern Med, 21,
just a few knowledgeable persons. Individual 995–1000.
physicians should not be discouraged 8* Siminoff, L.A. and Sturm, C.M.S. (2000). African-
from trying to effect positive change when American reluctance to donate: beliefs and attitudes
misinformation or lack of debate may lead to aobut organ donation and implications for policy.
the adoption of flawed regulations or laws that Kennedy Inst Ethics J, 10, 59–74.
are detrimental to patient care. 9* American Medical Association. (2001). Principles
of Medical Ethics. American Medical Association,
Chicago, IL.
References 10* American Medical Association. (2004) AMA Code
of Medical Ethics, Opinion 9.025. American Medical
1* National Conference of Commissioners on Uniform Association, Chicago, IL.
State Laws. (2006). Revised Uniform Anatomical
11* American Society of Anesthesiologists. (2008).
Gift Act with Prefatory Note and Comments. South
Guidelines for the Ethical Practice of Anesthesiology.
Carolina; National Conference of Commissioners on
Adopted 2003; amended 2008). American Society of
Uniform State Laws.
Anesthesiologists, Highland Park, IL.
2*  Christmas, A.B., Burris, G.W., Bogart, T.A., and Sing,
12* Van Norman, G, and Brown, S. (2007). Organ
R.F. (2008). Organ donation: family members not
donation a personal decision. Opinion, The Seattle Post
honoring patient wishes. J Trauma, 65(5), 1095–7.
Intelligencer, March 20.
3*  Truog, R., Cist, A.F.M., Brackett, S.E., et al. (2001).
Recommendations for end-of-life care in the intensive
care unit: The Ethics Committee of the Society of Further reading
Critical Care Medicine. Crit Care Med, 29, 2332–48. Beacuhamp, T. and Childress, J.F. (2009) Justice. In
4*  DeVita, M. and Caplan, A. (2007). Caring for organs Principles of Biomedical Ethics, 6th edn. New York,
or for patients? Ethical concerns about the Uniform NY: Oxford University Press.

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 Section 2
1 End-of-life issues
Chapter

22
Physician aid-in-dying and euthanasia
Alex Mauron and Samia Hurst

The Case in a Western intensive care unit, treatment limita-

tions were in force, albeit with significant variations
Mr. B., a successful 79-year-old scientist, has a very
­aggressive malignancy, is no longer able to work or func-
according to culture and religion.2 Foregoing life-
tion independently and is weakening rapidly. Oral medi- sustaining treatment on account of futility and/or
cation helps somewhat with his bone pain but does not patient wishes has become standard procedure and
alleviate his severe dyspnea. He asks his physician for there is a vast literature discussing how to do it in an
medication to “put him out of his misery”, but is told that ethically defensible way.
such treatment is “illegal.” The day before his planned The fatality of impending death has been replaced
admission to a nursing facility for hospice care, Mr. B., by what is aptly called “end-of-life decisions.” Do-not-
with a final surge of energy, goes to the shed behind his resuscitate (DNR) orders, advance directives, prac-
house and shoots himself fatally. His written farewell note tice guidelines and the like are tools for choosing and
to his family ends with “it is a shame that a man has to do
deciding where formerly no choice existed and no
this for himself.”
decision was required. This shift has implications for
This case occurred 50 years ago; what would have hap-
pened today? the way physicians should classify their death-related
actions. The smug distinction between “letting nature
Should physicians end a patient’s life at his or her take its course” (innocent) and “active killing” (guilty)
request (as in euthanasia), or otherwise collaborate is no longer tenable once it is clear that acceptable
with the ending of life at a patient’s initiative (as in forms of treatment limitation are causally connected
assisted suicide)? This question unavoidably raises to the patient’s death. That does not necessarily mean
two separate ethical issues. One regards the general that the traditional distinction between killing and
prohibition of killing, its justifications, and possible letting die is moot, but it does imply that the rel-
exceptions; the other concerns the specific obliga- evant distinctions are more subtle and go beyond a
tions of physicians and healthcare personnel in this mechanical analysis of causes and effects, actions and
respect. This question also demands a consideration omissions.
of historical context, since the phenomenology of The intentional ending of a human life at this per-
dying has changed a great deal over time. For centu- son’s request thus raises two distinctive ethical issues. It
ries “natural death” was conceived of by physicians is obvious that the moral and legal permissibility of vol-
and lay people alike as an experience that was at untary death, be it at another’s hand, or with another’s
once tamed by familiarity, and yet utterly unavoid- help, or wholly self-administered, has been a topic of
able. Dealing with death had much to do with social philosophical and religious controversy for millennia.
mores and religious rituals, little with medical inter- The debate still goes on and is reflected in the hetero-
ventions, which were in any event quite incapable of geneity of legislation concerning euthanasia, assisted
forestalling an inevitable demise. Modern medicine, suicide (with or without physician involvement), and
especially emergency medicine and critical care, has even suicide itself. At the same time, there has been a
changed all that and often made impending death the parallel debate in medical ethics, which is about the
locus of complex decisions and choices. Research, professional duty of physicians: does it necessitate the
including the classical ETHICUS study,1 has shown preservation of life no matter what? If not (as nearly
conclusively that for a majority of patients dying everybody agrees), what are the sorts of end-of-life

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
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management strategies that are ethically acceptable? as beyond the pale). We will also focus on physician-
Do they include physician-assisted suicide and volun- assisted suicide, even though we have to broaden our
tary active euthanasia? What about terminal sedation? perspective occasionally, as in discussing the Swiss
Both the broader societal discussion and the debate legal situation.
within medical ethics are important. They are related,
to be sure, but must not be confused.
Ethical arguments and legislation
Physician-assisted death harks back to a general debate
Definitions on voluntary death that has been going on for millen-
nia, and some of the arguments given today have been
“Physician aid-in-dying” is a somewhat ambiguous
present throughout this history. They closely parallel
term, requiring clarification. Although general ques-
arguments made in favor of or against euthanasia and
tions regarding end-of-life care and decision-making
assisted suicide.6
are related to our topic, not all of them are part of it.
This chapter is not about interrupting life support,
DNR orders, or palliative care, but about the wilful Arguments against euthanasia and assisted suicide
termination of a patient’s life by a physician and the (1) That although respect for autonomy is
willing collaboration of a physician to the patient’s important, it should not extend to euthanasia
suicide. The term “physician-assisted death” used or assisted suicide. For long periods of history,
by some authors is clear and covers our subject mat- lives were considered to belong to God, or
ter. Some practices may be seen as borderline, such the State, or both. In monarchies, suicide was
as terminal sedation, and we will therefore discuss a common law felony against the king. More
it also since it is a specific concern of anesthesiolo- recently, philosophers have argued that suicide
gists. The issue of the withdrawal of food and hydra- cannot be autonomous because it ends the
tion from comatose patients, or from dying patients possibility of autonomy. Nor can a request for
who request it, is often drawn into the legal con- assisted death be considered autonomous if it
troversy on physician-assisted death. Examples are is a symptom of a disease, such as depression: if
the case of Terry Schiavo3 or the very recent case of this is always the case, these requests are never
Eluana Englaro in Italy (a bill currently before the autonomous.
Italian senate would make hydration and alimen- (2) That beneficence does not necessarily extend to
tation compulsory).4 In fact, these broader end-of- authorizing assisted death, and should concentrate
life issues have a way of spilling over into the debate exclusively on the use of alternatives and the
on physician-assisted death, in part because similar promotion of well-conducted and universally
arguments have been used in both areas. As noted by available palliative care. Furthermore, requests
Dworkin in 2007: for assisted suicides are often cries for help, which
When these practices (i.e., withdrawal of life-support, should be answered with appropriate understanding
accepting a refusal of artificial hydration and alimenta- and care, rather than assisted death. This is part of
tion, etc.) were proposed by physicians, and when they suicide prevention, a major public health goal.
were sanctioned by the courts, there were the same kinds
(3) That although we allow withdrawal or
of prediction made by opponents as are now made about
physician-assisted suicide. Patients would be manipu-
withholding of life-sustaining interventions,
lated or coerced into making, or agreeing, to such this is significantly different from allowing
practices. Patients who might be cured by new discov- euthanasia or assisted suicide. The actual acts
eries would mistakenly request to be removed from life- are different: injecting a lethal medication, or
support. The slippery slope from voluntarily requesting removing an invasive apparatus, are not the same.
DNR to having such orders entered on their chart with- Moreover, physicians who withdraw treatment do
out consent would be traversed.5 not intend to end the patient’s life, but to put aside
Nevertheless, we will largely limit ourselves to a a medical intervention which could itself be the
consideration of voluntary active euthanasia and cause of further suffering.
­physician-assisted suicide. As regards euthanasia, (4) That allowing euthanasia or assisted suicide
this means that both nonvoluntary and involuntary would have severe adverse consequences, such
euthanasia are outside our remit (and universally seen as a trivialization of suicide, or a “slippery slope”
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 Section 2. End-of-life issues

leading to cases of euthanasia without patients’ patient requests to die, the physician intends
consent. Opponents point to data suggesting to end the patient’s life, and the patient indeed
that such involuntary euthanasia takes place in dies. The only difference is the “proximate
the Netherlands. They fear that patients may cause”: when life-sustaining treatment is
sometimes choose euthanasia under pressure, or removed, the patient is killed by his disease. In
to avoid becoming a burden on loved ones. the case of euthanasia, the direct cause of death is
the physician’s act, in the case of assisted suicide,
Arguments in favor of euthanasia and assisted suicide: it is the patient’s act. Proponents of voluntary
euthanasia question the moral significance of this
(1) That respect for autonomy does support
distinction.
allowing voluntary death, because autonomy
means self-ownership of persons and the right (4) That “slippery slope” arguments are not
to pursue our own goals in life, as long as we valid: controversial practices can be regulated
harm no one else. If autonomy means control and controlled. It would be surprising if we were
over how we live, it also entails control over the able to abide by a rule forbidding euthanasia, but
way we die, which has been considered since not by a rule limiting the circumstances where it
Antiquity to be the one undeniable human can take place. Countries where assisted suicide
freedom, and must be authorized as a liberty- and/or euthanasia are legal have not experienced
right in a liberal polity. Decriminalization of a slippery slope; since legislation authorizing
suicide also recognizes that choosing to die euthanasia and assisted suicide often comes with
can be a reasonable option, and makes assisted stricter requirements for notification, it is difficult
suicide a victimless crime. to know whether cases of involuntary euthanasia
increase or decrease following the legislative
(2) That even alleviation of physical pain has a
change.
failure rate, and even well developed palliative
care cannot address all types of suffering with The ethical status of physician participation in euthan-
equal success. Sometimes, living with a painful asia and suicide assistance is a distinct point in this
disease may reasonably be seen as worse than debate. Opponents highlight the tension between
death, we should therefore allow euthanasia assisting death and duties to preserve life, and risks
or assisted suicide in cases where palliation is to the physician–patient relationship. Proponents
ineffective. The epidemiology of legal assisted view assisting death as an intrinsic part of a humane
suicide is very different from that of suicide response to suffering, and a form of the respect owed
generally, so it is possible to allow the first without to patients’ self-determination. Moreover, the idea that
jeopardizing public health efforts to prevent the ­physician–patient relationship would suffer from
the latter. Although some requests for assisted allowing euthanasia or physician assisted suicide is
death are cries for help, this is not always the speculative, and data suggests that legalizing aid-in-
case: attempting to understand all such requests dying would not affect patients’ trust in their physician
in this way would represent “hermeneutic negatively.8
obstinacy” similar to the “therapeutic obstinacy” Currently, assisted suicide is legal in the US
involved in persisting with life sustaining states of Oregon, Washington and Montana, and
treatment over a patient’s refusal.7 The possibility in Switzerland, Luxemburg, Belgium, and the
of assisted death also reassures many people who Netherlands. Euthanasia is legal in the last three
are healthy, but know that they could become countries. All but one of these legislations provides
terminally ill someday, and that this could involve a detailed description of the circumstances where
intractable suffering. The possibility of euthanasia assisted death is permissible, require physician
or assisted suicide can alleviate some of their involvement, and mandate notification. The excep-
fears. tion is Switzerland, where nonphysicians can assist
(3) That euthanasia and assisted suicide are not suicide and where the only legal requirements are
significantly different from practices such as that the patient be capable of decision-making and
withdrawal of life sustaining treatments at perform the lethal act himself, and that the helper
the end of life, which are broadly accepted as be motivated only by altruistic motives. Typically,
ethically justified. In both types of cases the requirements for legal euthanasia or assisted suicide
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include that patients need to be capable of decision- Serious requests for assisted death are made by
making and persistently requesting death, and that only a minority of seriously ill patients. Intractable
there be otherwise intractable suffering. pain motivates requests infrequently. Psychological,
social, or existential suffering, such as loss of com-
munity, autonomy, or meaning, seem to motivate
Attitudes and practices euthanasia requests more often.14 Patients with symp-
Public attitudes toms of depression have been shown to be four times
Public attitudes toward assisted death vary between more likely to request euthanasia than those without
countries and with the sort of situation considered. In such symptoms.15 Although these results should be
the US two-thirds of surveyed members of the general taken seriously, they do not signify that all requests
public favor euthanasia or assisted suicide when pre- for assisted death are associated with depression. Fears
sented with the case of a patient in unremitting pain. that assisted dying would disproportionately affect vul-
When the case is changed to a patient suffering from nerable groups have also been voiced, but current data
functional debilitation, or who views life as no longer show otherwise.16
worth living, one-third no longer supports assisted The link between assisted dying legislation and
dying, and one third still does.9 In Europe, public atti- practices is complex. Up to 3.7% of US physicians
tudes differ between countries, with higher rates of reported having  – illegally  – practiced assisted sui-
acceptance in countries such as The Netherlands, but cide and up to 9.4% reported having practiced euthan-
also Denmark, Sweden, and France, and much lower asia.17 Intensive care unit physicians in France, where
rates in countries such as Romania, Malta, or Turkey. euthanasia is illegal, are more likely to report having
Factors associated with higher acceptance include practiced “deliberate administration of medication to
weaker religious beliefs, but also younger age, and speed death in patients with no chance of recovering a
higher educational level.10 meaningful life” compared with their colleagues from
11 European countries, including The Netherlands.18
Professional attitudes The Dutch Euthanasia Act seems to have been followed
by a small decrease in the number of euthanasia and
The American Medical Association, as well as physician
physician-assisted suicide cases.19 As Belgian doctors
associations in countries such as Norway, Germany, and
have pointed out, more transparent reporting is likely
the UK, have opposed euthanasia and assisted suicide,
to increase the effectiveness of social control of these
and physician participation specifically, maintaining
practices.20
that assisted dying conflicts with the role of doctors.
This opposition, however, is not universal. Physician
associations in The Netherlands do not maintain that Responding to requests for aid-in-dying
medical assistance in dying conflicts with the phys- A request for euthanasia or assisted suicide is an emo-
ician’s role; the Swiss Academy for Medical Sciences tionally taxing situation, where a thoughtful and
states that assisted suicide is “not a medical act,” but respectful response is particularly important. Several
nevertheless described circumstances where it finds it elements are crucial. First, some requests are expres-
to be professionally acceptable for a physician to assist sions of suffering rather than direct concrete requests
suicide.11 for assisted death, but not all of them are. Second,
adequate symptom management can significantly
Practices decrease the number of such requests. Third, the
Data from The Netherlands is the most system- patient’s decision-making capacity is a necessary con-
atically reported, and shows rates of notification dition of euthanasia and assisted suicide also where
increasing from 18% in 1990 to 80% in 2005.12 In these practices are legal. Fourth, addressing the issue
Switzerland, most suicide assistance is performed of aid-in-dying explicitly and non judgmentally is
through right-to-die organizations rather than indi- preferable to the alternatives. Fifth, even in countries
vidual physicians. From 1990 to the mid 2000s, the where euthanasia or assisted suicide is legal, there is
number of suicide assistance cases has remained no entitlement right to obtain it from a physician who
stable, with possibly a slight increase in the number disagrees.
of patients ­suffering from chronic rather than fatal Several approaches have been proposed. Two
disease.13 stages in responding to requests for euthanasia or
131
 Section 2. End-of-life issues

Patient’s request for euthanasia or assisted suicide regarding their indication in the patient’s specific cir-
Discuss and clarify the Screen for cumstances. Importantly, palliative sedation does not
request with the patient depression constitute assisted dying in the sense discussed in this
+
Assess all
chapter. In some cases, it can be a part of symptom
Is the patient capable of physical management at this stage.
decision-making? suffering Provide Many requests will be dropped following these
No treatment
Yes Assess all
steps. However, some do persist. In such cases, where
Engage in structured psych. / a competent patient persists in asking to die despite
social
discussion on advance care
suffering appropriate management of suffering, several situ-
planning / advance directives
ations exist.
If patient’s request persists One is the situation where a patient is under life-
Are life-sustaining sustaining therapy. Controversies surrounding treat-
interventions currently used?
ment withdrawal tend to increase as the invasiveness
No If yes, discontinue on competent patient’s request of the intervention decreases: withholding food and
Is assisted suicide or euthanasia legal in this situation? water is often more controversial than withholding
Yes If no, consider palliative sedation as alternative.
ventilator support. However, if any life-sustaining
intervention is being applied, its refusal by a compe-
Does the physician accept that in this
situation he should provide assisted death? tent patient is usually considered sufficient grounds to
Yes If no, refer to a colleague. withdraw it.
When no life-sustaining intervention is being
Suicide assistance / Euthanasia
used, the next steps will depend on the legal status of
Figure 22.1  Responding to requests for ­euthanasia or assisted
suicide euthanasia or assisted suicide, and on the physician’s
own convictions. Where assisted death is not legal,
or in situations that do not fulfill legally described
criteria, palliative sedation can again be considered
as an alternative at this stage. Indeed, it is sometimes
assisted suicide are outlined in Fig. 22.1. First, these preferred even in areas where assisted death would
requests should be carefully listened to. Many requests be legal. Finally, even in situations where euthanasia
for assisted death are expressions of suffering, and are or assisted suicide would be legally authorised, there
withdrawn by patients after appropriate symptom is no duty on the part of physicians to perform either
management. However, this is not always the case. intervention. In countries where assisted death is
Although the controversies and emotions surround- legal, an objecting physician can refer the patient
ing this topic can make these discussions difficult, whose request persists to a colleague. Where it is
remaining non-judgmental is important to patient known in advance that a physician would in any case
management. The patient’s request should be dis- refuse to assist death, this should be made clear to
cussed and clarified. If she is truly making a request to the patient as early as possible. It is of course import-
die, and is competent to make decisions, a structured ant to be clear on this point both in countries where
discussion about advance care planning should take assisted death is legal, and in countries where it is
place, and the possibility of writing advance directives not.
should be offered.
In all circumstances, suffering should be assessed Key points
using a holistic “total suffering” palliative care • Palliation with therapeutic intent, including
approach. Depression should be screened for and palliative sedation, is not equivalent to
treated if present. Where available, specialized pal- assisted death even in cases where the
liative care expertise should be offered. Whenever treatment may hasten death.
possible, symptom management should be handled
• Physician assisted suicide and voluntary
by a team of healthcare providers with complemen-
euthanasia are legal in some jurisdictions.
tary expertise. When they are likely to be called upon
• Arguments against physician assisted death
for specific interventions, such as palliative sedation,
usually refer to a violation of the physician’s
anaesthesiologists should be included in discussions
132
 Chapter 22. Physician aid-in-dying

8*  Hall, M., Trachtenberg, F., and Dugan, E. (2005). The

role and/or the potential for coercion of impact on patient trust of legalising physician aid-in-
vulnerable patients. dying. J Med Ethics, 31(12), 693–7.
• Arguments for physician-assisted death 9   Wolfe, J., Fairclough, D.L., Clarridge, B.R., et al.
usually refer to beneficence and patient (1999). Stability of attitudes regarding physician-
autonomy. assisted suicide and euthanasia among oncology
• Although many patients who request aid-in- patients, physicians, and the general public. J Clin
dying are depressed, not all requests are Oncol, 17(4), 1274.
associated with depression, nor does the 10* Cohen, J., Marcoux, I., Bilsen, J., et al. (2006). European
presence of depression necessarily invalidate public acceptance of euthanasia: socio-demographic
a request for aid-in-dying. and cultural factors associated with the acceptance
of euthanasia in 33 European countries. Soc Sci Med,
• Requests for aid-in-dying should be taken
63(3), 743–56.
seriously and carefully listened to. Screening
11  Académie Suisse des Sciences Médicales. (2004).
for and treatment of problematic symptoms
Directives médico-éthiques pour la prise en charge des
and depression may lead to withdrawal of the patientes et patients en fin de vie.
request.
12  Rurup, M.L., Buiting, H.M., Pasman, H.R., et al. (2008).
• When a request for aid-in-dying persists The reporting rate of euthanasia and physician-assisted
and no life-sustaining treatments are being suicide: a study of the trends. Med Care, 46(12),
employed, the response will depend on the 1198–202.
legal status of euthanasia or assisted suicide, 13  Fischer, S., Huber, C.A., Imhof, L., et al. (2008). Suicide
and on the physician’s own convictions. assisted by two Swiss right-to-die organisations. J Med
Ethics, 34(11), 810–14.
14* Georges, J.J., Onwuteaka-Philipsen, B.D., van der
Heide, A., et al. (2006). Requests to forgo potentially
References life-prolonging treatment and to hasten death in
1*  Sprung, C.L., S.L. Cohen, P. Sjokvist, M., et al. (2003). terminally ill cancer patients: a prospective study. J Pain
End-of-life practices in European intensive care Symptom Manage, 31(2), 100–10.
units: the Ethicus Study. JAMA, 290(6), 790–7. 15  van der Lee, M.L., van der Bom, J.G., Swarte, N.B.,
2*  Sprung, C.L., Maia, P., Bulow, H.H., et al. (2007). The et al. (2005). Euthanasia and depression: a prospective
importance of religious affiliation and culture on end- cohort study among terminally ill cancer patients. J
of-life decisions in European intensive care units. Intens Clin Oncol, 23(27), 6607–12.
Care Med, 33, 1732–9. 16* Battin, M.P., van der Heide, A., Ganzini, L., et al. (2007).
3   Schindler v. Schiavo, 780 So.2d 176 (Fla. 2001). Legal physician-assisted dying in Oregon and the
4   Senate, I. (2009). “Bill no. 1369.” Retrieved 5 May, 2009, Netherlands: evidence concerning the impact on patients
from http://www.senato.it/service/PDF/PDFServer/ in “vulnerable” groups. J Med Ethics, 33(10), 591–7.
BGT/00393277.pdf. 17  Emanuel, E.J. (2002). Euthanasia and physician-
5*  Dworkin, G. (2007). Physician-assisted death: the state assisted suicide: a review of the empirical data from the
of the debate. In The Oxford Handbook of Bioethics. United States. Arch Intern Med, 162(2), 142.
B. Steinbock, (ed). Oxford and New York: Oxford 18  Vincent, J.L. (1999). Forgoing life support in western
University Press, pp. 376–92. European intensive care units: the results of an ethical
6   Emanual, E.J. (2009). Euthanasia and physician- questionnaire. Crit Care Med, 27(8), 1626–33.
assisted suicide. UpTo Date online. Accessed June 3, 19  van der Heide, A., Onwuteaka-Philipsen, B.D.,
2010. Rurup, M.L., et al. (2007). End-of-life practices in the
7*  Mauron, A. (2006). La médecine moderne et Netherlands under the Euthanasia Act. N Engl J Med,
l’assistance au suicide en Suisse. Synthèse du point 356(19), 1957–65.
de vue de la CNE. Beihilfe zum Suizid in der Schweiz, 20  Smets, T., Bilsen, J., Cohen, J., et al. (2009). The
Beiträge aus Ethik, Recht, und Medizin. C. Rehmann- medical practice of euthanasia in Belgium and The
Sutter, A. Bondolfi, J. Fischer, and M. Leuthold (eds.). Netherlands: legal notification, control and evaluation
Nerm: Peter Lang. procedures. Health Policy, 90(2–3), 181–7.

133
 Section 2. End-of-life issues

Further reading Emanuel, L. L. (1998). Facing requests for physician-assisted

suicide: toward a practical and principled clinical skill
Ariès, P. (1974). Western Attitudes Toward Death: From the set. JAMA, 280(7), 643–7.
Middle Ages to the Present. Baltimore and London: The Hurst, S. A. and Mauron, A. (2006). The ethics of palliative
Johns Hopkins University Press. care and euthanasia: exploring common values. Palliat
Breitbart, W. (2010). Physician-assisted suicide ruling Med, 20(2), 107–12.
in Montana: struggling with care of the dying, O’ Neill, B. and Fallon, M. (1997). ABC of palliative care.
responsibility, and freedom in big sky country. Palliat Principles of palliative care and pain control. BMJ,
Support Care, 18, 1–6. 315(7111), 801–4.

134
Section Pain management

3
 Section 3
1 Pain management
Chapter

23
Ethical considerations in interventional
pain management
Andrea Trescot

The Case Mr. Summers’ insurance will not cover discogram

or intradiscal therapies, and requires preauthorization
Mr. Summers presents to the pain clinic with a several-
for even office injections. Insurance also covers only
year history of chronic low back and posterior right leg
short-acting opioids or generic morphine ER, and Mr.
pain. He describes his pain as 9/10, increased with activ-
Summers states that he has an “allergy” to morphine,
ity. MRI shows a bulging disc on the right at L45. He has
which caused nausea. Should the pain specialist give
been told that he is not a surgical candidate. He is cur-
Mr. Summers more opioids, discharge him, or insist on a
rently taking six oxycodone tablets per day, noting only
trial of injections?
temporary relief. He requests larger doses of opioids, but
his primary care physician (PCP) has referred him to … the profession (of pain medicine) must be informed
the clinic with only enough medicines to last until this by scientific knowledge that is contemporary and pro-
appointment. The PCP has also indicated that any fur- gressive, but it must also be sensitive to the subjectivity of
ther pain management, including opioid prescriptions, suffering, … to apply knowledge and skill … that ­ideally
will have to come from the clinic. meets each patient’s individual medical needs…this is
the basis of medicine as tekne … that combines … skill
Mr. Summers is agitated and hostile, displaying exag-
and … art and which is integrative … in the ideal1
gerated pain behaviors. He has difficulty sitting still dur-
ing the interview, getting up several times to walk around. In 1847, the code of ethics published by the American
Physical examination is difficult to perform because he Medical Association stated “… from the age of
complains of tenderness with every area palpated, but Hippocrates to the present time, the annals of every
there appears to be increased right paravertebral tone at civilized people contain abundant evidences of the
the level of the top of the iliac crest. There is pain with devotedness of medical men to the relief of their fel-
extension of the right leg at approximately 70 degrees. low-creatures from pain and disease …”2 Despite the
Reflexes, strength, and sensory findings are normal other intrusion of insurance forms and changing reimburse-
than “break away” weakness. EMG in the past was not ments, medicine in general and pain medicine spe-
completed because he could not tolerate the needle por- cifically continues to be a humanitarian pursuit with
tion of the examination. Careful review of the MRI films goals of relieving suffering and restoring function.
shows a high intensity zone on the right at L45, and a Patients rely on physicians to be ethically responsible
mild central bulge at that level. when recommending care or providing treatment.
Evaluation of Mr. Summers suggests a lumbar radic- Pain patients are particularly vulnerable to exploit-
ulopathy from a leaking disk or referred pain from inter- ation, because of a desperation related to unrelieved
nal disc disruption. However, there is also concern that pain, and the perception that a pill or an injection or
he is a drug-seeker. Management options include injec- a surgery will “fix” the problem. Therefore, each deci-
tion therapy (lumbar epidural, transforaminal epidural, sion in pain medicine needs to be viewed from both
discogram and possible intradiscal therapy) or more opi­ a therapeutic and ethical perspective. Pain physicians
oids (with or without adjuvant medications). He refuses must define the nature of pain, recognize the variabil-
injections, stating that a friend had injections, and “they ity and subjectivity of its expression in the pain patient,
didn’t help.” Furthermore, he states “the pills make the acknowledge the vulnerabilities rendered by pain,
pain go away.” describe the inherent characteristics and ­asymmetry

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
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 Section 3. Pain management

of the patient-clinician relationship, and define the radiologic findings in as many as 60% of asympto-
desired pain care end-point.3 matic patients.5 Even more concerning is that up to
With multidisciplinary or hospital-based pain clin- 40% of completely asymptomatic patients with posi-
ics, a professional ethicist may be readily available to tive MRIs are offered surgery, one harmful effect of
answer questions, offer advice, or arbitrate difficult poorly directed MRI over-testing. False positives are
decisions, such as whether the physician can ethically not just found in radiologic studies; 15% of asymp-
demand that a patient be subjected to interventional tomatic patients will have nerve conduction studies
procedures in order to obtain opioid prescriptions. that are compatible with the presence of carpal tunnel
However, with the proliferation of independent pain syndrome.6 Radiologic and neurodiagnostic studies
physicians and clinics, the availability of multidis- do not directly demonstrate “pain,” so how can the
ciplinary advice, include advice regarding ethics, is clinician tell if a patient is even really experiencing
diminished. It then becomes incumbent upon the pain pain, or is falsely reporting pain for other motives –
provider to resolve the ethical questions that are an for example, to obtain narcotics?
inherent part of the care of pain patients. The evaluation of pain involves a combination of
According to James Giordano, ethicist for the clues in the history (“pattern recognition”), and a tar-
American Society of Interventional Pain Physicians geted physical exam. It may also require the use of diag-
(ASIPP), the ethical crisis in pain care necessitates nostic injections or other interventional procedures.
a three step process:  identification of the problems, “The cause of a disorder is hidden in the patient’s his-
critical evaluation of various ethical systems, and “a tory and the site of the lesion is detected by physical
description of how the structure and function of the exam.”7 In this model, diagnostic injections become
practice –as a social good – might be enacted within integral to the evaluation process, much like an Xray to
a paradigm of (somewhat) non-hegemonious, inte- an orthopedic surgeon.
grative pain care.”4 Books such as this one attempt to Ethical concerns regarding interventional diag-
provide the practical wisdom that is critical to under- nostic and therapeutic procedures include physician
standing the ethical process. “Because if therapeutic concerns for nonmaleficence, as well as conflicts of
and moral agency are conjoined in the sound practice interest presented by third-party payers. By their
of pain medicine, then the ethical character of each nature, interventional procedures carry risks, both
pain physician becomes instrumental in contributing that there can be complications from the procedure
to and maintaining the overall moral integrity of the and that the results will lead the physician to the
profession.”5 wrong diagnostic conclusions and therefore an inap-
propriate therapeutic path. The subjective nature of
Ethical principles of beneficence and nonmaleficence pain reporting further complicates evaluation of pro-
An obvious precept of medical care is appropriate cedural results. Complications may be mitigated by
diagnosis of problems so that the most effective, and performing procedures in the safest environment pos-
hopefully least harmful, treatment can be offered. sible, with the most up-to-date equipment, and by an
One of the greatest limitations of pain management is experienced, highly-trained pain specialist. However,
therefore a lack of objective diagnostic tests. Internal multiple factors not under the direct control of the
medicine has blood sugar values and blood pressure physician or patient, such as third-party reimburse-
readings, cardiology has ST depression, and derma- ments, may have influence on such important safety
tology has pathology results. In pain management, factors as where and by whom pain procedures are
diagnostic testing is of limited utility, because posi- performed.
tive findings only indicate the presence of potential Pain procedures can be provided in a variety of
causes. No test measures pain itself, which is the sub- physical locations – the office, the hospital outpatient
jective experience that the patient reports. In the dis- department, or a freestanding ambulatory surgery
tant past, for example, a myelogram was the standard center. Although “minimally invasive,” many of the
test to evaluate back pain. Virtually anyone undergo- procedural injections are “maximally dangerous” with
ing a myelogram had reported having back pain, and the risk of seizures, hypotension, and cardiac arrest.
when the test revealed an abnormality, it was assumed Specialized equipment, such as fluoroscopy and resus-
to be the cause of the pain, and not merely an inci- citation equipment, which might mitigate this risk can
dental finding. MRI studies in asymptomatic patients, be quite expensive. In addition, procedures done in
however, have now shown “surgically significant” the office incur a cost of supplies that, until recently,
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 Chapter 23. Interventional pain management

was not reimbursed. The same procedure done in Patient B

Amount of percieved pain

the hospital or ambulatory surgery center (ASC), in
contrast, may be much more expensive for the patient
and the insurer. Some insurance programs, including
Medicare, in an effort to move procedures out of the
more expensive settings, have started to reimburse a
“site of service differential” to help cover of the physi-
cian cost of providing these services in an office. 0 4 6 8 10
Ethical conflicts can arise when deciding where to Pain score
schedule procedures, particularly if the pain physi-
cian involved has a financial interest in an ASC where Patient A

Amount of percieved pain

he or she performs procedures – a situation which is
increasingly common. Should the provider perform
the procedure in the office (where the cost is low to
the patient but the risks of inadequate facilities may
be high) or at the ASC (where there would be equip-
ment and personnel to handle emergency issues, but
at a higher cost to the patient, and a potential finan- 0 4 6 8 10
cial conflict of interest for the physician)? Is the pro- Pain score
cedure being done in the best interest of the patient,
or primarily for the financial gain of the provider? The
current system of reimbursement in the Unites States,
for example, favors serial, potentially ineffective or no objective tests for pain, which is by definition a sub-
less effective injections (which keeps the patient com- jective experience. Pain scores, often on a scale of 0 to
ing back) rather than potentially more expensive, but 10, are useful compare the improvement or lack thereof
curative treatment. after an interventional procedure. Although many
Insurance companies, in an effort to curb the esca- studies add, subtract and average pain scores, this does
lating costs of health care, have at times simply denied not necessarily express the patients’ pain experiences,
a variety of “high tech” procedures because of their since these numbers do not reflect discrete integers.
cost as a “supply side prudence.” But what happens Pain scores are not strictly linear, and can differ dra-
once such technical tools are deemed reasonable and matically from patient to patient (Fig. 23.1).
effective? If accessibility to new, more expensive treat- Evidence-based medicine (EBM) is a concept
ments remains restricted, development of new treat- designed to assist the clinician in the decision mak-
ments will be of little value.8 Furthermore, assessment ing process, and can be helpful in determining in gen-
of the clinical effectiveness of the treatment should eral what clinical course to recommend. Studies can
be as much if not more important than the cost when be enormously helpful in aiding medical decisions
determining reimbursements and promoting effective involving choices among competing alternative treat-
pain practice. As new treatments are developed, when ments. Clinical research, especially over the last few
the efficacy of interventional procedures is unproven, decades, as well as a spectacular increase in techno-
insurance companies have sometimes cloaked denial logical advances, has lead to a huge volume of relevant
of coverage not as “noncovered” service, but rather as data and an increase in the complexity of trade-offs
“experimental treatment.” “Non-covered” is subject to among various pain treatments. However, denying
appeal; “experimental” has less recourse. Payers then a treatment to an individual complex pain patient
do not have to claim that the therapy is inappropriate, because it has not been shown to be the most effec-
but merely that it is investigational because its efficacy tive for a population of patients may not be the best
is unproven. approach to an affliction that is highly individual in
Assessing efficacy of pain treatment can be difficult. nature. In the words of Michael Gorback, “We seem
Although there are journals filled with pain studies, to have lost the thread of EBM, which is to use the
studies of pain treatments have been remarkably diffi- best evidence available, not deny anything without a
cult to do. Unlike blood pressure or HgbA1C, there are positive RCT.”9

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 Section 3. Pain management

Patient vulnerability of inappropriate use of opioids includes the risks of

The pain patient is extremely vulnerable in the ­doctor – adverse side effects, ineffective (or less than optimally
patient relationship. He or she is utterly reliant on effective) pain management, problems of opioid toler-
the provider for continuing treatment of pain. If the ance, and in some cases even opioid addiction.
patient requires opioid treatment, he or she has few
other legal means by which to obtain it. Coercion by Legal implications in opioid prescribing
the physician is an ever-present possibility. In our case Pain management providers must deal with com-
example, the physician may be tempted to threaten to peting problems in pain management:  under treat-
withhold opioid prescriptions if the patient does not ment of pain and opioid abuse. The consequences of
agree to undergo interventional pain procedures. Even over-prescribing as well as under-prescribing opioids
if the physician does not intend to coerce the patient, can have profound legal implications. Providers who
the patient may nevertheless believe he or she had lim- under-prescribe can be accused of abuse, while those
ited autonomy in deciding what therapeutic options to who over-prescribe may be subject to charges of drug
pursue, and which ones they may refuse. trafficking.
Not only is the positive outcome of the procedure A number of systems guide and sustain the prac-
reliant on the skills and wisdom of the physician, but tice of caring for those who are in pain.11 The Drug
the negative outcome is as well. The physician has Administration Agency (DEA) has strict penalties
ethical obligations to be extremely vigilant, to con- for providers prescribing without “a legitimate med-
firm that the procedure is within the skill set of the ical process,” who are therefore in violation of the
provider, that the technique is the appropriate for this law, and subject to civil and/or criminal penalties.12
patient at this time, and that the diagnosis and pro- Responsible health-care professionals must expect
posed outcomes are as clearly defined as possible. that they will be held accountable for their actions.
Gone are the days when public trust was so complete
Professional treatment guidelines – do they help or harm? that healthcare professionals were subject only to a
Commonly prescribed medical treatments, such as exog- limited sphere of oversight, accompanied by infor-
enous estrogen to prevent heart disease in postmenopau- mal and very private sanctions when things had
sal women and the efficacy of knee arthroscopies, have, in not gone well.13 In US vs. Shaygan,14 a Mayo Clinic
rigorous testing, not shown to be effective. Professional trained internist was charged with 20 counts of pre-
groups often review relevant clinical studies and physi- scribing without a legitimate medical purpose. He
cian experience in order to provide general advice about faced 20 years in prison for writing opioids for pain
useful and non-useful treatments. It is widely held that patients without aggressive treatment or monitoring.
adherence to guidelines should improve outcomes over- In Oregon and California, there have been two cases
all. However, guidelines do not encourage clinicians to of physicians sued for under-treating patients. The
consider and treat each patient as an individual, and do California case resulted in an initial $1.5 million ver-
not necessarily stimulate original research. Guidelines dict against the physician (which was subsequently
are created by a laborious and artificial process, and at reduced). Another legacy of cases such as this are
times may even be obsolete by the time they are pub- increasing state regulations of medical practice, such
lished. They are often published with industry support, as a new California Law (AB 487) that requires every
and can have a major impact on sales of industry prod- doctor in California to obtain 12 hours of CME credit
ucts.10 Therefore, although well-constructed guidelines in pain management and end-of-life care.15
generally have positive effects on general patient out- In the US, the Federation of State Medical Boards
comes, they nevertheless must be interpreted with their policies16 include the following.
shortcomings and conflicts of interest in mind, and in • Pain management is important and integral to
the context of each individual patient’s situation. the practice of medicine.
• Use of opioids may be necessary for pain relief.
• Use of opioids for something other than a
Prescribing opioids: legal and ethical legitimate medical purpose poses a threat to the
concerns individual and society.
The prescribing of opioids is fraught with dangers • Physicians have a responsibility to minimize the
for physician and patient alike. For patients, the risk potential for abuse and diversion.
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 Chapter 23. Interventional pain management

• A complete patient evaluation should be interviewed regarding previous failure of temporary

performed. relief from injections or, if no prior injections, a his-
• A written treatment plan should be given to the tory of difficulty getting numb at the dentist.17 Of 250
patient. patients with this history were skin tested with lido-
• Informed patient consent and agreement for caine, bupivicaine, and mepivicaine, 36% (7.5% of the
treatment should be obtained. total number of patients) were noted to only be numb
• Periodic review of the course of treatment should to mepivicaine, while another 17% (3.8% of the total)
take place. were numb only to lidocaine. Many, if not most, pain
• Physicians should show willingness to refer. procedures are done with bupivicaine, which did not
work on 10% of the total population and almost 50%
• Physicians should maintain complete and current
medical records. of the patients with a prior failed procedure. In those
patients in whom bupivicaine did not work, repeating
• Physicians may deviate from the recommended
the same procedure with the appropriate local anes-
treatment steps if there is good cause.
thetic resulted in sustained relief in more than 60% of
the patients.
Clinical suggestions (2)  Perform a meticulous physical examination.
The ethical issues of coercion (“I won’t write for pain
medications unless you get an injection”), financial gain A meticulous physical exam, with attention to the most
(injection treatment are much higher reimbursed com- common pain generators, coupled with a recognition
pared to evaluation and management), opioidophobia of common patterns of pain will help guide to the diag-
(physician concern regarding opioid prescribing), as nosis, and from that the appropriate treatment. For
well as lack of education (“If a patient goes through example, pain radiating into the groin and the testicles
withdrawal, that means the patient is addicted”), has (less commonly described into the vaginal region in
led to a state of fear as well as greed among some phy- women), coupled with the description from the male
sicians. The patient is caught in the middle, between patient that his testicles “are in a vise” should lead to a
inappropriate opioid use (both over-prescribing, directed physical exam of either the ilioinguinal nerve
which leads to iatrogenic addiction, and under-pre- or the iliolumbar ligament.
scribing due to refusal to prescribe) and inappropriate (3)  Use diagnostic procedures appropriately.
injection therapy (which exposes the patient to multi-
ple expensive but often ineffective treatments, with the Based on the tenderness found on exam, a directed
concomitant risks of steroid side effects, nerve injuries, injection (with a peripheral nerve stimulator for the
potentially increased pain, and possible death). A care- ilioinguinal nerve, or under fluoroscopy for the iliol-
ful review of the agenda of both the patient and phy- umbar ligament), using the local anesthetic that works
sician should help to clarify the issues of self-interest most effectively for this patient and a small dose of
versus appropriate care. deposteroid if appropriate, may establish an accurate
diagnosis. Based on the response of those injections,
further therapy (cryoneuroablation for the ilioinguinal
An approach to the clinical problem nerve, radiofrequency lesioning or regenerative injec-
(1) Obtain an appropriate history of prior response to tion therapy for the iliolumbar ligament) provides a
pain interventions. rational, stepwise approach to the diagnosis and treat-
ment of the presenting pain problem.
Getting an accurate history of the initial response to
prior injection therapy is critical to interpretating a
subsequent negative response. For example, if there Case resolution
was no temporary response the another injection, it The provider discussed with Mr. Summers the inadvis-
may indicate that the local anesthetic wasn’t in the right ability of long-term opioid therapy in the face of treat-
place (failure of accurate diagnosis or failure of accu- able disease, using an analogy of appendicitis (“It would
rate placement), or that the patient doesn’t respond be inappropriate to just give opioids to a patient with
to that local anesthetic, rather than that injection appendicitis, though you would be willing to support
therapy has failed. A cohort of 1198 consecutive pain the patient while you wait for his medical condition to
patients undergoing interventional procedures were improve or the OR staff to arrive, and you would give
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 Section 3. Pain management

opioids postoperatively as the surgical site heals”). After References

a discussion of the proposed etiology of the pain, and
1*  Giordano, J. and Jonas, W.J. (2007). Asclepius and
the need for an accurate diagnosis (“you can’t treat what
Hygieia in dialectic: philosophical, ethical and
you can’t diagnose”), and skin testing to identify the pragmatic bases of an integrative medicine. Integrative
most appropriate local anesthetic, the patient agreed to Med Insights, 2, 89–101.
undergo a diagnostic and potentially therapeutic trans- 2* American Medical Association. (1847) Code of
foraminal epidural. Because of the apparent neuropathic Medical Ethics of the American Medical Association.
nature of the pain, an anticonvulsant was added to the Chicago: American Medical Association Press.
short acting opioid. Although the desired effect would 3  Giordano, J. and Schatman, M.E. (2008). An ethical
be improved pain relief and therefore decreased opioid analysis of crisis in chronic pain care: facts, issues, and
use, the patient and physician also agreed to consider a problems in pain medicine; Part 2. Pain Physician, 11,
long-acting opioid such as methadone as an alternative 589–595.
if there was not sustained improvement in the patient’s 4* Giordano, J. (2008). Ethics of, and in, pain
pain with the above interventions. After a detailed medicine: constructs, content, and contexts of
informed consent regarding the risks and potential com- application. Pain Physician, 11, 391–392
plications of opioid use, and a screening urine drug test, 5  Jensen, M.C., Brant-Zawadzki, M.N., Obuchowski, N.,
patient was given a prescription for 1 month of opioids et al. (1994). Magnetic resonance imaging in the lumbar
and an appointment for the diagnostic injection. spine in people without back pain. NEJM, 331, 69–73.
6  Artoshi, I., Gummesson, C., Johnsson, R., et al. (1999).
Prevalence of carpal tunnel yndrome in a general
Key points
population. JAMA, 282(2), 152–8.
• A primary goal of medical care is the relief of 7  A. Staal, Department of Neurology, Leyden University,
suffering and restoration of function. Holland.
• Pain is a subjective patient experience, 8  Giordano, J. and Schatman, M.E. (2008). An ethical
and one of the greatest limitations of pain analysis of crisis in chronic pain care: facts, issues, and
management is a lack of objective diagnostic problems in pain medicine; Part 3. Pain Physician, 11,
tests that identify and quantify pain. 775–84.
• The use of interventional procedures to 9  Michael Gorback, MD, Center for Pain Relief,
diagnose and treat pain involves ethical Houston, TX.
concerns of beneficence and nonmaleficence 10  Amerlinga, R., Winchester, J.F., and Ronco, C. (2008).
as well as potential financial conflicts of Guidelines have done more harm than good. Blood
Purif, 26, 73–6.
interest for the physician.
11  Giordano, J. (2008). Ethic of, and in, pain
• Third party payers exert additional influence
medicine: constructs, content, and contexts of
on reimbursements, and the locations where application. Pain Physician, 11, 391–2.
pain procedures can be performed. This in
12  Branding, F.H. (1995). The impact of controlled
turn can have affects on patient safety, as well substance federal aspects of managing regulations on
as access to new procedures that might be the practice of pharmacy. J Pharm Pract, 8, 130–7.
deemed “investigational.” 13  Brushwood, D.B. (2001). From confrontation
• In pain management, patient vulnerability to collaboration: collegial collaboration and the
is a prominent feature of the doctor-patient expanding role of pharmacists in the management of
relationship. Coercion, intentional or chronic pain. J Law Med Ethics, 29, 69–83.
otherwise, is an ever-present possibility. 14   United States v. Shaygan, Case No. 08–20112-CR, 2009.
• Opioid prescribing is guided by both legal 15  Wilner, A. (2008) Medical-legal aspects of managing
regulations and professional guidelines. In the chronic pain. AAPM 19th annual meeting.
US, the Federation of State Medical Boards has Nashville, TN.
express policies on pain management and the 16   Federation of State Medical Boards. www.fsmb.org.
obligations of physicians involved in opioid 17  Trescot, A. (2003). Local anesthetic “resistance.” Pain
prescribing. Physician, 6, 291–3.

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1 Pain management
Chapter

24
Conjoining interventional pain management
and palliative care: considerations for
practice, ethics and policy
James Giordano and Gerhard Höver

The Casea A moral obligation to treat pain

A 61-year-old woman with metastatic colon cancer presents Technological advancements within science and medi-
with intractable abdominal pain. Since her initial diagno- cine have enabled prolongation of the lifespan for
sis 13 years ago, she has undergone chemotherapy, multiple those patients with incurable diseases. Yet, at the same
colon surgeries, radiofrequency ablation of liver metasta- time, such relative successes have fostered an increased
ses, and excision of a solitary pulmonary metastasis. A CT prevalence of chronic illness and subjective suffering –
scan shows enlarging liver metastases involving the capsule
including intractable pain – due in part to the inability
and para-aortic lymph nodes.
to completely eradicate symptoms, and to the pro-
The patient has been relatively pain-free until 7 months
prior to consultation with a local anesthesiologist who spe- gressive use and sometimes exhaustion of therapeutic
cializes in interventional pain managmeent. Prior to con- and economic resources available to the patient. This
sultation, initial treatment of pain consisted of oxycodone has compelled an increased impetus for medicine to
and acetaminophen, followed by sustained-release mor- develop those dimensions of practice that seek to heal
phine titrated over several months to a total of 1200 mg what cannot be cured. To a significant extent, pain
daily. Sustained release morphine was then supplemented medicine and palliative care have arisen from, and seek
with immediate-release morphine (600 mg) up to four to meet, this need.
times daily for breakthrough pain. Most recently, she was The obligation to treat pain and suffering, while
switched to fentanyl patches plus continued oral morphine. inherent to all of medicine, is by definition most fun-
At the time of consultation she was using thirty 100 mcg/h
damental to the profession of pain medicine and pal-
patches every 3 days.
liative care.1 Clearly, pain management can be, and
Despite somnolence, she continues to complain of severe
constant sharp, aching and “knife-like:  upper and lower often is necessary, albeit not sufficient for rendering
abdominal pain, with self-rated pain intensity between 7 sound, palliative care. But technically effective pain
and 10 on a 0 to10 scale, with minimal movement bringing care must also be rendered in ways that uphold the
pain intensity up to 10. moral affirmations of medicine, and while certain
The anesthesiologist performs a neurolytic celiac plexus ethical (and legal) frameworks exist to guide the
block, which decreases her baseline pain from a 7 rating to a tenor, scope and limits of the profession, the actual
4. A 4 mg intrathecal test dose of morphine reduces her pain implementation of care is reliant upon the physician.
rating further to 1–2, with no adverse effects. The anesthe- In this way, the physician is both a therapeutic and
siologist would like to refer her to a multidisciplinary pain moral agent, given that any (if not all) clinical deci-
clinic for possible implantation of a morphine spinal deliv-
sions affect the vulnerability of the patient, reflect the
ery system, but the patient’s insurance company has thus
asymmetries of knowledge and power between phys-
far refused to approve the consultation or implantation,
because studies suggest that these devices are cost-effective ician and patient, and impact trust within the medical
over continued systemic analgesic management only after relationship.
18–30 months of therapy. They point out that she has had The complexity of pain and pain care is such that
significant improvement in her pain after neurolytic block, a simple, “one-size fits all” approach to management
and is unlikely to survive long enough to make intraspinal is not practical, nor ethically justifiable. An integra-
therapy cost-effective, even if it provides better quality of tive use of interventional, pharmacologic, physiatric,
pain relief. and psychiatric pain management may represent a

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
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 Section 3. Pain management

viable option, both early in and throughout the care of (1) the noted achievements of technology in medi-
of long-term and terminal pain patients. In this con- cine and (2) the explicit call to use such advancements
text, interventional techniques may be especially use- to address the increasing incidence and prevalence of
ful because of their capacity to effectively reduce pain, chronic pain, then special provisions for adequate
make patients more amenable to other therapeutics, funding of both inpatient and outpatient approaches
and enhance patients’ quality of life. must be developed and implemented.
However, to safely, effectively, and ethically deal
with the often complex pathologies of chronic pain
Interventional pain medicine in integrative patients, it is necessary to maintain multi-disciplinary
pain care: practical and ethical claims and integrative treatment provided by professions focal
If the past 10 years’ congressionally declared “decade of to pain- and palliative care (e.g. specialized physicians,
pain control and research” in the US has done nothing social workers, physiotherapists, psychologists, clergy
else, it has certainly instigated: (1) a more internation- and secular spiritual counsellors, et al.). In this way,
alized interest in the problem of pain and the difficulties treatment would constitute a service of ongoing assess-
and responsibilities of pain care; and (2) a more well- ment and interventions that are rendered by a multi-
defined need – and thus goal – for biomedical research professional, closely-knit team on a regular basis, as
to facilitate improved translational applications and appropriate to both the changing status and needs of
models.2 Despite such progress, interventional man- each specific patient.
agement techniques still tend to be under-utilized It is difficult to categorize chronic pain patients in
within palliative care – particularly that which is pro- a homogeneous cost group within current DRG sys-
vided in a paradigm of long-term (i.e., not end-of-life) tems, and so an inter-disciplinary pain/palliative care
treatment. could be seen as impossible to finance because of its
A number of long-held beliefs may contribute to requisite utilization of diverse resources. The lack of
under-utilization. Integrative pain medicine and pal- a more encompassing integrative pain/palliative care
liative care may appear to be expensive or not cost- paradigm reflects the inchoate nature of the profes-
effective from the perspective of hospital operators sion of “pain medicine.” This has given rise to mis-
and insurance companies. The problem chiefly lies in conceptions that interventional pain management is a
an inability to calculate the cost of pain- and pallia- “stand-alone” approach, and led to the opinion that its
tive care given the relative uncertainties of matching ongoing, collaborative use with other disciplines (e.g.,
objective medical treatments to subjectively defined primary care, physiatry, and psychiatry/psychology)
states (i.e., pain and suffering) and ends (e.g., pal- would incur unnecessarily high costs that would be
liation). Long-term pain care can be viewed as cost difficult to advocate.
intensive by insurance providers and hospital opera- But is this latter opinion correct? Previous
tors, with perceived high expenses evoked by the studies have shown that the employment of col-
requirements for both medical staff and equipment/ laborative interventional techniques within an
facility resource utilization. From a perspective of inter-­disciplinary pain/palliative care paradigm
hospital economics, prima facie it might not seem can be both cost- and time-effective.4 For example,
to be “worthwhile” to care for chronic pain patients, when compared with long-term use of systemic-
given costs incurred relative to payment schedules ally administered primary and adjunctive/adjuvant
established according to existing diagnosis-related analgesics, interventional techniques reveal a very
group (DRG) treatment classification systems. The favorable cost: benefit ratio. In the case of the afore-
development and expansion of inpatient and/or out- mentioned patient, the large doses of opioid required
patient pain- and palliative-care networks are not to achieve even dissatisfactory pain control were
generally facilitated by current DRG systems. This is estimated to cost approximately $10 000 per month,
because DRGs are not designed to reflect: (1) the wide while the estimated total combined cost of intra-
pathological variance of chronic pain patients; and (2) thecal pump placement, intrathecal and oral mor-
the finances required to support services necessary phine and the neurolytic block was approximately
to effectively and ethically treat chronic pain condi- $5000 per month over the first 3 months.5 Thus, as
tions.3 Thus, if the goal of providing high-quality pain this case illustrates, even in those cases in which
medicine and palliative care is to be achieved in light analgesia is less than complete, but meaningful

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 Chapter 24. Palliative interventional pain therapy

pain relief is nonetheless achieved, the cost and time well, both disciplines encounter and must deal with
savings incurred by reducing the amount of sys- the clinical, economic, moral, and legal problems that
temic drugs used, and the time needed to obtain sta- are related to medical decisions regarding the nature,
ble effects might well balance and justify the initial scope and extent of such care. Therefore, interven-
expenses of interventional procedures. Clearly, how- tional pain medicine and palliative care could benefit
ever, the use of nerve blocks and (rather than “or”) from a shared orientation and inter-disciplinarity, and
pharmacological, physical medicine and psychiatric/ can be seen as mutual and reciprocal, constituting a
psychological approaches within a methodologically larger professional domain that is centered upon the
conjoined treatment protocol affords considerable treatment of pain – not merely as an object, but as an
complementary attributes. existential predicament of the patient who is the moral
For interventional pain medicine to be truly effect- subject of clinical responsibility.
ive within such a collaborative, integrative system, the
interventional pain specialist must realize that the use On the need for policy: bringing
of techniques and technologies – despite being a sig-
nificant component of practice – does not in any way stakeholders together
lessen the pain physician’s practical and moral role and Clinical moral responsibility dictates that when cure is
obligations qua physician. Interventional pain special- no longer possible, healing care must be maximized.
ists must assume at least some level of responsibility In this way, the collaboration and conjoining of inter-
for the ongoing management of the patients in their ventional pain management and palliative care may
charge. The sole provision of interventional techniques well serve the scope, purposes and obligations of pain
without accepting and meeting the broader medical treatment. However, facilities committed to this type of
needs of the pain patient, either singularly, or in col- inter-disciplinary approach are limited and diminish-
laboration with other physicians, might be regarded ing, and therefore assembling these resources becomes
as a form of abandonment, and in this way rebuts the problematic and non-sustainable. Multi-practitioner
physician’s act of profession. Pharmacologic and psy- pain management practices can be found in most urban
chological management of chronic pain – and the intri- areas in the US and throughout western Europe, yet in
cacies of dealing with the chronic pain patient in an the US the number of multi-disciplinary pain centers
often litigious environment – can be difficult, but such (MPCs) is declining as a result of prior economic con-
is the nature of the profession and practice. cerns, constraints, and misuses. This both reflects the
Ethically sound practice requires that the physi- economic turn away from complementarity in pain
cian: (1) use the most current information on pain and care, and contributes to it.
pain-related pathologies (e.g., substance abuse, psy- This decline has become a quantitative and quali-
chopathology); and (2) recognize and understand the tative barrier to the effective practice of integrative
medically relevant bio-psychosocial needs a particular pain/palliative care, and is an intimidating prospect
patient may have, and how these needs may be served that compels the proposal and ratification of reformed
through an integrative, pluralist approach that con- guidelines and policies, both in the US, and on a more
joins other specialties (e.g., psychiatry, etc.). global scale. Recent calls for insurance companies, as
It is important to remember that from the medical well as government agencies to establish programs
perspective, the “pain patient” is defined by signs and of long-term pain care reflect these concerns and
symptoms (i.e., pain and its resultant bio-psychosocial promptings. The primacy of patients’ best interests
suffering). Assessing and diagnosing pain is often diffi- cannot, nor should not be denied, nor subordinated
cult, and establishing precise trajectories and limits of to other, extraneous goals. But medicine does not exist
care can be equally troublesome – practically, ethically, in a socio-economic vacuum, and if these therapeutic
and legally. Although interventional pain medicine and and ethical “goods” are to be appropriately rendered to
palliative care seem to have somewhat different clin- those in pain, the systems utilized toward these ends
ical structures, both are focal to apprehending the sub- must be practically enacted, and we must recognize
jectivity of pain and suffering, and merging patients’ how the relative interests of practitioners, the health-
subjective experience of pain – and clinicians’ personal care and insurance community, and the public at-large
and professional knowledge and perspectives  – to affect any realistic dynamic of costs and benefits in the
the objectivity of pain assessment and treatment. As provision of care. In this way, it is important to consider

145
 Section 3. Pain management

the needs and values of each of these stakeholder • Interventional pain management techniques
groups, not in isolation, but in concert. A strategy of and integrative pain medicine are under-
rapprochement is necessary to reconcile the tensions utilized, due to misperceptions by hospital
that exist among and between these groups in the best operators and insurance companies about cost
interests of the patient, so as to develop policies that effectiveness.
incorporate “… an ethical ‘infrastructure and func- • Employment of collaborative interventional
tion’ that engages ethical systems and approaches in techniques, however, has been shown to be
ways that support and sustain the good to be provided both cost and time effective.
on individual and public levels”.6 Physicians should
• Even in cases of incomplete pain relief,
advocate policy development that is directed toward
meaningful pain relief may nevertheless
enabling the profession and practice of pain/palliative
be achieved by use of a multi-disciplinary
care to empower the pain patient.
approach.
It is important to see the patient not only as a vic-
• Physicians should advocate policy
tim of her disorder, despite the reality that medical
development that is directed toward
treatment is, in the first place, based upon the presence
developing and enabling the profession and
of identifiable and categorical symptoms and distress.
practice of pain/palliative care.
It is also important to see that the pain patient has
fears and hopes. Reflection upon her existential prob-
lems is not only a personal challenge for the patient,
as well as her family, friends, and others, but can also Acknowledgments
pose professional challenges and opportunities to the This work was supported, in part, by funding from
clinician. the Nour Foundation, and an American Academy of
Unavoidably, life entails some measure of pain and Pain Medicine-Pfizer National Visiting Professorship
suffering. This should not foster a sense of existential at Texas Tech University Health Sciences Center (JG).
nihilism. To the contrary, it serves as a motivation to This work was completed as part of the N3P3 Project
move away from any passive consideration or experi- (Neuroscience, Neurophilosophy and Neuroethics
ence of pain and suffering, and assume a more active, of Pain, Pain Care, and Pain Policy) that conjoins
anticipatory and therefore authentic approach to care. the authors and their respective institutions. Thanks
In this sense, “care” may be translated from its Latin to Drs. Mark V. Boswell, Carlos Gomez and James
origin, cura, as “concern” or “regard,” and this is philo- Harrison for intellectual collaboration on prior work
sophically consistent with the goals, ends, and “prom- regarding the role of interventional pain medicine in
ise” of pain/palliative medicine.7 palliative care.
It has been said that philosophy teaches humanity
how to suffer. In light of this, the authors propose that a
philosophical, and practical conjoinment of pain/pal- Notes
a
liative care affords purchase to learn not only how we  Although this is a fictional case, some facts and cost analysis
are based on an actual case reported in the literature: (Seamans,
suffer (i.e.- a focus upon pain and its meanings), but D.P., Wong, G.Y., and Wilson, J.L. (2000). J Clin Oncol, 28(7),
how we can – and should – concern, regard, and treat 1598–1600.)
those in pain.

Key points References

1*  Giordano, J. (2006). Hospice, palliative care, and pain
• As prolonged survival of previously terminal
medicine: meeting the obligations of non-abandonment
medical conditions has increased, so has the
and preserving the diginity of terminally ill patients. Del
prevalence of chronic and/or intractable pain Med J, 78(11), 419–22.
and suffering.
2   Boswell, M.V. and Giordano, J. (2009). Reflection,
• A “one-size-fits-all” approach to pain analysis and change: the decade of pain control
management is not practical, nor ethically and research and its lessons for the future of pain
justifiable. management. Pain Physician, 12, 1–7.

146
 Chapter 24. Palliative interventional pain therapy

3*  Ewald, H. (2004). Stationäre Palliativmedizin. Management, Schatman, M.E. (ed.) NY: Informa,
Finanzierung und Qualitätskriterien unter DRG- pp. 1–18.
Bedingungen, 3. Petersberger Gesundheitssymposium; Giordano, J. (2009). Pain: Mind, Meaning and Medicine.
Palliativmedizin: Herausforderung für das Glen Falls, PA: PPM Communications.
Gesundheitssystem. 1 July. Giordano, J., Benedikter, R. and Schatman, M.E. (2009).
4   Manchikanti, L., Singh, V., Kloth, D. et al. Interventional In: Giordano J, Boswell MV (eds.) Pain Medicine:
techniques in the management of chronic pain. Pain Philosophy, Ethics and Policy. Oxon, UK: Linton Atlantic,
Physician 2001; 4(1): 24–98. pp. 39–50.
5   Seamans, D.P., Wong, G.Y., and Wilson, J.L. (2000). Höver G (2001/2) „Qualität“ Bedeutung und ethische
Interventional pain therapy for interactable abdominal Dimensionen einer Schlüsselkategorie hospizlicher
cancer pain. J Clin Oncol, 18(7), 1598–600. Arbeit. Rheinisches Jahrbuch für Volkskunde, 34,
6   Giordano, J., Schatman, M.E., and Höver, G. (2009). 205–12.
A crisis in chronic pain care – an ethical analysis, Maricich, Y. and Giordano, J. (2009) Chronic pain,
Part I. Facts, issues, and problems. Pain Physician, 12, subjectivity, and the ethics of pain medicine:
803–13. A deontic structure and the importance of moral
7*  Graf, G. and Höver, G. (2006). Hospiz als agency. In: Giordano J, Boswell MV . (eds.) Pain
Versprechen: Zur ethischen Grundlegung der der Medicine: Philosophy, Ethics and Policy. Oxon, UK:
Hospizidee. Der Hospizverlag. Linton Atlantic, pp. 85–94.

Further reading
Giordano, J. (2006). Pain, the patient and the
physician: philosophy and virtue ethics in pain
medicine. In Ethical Issues in Chronic Pain

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1 Pain management
Chapter

25
Opioid therapy in addicted patients:
background and perspective from the UK
William Notcutt

Three Casesa of investigation and therapy. He is using slow release mor-

phine, diazepam, and amitriptyline. When he can get can-
nabis, he finds this is very effective for symptom control.
Case 1 He says that his back is much worse now and asks for an
Alesha, age 35, has chronic leg pain secondary to vascular increase in opiate. He indicates that he might go back to
damage from previous recurrent groin infections associ- buying on the street.
ated with intravenous opioid use. Having a baby was Should the physician increase his morphine dose, or
the ­stimulus to come off her drugs but she has struggled prescribe him a synthetic cannabis analogue?
to maintain this state because of her pain and her impov-
erished living conditions. She sometimes smokes cannabis Most, if not all, doctors and nurses in the UK are now
to relax and help her sleep. She uses codeine, which is of educated in the basics of ethics and are familiar with
minimal help for the pain. She is supported by a psychi- the common four principles of autonomy, benefi-
atric social worker who attends the clinic with her and cence, nonmaleficence, and justice/fairness. They are
she has never missed an appointment. These are now at easy to understand and to apply to clinical practice
3-month intervals. She does not get on with her GP who as a source of guidance. Further, there is a percep-
she describes as an “Arse.” tion in the UK that a court would look favorably on
Should she be prescribed a long-acting opioid, such as a doctor who has acted using reasonable and demon-
slow release morphine, in a dose that will give her reason- strable ethical process in decision-making, whatever
able control?
the outcome (based on the UK tradition of the Bolam
Test1 and later, the Bolitho judgment,2 in determining
Case 2 negligence).3
Ian, age 54, has been admitted to hospital with acute alco-
hol poisoning. He drinks two to three bottles of spirits a Ethical principles
day. He also takes morphine for chronic back pain due
to two wedge fractures of lumbar vertebra. He has been Autonomy
with the addiction services in the past, but has a chaotic Just because a patient has a dependency problem, this
lifestyle. His GP provides him with oral morphine for his is no justification for denying their right to have their
pain. He only likes immediate release opiates, but has pain managed in an appropriate fashion and to being
remained on a stable dose for some months. On the acute involved in decisions about treatment. Pain control
medical ward he is suffering severe withdrawal symptoms
may be difficult to achieve but clinicians have a duty
and has been given chlordiazepoxide. He has not had
morphine for 2–3 days.
of care to attempt this. The patient should have some
Should he have his morphine restarted at the previous autonomy to determine, within reason, his or her pre-
dose? ferred approach. In cancer care we allow the patient to
decide on treatment, from a range of drug and proced-
ure options that may all be potentially toxic and harm-
Case 3 ful. Equally, we don’t agree to harmful therapeutic
Peter, age 40, has had three prison terms for violence. He options. Doctors and nurses also have the right to not
has a significant history of drug misuse. He has chronic low being abused, either by the patient, relatives, friends, or
back pain for 12 years and has been through a full range by the state authorities.

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
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 Chapter 25. Opioid therapy in addicted patients (UK)

Beneficence morphine for a “trip,” vomited while unconscious, and

There is a widely held acceptance that pain control died. While these occurrences should lead to a search
has benefits for both the individual and those around for safeguards, they are not an adequate excuse for not
him/her. Therefore, beneficence is achieved by work- providing, or attempting to provide, appropriate anal-
ing towards this goal. However, determining the bal- gesia for pain.
ance between analgesia and feel-good/pleasure effects
Justice
in a patient with a significant dependency potential
is difficult. A patient is likely to derive health benefits Perhaps the most common ethical principle that is
from having a prescribed, standardized, and uncon- flouted is that of justice and fairness. Patients with
taminated source of their drug rather than being dependency problems are often given a low priority for
tempted to purchase on the street. Working with pain therapy due to their drug habit, lifestyle, attitudes
others to control abnormal behaviors associated with to staff, and other personal issues. We easily lose impar-
pain and to reduce chaotic lifestyles will be helpful, tiality, objectivity, compassion, interest, and patience.
although for some patients this may become mere Interventional treatments are refused on “psycho-
containment of the situation rather than progressive logical” grounds. However, we have a “duty of care” and
improvement. Containment, however, is better than if we will not deliver it, then we should find others who
deterioration. will (perhaps comparable to the duty of a physician-
conscientious objector to abortion to nevertheless find
other caregivers for the patient). Overcoming the nega-
Nonmaleficence
tivity can be very difficult when addressing the pain
Providing a legitimate source of a drug for pain has its problems of the addicted patients who, for example,
risks. A patient may see this as a way to support a drug usually do not have interesting problems, are often not
dependency habit if the doctor can be convinced that “nice” patients to treat, may be difficult to trust, and
the pain is the dominant problem. However, failing often waste clinical time and appointments, among
to help a patient with chronic pain may have a major other issues.
impact on the rest of the family and local society. A
similar situation occurs when such a patient is admit- The principle of double effect
ted to a ward with an acute pain problem. They can be In the past, doctors have extensively debated the ethics
disruptive when they cannot get their usual level of of a principle of “double effect” of opiate use in pallia-
drug intake, or the extra medication, or alternatives tive care, although the evidence that this is a problem is
needed to control the additional pain. One common almost nonexistent.4 (For further discussion of “double
reason for failure to manage this situation is that the effect” see Chapter 15). In the UK it does not seem to be
doctors lack knowledge in prescribing appropriate considered as a significant concern. However, the doc-
amounts of medication. For example, finding patients trine of “double effect” is broader, explaining the per-
prescribed a mere 10 mg of oral morphine for break- missibility of an action that may have some benefit but
through pain, when their normal daily baseline intake might also cause harm as a side effect. A judgment has to
is 500 mg of morphine, is a common occurrence. be made between the potential benefits and the harms.
Similarly, wholly inadequate bolus doses of opioid are Therefore, perhaps we should redefine the use of the
often programmed into PCA devices for post-operative term and apply it to the use of opioids (and other drugs)
pain in these patients, because doctors are terrified of in relieving pain in the potentially dependent patient.
causing an overdose by giving more than the standard
dose used for an opioid naïve patient. Lack of adequate
education in pain management for all clinicians is a Opiate prescribing in the UK
serious systemic ethical failure. As in the US, the UK has seen a substantial increase
Inevitably there are the occasional tragedies, as in the prescribing of opiates for non-malignant pain.
opioids are dangerous in the wrong hands. A patient There are perhaps two major causes. First, since the
of the author’s, who had proved very difficult to man- early 1980s, doctors have become confident in the man-
age, went for a night out with a friend. While away, the agement of the use of opiates in malignancy and this
troubled adolescent daughter broke into her mother’s experience has been translated to non-malignant pain.
apartment with some friends and decided to have Second, with the exception of gabapentinoids, there
a party. She searched out her mother’s slow-release have been no significant pharmacological advances in
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 Section 3. Pain management

Table 25.1. Often misunderstood or misused terms in opioid dependency

Term
Tolerance A pharmacologic property defined as the need for increasing doses to maintain
therapeutic effects.
Physical dependence A physiologic phenomenon defined solely by the development of an abstinence
(withdrawal) syndrome following discontinuation of therapy, substantial dose
reduction, or administration of an antagonist drug
Psychological dependence A desire to continue a medication because it produces a sense of well-being;
abstinence leads to anxiety, but not withdrawal syndrome.
Withdrawal syndrome A clinical syndrome of physiologic manifestations after acute removal of a
particular medication or substance. In the case of opioid withdrawal, symptoms
and signs can include flu-like symptoms, yawning, agitation, restlessness, anxiety,
insomnia, dilated pupils, piloerection, nausea and vomiting, abdominal pain,
tachycardia, and hypertension.
Pseudo-addiction The development of aberrant behavior in cancer patients who are experiencing
unrelieved pain. With improved analgesia, the behaviors cease.
Chemical coping A syndrome described in some pain patients who periodically display aberrant
behaviors or have a mixed response to opioid therapy. Described by some as a
“middle ground” between compliant opioid use and addiction.
Substance misuse or abuse Excessive or inappropriate use of a chemical substance.
Addiction A psychological and behavioral syndrome characterized by: (1) loss of control over
drug use; (2) compulsive drug use; and (3) continued use despite harm.

pain treatment except in modes of drug delivery. The or chronic pain, acute flare-ups of chronic pain, or
desire for simple techniques for relieving pain has led pain associated with malignancy, AIDS or other life-
doctors, particularly pain clinicians, to see opioids as a limiting diseases. Furthermore, such patients may be
useful and valuable option and so there has been a drift taking their drugs for a variety of reasons (euphoria,
to expand their use. escapism, relief of withdrawal symptoms, medicinal
In the author’s own experience, in general, pre- purposes, or a combination). The need for training in
scribing habits by pain specialists have had an “educa- this area has been recognized and this is incorporated
tional role” and are taken up by general practitioners, into the International Association for the Study of Pain
albeit a year or two later. However, in general, train- (IASP) Curriculum.8 The reality is that there are large
ing in the management of chronic pain is still woefully numbers of clinicians that are highly skilled in inter-
inadequate.5–7 Furthermore, few doctors, including ventional pain practice, but the same is not true for
pain clinicians, develop a comprehensive practice treating pain in patients with dependency.
in the area of chronic pain in the opioid-dependent
patient, because they often find the legal, ethical, and Key differences between the UK and the US
practical problems overwhelming. The organization of the Health Service is a major
difference between the UK and the US. All patients
Opioid dependency – a misunderstood problem have a general practitioner who is the key both to
Despite the increasing recognition of chronic pain ongoing prescribing and to the access to secondary
and opioid use, there is still much misunderstanding care. There is a very limited role for the hospital emer-
in the minds of doctors and nurses over the termin- gency department to act as a primary health clinic
ology associated with opioid dependency. Doctors still and the access to a supply of opioids at this point is
often describe patients as being addicted to their anal- minimal. In hospital practice there is usually good,
gesics when in reality they may have some degree of regular communication with the general practitioner.
dependency, but are not engaged in patterns of behav- The normal practice would be to agree that there
ior associated with addiction (Table 25.1). Conversely, should only be one prescribing point for the patient.
people with dependency problems may develop acute Initially, the pain clinic may manage prescribing until
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 Chapter 25. Opioid therapy in addicted patients (UK)

optimum dosing is achieved before returning this The regulatory authorities however, did not appear to
to the general practitioner. Some pain services have engage in any debate on the ethics of this with pain cli-
also developed strong links with the local addiction nicians. There are many other aspects of modern life
services to manage the addict with pain problems by that are useful and safe, but dangerous in the hands of
running joint clinics. the irresponsible. The drug alcohol and the automobile
Hence, in the UK, there is very little ability to go are two good examples.
from doctor to doctor to obtain more and more pre-
scription drugs. In practice, patients occasionally Professional guidelines
“lose” their drugs or use an excess, although they
The clinician trying to treat the problem patient with
quickly learn that their requests for replacement are
opioid dependency will find little evidence from clinical
rarely accepted. The ability for the well off and well
trials to guide pain management. What information
connected to access such drugs from private practi-
there is has been extensively reviewed but the advice and
tioners is limited. Close oversight by regulators iden-
guidance available are based on opinion and consen-
tifies aberrant and/or high cost prescribing of opioids
sus.9, 10 We are left in a situation where we are often faced
prescribed in primary care in locality. Prescribing
with complex patients with complex problems and with
opiates for registered addicts is managed through the
limited resources and abilities to manage them. Trying
addiction services, in general. Therefore, the access to
to do the best for these patients is not determined by
opiates is reasonably well controlled and GPs take part
long-established medical and scientific principles. The
in the long-term management of patients using opi-
American and British Pain Societies have however, pro-
ates for pain, often sharing care with the pain clinics
duced guidelines giving practical advice.11, 12
and palliative care services.
The British Guidelines also give examples of spe-
Diversion of prescribed opioids does not appear
cific patient problems and how to deal with them.
to be a great problem in the UK. In the past, problems
However, most patients present with a number of
of diversion were well recognized with short-acting
interconnected issues that are not easily resolvable, as
opioids such as Dipipanone (Diconal), Dextromoride
in our case examples. The objective of achieving good
(Palfium) and Pethidine (Meperidine). This was
pain control, good coping skills, and compliant, lim-
resolved by either the agreed local banning of the
ited drug use is usually unattainable. Therefore, com-
drugs, or by agreed tight restriction in prescribing.
promise and pragmatism are often needed to contain
Furthermore, it is well recognized in primary care now
unsolvable problems. If this is supported by the explicit
through education that these drugs have no use for
use of ethical principles, it may be possible to find the
managing chronic pain. It is notable that, in the UK, the
optimum way forward.
use of diamorphine (heroin) has never been discontin-
In the UK, Clinical Ethics Committees are still
ued, unlike most other countries. Its use is principally
emerging and evolving. They have commonly pro-
within hospital practice and in palliative care. There
vided an advisory service to the clinician to help with
has neither been any evidence of a significant problem
decision-making but in general, do not hand down
with diversion nor any contribution to the widespread
formal judgments. Unfortunately, most public debate
problems of recreational heroin use. Some addicts have
of ethical issues seems to revolve around exotic prob-
been prescribed pharmaceutical grade heroin regularly
lems at the extremes of life rather than the everyday
to manage their addiction and there is also open debate
problems of clinical practice. Occasionally, clinicians
about the possibilities of this approach to reduce their
refer complex cases to the courts for a decision, thereby
health problems. For the addict then there would be
obtaining the protection of the law, but in reality, hand-
little incentive to exchange a quality product for other
ing over medical problems to nonclinicians.
street drugs.
In contrast, the mild opioid, Dextropropoxyphene,
combined with Paracetamol is widely used and well tol- Case resolution – UK perspective
erated by many patients. It has been withdrawn recently
because of concerns over its potential lethal effect Case 1
when taken in deliberate overdose. The withdrawal of After getting to know Alesha, we discussed the use
the drug led to many patients suffering increased pain of strong opioids, recognizing the risks. She opted
when they were unable to find a suitable alternative. for transdermal fentanyl and settled at a stable dose.

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 Section 3. Pain management

Unfortunately she developed skin problems and had Case 3

to discontinue the drug. She used oral ketamine for a Perhaps the most important ethical principle in man-
short period but disliked its effect on her. She moved aging Peter is fairness in management, however lim-
to slow release morphine twice a day, having originally ited, within the medical services. He was not a friendly
been reluctant to have access to a quantity of tablets. In individual. He had been offered and had tried other
this way her autonomy was respected in her participa- treatments thereby fulfilling his right to appropri-
tion in the management of her care. ate management of his problem. Dose escalation was
Her general practitioner prescribed the medi- not an option, as it was very unlikely to provide any
cation under the pain clinic’s instruction, and was improvement in pain control. His threat to obtain
the only source of supply thereby reducing harm. street opioids was unlikely to be carried through as his
Having originally been seen at 4-weekly periods, she mobility and finances were limited.
is now seen in the pain clinic every 3 months. She is In the UK, admitting cannabis use to a medical
happy and confident with her current progress and practitioner is not uncommon and, in some commu-
pain control, as is her social worker and she has had nities, its use is so widespread, it would be reasonable
fairness in her treatment. This approach has also to include it in a review of a patient’s pharmaco-
helped improve her relationship with her general logical pain management. Its use here is probably
practitioner. recreational/euphoric as much as therapeutic. This
then can be seen as beneficial for him in helping him
Case 2
cope. However, prescribing a substitute would likely
Ian had a chaotic lifestyle. The opioid helped his back be ineffective through his need to get some form of
pain as did his alcohol. There was no other treatment “high.” The likelihood of harm from this is minimal
that would be of help to his back in these circum- (nonmaleficence). Therefore, accepting its use and
stances as he was not suitable for vertebroplasty. On the overall safety of the drug in comparison to most
the ward he was accurate in his description of his opi- others in routine use for pain, is the current manage-
oid usage (confirmed by his general practitioner). He ment approach. He will continue to be seen regularly
was also clearly suffering severe alcohol withdrawal to support the general practitioner in his manage-
symptoms. ment (duty of care).
We restarted his regular morphine dose (to treat
pain and prevent opioid withdrawal), and quickly
controlled his alcohol withdrawal symptoms (with Key points
chlordiazepoxide and other supportive measures).
• Ethical problems presented by opioid-
His symptoms and his abusive behavior settled. His
dependent patients who are suffering pain
general physical condition improved and he was
are challenging, but can be guided by simple
­discharged home. He was lost to follow-up in pri–
principles of ethical medical practice.
mary care.
• A patient’s dependency problem is not a
Normally, opiate prescription for primary opioid
justification for denying appropriate pain
addiction would be in the hands of addiction services
management. Clinicians have a “duty of care”
and not the general practitioner. Here, the opioid was
to try to achieve pain control.
used for pain. It can be considered that controlling
some of his pain with morphine was better for him • Appropriate pain control benefits both
than his using alcohol for the same purpose therefore the patient and those surrounding them.
being beneficent. Two risks of harm are possible: diver- Containment of aberrant behaviors may
sion to pay for alcohol, and overdose. His right to use be the best that can be achieved; however,
a medicine that helped his pain was negotiated and containment is better than deterioration
managed by his general practitioner. Restarting his • A major problem with pain management in
morphine on the ward was beneficial to him (and to the patient with opioid dependency is lack
those around) and it was helpful to have recognized of physician knowledge about appropriate
and treated his dependency. The duty of care was met. prescribing; education of physicians is
The general practitioner will continue the long-term key to developing reasonable prescribing
care as best he can. practices.

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 Chapter 25. Opioid therapy in addicted patients (UK)

8  Charlton, J.E. (ed). (2005). Core Curriculum for

• A principle like that of “double effect” might
Professional Education in Pain, Seattle: WA, IASP Press.
be useful in defining appropriate physician
9  AAPM Clinical Guidelines for the Use of Chronic Opioid
behavior in relieving pain in the potentially
Therapy in Chronic Noncancer Pain. APS Evidence
dependent patient.
Review American Pain Society. opioid/pub/pdf/org.
ampainsoc.WWW_final_evidence_pdf.report.
10  Ballantyne, J. and LaForge, S. (2007). Opioid
Notes dependence and addiction during opioid treatment of
a
 These are real examples from a single UK clinic. In this chronic pain. Pain, 129, 235–55.
chapter, Dr. Notcutt discusses management of the cases
11  Clinical Guidelines for the Use of Chronic Opioid
from a UK perspective incorporating basic clinical
Therapy in Chronic Noncancer Pain. (2009). American
ethics. In the following chapter, the same cases will be
discussed by Dr. Ballantyne from a US perspective. The Pain Society – American Academy of Pain Medicine
UK perspective presents what actually happened, while Opioids Guidelines. J Pain, 10(2), 113–30.
the US perspective presents how the cases may be han- 12  Pain and substance misuse: improving the patient
dled differently by a physician in the US, understanding experience. (2006). London UK: British Pain Society.
that opinion and practice vary considerably even within
a single practice, and certainly across any single nation.
Further reading
AAPM Council on Ethics. (2005). Ethics charter from
References American Academy of Pain Medicine. Pain Medicine,
1  Bolam v. Friern Hospital Management Committee 6(3), 203–12.
[1957] 1 WLR 583. The Bolam test states that if a doctor American Pain Society. (2009). Clinical guidelines for the
reaches the standard of a responsible body of medical use of chronic opioid therapy in chronic noncancer
opinion, he is not negligent. pain. American Academy of Pain Medicine Opioids
2  Bolitho v. City and Hackney Heath Authority [1998] Guidelines. J Pain, 10(2), 113–30.
9 MLR 26 (HL). In this judgment, it was determined American Pain Society. Evidence Review: APS-
that a judge must be satisfied that the body of expert AAPM Clinical Guidelines for the Use of Chronic
opinion relied upon must have some demonstrable Opioid Therapy in Chronic Noncancer Pain. www.
logical basis, and is not accepted solely because it ampainsoc.org/pub/pdf/opioid_final_evidence_
comes from an expert body. report.pdf.
3  Hurwitz, B. (2004). How does evidence based guidance Bannister, J. (2005). Running a pain and dependency
influence determinations of medical negligence? BMJ, clinic. In Managing Pain and Addiction – Opening
329, 1024–8. Pandora’s Box. University of Dundee. Conference
4  Fohr, S.A. (1998). The double effect of pain medication. communication.
J Palliat Med, 1, 315–28. British Pain Society. (2006). Improving the Patient
5*  The Pain Education Special Interest Group of the Experience: Pain and Substance Misuse. London, UK.
British Pain Society. (2009). Survey of undergraduate Fishbain, D. (2003). Chronic opioid treatment, addiction
pain curricula for healthcare professionals in the and pseudo-addiction in patients with chronic pain.
United Kingdom. The British Pain Society, London UK. Psychiatric Times Newsletter, 20, 2.
6*  Annual Report of the Chief Medical Officer on the Littlejohn, C., Baldacchino, A., and Bannister, J. (2004).
State of Public Health 2008. Department of Health Chronic non-cancer pain and opioid dependence. J Roy
Publications (2009) pp. 33–39 [www.dh.gov.uk]. Soc Med, 97, 62–5.
7   Notcutt, W. and Gibbs, G. (2010). Inadequate pain Portenoy, R.K. (2006). Opioid therapy for chronic non-
management: myth, stigma and professional fear. malignant pain: clinicians’ perspective. J Law Med
Postgrad Med J (accepted for publication). Ethics, 24(4), 296–309.

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1 Pain management
Chapter

26
Opioid therapy in addicted patients:
background and perspective from the US
Jane C. Ballantyne and Joseph Klein

The three cases illegal for physicians to prescribe opioids for the treat-
ment of opioid addiction, opioid treatment of pain
Please refer to the previous chapter’s cases for discussion.
practically ceased. Not knowing which of their patients
might be addicted, doctors in the US were intimidated
Opium addiction as a social problem lest they lose their medical license, or worse still, suffer
Although opium derivatives have been used since criminal prosecution. The laws in other Western coun-
antiquity for medicinal and recreational purposes, tries were less constraining. In the UK, guided by the
recognition of opioid addiction as a significant social Rolleston Committee (1924–1965), physicians were
problem emerged only relatively recently. The opium allowed to give their addicted patients diamorphine
eaters of the eighteenth and nineteenth centuries con- (heroin), syringes, and needles. At the time, heroin
sumed fairly low doses of active drug. Intoxication proliferation was less of a problem in the UK than in
and addiction certainly existed, but the lack of wide- the US: in 1958 there were only 62 known heroin users
spread availability prevented broad societal ramifica- in the UK, a number that would soon increase several-
tions. Nonetheless, a stigma was attached to opium fold. In The (London) Times in 1955 it was argued:
consumption by a largely religious society that ‘Heroin addiction in Great Britain is practically unknown
valued suffering as a moral good. The Quakers, for and it is difficult to see why administrative action … should
example, likened the soul to a physical entity; intoxi- be allowed to hinder the relief of suffering.”2 “Do not let us
cating substances impaired self-restraint, leading to follow along the path of prohibition – a bad and danger-
lapses in moral judgment and consequent damage ous way’.3
to the soul. Despite these views, few restrictions on In a description of the London drug scene in the 1960s,
opium existed. the preacher Kenneth Leech wrote:
With the emergence of purified morphine and ‘To cut off the supply by prescription would be easy; it
later heroin, the deleterious effects of opioids on has been done in the United States where doctors are not
individuals and society came into focus. In the US, allowed to prescribe for addicts, with the result that the pro-
the number of narcotic addicts exploded, crime rose, vision of drugs has become a flourishing industry and drug
and worker productivity declined. Legislation soon addiction increases there yearly.’4
followed. The Harrison Act of 1914 restricted opioid The differences between the US and other Western
and cocaine distribution to registered physicians and countries persisted into the late 1960s when US
pharmacies. By the 1920s, authorities jailed physi- President Richard Nixon’s “War on Drugs” led to even
cians for distributing opioids outside their profes- stricter regulations. The effect on the medical use of
sional “course of conduct,” thus setting a precedent opioids in the US was disastrous. By the second half
that would affect opioid prescribing for decades. of the twentieth century, both addiction and pain were
Britain soon followed with its own legislation, the undertreated, with baleful consequences. When the
Dangerous Drugs Act, in 1920. iniquities of undertreatment were recognized, opi-
oid advocacy was born. In the US, addiction advocacy
Regulatory influence brought about the re-establishment of opioid (metha-
In the US, after Webb versus the United States1 and pro- done) treatment for addiction in 1974 (Narcotic Addict
visions of the 1914 Harrison Narcotic Drug Act made it Treatment Act); pain advocacy during the 1970s and

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
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 Chapter 26. Opioid therapy in addicted patients (US)

1980s brought about the re-establishment of opioids as appears to have been achieved in the UK, seems
for the treatment of acute and cancer pain, principles ideal, yet the balance between prescription and illicit
that were later extended to chronic pain. opioid abuse will always be precarious.

Prevalence of prescription opioid abuse Enactment of laws and their effect

Historically, under-treatment of pain as a conse-
quence of draconian anti-drug laws occurred mainly on opioid prescribing for pain
in the US. The swing of the pendulum towards In the US, the Controlled Substances Act of 1970 uni-
over-use, or at least careless use, of opioids for pain fied many previous laws under a single framework
seems also a uniquely American problem,5 reflected regulating the manufacture, distribution, prescription,
in alarming statistics that demonstrate precipitous and dispensing of opioids and other substances with
increases in prescription opioid abuse over the past abuse potential. Controlled substances were assigned
decade, to the extent that prescription opioid abuse to one of five schedules based on their medical util-
is now more ­prevalent in the US than is illicit her- ity and abuse potential. The Controlled Substance Act
oin abuse.6 (Figure 26.1) Successful marketing of defines neither legitimate medical purpose nor stand-
“designer” opioids increased prescribing of opioids ards of professional practice: this falls to the state med-
for chronic pain.7 Increased prescribing for pain ical boards, professional societies, the Department of
resulted in increased opioid analgesics in homes, Justice, or even lay juries in criminal trials. Criminal
pharmacies, and on the streets, and has likely con- charges against physicians generally arise only when
tributed to the disturbing increases in prescrip- both bad practice and bad intention by the practitioner
tion drug abuse and related deaths seen in the US.8 are established.
Surveys such as the National Household Survey do Because of legal constraints placed on opioid pre-
not exist in the UK, and it may be that, without an scribing in the US, gross negligence (bad practice) may
effective early warning system, the extent of the prob- lead to criminal prosecution even when there is good
lem of prescription opioid abuse is unknown in UK.9 intention. For example, a physician is more likely to be
Whatever the benefits of the UK’s relatively forgiv- accused of involuntary manslaughter if the drug cho-
ing approach to controlling addiction in terms of not sen for overdose by a suicidal patient is an opioid rather
having inhibited opioid prescribing for pain to the than a noncontrolled drug such as a tricyclic antidepres-
same extent as in the US, UK policies seem to be fail- sant. In People v Schade, a physician was convicted of
ing to control problematic illicit drug use when com- involuntary manslaughter when a patient with known
pared to other European countries. The UK now has addiction and suicidal ideation killed himself with an
the worst illicit drug problem in Europe, a situation opioid that had been prescribed within days of a previ-
that is bound to impact UK general practitioners at ous suicide attempt. The jury deemed this to be reckless
the intersection of pain and addiction. Effective con- facilitation of a suicide. Had the medication not been a
finement of prescription opioid use to medical use, controlled substance, the physician more likely would

Marijuana 4198 Figure 26.1. Dependence or Abuse of

Specific Illicit Drugs among Persons Aged
Cocaine 1515 12 or Older: 2003
Pain rellevers 1424
Tranquilizers 435
Stimulants 378
Hallucinogens 321
Heroin 189
Inhalants 169
Sedatives 158

0 500 1000 1500 2000 2500 3000 3500 4000 4500

Numbers (in thousands) of users with dependence or Abuse

155
 Section 3. Pain management

have faced malpractice (a civil action not subject to forms. In 2006, the Misuse of Drugs Regulations were
incarceration), rather than criminal charges.10 changed, and new arrangements made for prescribing
The perception of risk of even being investigated, controlled substances on special forms.13
let alone being tried and convicted on criminal charges,
has deterred many physicians from aggressively treat-
ing pain with controlled substances. In the US there
Demanding opioids: the impact of cultural
is a risk also of being charged with undertreatment of and healthcare system differences
pain. In 2001 a California physician was convicted of At the end of the twentieth century, doctors stopped
elder abuse for underprescribing pain medications in a worrying that opioid treatment of chronic pain was
malpractice suit. The jury awarded the family $1.5 mil- neither effective nor safe, and caution turned to con-
lion.11 Cases such as these have raised significant soci- fidence. It was believed that treatment could relieve
etal debate on the role of the courts in dictating what people of the burden of chronic pain and improve
constitutes a “legitimate medical purpose,” a role histor- their lives. This philosophical shift was important
ically the purview of state medical boards and profes- for persuading the medical community that opioids
sional societies. Contradictory legal precedent places should be widely used for the treatment of chronic
physicians in a quandary: prescribe liberally and risk pain. But what if, after all, opioids are not so effective
possible criminal investigation or prescribe sparingly for relieving pain and improving lives, as has been sug-
and risk civil proceedings for the undertreatment of gested by several recently published epidemiological
pain. The war on drugs collides with another American studies?14 Is patient desire for opioid treatment of their
phenomenon, patient advocacy for the right to pain pain enough?
control. Physicians are left caught in the middle. Studies are beginning to show that pain treatment,
Because UK drug regulations are less restrictive any pain treatment, can produce positive patient satis-
than those in the US, criminal prosecution of physi- faction ratings even if that treatment fails to produce
cians on charges related to opioids were virtually the results treating clinicians want to see (improve-
unheard of until the notorious case of Harold Shipman ment in pain, function, and quality of life).15 Simply
in 1998. Harold Shipman was a general practitioner validating a pain complaint by continuing treatment
who was tried and convicted of the murders of 15 eld- may be enough to satisfy patients. But if that treat-
erly patients. He had administered diamorphine (a ment is an opioid, then there are several reasons why
legal drug in the UK for clinical use). After his trial, a the treatment could produce good satisfaction ratings
special inquiry (the Shipman Inquiry) found evidence despite failing to achieve the primary goals of treat-
to suggest that he had, in fact, killed as many as 250 ment. Only a few patients will develop true addiction,
people. The press coverage of the case was such that but many if not all patients receiving continuous opi-
Harold Shipman’s activities became well known in oid treatment will develop dependence (physical and
the UK. Unlike the US, where criminal prosecution psychological).16 They may therefore give up opioids
of physicians had occurred relatively frequently with only with difficulty, even when such drugs are not work-
an insidious effect on opioid prescribing for pain, the ing well. By the definition of addiction, those patients
Shipman case had an immediate and profound effect that do develop iatrogenic addiction will desire opioids
on opioid prescribing in the UK. The Shipman Inquiry beyond their ability to improve quality of life. Many
was damning in its criticism of the General Medical patients will rely on opioids to treat symptoms other
Council (the body that accredits British doctors) saying than pain (“chemical copers”). The addictive proper-
that the body had protected doctors at the expense of ties of opioids introduce complications such as deliber-
protecting patients.12 The inquiry suggested two ways ate or careless diversion. There is also a sense that there
in which risk might be reduced, which had been recog- is nowhere to go beyond opioid treatment – that there
nized in earlier legislation but never implemented: they is nothing better, so it must be good.
found that doctors should not be allowed to prescribe The issue of patients desiring opioid treatment,
controlled substances:  (1) for their own use; or (2) even when the treatment fails to achieve conventional
when not in “actual practice” (with an active medical treatment goals, exposes some important differences
license). Another provision that had been suggested in between the US and the UK. Consider first the pro-
earlier regulations, but never implemented, was that found cultural differences that drive ethical and moral
all private prescriptions should be written on special arguments in these two countries. Liberty and the right

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 Chapter 26. Opioid therapy in addicted patients (US)

to pursue happiness were fundamental to the consti- performance of individual clinics and clinicians.
tution of the New World – values that have remained Failure to compete in terms of patient satisfaction
central to the American character ever since. In the US, could mean institutional failure, loss of institutional
the rights of the individual are of primary importance. support, or loss of livelihood for clinicians. Patient
In healthcare, this means that patients dominate in satisfaction with opioid treatment without any other
healthcare decisions, provided they or their insurance demonstrable benefit presents a dilemma for some
can pay. Statutes are written to ensure that patients clinicians, who may feel pressured to prescribe against
have a right to determine their own treatment, includ- their better judgment. The conflicts that can arise in
ing Intractable Pain Statutes that establish the right of discussing withdrawal of opioid treatment in patients
patients to receive opioids for the treatment of intract- who have not demonstrated traditional signs of clinical
able pain.17 Physicians are supposed to help inform efficacy may deter many clinicians, since it is much eas-
patients about the capability of a treatment to achieve ier to simply prescribe the opioids the patient is seek-
its goals, and to steer the patient’s decision within a ing. A business model of healthcare may thus promote
guidance-co-operation model, as distinct from the a tendency to overprescribe.
paternalistic model of care seen more often in gov-
ernment run healthcare systems. This forms the basis
of the shared decision-making that is prevalent in US
Case resolutions
healthcare. Case 1
The best way to keep Alesha’s addiction under con-
Medical ethics: the role of patient choice trol is to formalize her addiction treatment, ideally
The most difficult ethical arguments arise when there in recognition that she needs both pain and addiction
is this difference of opinion between the patient and treatment. Opioid maintenance or analgesic treatment
physician, especially when the argument pitches the alone will not be enough to control either her pain or
individual patient against the needs of society.18 In the her addiction, and counseling and other nonmedical
US, there is cultural bias to allow patient choices, while interventions should be an integral part of treatment.
in the UK healthcare system and culture, a more social- In the US, a patient like this may fall through the cracks
ist approach is encouraged. This difference becomes if she doesn’t have some sort of healthcare coverage
important when considering the role of patient satis- (e.g. Medicaid). It is highly likely that this patient will
faction as an “outcome” of opioid treatment. Addiction suffer a relapse if she does not receive appropriate treat-
risk aside, if opioid treatment of chronic pain effect- ment. The ethical issues that arise here are: (1) that the
ively achieves any of the conventional goals of treat- stigma of addiction affects physicians’ prejudices and
ment (e.g., sustained pain relief), most people would their willingness to treat pain with opioids; and (2) she
agree that there is a strong argument for providing it. If may be denied appropriate medical care because of lack
the treatment is desired but not effective, or even harm- of, or limited, benefits – a reason some may argue at the
ful, then differences in the value placed on patient satis- broad political level that it is unethical to continue with
faction will be starkly exposed. the current healthcare system and its disparities.
The US healthcare system is unique in that it is
the only system in the world that relies on employ- Case 2
ers, through insurance agencies, to fund healthcare. Ian is in a high-risk, low-benefit category for opi-
Medicare and Medicaid fund healthcare for the elderly oid pain treatment. He presents a high risk of misuse
and the impoverished, respectively. The truly unin- due to his alcoholism and chaotic lifestyle, and he has
sured are a small minority of the population. Healthcare a pain condition that can be effectively treated using
in the US is therefore driven by marketing  –  not by non-opioid approaches. Ideally, he should be offered
­welfare – politics, and the model of American health- both addiction and chronic pain treatment, the latter
care is a business model. being with nonopioid approaches. The ethical issue
Attention to pain, and successful treatment of here is whether physicians can and should withhold
pain, have become important markers of quality of opioids if they believe that in prescribing, they could
care. Measures of patient satisfaction are now included do harm. In the US, the physician risks losing DEA cer-
in most hospital outcome metrics, and are used for tification or medical license if prescribing to a patient
accreditation of US hospitals, as well as to assess the who subsequently harms him/herself. Fear of liability
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 Section 3. Pain management

thus becomes a significant factor in clinical decision treatment has long been maintained as being
making. humane, ethical, and necessary.
Case 3 • Physician choices in the US are influenced by
legal issues; US physicians can be held liable
Evidence and expert opinion strongly suggests that
for both over-treatment and under-treatment
open-ended dose escalation doesn’t work, and even-
of pain, while in the UK such cases are rare.
tually leads to opioid refractoriness. Peter should be
advised that, if the opioid is no longer working well, • Fears of civil or criminal prosecution may
his choices include opioid holiday or opioid switch, but unduly influence physicians in the US,
not dose increase. Peter’s concomitant marijuana issue placing self-interest ahead of the traditional
is always tough. Since marijuana use is illegal in the US, prioritization of beneficence and respect for
the physician can either take the hard line of not pre- patient autonomy.
scribing opioids to patients who use marijuana (which • Differences between the US and UK in
may be revealed on the urine toxicology screen even healthcare provision additionally influence
if the patient doesn’t admit to use) or deal with it in a opioid prescribing.
“don’t ask, don’t tell” manner. He would probably not • Lack of universal healthcare coverage in the
be prescribed a synthetic cannabis analogue because US means that, at one end of the spectrum,
it doesn’t work well for pain. This author would not for the uninsured, it may not be possible
be threatened by the patient’s statement about going to offer appropriate care for pain and
back to buying on the street, since she cannot prevent addiction.
that. Ethically, the physician is bound to treat pain to • At the other end of the spectrum, strong
the best of their ability according to their knowledge. patient advocacy and the established rights
In this case, that would be with a rational and stable of the insured, mean that patients dominate
does of opioid, with the usual safeguards. Although in healthcare decisions, including the right to
for a patient who has already threatened to “buy on the receive opioids. The paternalistic approach
street,” there will always be a risk of him selling his pre- more predominant in universal healthcare
scribed opioid, on balance this tendency may be better systems is not appropriate in the US. This
controlled if he is provided with a stable dose of opioid produces ethical dilemmas for the US
in a medical setting. Some American physicians may physician whose concept of risk versus benefit
fear regulatory scrutiny in this situation, with appro- may differ from that of the patient, and who
priate documentation of this rationale for the treat- additionally may be driven to produce good
ment decision, they would be unlikely to be faulted by patient satisfaction ratings in a market-driven
the authorities. healthcare system.

Key points References

• Differences in history, culture, healthcare 1   Webb et al. v United States, 249 US 96 (1919).
systems, laws, and attitudes have significantly 2   Horder, T.J. (1955). Manufacture of Heroin. The Times,
affected perspectives on the ethical London. 26th May;11e.
management of opioid use between the US and 3   Webb-Johnson, A.E. House of Lords debates, 13th
the UK. December 1955, vol 195, columns 45–6
• Use of illicit opioids in the US has lead to 4   Leech, K. (1991). The London Drug Scene in the 1960s.
reactionary legislation with harsh penalties. Policing and Prescribing, eds. Whynes D and Bean P.
McMillan, London UK, pp. 43–4.
The present state of affairs is that abuse of
5*  Zacny, J., Bigelow, G., Compton, P., et al. (2003).
prescription opioids is more prevalent in the
College on Problems of Drug Dependence taskforce
US than abuse of “street” heroin.
on prescription opioid non-medical use and
• Opioid treatment of pain has periodically abuse: position statement. Drug Alcohol Depend, 69(3),
come under intense scrutiny in the US, 215–32.
resulting in fluctuations between under- and 6   Office of Applied Studies (2008). Results from
overtreatment of pain. In the UK, opioid the 2007 National Survey on Drug Use and

158
 Chapter 26. Opioid therapy in addicted patients (US)

Health: National findings (DHHS Publication No. 13  Department of Health (2006). Safer Management of
SMA 08–4343, NSDUH Series H-34. Rockville, Controlled Drugs (CDs): Private CD prescriptions
MD: Substance Abuse and Mental Health Services and other changes to the prescribing and
Administration. dispensing of controlled drugs (CDs). Guidance for
7*  Van Zee A. (2009). The promotion and marketing of Implementations. Gateway Reference: 6820.
oxycontin: commercial triumph, public health tragedy. 14  Eriksen, J., Sjogren, P., Bruera, E., et al. (2006). Critical
Am J Public Health, 99(2), 221–7. issues on opioids in chronic non-cancer pain. An
8*  Kuehn, B.M. (2007). Opioid prescriptions soar: increase epidemiological study. Pain, 125, 172–9.
in legitimate use as well as abuse. JAMA, 17(3), 249. 15* Ballantyne, J.C. and Fleisher, L.A. (2010). Ethical issues
9*  Spence, D. (2010) Bad medicine: pain. Br Med J, 340, in opioid prescribing for chronic pain. Pain, 148(3),
b5683. 365–7.
10  Romanow, K. (2003). Criminal law: physician 16* Ballantyne, J.C. and LaForge, S.L. (2007). Opioid
convicted for recklessly prescribing OxyContin. J Law dependence and addiction in opioid treated pain
Med Ethics, 31(1), 154–5. patients. Pain, 129, 235–55.
11  Bergman v. Eden Medical Center, No. H205732–1 (Cal. 17  Dubois, M.Y. (2005). The birth of an ethics charter for
Super. Ct. Aug. 20, 2001). pain medicine. Pain Med, 6(3), 201–2.
12  The Shipman Inquiry. http://www.the-shipman- 18* Rubin, S.B. (2007). If we think it’s futile, can’t we just say
inquiry.org.uk/home.asp. no? HEC Forum, 19(1), 45–65.

159
Section Research and publication

4
 Section 4
1 Research and publication
Chapter

27
Ethics in anesthesiology research
using human subjects
A.M. Viens

The Case research ethics share a common reason for undertak-

ing such activities: to improve clinical practice and care.
A group of anesthesia researchers undertook a research
Research constructed, conducted, and disseminated in
project to determine if injection of a sedative drug into
the subarachnoid space would improve effectiveness of
an ethical fashion will likely lead to quality improve-
pain control post-operatively for labor and delivery. The ment, improved outcomes, shared knowledge and best
literature at the time had scant information about tox- practices, amongst other considerations.
icity of the drug in question when administered in this Research ethics in general, and the ethical con-
way, although some anesthesiologists had been doing so duct of clinical research in particular, are concerned
anyway. While a handful of studies had demonstrated with ensuring research participants and their interests
no obvious adverse outcomes in animal models, several are protected, and that the clinical research they are
studies suggested dramatically otherwise, including one involved in serves the interests of science and the com-
study in which rabbits demonstrated serious spinal cord munity in which it is conducted.
histological changes. No study had examined the use of Most anesthesiologists will split their time work-
the drug in the dosage and mode of administration pro-
ing in the operating room, intensive care unit, or pain
posed by the investigators. The investigators obtained
institutional ethics review board approval and the study
clinic and divide the rest of their time in administra-
was carried out. No human subjects appeared to suffer an tive, teaching, and research roles. Each of these posi-
adverse effect. A modest improvement in analgesia was tions and environments will have their own obligations
seen in some, but not all, patients. The project was writ- associated with them; and it is often the case that many
ten up and submitted to a journal for publication. of the obligations and issues that arise in the clinical
setting will have some overlap with research activities.
All anesthesiologists will encounter ethical issues
Anesthesiologists conducting research have obliga-
related to research. It may be through engaging in
tions to patients, colleagues, and society that should be
their own primary or clinical research projects, in their
adhered to. Some of the main research-based obliga-
practice treating a patient who is a research participant
tions include the following.
in a project from another treating speciality, apply-
ing for research funding and ethics approval, pub- • Study design and performance should be based on
lishing research results, or even through determining a thorough knowledge of the scientific literature
departmental/divisional funding priorities. The focus and other relevant sources of information.
of this chapter will be solely on the ethics of conduct- • Studies should address a research question of
ing research involving human subjects – in particular, sufficient value to participants to justify risk
some of the main ethical issues that arise with the kind exposure.
of research conducted by anesthesiologists in clinical • There should be clear research question(s) that can
settings. be answered reliably and efficiently.
The history of anesthesiology research on human • Sufficient number of participants should be
subjects, while at times undertaken in varying degrees enrolled in a reasonable period.
of ethically permissible ways, has produced many tech- • All research projects should be reviewed by
niques that are the mainstay of modern surgical, peri- relevant research ethics committee(s) for
operative and intensive care. It should be recognized consideration, comment, guidance, and approval
by anesthesiologists that both clinical research and before the study begins (even studies that are

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
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 Section 4. Research and publication

noninvasive or involve accepted therapies obtained, also presents specific challenges. As a result
need approval both for regulatory reasons and of this, this chapter will focus on three areas where these
to consider issues of confidentiality, cost and issues are especially important for the ethical conduct
voluntariness). of clinical anesthesiology research:  enrollment and
• Informed consent should be obtained for all parts of consent, potential conflicts of interest, and the balance
the project, including any resulting adverse effects of risk and benefit.
that may require modification of protocols or care.
• Undue inducements, duress, or coercion should Enrollment and consent in clinical research
not be used in recruiting or retaining participants.
Free and informed consent to participate in a
• Research should be conducted only by individuals research project must be obtained from the partici-
with the appropriate medical qualifications and pant or from an appropriate legally designated rep-
scientific training. resentative for participants who do not possess the
• Findings should be valid and reproducible. capacity to consent. Participants incapable of pro-
• Research design should be preceded by careful viding consent for research participation require
assessment of predictable risks and burdens to the special protection.
individuals and communities, and participation The consent process should involve providing the
should be dependent upon confidence that the participant with sufficient information  – in lay lan-
risks involved can be satisfactorily managed. guage  – that includes the aims of the research and
• Research protocols, and information given to potential outcomes, inclusion and exclusion criteria,
participants, should have clear provisions for what happens if the participant agrees to take part,
treating and/or compensating subjects who are what methods, techniques, or devices will be used, any
harmed as a consequence of participation in the risks or benefits to participating, what will happen to
research study. specimens or data obtained from research, arrange-
• Participant privacy and confidentiality in the ments for ensuring anonymity or confidentiality, and
collection, analysis, storage and/or reuse of identi­ how results will be disseminated, amongst other rele-
fiable and anonymized data should be ensured. vant considerations.
• Positive and negative research findings should be It should be made clear that the primary purpose
disseminated. for medical research is to understand the nature of
To some, these may seem like scientific or legal con- disease and/or improve preventive, diagnostic, and
siderations, and not ethical considerations. However, therapeutic interventions. As such, the decision to
these considerations are ethical in that designing and participate in research need not result in any direct
executing a study that is not scientifically rigorous or personal benefit – even if there are associated indirect
exhibits scientific misconduct puts participants at risk benefits. It should also be made clear that a decision
of burden, loss, or harm. not to participate will have absolutely no effect on their
clinical care.
Research participants need to be given sufficient
Why anesthesiology research is special time to reflect on the information contained within the
The kind of research conducted by anesthesiologists project description and consent form, and to consult
deserves special attention by virtue of the fact that a with friends or family members (should they wish).
good deal of the human subject research conducted The unique environment in which most clinical anes-
will be with participants who are potentially themselves thesiology research takes place will make this a chal-
vulnerable  – children, women in labor, critically ill lenge that must still be accommodated.
patients – or in temporary vulnerable states – individ- It must be made unambiguous that research parti­
uals who are sedated, unconscious, about to undergo cipants and their data (assuming it is not anonymised)
surgery, in pain, or being resuscitated. This is not to can be withdrawn from a study at any time without
say that vulnerability is not found in other areas of explanation and that this withdrawal will also have
research, merely that it is an acute and central concern absolutely no effect on the quality or level of their clin-
in anesthesiology and peri-operative clinical research. ical care. Research involving general anesthetics or
Moreover, the unique environment in which clinical other potent central nervous system depressant medi-
anesthesiology research is conducted and consent is cations will constrain a participant’s ability to exercise
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 Chapter 27. Anesthesiology research: human subjects

their right to withdraw from a study and this factor of interest must be mitigated or removed. Other finan-
must also be taken into account and accommodated cial conflicts of interest may include finder’s fees, insti-
within the design and conduct of a study. Due attention tutional funding and sponsorship, owning stock in a
must also be paid to the fact that approaching patients company whose product you are researching, or being
in a clinical setting for research purposes will raise involved in a spin-off company that may commercial-
questions about a patient’s privacy and the confidenti- ize the results of the study. Research protocols, par-
ality of medical information and research data. ticipant information sheets, the consent process, and
The Canadian Anesthesiologists’ Society1 suggests publication/presentation of the resulting research find-
that pre-operative consent for clinical anesthesiology ings should include information regarding all potential
research may be obtained either before admission or conflicts of interest, including funding, sponsors, affili-
on the day of the scheduled surgery provided that: ations, and positions.
(1) Patients are not under the influence of Another area of concern is that potential research
premedication. participants may be in a dependent relationship with
(2) Risk to the patient and time commitment to the anesthesiologists – either as the direct treating phys-
study are not significantly different from routine ician or by being a patient who is treated by a col-
clinical care (e.g., during drug trials in which a league on the same service. Many patients will find an
patient may be randomly assigned to receive one approach to participate in a research project by their
of several anesthetic regimens, using approved treating anesthesiologists or a project being conducted
medications). at the institution in which they are receiving treatment
(3) After verbal explanation from the investigator more difficult to turn down than they might otherwise
or research assistant, and in the absence of have in a different setting. Anesthesiologists need to be
the investigator or research assistant, patients careful in their approach of potential participants for
are given time to read the information sheet enrollment that the attitude, situation, or environment
and consider the risks and benefits. Patients is not in any way coercive or involves an unnecessary
should have an opportunity to raise any further pressure. If possible, it may be advisable to have an
questions or seek clarification on any points appropriately qualified individual who is completely
concerning the nature of the study, alternatives, independent of the physician or research relationship
risks, benefits, etc. conduct the participant enrollment and/or consent
(4) Patients who feel they are under duress, or require process.
more time to make a decision, should be advised According to King and Churchill,2 physician-
to decline participation in the study. ­researchers should:
(5) Investigators document in the healthcare chart • Discuss the differences between research and
the nature of their consent process for patients medical practice with patients.
who agree to participate in a research protocol. • Disclose both physician and researcher roles to
patients, and distinguish them (‘‘switch hats’’) as
needed.
Dual role of anesthesiologist and clinical • Consistently use ‘‘research’’ terminology,
researcher not ‘‘treatment’’ language, when referring
When anesthesiologists who treat patients also engage to investigators, subjects, and experimental
in clinical research, they take on dual roles that have interventions.
important differences that may give rise to potential • Present benefit to society as the sole or primary
conflicts or obligations that come into tension with an goal of research.
anesthesiologist’s duty of care.2 • Explain that benefit to research participants, while
One area of potential concern is financial conflicts often hoped for, is always uncertain and may be
of interest.3 While the vast majority of clinical research unlikely or impossible, depending on the design
is undertaken for scientific reasons, it is undeniable that and phase of the trial.
there are a number of positive upshots that can result, • State when clinical benefit from the experimental
including promotion, tenure, funding, prestige, etc. As intervention in a study is not possible or not
a result, the existence and even appearance of conflicts likely.

165
 Section 4. Research and publication

• When clinical benefit from the experimental all of the scientific information available on safety and
intervention in a study is reasonably possible, efficacy – or both.
describe it clearly, including its nature, magnitude, Moreover, even with such issues, the journal in
duration, likelihood, and limits. which the research was published could not resist the
• Remember that, even though clinical research desire to publish the findings given the lack of nega-
is not medical practice, researchers can, do, tive outcomes and the parallel publication from an
and should care about and for their research unconnected source of a well-designed animal model
subjects. that, in some aspects, paralleled the experiment involv-
ing human subjects. While the journal did include
The Helsinki Declaration4 maintains that, “The phys-
an editorial accompanying publication of the article
ician may combine medical research with medical
care only to the extent that the research is justified that outlined the ethical dilemmas in which the edi-
tors found themselves in, it does raise the question of
by its potential preventive, diagnostic or therapeutic
whether publishing the results will have the effect of
value and if the physician has good reason to believe
making it easier to justify other cases of publishing
that participation in the research study will not
unethical research results. The Helsinki Declaration4
adversely affect the health of the patients who serve
requires that medical research must conform to prior
as research subjects.” When holding the dual role of
“… adequate laboratory and animal experimenta-
clinician and researcher, in circumstances where the
tion…” and that “[r]eports of research not in accord-
two come into conflict (or the potential exists to give
ance with the principles of this Declaration should not
rise to the appearance of conflict), the role of clinician
be accepted for publication”. (For more on publication
must take priority over the role of researcher.
ethics, see Chapter 35.)
This example is also illustrative of an issue that
Risk, benefit, and clinical trials frequently occurs in clinical anesthesiology research
Many of the risks and benefits associated with partici- directed at symptom management (e.g., pain, anxiety,
pation in clinical anesthesiology research are based on nausea), for which adequate, if not perfect, treatments
the use of the anesthetic itself and not participation in already exist. That is, that this study exposed its subjects
the research project.1 However, this is not always the to potential adverse neurologic consequences for min-
case. The case study at the beginning of the chapter, imal gain in an area that already has significant proven
which is based on an actual research study, contains a treatments. When undertaking this kind of research,
number of ethical issues of concern that could arise in investigators should be able to demonstrate that there is
other clinical anesthesiology research. no reasonable alternative therapy or methodology that
The investigators conducted their research pro- would eliminate or mitigate the risks associated with
ject when there was inadequate information at the participating in the research study. (See also Chapter
time the study was performed, regarding the safety 32.) While we must be vigilant against the increased
of the proposed procedure. The benefits arising from risk of harm associated with participating in research,
the study were questionable  – very effective labor it must also be recognized that such risks include
analgesia already existed at the time and, as such, the being exposed to untested or unevaluated medical
research outcome did not appear to warrant the risks. interventions.5
The quality of the informed consent obtained could While research ethics is a large area with many
also be called into question, since the investigators interesting and complex issues, this chapter has only
very probably did not disclose the results of some ani- been able to touch on some of the main ethical con-
mal model experiments, which affects the accuracy of cerns associated with clinical anesthesiology research.
communicating the full risks and benefits of participa- Researchers are encouraged to apply, and interpret,
tion. It is difficult to imagine that many patients would existing ethical guidance to research design and con-
have agreed to the experiment if they knew what hap- duct, as well as to do further research and reading on
pened to the rabbits. The fact that these issues were issues in which they want more in-depth information
not flagged by the research ethics committee leads one and analysis. In addition to the ethical issues discussed
to believe that either there was a failure to adequately here, it is very important that professional, institu-
screen the study or the investigators did not provide tional and legal requirements concerning research with

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 Chapter 27. Anesthesiology research: human subjects

human subjects within your jurisdiction are adhered Bioethics. Singer, P.A. and Viens, A.M., eds. Cambridge,
to, and respected. UK: Cambridge University Press, pp. 214–21.
3*  Lemmens, T. and Luther, L. (2008). Financial conflicts of
Key points interest in medical research. In The Cambridge Textbook
of Bioethics. Singer, P.A. and Viens, A.M., eds. Cambridge,
• Research studies involving human subjects UK: Cambridge University Press, pp. 222–30.
should be based on a thorough knowledge of 4*  World Medical Association. (2008) Declaration
the scientific literature, and should address of Helsinki: Ethical Principles for Medical Research
questions of sufficient importance to warrant Involving Human Subjects. Washington: World Medical
the risks. Association.
• All research should be reviewed by relevant 5*  Ashcroft, R.A. and Viens, A.M. Clinical Trials. In The
research committees for guidance and Cambridge Textbook of Bioethics. Singer, P.A. and Viens,
approval. A.M., eds. Cambridge, UK: Cambridge University Press,
• Informed consent should be obtained from pp. 201–6.
subjects, without undue inducements, duress
or coercion. Further reading
• Subjects should be given sufficient time to Beauhamp, T.L. and Childress, J.F. (2001). Principles of
reflect on the information they are given about Biomedical Ethics, 5th edn. New York, NY: Oxford
the research study. University Press
• Decisions not to participate or to withdraw CIOMS (2002). International Ethical Guidelines for
Biomedical Research Involving Human Subjects.
from a study should never affect the quality or
Geneva: Council for International Organisations of
level of a patient’s care.
Medical Sciences.
• Conflicts of interest on the part of the
Faden, R. and Beachamp, T.L. (1986). A History and Theory
researcher should be avoided or mitigated, of Informed Consent. New York, NY: Oxford University
and where they exist be disclosed to subjects. Press.
• Both positive and negative results of the Freedman, B. (1987). Scientific value and validity as ethical
research should be disseminated. requirements for research: a proposed explanation. IRB,
• Particular care should be given when research Rev Hum Subj Res 17, 7–10.
is directed at conditions for which adequate, if Maltby, J.R. and Eagle, C. J. (1993). Informed consent for
imperfect, treatments already exist. clinical anaesthesia research. Can J Anaesth, 40, 891–6.
Levine, R.J. (1988). Ethics and Regulation of Clinical
Research. New Haven, CT: Yale University Press.
References Slowther, A. and Kleinman, I. (2008). Confidentiality.
1*  Committee on Bioethics (1999). Guidelines on the Ethics In: Singer P.A. and Viens, A.M., eds. The Cambridge
of Clinical Research in Anesthesia. Toronto: Canadian Textbook of Bioethics. Cambridge, UK: Cambridge
Anesthesiologists’ Society. University Press. pp. 43–8.
2*  King, N.M.P. and Churchill, L. (2008). Clinical research Sykes, K. and Bunker, J., eds. (2007). Anaesthesia and
and the physician-patient relationship: the dual roles of the Practice of Medicine: Historical Perspectives.
physician and researcher. In The Cambridge Textbook of London: Royal Society of Medicine Press.

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Chapter

28
Animal subjects research Part I:
Do animals have rights?
Nancy  S. Jecker

The Case of Laika when it would not be acceptable to use human beings,
and what accounts for this difference?
In 1957, a stray dog from Moscow named Laika, described
In this chapter we consider what it means to say that
by her keepers as “quiet and charming,” became the first ani-
mal to orbit the planet, and the first death in orbit. Training a being deserves moral consideration. We ask what it
for her mission included subjection to confinement in means to say that a being has a right to life. We then
progressively smaller cages for up to 20 consecutive days, consider the claim that, even if a being lacks a right to
during which she was whining and restless and would stop life, it deserves to have its interests taken into account.
urinating or defecating for prolonged periods of time. She Finally, we consider the application of these ideas to
was placed in centrifuges simulating rocket acceleration research with animals.
and the noises of the spacecraft, causing extreme changes
in her blood pressure and pulse. On the day before her mis-
sion, Dr. Vladimir Yazdovsky took her home to play with Human beings, animals, and persons
his children. He later said, “I wanted to do something nice Throughout this discussion the term, “person,” refers
for her: she had so little time left to live.”1 to any living being of any species whose characteris-
In the capsule, she was confined by a harness that tics entitle it to a right to life. Thus the term “person,”
allowed her only to sit, stand and lie down in one place. as defined here, is a moral or ethical term, not a bio-
A launch pad malfunction kept her waiting for 3 days
logical one, and quite distinct from the term “human
in freezing temperatures inside a capsule the size of a
washing machine before she was launched into orbit.
being.”
Although it was reported at the time that Laika lived The term, “human being,” refers to anything that
for 7 days in space and was then was mercifully eutha- is biologically alive and belongs to the species, Homo
nized with a pre-programmed portion of poisoned food, sapiens. In this definition, the term “human being”
in 2002 it was revealed that she had, in fact, died only a obviously includes normal human children and adults,
few hours into orbit as a result of broiling heat due to a but also includes prenatal human life, human beings
thermo-regulator failure.2 In 1998, Oleg Gazenko, one of with physical or mental abnormalities, and humans
the scientists involved, expressed his regret: in a persistent vegetative state who will never regain
“Work with animals is a source of suffering to all of consciousness.
us  … The more time passes, the more I’m sorry about it. To assume that only instances of human life could
We shouldn’t have done it. We did not learn enough from
count as persons in a moral sense, and so possess a
this mission to justify the death of the dog.”3
right to life, would be a moral error analogous to claim-
The case of Laika, and other cases involving the use of ing that only members of favored racial groups possess
animals to serve human ends, raise moral questions certain rights or are persons. The latter mistake is called
such as the following. Is there something distinctive racism; the former might thus be called speciesism. To
about humanity? Do humans have a special moral sta- avoid this mistake, we cannot assume membership in
tus that nonhumans lack? Is there a quality that human a species represents a necessary or sufficient condition
beings alone possess that qualifies them for higher for personhood, but must instead identify a quality
moral standing? If not, should we broaden our concep- independent of species that establishes personhood.
tion of who is a member of our moral community? If In many cases most agree about who is and is not
it is sometimes acceptable to use animals in research, a person. For example, normal adult human beings

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
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 Chapter 28. Animal subjects research Part I

are considered to be the sort of beings of whom per- that humanity which it is his duty to show towards
sonhood can be predicated. Many will also agree that mankind.”4
certain living things are not persons. For instance, Kant understood our duties to human beings as dir-
there is not widespread belief that trees are persons. ect duties, but regarded our duties to animals as indir-
That is not to say that we ought not to take good care ect duties. Direct duties are duties we owe someone for
of trees. Saying that trees are not persons is merely their own sake. Indirect duties are duties we owe to
saying that trees do not have a right to life, nor are someone for the sake of someone else. For instance, if
trees entitled for their own sake to have their lives a child is cruel to animals by pinching a cat’s tail, Kant’s
preserved. worry was that the child may go on to develop a cor-
In-between the cases of trees and normal human responding sentiment of cruelty to humans, and may
beings, is a spectrum of less obvious cases. Do per- treat humans cruelly too. The reason that it is wrong for
manently unconscious human beings, human fetuses, a child to pinch the tail of an animal, according to Kant,
human beings who will live in the distant future, or is that doing so will ultimately harm human beings,
intelligent life that we might encounter on other plan- who matter morally for their own sake. Thus, the child
ets qualify as persons? What about members of other has a duty to the cat for the sake of her fellow human
terrestrial species? Are nonhumans animals, such as beings.
dogs, chimpanzees, or dolphins, persons? The philosophical basis for the above distinction
To focus on the specific question of whether per- is Kant’s idea that human beings, by virtue of their
sonhood applies to nonhuman animals (henceforth rational agency, are persons and possess intrinsic
referred to simply as “animals”) here on earth, let us moral worth. Kant’s position is not speciesist, because
consider three distinct views one might hold. First, the ultimate basis for the dignity of human beings is
what we shall call a conservative position claims that not species membership, per se, but rational nature. As
no animals are persons with a right to life. A second, Wood notes, “Kant thought it quite likely that there are
moderate position asserts that at least some animals rational beings on other planets; they would be ends in
deserve moral consideration for their own sake, but no themselves every bit as much as human beings …”5
animals have a right to life. A third view, which we shall It follows from Kant’s philosophy that we should
call a liberal view, holds that at least some animals are not cause suffering to animals, for example, by per-
persons with a right to life. forming painful experiments “for the sake of mere
speculation, when the end could also be achieved with-
out these.”6 However, Kant thought that we do have a
Are animals “persons”? right to kill animals, provided we do not cause pain
and suffering or kill merely for sport. Kant encouraged
The “conservative” view the humane treatment of animals who work for us, as
Perhaps the best known proponent of the conservative well as gratitude. In his lectures, he told a story about
position is Immanuel Kant. Kant believed that human the philosopher, Leibniz, who reportedly returns a
beings alone qualify as persons by virtue of their worm to its leaf when done examining it.7 For Kant,
rational capacities. He wrote: this exemplified the attitude humans should cultivate
… every rational being, exists as an end in himself and toward animals.
not merely as a means to be arbitrarily used by this or that Despite the fact that Kant’s philosophy encour-
will…Beings whose existence depends not on our will
ages the humane treatment of animals, critics charge
but on nature have, nevertheless, if they are not rational
that it gives insufficient regard to animals. Allen Wood
beings, only a relative value as means and are therefore
called things.4 maintains that, by virtue of the fact that animals are
not persons in Kant’s approach, we are permitted to
For Kant, humanity had an intrinsic and unconditional treat animals solely as instruments or objects of human
value. By contrast, animals had only a relative or instru- goals. To illustrate this, he asks us to imagine the fol-
mental value. Elaborating this position in “Duties to lowing possibility:
Animals and Spirits,” Kant stated: If it happened to be a quirk of human psychology that
… if a man shoots his dog because the animal is no ­torturing animals would make us that much kinder
longer capable of service, he does not fail in his duty to toward humans (perhaps by venting our aggressive
the dog,…but his act is inhuman and damages in ­himself impulses on helpless victims), then Kant’s argument

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would apparently make it a duty to inflict gratuitous cru- rationality that we find in humans.11 Moreover, some
elty on puppies and kittens so as to make us that much human beings lack rationality and the correspond-
kinder to people.8 ing ability to morally evaluate their reasons for act-
If Wood’s reasoning is correct, then even though Kant ing. Human infants are potentially, but not actually,
himself rejects cruelty to animals, his philosophy still rational; permanently unconscious human beings
allows this possibility. lack rationality altogether; and humans with cer-
In response, defenders of Kant’s approach can argue tain forms of dementia or mental retardation may
that it is inconsistent with Kantian ethics to treat ani- possess only fragments of rationality. In all of these
mals as mere things for our use or enjoyment. Kantian cases, human beings cannot be what Korsgaard calls
philosophy, as they interpret it, emphasizes our posi- “sources of normativity.” Many moderates and lib-
tive duties with regard to animals, even if we have no erals conclude that, if rationality in some form is a
duties toward them. O’Neill, for example, argues that necessary and sufficient condition for personhood,
the fact that Kant’s allowance for indirect duties to ani- then at least some humans are not persons, and at
mals is not trivial, because “Kant endorses more or less least some animals are persons.
the range of ethical concern for non-human animals If personhood and humanity are not coextensive,
that more traditional utilitarians allowed: welfare, but this creates an opportunity to explore the possibil-
not rights.”9 ity that animals possess a right to life – the position
Contemporary Kantian scholars further develop favored by liberals. One way this position is defended is
Kant’s conservative position in a variety of ways. to underscore the idea that there is no criterion that all
Christine Korsgaard proposes that what distinguishes humans possess and all animals lack that is a necessary
humans is their capacity for a special sort of rational- requirement for personhood. Tom Regan, for example,
ity. Humans alone use reason to reflect about morality, states the general argument in support of a conserva-
to be what Korsgaard calls “sources of normativity.”10 tive stance looks like this:
Humans alone face the problem of normativity:  the
problem of considering the morality of their reasons for
The conservative argument
acting and deciding what they ought to do. According
to Korsgaard, (1)  For X to be a person, X must have A.
We human animals turn our attention on to our percep- (2)  Humans have A.
tions and desires themselves, on to our own mental activ- (3)  Animals do not have A.
ities, and we are conscious of them. That is why we can (4) Therefore, humans are persons and animals are
think about them … And this sets us a problem that no not.12
other animal has. It is the problem of the normative…
The reflective mind cannot settle for perception and Regan rebuts the conservative argument by showing
desire, not just as such. It needs a reason.7 that there is no quality, A, that can be used in the prem-
ises of this argument to establish the argument’s conclu-
While some animals act on reasons, Korsgaard insists
sion. For example, suppose the conservative proposes
that only humans act on normative reasons. Korsgaard
that the quality most essential for personhood is sen-
believes a capacity to consider the moral basis for
tience. Regan’s reply would be that some humans, such
action is a necessary feature of moral personhood that
as those in a persistent vegetative state, lack sentience,
humans have and that animals lack. She concludes that
while many animals have it. Or, suppose a conserva-
animals on earth are not the kind of beings for whom
tive proposes instead that possessing a concept of self
personhood is possible.
is essential for personhood. Regan’s reply would be to
call attention to the fact that this quality is inadequate,
The “liberal” view since some human beings, such as infants and those
In contrast to conservatives, both moderates and with profound mental retardation, lack a concept of
liberals argue that animals deserve moral consider- self. Likewise, if the quality considered fundamental
ation in their own right. They claim that many mor- to personhood is possession of positive interests, such
ally important qualities, such as rationality, exist in as desires, goals, hopes, and preferences, Regan would
some intelligent animals. Singer and Cavaileri hold point out that there are humans who lack these qual-
that apes display many fragments of the forms of ities and animals who have them.

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Regan concludes that at least some animals satisfy different question, namely: is it wrong to cause animals
whatever criterion one might advance as a necessary to suffer? Peter Singer thinks that, regardless of where
condition for personhood, and at least some human one comes down on the question of whether animals
beings fail to satisfy it. In other words, there is no A have rights, they have interests,13 specifically, an interest
which is non-arbitrary and such that all humans pos- in avoiding suffering. According to Singer, it is wrong
sess A and no animals possess A. Therefore, it is incon- to eat meat given modern methods of meat production
sistent to believe that all and only humans possess or to use animals in scientific research for trivial pur-
a right to life. Regan says we must therefore choose poses, because of the interest animals have in avoid-
between two options: ing suffering. Thus, according to Singer, the moderate
(1) Deny a right to life to both animals and defective position is sufficient to establish that we must bring
humans, or animals into our sphere of moral concern. Even if it
(2) Grant a right to life to both animals and defective is sometimes acceptable to use animals or to end their
humans. lives painlessly, many of our current practices would
Regan himself endorses the latter option, granting have to change if the moderate position is correct.
a right to life to both animals and impaired human In support of this approach, Singer advances the
beings. However, it would seem that to ethically jus- following Principle of Equal Consideration:
tify current practices, such as using animals in biomed- The interests of every being must be given equal consid-
eration, in proportion to their degree of seriousness for
ical research or consuming meat, we would be forced
the being in question.
to choose the former option: deny both animals and
impaired human beings a right to life. Yet, if we choose This principle begins with the idea of having an inter-
this option, we are left with the question of how we est. According to Singer, the capacity for suffering or
can ethically justify a requirement to treat impaired enjoyment is sufficient to establish that a being has an
humans better than animals. The conclusion Regan interest. A cat or dog, for example, suffers terribly if
and other liberals draw is that, to avoid this conse- it is picked up by its tail and thrown across the room,
quence, we should predicate personhood of impaired and so it has a clear interest in avoiding this. Similarly,
human beings, and also acknowledge that at least some some experiments subject animals to pain, stress, anx-
animals are persons as well. iety, illness, and other forms of suffering. Without a
Both the conservative and liberal positions represent doubt, animals have an interest in avoiding suffering
a “deontological” approach to ethics. Deontological produced in this way.
approaches hold that there are certain overriding moral But there is a difference between equal consideration
principles or duties that apply irrespective of whether and equal treatment. In fact, equal consideration for the
fulfilling their requirements is burdensome or produces interests of humans and animals might require very
the best consequences overall. If the basis of our duties to different treatment. Consideration for the interests of a
humans or animals is rights, then we must discharge our pig might require no more than that we leave a pig with
duties regardless of whether doing so is convenient or other pigs in a place where there is adequate food and
promotes the general happiness. According to a rights- room to run freely, whereas concern for the interests of
based liberal view, any practice that fails to respect the a child growing up in America might require that we
rights of those animals who possess them is wrong. So teach the child to read.
if we eat, hunt, experiment on, or use animals for enter- In some cases, the greater mental power of normal
tainment, this is wrong if the animals in question have adults will mean that they will suffer more. They will
a right to life, even if it produces a tremendous amount anticipate suffering, remember it, and have a fuller idea
of benefit for others. Likewise, if all human beings are of their predicament. In other cases, the greater mental
persons with a right to life, as conservatives claim, then powers of normal adults will mean that they suffer less.
there is no condition where we would be justified in sac- As Singer notes, prisoners during wartime are able to
rificing a human life in order to bring about the greater understand that:
good for society at large. although they must submit to capture, search, and con-
finement, they will not otherwise be harmed and will
The “moderate” view be set free at the conclusion of hostilities. If we capture
Let us set aside the question of whether animals are wild animals, however, we cannot explain that we are not
­persons with a right to life, and turn to consider a threatening their lives.10

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Singer draws on these ideas to develop the fol- our actions produce as much pleasure and happiness
lowing argument against certain forms of animal and as little pain and misery as possible for all beings
experimentation. that have the capacity to experience happiness and
(1) The interests of every being must be given equal misery.
consideration, in proportion to their degree of The general structure of Singer’s argument can
seriousness for the being in question. be applied in many other areas. For example, Singer
(2) Animals have a very serious interest in avoiding advances a similar argument in support of taking ser-
suffering and in being able to live in a way that iously the suffering of animals used in modern meth-
allows their instinctive desires and drives to be ods of meat production. As in the argument about
satisfied. using animals in experiments, Singer is not putting
(3) Animal research causes serious suffering and does forth an absolutist conclusion. Rather than support-
not permit animals to satisfy instinctive desires ing strict vegetarianism, he allows for the possibility
and drives. that eating meat is sometimes morally acceptable. For
(4) A great deal of animal research satisfies no direct example, it is permissible to consume meat when a
or urgent purpose, or satisfies only relatively wild animal that is painlessly killed is eaten by people
minor human interests. who would otherwise suffer hunger.
Opponents of Singer’s moderate position argue
(5) Therefore, continuing with a great deal of animal
that the position entails consequences we are not will-
research involves weighting relatively minor
ing to accept. One such consequence is that, just as we
human interests above very serious interests of
are sometimes ethically allowed to eat animals, or to
the animals in question, and hence is morally
end the lives of animals painlessly in a medical experi-
unacceptable.
ment, so too we would sometimes be ethically allowed
(6) In many cases, it is not possible to conduct these
to eat humans for meat or to end their lives painlessly
experiments without using the sorts of methods
in a medical experiment. This objection to Singer
which are objectionable.
holds that by failing to recognize the inviolability of
(7) Therefore, in many cases, we should end current the moral claims of all morally considerable beings,
animal research. “utilitarianism cannot accommodate one of our most
Note that Singer’s argument does not conclude with basic prima facie principles, namely that killing a mor-
an absolute probation against inflicting pain and suf- ally considerable being is wrong.”14
fering on animals. Nor does it ban experiments that In contrast to a conservative or liberal position,
result in the painless death of animals. Singer is not a moderate position is vulnerable to such an objec-
saying that all experimenting on animals ought to tion precisely because it does not ascribe a right to
stop immediately. Instead, the argument establishes life to humans or animals. Thus, for a moderate, such
that the suffering of animals must be taken seriously as Singer, our duties to other beings, whether human
and justified by the positive benefits it helps to bring beings or animals, depend on what competing inter-
about. It is consistent with this argument to allow ests happen to be at stake in any given situation.
experimenting on animals in situations where the In contrast to the deontological approaches of
trade-offs justify the pain and suffering inflicted. As Kant and Regan, Singer’s approach is an example of
Singer notes, “We have still not answered the ques- a consequentialist view. Consequentialist arguments
tion of when an experiment might be justifiable. It hold that the moral worth of our actions is measured
will not do to say ‘Never!’ Putting morality in such solely by the consequences they produce, not by their
black and white terms is appealing, because it elimi- conformity to an overarching principle or duty. For
nates the need to think about particular cases; but this reason, Singer can say, for example, that:
in extreme circumstances, such absolutist answers
always break down.” Singer proposes that a good test Torturing a human being is almost always wrong, but
of whether an experiment is ethically justified is to it is not absolutely wrong. If torture were the only way
consider whether or not we would consider conduct- in which we could discover the location of a nuclear
ing it on humans who are impaired and have a men- bomb hidden in a New York City basement and timed
tal life similar to the animal we are proposing to use. to go off within the hour, then torture would be
justifiable.13
For Singer, the ethically crucial requirement is that

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Likewise, experimenting on brain-damaged human 2  Whitehouse, D. First Dog in Space Died Within Hours.
beings will almost never be justified, but under rare BBC News, World Edition. Monday 28 October 2002,
circumstances could be. 10:34 GMT. http://news.bbc.co.uk/.
3  Oleg Gazenko, speaking at a Moscow news conference
in 1998.
Key points
4  Kant, I. (1998). The Groundwork for the Metaphysics
• There are three distinct answers one might of Morals, Mary J. Gregor (trans.), Cambridge,
give to the question, is there anything morally UK: Cambridge University Press, p. 428
distinctive about humanity? 5  Wood, A. (1998). Kant on duties regarding nonrational
• The “conservative” answer: humans alone nature I. Proceedings of the Aristotelian Society Suppl.
have moral standing and a right to life. 72, 189–210 at 189.
• The “liberal” approach: some animals possess 6  Kant, I. (1996). Metaphysics of Morals, Gregor, M., ed.,
qualities that conservatives equate with moral transl. Cambridge, UK: Cambridge University Press,
p. 193.
standing and “personhood,” and some human
beings lack those qualities. 7*  Kant, I. (1997). Lectures on Ethics, transl. by
P. Health; Health, P. and Schneewind, J., eds. New
• The “moderate” view: what is morally York: Cambridge University Press, pp. 212–13.
important about humans and animals is their
8  Wood, A. (1998). Kant on duties regarding nonrational
capacity to suffer; both humans and animals nature I. Proceedings of the Aristotelian Society Suppl,
have an interest in avoiding suffering. 72 (sup plement), 189–210 at 194–5.
• For moderates, the moral acceptability of 9  O’Neill and Kant O. on duties regarding nonrational
animal research depends on the balance nature II. Proceedings of the Aristotelian Society Suppl,
of the suffering produced weighed against 72, 211–228, at 223.
the importance of the interests the research 10* Korsgaard, C. (2005). Fellow creatures: Kantian ethics
serves: when animal research serves relatively and our duties to animals. The Tanner Lectures on
minor, indirect, or nonurgent interests, Human Values, 25, 77–110.
but causes serious suffering, it is morally 11  Singer, P. and Cavalieri, P. (1993). The Great Ape Project.
unacceptable. Fourth Estate, London, discussed in O’Neill O. Kant on
• Both liberals and conservatives hold that there Duties Regarding Nonrational Nature II. Proceedings of
are absolute prohibitions against harming the Aristotelian Society, 72 (suppl), 211–228 at 224.
“persons” or treating them as a means only; 12* Regan, T. (1976). Do animals have a right to life? In
these apply regardless of whether abiding Animal Rights and Human Obligations. Regan, T. and
by such prohibitions produces the best Singer, P., eds. New Jersey: Englewood Cliffs,
consequences overall. pp. 197–204.
• For both liberals and conservatives the moral 13* Singer, P. (2009). Animal Liberation, updated edition.
New York: Harper Collins.
acceptability of research with animals or
human beings depends on whether or not the 14  The moral status of animals. Stanford Encyclopedia of
Philosophy. Accessed http://plato.stanford.edu/entries/
subjects of research are persons with a right
moral-animal/ (Accessed March 8, 2009).
to life.

References Further reading

1  Isachenkov, V. Space Dog Monument Opens in Russia. Kant, I. (1963) Duties to animals and spirits. In Kant I,
AP Moscow. Friday April 11, 2008 http://www.msnbc. Lectures on Ehics, transl. by L. Infield. New York: Hackett
msn.com/id/24069819/. Publishing Company, p. 240.

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 Section 4
1 Research and publication
Chapter

29
Animal subjects research Part II: Ethics
of animal experimentation
Gail A. Van Norman

The Case frameworks regarding the use of animals by humans

are evolving; nevertheless, there is moral, scientific, and
Fifty hemophilic mice are anesthetized with an intraperito-
public consensus about animals in research. It is likely
neal injection of ketamine (which kills six mice), followed
by blunt force trauma to a knee joint in half of the survi-
that this consensus will evolve as our understanding of
section
vors. Post-trauma analgesics are1administered only on day ­nonhuman animals deepens – their experiences, intel-
0 and 1 following knee trauma. Two days later, and every ligence, and capacities for suffering, pain, and enjoy-
2–4 days thereafter, all mice are placed on a rotating rod ment. But it is imperative that every physician and
and forced to ambulate until they fall off. Blunt trauma researcher who uses animals in teaching, testing, and/
is administered in the test group weekly, and the process or experimentation understands that they have explicit
repeated. After 4 weeks, all mice are killed to examine their ethical obligations to their animal subjects.
joints. The authors conclude that joint trauma and hemar-
throsis leads to problems with ambulation and hemophilic
synovitis –“consistent with clinical experience.”1 Moral justifications of animal research
The editors of the journal in which this experiment At its heart, the debate over the use of animals in
appeared commented that the manuscript “proved chal- research is centered on a single moral question:  are
lenging on review,” citing obligations of journal editors to humans morally justified in using animals in this way?
assure that investigators minimize animal pain and suf- Ethical arguments favoring animal experimentation
fering. One reviewer points out that progressive joint func- generally fall into two categories:  (1) humans have
tional limitation is well known in human patients with
higher moral standing than animals and have a right
hemophilia, particularly following trauma associated with
hemarthrosis. He also raises concerns about animal suffer-
to use animals in experiments that better human lives,
ing, pointing out that, although they were given analgesia and (2) the benefits of animal experimentation out-
for a brief period following acute trauma, the mice were weigh the harms, and that animal experimentation is
forced thereafter to ambulate on traumatized joints with- sometimes the only way in which science can answer
out analgesia.2 Mice in the test group lost weight, limped, important questions necessary to human well-being.
and fell off the rotating rod more quickly, all of which might
be signs of pain and suffering that went untreated. The moral standing of humans versus animals
Nonhuman animals are used as subjects in research Western culture is heavily imbued with Judeo-
experiments, as test subjects for industries, and as Christian traditions, in which animal interests are
objects for dissection and instruction in science class- subordinate to those of humans. Earth and its contents
rooms – a subject of intense moral dispute. Most were bequeathed by a Creator to humankind to benefit
reviews addressing the ethics of animal research humans. This view is still prominent among conserva-
describe this debate as a war of wills between scientists tive Judeo-Christian leaders:
and animal rights activists. Extremism on both fronts “The animal rights movement can best be understood by
viewing it as an attempt to undo the opening chapters of
garners media attention. Leading scientists, and even
the biblical Book of Genesis.” 3
some ethicists to insist that there is “no consensus”
about the appropriate use of, and treatment of ani- In the last 50 years, detrimental effects of human pop­
mals in testing, education, and research. But this is a ulations on the environment have begun to threaten
distorted and misleading perspective. Specific moral global repercussions. The views of conservative

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
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 Chapter 29. Animal subjects research Part II

Judeo-Christian philosophers toward man’s relation-

­
“episodic recall,” believed to be an important marker
ship with the planet and nonhuman animals have begun of sentience.9 Whales and dolphins understand sym-
to shift in response, but still describe the ethical obliga- bolic representations and have self-awareness,10 which
tions of humans in the utilitarian framework of serv- has also been demonstrated in primates, elephants,11
ing the ultimate interests of mankind – i.e., we should and magpies.12
take care of the environment and animals because, if Why have animal researchers been slow to acknow-
we don’t, it will lead to depletion of resources and jeop- ledge these critical similarities with humans? Zoologist
ardize the future of human existence. Frans de Waal proposes that “Our culture and domin-
Many twentieth-century religious scholars were ant religion have tied human dignity and self-worth to
challenged to reconcile new scientific theories and our separation from nature and distinctness from other
evidence (e.g., the theory of evolution and the fossil animals.” This cultural bias, he argues, keeps scientists
record supporting it) with mainstream theology. Pierre from recognizing how similar humans and other ani-
Teilhard de Chardin, a Jesuit priest and paleontolo- mals really are, and thereby weakening arguments of
gist, argued that, in parallel with biological evolution, human moral superiority.13
humans are a part of a continuum in a “spiritual evolu- Bioethicist Bernard Rollin suggests that scientists
tion” that also includes plants and animals.*4 Breaking now have an “ideology” of their own, in which they
down bright theological lines between animals and assert that science is “objective” and not burdened by
humans begs the question of whether our relationship moral values. “The bottom line,” he says, is the belief
with animals should really be viewed only through a that “science might provide society with the facts rel-
utilitarian glass. Are we allowed to treat animals in evant to making moral decisions, but it steers clear of
ways that only promote human interests? Or do they any ethical debate.”14 But if it were true that there is
have legitimate “interests” of their own? (For more dis- no moral dimension to scientific endeavor, then there
cussion of ethical arguments regarding animal inter- would be no need to argue that animal experimenta-
ests and rights, see Chapter 28.) tion is permissible, nor that cruel experimentation on
human subjects must be disallowed because it violates
Are humans and nonhuman animals fundamentally moral principles. Almost any experiment that simply
different? produced new information would be allowed under
Up until the mid-to-late twentieth century, Western such an ideology, without regard for treatment of any
biologists operated under a “Cartesian” paradigm of its subjects, human or animal. The idea that medical
that attributed minimal, if any, intelligence to nonhu- research is immune from moral consideration has long
man species. Reasoning, emotions, and suffering were been discredited, as exemplified in the Doctor’s Trial at
believed to be uniquely human attributes  – animals Nuremberg after World War II.
were merely pre-programmed, instinct-driven robots Most bioethicists concede that many animals have
that did not have moral standing. at least some moral standing, although which animals
“They eat without pleasure, cry without pain, grow with- and how much moral standing are unclear. Deliberately
out knowing it; they desire nothing, fear nothing, know causing an animal to suffer due to pain, fear, starva-
nothing.”5 tion, illness, or poor conditions of care constitutes a
moral harm to be prevented or mitigated, and con-
Current research demonstrates unequivocally that,
sidered carefully against the benefits such conditions
far from being simple bundles of instinctual program-
might produce. Apart from any consideration of ani-
ming, the intellectual abilities of animals parallel that
mal “rights,” many ethicists propose that cruelty to ani-
of humans in many startling ways. The manufacture
mals should still be discouraged, because it is likely that
and use of tools, long held to be a uniquely human abil-
those who are cruel to animals will be cruel to humans
ity, is now well described in nonprimate and even non-
as well.
mammalian species.6 Animals demonstrate “culture,”
in which uniquely individual and adaptive behaviors
are passed within social groups by observation and Assessing the benefits of animal research
mimicry, and not by instinct or genetic program- There is no doubt that animal experimentation has
ming.7 The great apes appear to be capable of learning contributed to advances in anesthesia, cardiovascular
and using symbolic language, an important marker and orthopedic surgery, treatment of such diseases
of abstract thinking.8 Meadow voles demonstrate as diabetes and hemophilia, vaccines, antimicrobial
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 Section 4. Research and publication

agents, cancer therapy, treatment protocols for trauma Burns, “As physicians, researchers, and educators, we
and shock, and many other areas. Yet is it simply not must take a long-overdue objective look at how and
sensible to assert that medical science would have why we use animals in research and education. A great
come to a complete halt without animal experimenta- deal of animal-based research adds very little to our
tion. As Harold Hewitt, himself an animal researcher, understanding of the diagnosis and treatment of our
points out: patients.”21
‘It underrates the ingenuity of researchers to assert that How many animals are used in research and test-
medical progress would have been seriously impeded ing laboratories? According to the United States
had animal experiments been illegal, although a different Department of Agriculture (USDA), the use of “report-
strategy would have been required. It is the skill of the able” animals in research has declined steadily, from
scientist to find a way around the intellectual, technical over 2 million animals in 1992, to just over 1 million
and ethical limits to investigation. No one complains,
in 2007.22 Because a 2002 amendment to the Animal
surely that we have been denied the benefit of potential
Welfare Act (AWA) exempted laboratories from
advances by prohibiting experiments on unsuspecting
patients, criminals or idiots.15 reporting research on birds, rats, and mice, USDA sta-
tistics only reflect the use of cats, dogs, hamsters, rab-
The contributions of animal experimentation to human
bits, guinea pigs, primates, and farm animals. Rats and
medicine may also be greatly over-estimated. Critical
mice are estimated to comprise approximately 95%
analysis of the quality of animal experimentation leads
of laboratory animals in research, and it is estimated
to disturbing conclusions. A systematic review of ani-
that over 20 million animals are actually experimented
mal experiments in fluid resuscitation, for example,
on every year in the US.23 In 2007, about half of the
found that many studies were fraught with poor
reported experiments produced pain in the subjects,
design, were statistically underpowered, showed evi-
and almost 80 000 animals were subjected to pain
dence of publication bias, and were seldom subjected
without analgesia. An accurate number regarding how
to cross-species analysis or meta-analysis to determine
many “exempted” animals are subjected to untreated
if the results were even applicable to humans.16 Animal
pain during research protocols is unavailable, but pre-
trials have been frequently conducted simultaneously
sumed to be in the millions.
with human trials, and were thus superfluous. They
According to the Home Office of Great Britain,
often set out to answer questions that had already been
approximately 3.7 million procedures were done on
answered or could have been answered by a system-
animals  – including all vertebrates and one species
atic review of existing studies.17 Historically, animal
of octopus – in research in the UK in 2008 that was
experimentation has, at times, been frankly mislead-
deemed “likely to cause pain, suffering, distress, or last-
ing. It probably actually impeded such endeavors as
ing harm.” In only about 35% of procedures was some
developing the polio vaccine; understanding the role of
form of anesthesia or analgesia used.24
asbestos exposure and lung disease; understanding the
connections between tobacco smoke and lung cancer;
and in developing other cancer treatments.18 Public perceptions and public consensus
An analysis of 76 animal studies cited in seven Scientists rightfully point out that research based
prominent scientific journals found that almost half solely on tissue cultures and cell lines may not accur-
were never subsequently tested in human trials. Of ately mimic conditions found in a human being. Many
those that had been tested in humans, 18% were con- tests felt to be essential to human health, such as testing
tradicted in the humans. Only 37% were eventually drugs and chemicals for teratogenic potential, do not
confirmed in human studies. Almost two-thirds of ani- currently have reasonable alternatives to animal test-
mal studies were not confirmed by testing in humans, ing and pose too high a risk for human testing. Would
and did not result in any human benefit.19 Another we be willing to give up important health protections
review of 221 experiments involving over 7000 ani- for human beings in order to eliminate animal research
mals found that results were in agreement with human entirely?
studies in only 50% of cases. The authors found that A 2008 US poll found that public concern about
basic methodological errors, such as lack of random- treatment of animals is significant; all but 3% believe
ization and blinding, poor sample size, and publica- that animals require protection, and a startling 25%
tion bias probably contributed to poor concordance believed that animals should have the exact same rights
with human studies.20 In the words of physician R. as humans to be free from harm and exploitation. A
176
 Chapter 29. Animal subjects research Part II

significant portion of respondents (35%) would ban all euthanasia. In Great Britain, the Animals (Scientific
medical research on animals, and 39% would ban all Procedures) Act of 1986 (ASPA) regulates experimen-
product testing on animals.25 In a 2007 poll, 37% rated tation that might cause “pain, distress, suffering or last-
medical testing on animals as “morally wrong.”26 A ing harm” to any vertebrate animal (and one species of
1994 comparison of public opinion regarding animal octopus).30 In 1999, the UK introduced ethical review
research across 15 nations indicates that opposition to of scientific research involving living animals through
any research that causes pain or injury to animal sub- local ethical review committees. In the European
jects is common globally – ranging from about 35% in Union (EU), agreement on the protection of animals in
Portugal to almost 70% in France.27 research was codified in the 1986 European convention
for the Protection of Animals used for Experimental
and Other Scientific Purposes.*31 Laws and regulations
The three Rs of the US, UK, EU, and others have recognized the
In 1954 William Russell, a zoologist and classical “3Rs” as foundational to ethical animal experimenta-
scholar, and Rex Burch, a microbiologist, were tion, and explicitly call for the replacement of animals
appointed by the Universities Federation for Animal in scientific research whenever possible.
Welfare in the UK to systematically study the eth- ‘A research institution that receives money and support
ical aspects of laboratory research. The result was from the public is responsible for conducting research
the seminal publication of The Principles of Humane according to the limits set by society…the use of animals
Experimental Technique in 1959.28 They stated that in research is a privilege, and not a right. The consensus
“the humanest possible treatment of experimen- at this time in the United States is that animals should be
tal animals, far from being an obstacle, is actually a treated humanely and that pain and distress should be
prerequisite for successful animal experimentation.” minimized when animals are used for research or teach-
In fact, as J. Edward Gates from the University of ing purposes.’29
Maryland observes, “Pain and stress adds an uncon- A number of national and international scientific
trollable variable into an experiment, and so it is in the organizations provide information for researchers
interest of good science to control pain and distress seeking alternatives to animal experimentation and
whenever possible.”29 testing, as well as the use of live animals in education.
Russell and Burch introduced the “3 Rs” of humane Several resources may be found in “Further reading” at
experimentation. These principles were:  (1) replace- the end of this chapter.
ment of animal subjects whenever possible with other IACUCs in the US, and ethical review committees in
methodologies, human volunteers, or computer mod- the UK can play a significant role in enforcing the 3Rs,
eling; (2) reduction of animal use by using fewer ani- by refusing to approve studies that are poorly designed;
mals or obtaining more information from the same are not anticipated to significantly alter existing know-
number of animals; and (3) refinement by improving ledge; could have been conducted in humans or alter-
scientific procedures and husbandry to minimize native models; do not use the bare minimum number
actual or potential pain, suffering, distress, or lasting of animals; and do not provide adequate management
harm, and increase animal welfare when animal use is of pain and distress. However, there is considerable
unavoidable. These principles now form the bedrock of resistance among IACUC’s to becoming reviewers of
ethical animal use in laboratory research. “scientific merit” rather than simply overseeing animal
care.32 In addition, it is clear that many IACUC mem-
Current issues bers do not have adequate education in ethical issues
Most Western nations now have laws regulating the in animal research and ethical decision-making to per-
treatment of animals in research and industry testing. form well as ethics reviewers.33
In the US, federal legislation includes the AWA, initially Because publication is an important determinant
passed in 1966. The Health Extension Act in 1985 and of research funding, professional promotion, and
amendments to the AWA required the establishment academic prestige, peer-review journal editors and
of Institutional Animal Care and Use Committees reviewers have significant power to impact researcher
(IACUCs), to oversee conditions of laboratory animals, behavior. Yet evidence points to a systematic lack of
review and approve animal research protocols, and edu- competent peer-review in animal studies. In an analy-
cate and train investigators in ethical issues and aspects sis of 271 published animal research studies,34 only
of animal handling such as anesthesia, analgesia, and 59% stated the hypothesis they were testing, over 85%
177
 Section 4. Research and publication

did not use randomization or blinding to reduce bias, pledges not to publish studies that do not meet
and 30% did not identify the statistical methods used editorial or humane guidelines.
in analysis. In many, basic information was omitted,
such as the total number of animals, and the strain, sex,
age, and weights of the animals used – all factors that References
clearly can affect experimental results. 1  Mejia-Carvajal, C., Hakobyan, N., Enockson, C., and
A study of journal editorial policies among 236 ran- Valentino, L.A. (2008). The impact of joint bleeding
domly selected English language peer-review journals and synovitis on physical ability and joint function in a
murine model of haemophilic synovitis. Haemophilia,
that publish animal research found that 53% did not
15, 119–26.
have a relevant editorial policy. Of 111 journals that did
2  Berntorp, E. (2008). Protecting the joints of mice and
have policies, only one explicitly mentioned adherence
men. Haemophilia, 14, 117–18.
to the 3Rs, and only one had a statement that adherence
3  Environmental stewardship in the Judeo-Christian
to their policy was a prerequisite for publication.35
tradition: Jewish, Catholic, and Protestant Wisdom
Subjecting animal studies to the same strict level of
on the Environment. Barkey MB, edit. (2009). The
review afforded human subjects studies, and requir- Interfaith Council on Environmental Stewardship.
ing adherence to ethical guidelines as a prerequisite Action Institute, Grand Rapids MI. http://www.acton.
for publication may be important ways to encourage org/ppolicy/environment/ppolicy_environment_
more rigorous research design, and conformation to theology_monograph.php.
the principles of replace, reduce, and refine. 4*  Teilhard De Chardin, P. (1959). The Human
Phenomenon. New York, NY: Harper and Row
Key points 5  Philosopher Nichoas Malebranche, 1638–1715.
• Mainstream scientific study has now 6  Taylor, A.H., Hunt, G. R., Holtzhalder, C., and Gray,
challenged long-held beliefs that animals are R.D. (2007). Spontaneous metatool use by New
Caledonian crows. Curr Biol 17(17), 1504–7.
fundamentally different than humans in many
morally relevant ways. 7  Byrne, R.W., Barnard, P.J., Davidson, I., et al. (2004).
Understanding culture across species. Trends in
• Public opinion, scientific communities, and Cognitive Sciences, 8(8), 341–6; Madden, J.R. (2008). Do
biomedical ethicists agree that researchers bowerbirds exhibit culture? Anim Cogn, 11(1), 1–12.
have moral obligations to reduce or eliminate 8  Tanner, J.E., Patterson, F.G., and Byrne, R.W. (2006).
animal suffering in research, and to strive to The development of spontaneous gestures in zoo-living
eliminate animal experimentation altogether. gorillas and sign-taught gorillas: from action and location
• The 3Rs of animal research ethics: replace, to object representation. J Devel Process, 1, 69–102.
reduce, and refine have been adopted 9  Ferkin, M.H., Combs, A., delBarco-Trillo, J., et al.
internationally in legislation and regulations (2007). Meadow voles, microtus pennsylvaicus, have the
regarding animal research. capacity to recall the “what”, “where”, and “when” of a
• Animal researchers have ethical obligations to past single event. Anim Cogn, 11(1), 147–59.
seek alternative models whenever possible, to 10  Marino, L., Connor, R.C., Fordyce, E., et al. (2007).
design research protocols that use the fewest Cetaceans have complex brains for complex cognition.
numbers of animals for meaningful results, PLoS Biol, 5(5), e139.
and to offer humane care that reduces pain, 11  Plotnik, J.M., de Waal, F.B., and Reiss, D. (2006). Self-
distress and harm when using animals in recognition in an Asian elephant. Proc Natl Acad Sci
USA, 103(45), 17053–7.
research.
12  Prior, H., Schwarz, A., and Gunturkun, O. (2008).
• IACUCs have regulatory obligations to review
Mirror-induced behavior in the magpie (Pica
research protocols to assure that redundant,
pica): evidence of self-recognition. PLoS Biol, 6(8), e202.
insignificant, or poorly designed research is
13* De Waal, F. (2001). The Ape and the Sushi Master;
not allowed.
Reflections of a Primatologist. New York, NY: Basic Books.
• Biomedical journals should have established
14  Rollin, B.E. (2007). Animal research: a moral science.
policies regarding publication of animal EMBO Rep, 8(6), 521–5.
research, including emphasis on the 3Rs, and
15  Hewitt, H. (1990). Benefits of animal research and the
doctor’s responsibility. BMJ, 300, 811.

178
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16  Roberts, I., Kwan, I., Evans, P., et al. (2002). Does 31* European Convention for the Protection of Vertebrate
animal experimentation inform human healthcare? Animals used for Experimental and Other Scientific
Observations from a systematic review of international Purposes. Strasbourg, 18.III.1986 (amended Dec 2,
animal experiematns on fluid resuscitation. BMJ, 324, 2005 to reflect formation of the European Union).
474. http://conventions.coe.int/treaty/en/treaties/html/
17* Pound, P., Ebrahim, S., Sandercock, P., et al. (2004). 123.htm
Where is the evidence that animal research benefits 32  Rowan, A.N. (1990). Animals, science, and ethics –
humans? BMJ, 328, 514–17. section IV. Ethical review and the animal care and use
18  Dennis, C. (2006). Cancer: Off by a whisker. Nature, committee. Hastings Cent Rep, 20(3), s19–24.
442, 739–41. 33  Houde, L., Dumas, C. and Leroux, T. (2009).
19  Hackam, D.G. and Redelmeier, D.A. (2006). Ethics: views from IACUC members. Altern Lab Anim,
Translation of research evidence from animals to 37(3), 291–6.
humans. JAMA, 296, 1731–2. 34* Kilkenny, C., Parsons, N., Kadyszewski, E., et al. (2009).
20  Perel, P., Roberts, I., Sena, E., et al. (2007). Comparison Survey of the quality of experimental design, statistical
of treatment effects between animal experiments and analysis and reporting of research using animals. PLoS
clinical trials: systematic review. BMJ, 334, 197–203. One, 4(11), e7824.
21  Burns, R. (1989). Animals in research. Acad Med, 62, 780. 35* Osborne, N.J., Payne, D., and Newman, M.L. (2009).
22  Animal care annual report of activities, fiscal year Journal editoral policies, animal welfare, and the 3Rs.
2007. United States Department of Agriculture, August Am J Bioeth, 9(12), 55–9.
2008. http://www.aphis.usda.gov/publications/animal_
welfare/content/printable_version/2007_AC_Report. Further reading
pdf
Cavalieri, P. (2009). The ruses of reason strategies of
23  Trull, F.L. and Rich, B.A. (1999). More regulation of exclusion. Logos, 8(1).
rodents. Science, 284, 1463.
Fund for the Replacement of Animals in Medical
24  Statistics of scientific procedures on living Experiments (FRAME). http://www.frame.org.uk/page.
animals: Great Britain 2008. Home Office. Ordered php?pg_id=152.
by the House of Commons to be printed. London.
Gaul, G.M. (2008). In US, few alternatives to testing on
July, 2009. http://www.homeoffice.gov.uk/rds/pdfs09/
animals. The Washington Post. April 12.
spanimals08.pdf.
Harrison, P. (1992). Descartes on animals. Philos Quart,
25  Post Derby tragedy, 38% support banning animal
42(167), 219–27.
racing. The Gallup Organization. May 15, 2008. http://
www.gallup.com/poll/107293/PostDerby-Tragedy-38- Hastings Center Report Special Supplement. (1990).
Support-Banning-Animal-Racing.aspx. Animals, Science and Ethics. Donnelley, S., and Nolan, K.
eds. 20(3), s1–32.
26  Americans rate the morality of 16 social issues. The
Gallup Organization. June 4, 2007. http://www.gallup. Hobson-West, P. (2010). The role of ‘public opinion’ in the
com/poll/27757/Americans-Rate-Morality-Social- UK animal research debate. J Med Ethics, 36, 46–9.
Issues.aspx. The Humane Society of the United States. Biomedical
27* Pifer, L., Shimizu, K., and Pifer, R. (1994). Public Research. http://www.humanesociety.org/issues/
attitudes toward animal research: some international biomedical_research/Accessed March 1, 2010.
comparisons. Soc Animals, 2(2), 95–113. The Johns Hopkins Center for Alternatives to Animal
28* Russell, W. and Burch, R. (1959). The Principles of Testing. http://caat.jhsph.edu/contact/index.htm.
Humane Experimental Technique. London: Methuen Kilkenny, C., Parsons, N., Kadyszewski, E., et al. (2009).
and Co. Ltd. Survey of the quality of experimental design, statistical
29  Gates, J.E. Committee Chair, Appalachian Laboratory, analysis and reporting of research using animals. PLoS
University of Maryland Center for Environmental One, 4(11), e7824.
Science (Lecture: Insitutional Animal Care and Use Langley, G. (2009). The validity of animal experiments in
Committee, General Information). medical research. Revue Semestrielle de Droit Animalier,
30  Animal (Scientific Proceures) Act 1986. Great Britain. 1, 161–8.
http://www.archive.official-documents.co.uk/ NC3Rs. National Center for Replacement, Refinement, and
document/hoc/321/321.htm Reduction. http://www.nc3rs.org.uk/.

179
 Section 4
1 Research and publication section 1
Chapter

30
Ethical function of human subjects
review boards: a US perspective
Jeffrey H. Silverstein

The Case of the lapse in initial reporting by the investigator? Should

the participants be notified of a failure to inform them of
An investigator submits a project that proposes to use this risk of malignancy?
an antibiotic for treatment of an unusual infection that
afflicts as small number of patients following colonic In a previous chapter, Dr. Viens describes the ethical
interposition following esophagectomy. Although the basis for the conduct of research on human subjects.
number of cases of this type of postoperative esophagitis All researcher who have participated in these activities
are small, the suffering of the patients with this compli- rapidly learn that adherence to the ethical principles
cation is severe. The proposed antibiotic is approved for outlined are not left up to the individual investigator,
clinical treatment of anaerobic infections but is a second but require a formal review process by independent
line drug and is not frequently used for this purpose in individuals. This review process is the basis of exten-
clinical practice. A related drug is one of the most com-
sive regulatory statues.
monly used therapies for treatment and prophylaxis of
anaerobic infections, being administered to thousands of
patients every day in the US. What is the purpose of an IRB and how did
The application is extensive and includes a number of
case reports of successful treatment of post esophagectomy they evolve?
colonic interposition inflammation and a small animal The history of protecting human subjects in research
study that also suggests the treatment will be effective. The goes back into antiquity. While it might be thought that
side effect profile of the medication is similar to many anti- societies would proactively define norms and mores
biotics – including gastric distress, possible allergy and the regarding how one can experiment on fellow humans,
risk of subsequent resistant infection. in practice, our regulatory structure has evolved almost
The project accrues a small number of patients and
exclusively in the wake of scandal and disaster. Indeed,
is reviewed annually for two subsequent years. Few
the history of human subjects protections and the ini-
adverse or unanticipated events are reported. During the
third annual evaluation, one of the IRB reviewers notes tial creation of formalized institutional review boards
that there is a specific warning from the Food and Drug followed a specific series of incidents that were both
Administration (FDA) indicating that a similar drug (not unacceptable and well publicized.
the one in use, but the more common one that is adminis- Most treatises on human subjects protection begin
tered regularly) has been shown to cause cancer in a small their discussion with the effort at codifying research
number of mice when administered for prolonged periods ethics undertaken by the Judges for the Nazi Doctors
of time. The drug proposed for this project has never been Trial following World War II. In this case, experiments
reported to cause cancer in either animals or humans and were conducted, some with little legitimate scientific
the related drug has never been reported to cause cancer in intent, which caused extreme suffering and frequent
humans. In reviewing the literature and documentation, it
deaths. Many were specifically designed to understand
is clear that this warning was known when the project was
the limitations of human tolerance to hypothermia,
initially reviewed, but was not included in the presentation
from the investigator, nor was it noted by the IRB reviewers low oxygen tension high altitude situations and immer-
during the initial review or the first two annual reviews of sion in salt water, all problems suffered by combatants
the project. on both sides of the conflict. These experiments were
Was it ethical to approve the study initially? Did the intended to assist scientists in developing means to
IRB do its job in reviewing this project? What is the nature support soldiers and sailors engaged in the war effort.

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
180
 Chapter 30. Human subjects review boards (US)

Some were published in reputable scientific journals. Table 30.1. The Nuremberg Code
Nonetheless, these experiments were widely consid-
Nuremberg Code
ered unethical and the war crimes tribunal following
the war prosecuted the doctors involved in these exper- •  Voluntary informed consent
iments. The judges assigned to the trial found that there •  Anticipate scientific benefit
were essentially no coherent codes of conduct regard- •  Benefit outweighs risk
ing human experimentation for reference. Therefore, •  Animal experimentation first
in 1947, they elaborated what has become known as the
•  Avoid suffering
Nuremberg Code (Table 30.1) as a guide document for
understanding what should have happened in the wake •  No intentional death or disability
of tragedy. •  Protection from harm
On the basis of this construct, many of the doc- •  Subject free to stop
tors and participants in those experiments were con- •  Qualified investigators
victed. Many of the concepts were elaborated upon in
•  Investigator will stop if harm occurs
a subsequent document created by the World Health
Organization, which is called the Declaration of Helsinki.
The Declaration is an ethics document, as opposed to a erupted led to the formation of the National Bioethics
regulatory or legal document. Its continued evolution Commission and the elaboration of what became
has created controversy in the last few years.1 known as the Belmont Report.
A key moment in the evolution of American The Belmont Report elaborated three basic princi-
research oversight was the seminal publication in 1966 ples: autonomy, beneficence, and justice, which remain
of an article in the New England Journal of Medicine the ethical underpinnings of American human research
entitled “Chronicle of 22 unethical studies.”2 The protections.3 This was soon followed by federal regula-
author Henry Knowles Beecher was one of the most tions that created a standard for evaluation, review and
famous anesthesiologists of his day and the anesthesia consenting for humans participating in research sub-
laboratories at Harvard still bear his name. This ­article jects. The role of Institutional Review Boards (IRBs)
delineated a large series of published studies that was carefully described “The IRB shall be sufficiently
Dr. Beecher contended had failed to follow the ethical qualified through the experience and expertise of its
principles of the day. members and the diversity of the members, including
consideration of race, gender, and cultural backgrounds
and sensitivity to such issues as community attitudes,
The Tuskeegee experiment and to promote respect for its advice and counsel in safe-
the Belmont Report guarding the rights and welfare of human subjects…the
The first set of human subjects regulations were IRB shall be able to ascertain the acceptability of pro-
elaborated by the then nascent National Institutes posed research in terms of institutional commitments
of Health. However, the true watershed event in US and regulations, applicable law, and standards of pro-
research ethics was the description of the Tuskeegee fessional conduct…The IRB shall therefore include
experiment. Officially titled “ Tuskegee syphilis study persons knowledgeable in these areas.”4
or Public Health Service syphilis study,” the Tuskegee Of note, there are two separate, related, but distinct
experiment, at least in its initial conception, was a sets of regulations in the USs. Most research under-
scientifically valid observational study of the natural taken at medical schools with funding from the NIH
history of syphilis. When this started in 1932, syphilis are governed by the Department of Health and Human
was a major health problem with no cure and which Services Protection of Human Subjects found at 45
created a hugely varied pantheon of symptoms. A CFR 46 (CFR = Code of Federal Regulations). However,
similar study was under way in Sweden at the time. there is a separate, similar, but not identical set of regu-
Unfortunately, when it became known that syphilis lations that govern the Food and Drug Administration.
could be cured with penicillin in the mid 1940s, the Anyone proposing to submit a drug for FDA approval
scientists involved did not stop or redesign the study. must follow those regulations.5 In many cases, both
The subjects were all male African-American prison- sets of regulations apply simultaneously.
ers in southern jails who had no idea that they were Even with this set of regulations in place, IRBs
part of a research study. The national scandal that remained somewhat sleepy backwaters of compliance
181
 Section 4. Research and publication

in major medical schools. Following another series of calculation with a definable answer. Risk involves the
scandals, federal authorities removed the authoriza- expected value and likelihood of one or more future
tion to use federal monies for research from a number events. Unfortunately, the concept of risk is not defined
of major educational institutions in the late 1980s and in federal regulations and remains a particularly diffi-
early 1990s. This resulted in a major overhaul and signifi- cult concept to apply in the setting of human experi-
cant augmentation of the human subjects protections mentation. Bioethicists, such a Ezekiel Emmanuel
programs in all major schools and the rapid evolution from the National Institutes of Health have argued for
of independent institutional review boards. Since that an actuarial definition of risk, based on the statistical
time, there has been an appreciation that human sub- likelihood of a an untoward occurrence. In this con-
jects protections is a profession, which has evolved it’s struct, human research is, for the most part, much safer
own certification process for individuals (CIP – certified than many daily human activities such a driving a car
IRB professional) and an accreditation process for pro- or participating in a contact sport such as football. On
grams (AAHRPP – Association for the Accreditation of a practical basis, IRBs find themselves considering risk
Human Research Protection Programs). in a relation to a relative level of tolerance or acceptabil-
IRBs have frequently been referred to as ethics ity. So, while the risk of driving a car is well understood,
boards and indeed the charge includes the assessment it is also generally acceptable in that very few individ-
of the ethics of a proposed study. However, in practice uals would consider not using an automobile based on
modern IRBs are responsible for assuring that investi- the risk of death or injury, while a much lower absolute
gators are in compliance with the regulations regarding likelihood of injury or death in a biomedical research is
human subjects research. Thus, the content of informed not so well accepted.
consent documents, which is delineated in US federal The index case provides an interesting example.
regulations and compliance with specific protections The cancer warning for the drug was established based
afforded to special groups of potential participants on animal experiments of a related drug. There was no
are required activities that IRBs must document. This indication that the related drug actually did produce
compliance function frequently appears to take prece- cancer in any humans and the actual drug in use was
dence over the pure ethics of a clinical trial. Whether never tested for chronic use in animals, so the actual
this type of review is more or less beneficial to the goal drug proposed for the study had never been reported
of protecting human subjects is an interesting ethical to cause cancer. The warning was based on very little
question in its own right, but one beyond the scope of information and could arguably be dismissed from a
this chapter. scientific basis; however, failing to note the warning
In the index case presented above, both the IRB and was clearly an error on the part of both the investiga-
the investigator apparently failed to properly identify tor and the review board. Any risk of cancer, no matter
a specific risk. This failure could be described as a fail- how small or theoretical, might be legitimately consid-
ure of the principle of beneficence, and nonmaleficenc ered to be significant.
(the principle to do no harm). It can also be seen as
having severely limited the autonomy of the partici-
pants, whom, in the absence of a potentially critical What is the IRB’s role in scientific review?
piece of information, might not have been able to make A frequent complaint leveled against current IRBs
an informed decision regarding their participation. is the tendency to review the scientific design of a
Appropriate actions following the identification of such research proposal. Investigators argue, with some jus-
risks should include the notification of participants. tification that scientific review occurs at other venues.
Particularly for major grants, such as those funded
Determination of risk, risk/benefit ratio, by the National Institutes of Health, extensive review
by panels of experts have critiqued the scientific con-
and risk management tent of the proposal. One could legitimately argue that
One of the principal obligations of IRBs is the deter- IRBs, even with some direct expertise, are not as well
mination of the level of risk posed to a participant equipped and provide little added value to previous
and assuring that the risks are both acceptable and professional scientific review. Even in the absence of
minimized by appropriate research design risk. This this highly sophisticated professional review process,
idea is frequently couched in the phrase risk/benefit many institutions have internal scientific review bod-
ratio, which makes this determination sound like a ies that can provide high quality review of the science
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 Chapter 30. Human subjects review boards (US)

underlying a proposal. These groups should be at least These projects probably benefit from the expert reviews
as good at evaluating the current standard of care and provided by an IRB. Much current science could be
determining whether an experiment is justified and argued to be repetitive with little to be offered in terms
well designed. of significant scientific progress. While major funding
High-quality scientific review should be extremely agencies require a project to be innovative and signifi-
helpful to an IRB reviewing a project. A human sub- cant, the tremendous expansion of the medical litera-
jects’ reviewer should be able to have confidence that a ture has resulted in large numbers of scientific reports
project reviewed and funded by an auspicious national that do not have a major impact. Pharmaceutical
body represents quality science. One might argue that companies are particularly interested in maintaining
a project prepared by a major pharmaceutical manu- drugs on patent and are frequently accused of test-
facturer who employs skilled personnel with extensive ing new articles with limited advantages over existing
experience in research design is equally well designed. It medications. For the most part, IRBs have been reluc-
is beneficial for these projects to have previous focused tant to take issue with well-designed research which
scientific review prior to submission to the IRB. promises minor scientific or medical value. Most IRB
IRBs are supposed to minimize risk by ensuring members would find that role unappealing and diffi-
appropriate research design. This is the standard justi- cult to fulfill.
fication used by most IRBs to question a study design. A difficult problem arises when poorly designed
A number of circumstances arise. For major projects research poses minimal or no risk, but is unlikely to
that have been reviewed, it may be that the contingen- answer the proposed questions, due, for example, to
cies of human subjects protections were not considered a lack of proper controls or the inclusion of too few
during the design or review of the project. For projects patients to achieve statistical significance. Some IRBs
reviewed by the National Institutes of Health, this would argue that poor science represents an unaccept-
changed a few years ago, so that all projects including able risk, even if the primary “risk” involved is wast-
human subjects must now have a section describing ing the time of a participant. Others would argue
human subjects protections. This change in the scien- that, in the absence of any definable risk of injury, for
tific review process has been a major improvement in example, in an innocuous anonymous survey, the IRB
scientific review that should minimize discrepancies is not justified in suggesting alterations to a project.
seen in the past. Because the primary model ensconced in the regula-
Even with this process, there may remain legitim- tions is based on significant clinical trials, it can be
ate differences in the evaluation of a design. A poign- argued that applying these principles to minimal risk
ant example has arisen in the latest rendition of the types of projects is either inappropriate or a waste of
Declaration of Helsinki, which seeks to minimize the resources.6 Although an ongoing problem, there is lit-
use of placebo controls. The supporters of this docu- tle appearance that this issue will be resolved at a fed-
ment contend that the use of placebos in rarely justi- eral level any time soon.
fied. For example, if a new analgesic was to be tested, In the index case, there was no concern regarding
one could argue that we don’t need one that is better the design. Had the information regarding the risk
than nothing, but rather one that is as good as or better of the test substance been discussed at the initial review,
than current therapy. Therefore, one should not design the project most likely would still have been approved,
a trial that compares such a drug to placebo, but rather although the information regarding this risk would
to an active standard of care control drug. Interestingly, have been discussed and included in the information
the US FDA has rejected the current Declaration of provided to potential participants. In the age of the
Helsinki over this issue (among others) and continues internet, where information is easily accessible, it is
to support and sometimes require placebo-control- reasonable to question whether it is the responsibility
led studies prior to approval of a new drug. IRBs fre- of IRB reviewers to “go beyond” what the researcher
quently have a difficult time reconciling these different supplies in order to do a thorough review. In the index
positions. case, this did not happen during the initial review, but
Furthermore, much research that is reviewed by did occur during subsequent review. It is hard to argue
IRBs has not undergone such extensive, if any peer that IRBs should not be looking for this additional
review and might have been written by individuals information, but it is also difficult to set standards for
with little experience is writing research proposals. what should be reviewed.

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 Section 4. Research and publication

New issues facing IRBs • Determination of risks and assuring that

IRB review is a continually evolving process. In recent risks are both acceptable and minimized is an
years, issues of privacy and confidentiality have important part of IRB review. Minimization
become major focuses of human subjects protections of risk includes assurance of appropriate
under the guise of the Health Insurance Portability research design.
and Accountability Act of 1996. Initially designed to • Additional new issues facing IRBs include
avoid loss of insurance based on violations of priv- protection of the identities of human subjects,
acy, the rules regarding privacy and confidentiality and the minimization of conflicts of interest in
have proven daunting to review and enforce. Consent research.
documents have expanded greatly to accommodate
required language. Investigators have legitimately
complained that the requirements are excessive and
impair research activities. Balancing these concerns References
are the very real problems associated with identity 1* The World Medical Association Declaration of Helsinki.
loss and the concerns that private health informa- Ethical Principles for Medical Research Involving
tion could be used to discriminate against individ- Human Subjects. Adopted by the WMA General
uals. IRBs have also become embroiled in the desire Assembly, Helsinki, Finland, June 1964. Last amended
to minimize conflicts of interest in research. All of this by the WMA General Assembly, Seoul, October 2008.
http://www.wma.net/en/30publications/10policies/b3/
activity has created an increasing burden for investi-
index.html.
gators, IRB members and human subjects protection
2*  Beecher, H.K. (1966). Ethics and clinical research. N Eng
program staff members. Fortunately, there seems to
J Med, 274(24), 1354–60.
be a movement to simplify and streamline some of
3  The National Commission for the Protection of Human
these review processes. One can only hope that we will
Subjects of Biomedical and Behavioral Research. (1979).
achieve a balance of appropriate review and adequate The Belmont Report: Ethical Principles and Guidelines
protections which can be accomplished in an efficient for the Protection of Human Subjects of Research. Dept
and professional manner. of Health, Education and Welfare.
4  21CFR56.107. Code of Federal Regulations. Title 21,
Key points volume 1. Part 56: Insitutional Review Boards. Subpart
B: Organization and Personnel. Revised April 1, 2009.
• Regulation of human subjects research has
5  Informed consent: 21 CFR 50, Institutional Review
evolved in the wake of scandals involving Boards: 21 CFR 56.
mistreatment of human research subjects.
6*  Gawande, A. (2009). The Checklist Manifesto, How to Get
• Modern human subjects protections had Things Right. New York: Henry Holt.
their roots in the war crimes trials of German
physicians who experimented on prisoners
during World War II. Further reading
• Important early declarations regarding the Annas, G.J. and Gordon, M.A., eds (1992). The Nazi
ethical treatment of human research subjects Doctors and the Nuremberg Code. Human Rights in
include the Nuremberg Code, and the WMA Human Experimentation. New York: Oxford University
Declaration of Helsinki. Press.
• The description of the Tuskeegee Experiment Code of Federal Regulations. TITLE 45:Public Welfare
was a watershed event in the history of Department of Health and Human Services, Part 46.
US human research ethics, leading to the Protection of Human Subjects http://www.hhs.gov/
ohrp/humansubjects/guidance/45cfr46.htmP.
publication of the Belmont report elaborating
the ethical principles in treatment of human Jones, J.H. (1983). Bad Blood: The Tuskeegee Syphilis
Experiment. New York: The Free Press
subjects research.
Wendler, D., Belsky, L., Thompson, K.M., and Emanuel, E.J.
• US IRBs have largely functioned as regulatory
(2005). Quantifying the federal minimal risk
bodies assuring compliance with federal standard: implications for pediatric research without a
regulations. prospect of direct benefit. JAMA, 294, 826–32.

184
 Section 4
1 Research and publication
Chapter

31
section 1
Research with vulnerable persons
such as children and prisoners
Samia Hurst and Bernice Elger

The Case This does not mean that vulnerable persons should
never be enrolled in research. Historically, scandals
Complex regional pain syndromes (CRPS) are increasingly
have involved abusive studies where vulnerable per-
­recognized in children, and treatment is unsatisfactory in
many cases. An anesthesiologist designs a clinical research
sons were included because they were less able to resist.
project to study the efficacy of lumbar sympathetic blockade Excluding vulnerable persons from research entirely,
(LSB) with lidocaine compared to intravenous (IV) lidocaine however, can lead to their exclusion from: (1) research
in pediatric patients with CRPS who have not responded to with potential benefit; and (2) the more general benefits
traditional therapy. The study is a double-blind placebo- of the research endeavor: knowledge about conditions
controlled study, involving 40 children between the ages of 7 relevant to them, their sometimes specific needs and
and 12. All will receive general anesthesia and placement of risks, and the possibility to generalize available data to
a lumbar sympathetic catheter. Patients will then be rand- the situations they present with.
omized to receive either IV lidocaine plus saline via lumbar
sympathetic catheter, or LSB with lidocaine plus IV saline.
In obtaining informed consent, the researcher explains to Who is vulnerable?
parents and children (to the degree that the children can Attempts to define vulnerability have differed in
understand) the risks of general anesthesia and lumbar their scope.1 A European “principle of vulnerability”
sympathetic catheter placement. presents it as a universal expression of the human
In answer to the expressed desires and expectations from condition.2 Such broad definitions, encompassing
patients and parents of pain relief, the researcher informs
humanity in its entirety,3,4 are unhelpful in protect-
them that the “real” drug may be effective (in fact, he thinks
it will be), but that it is equally important that research-
ing human subjects as they cannot provide reasons
ers determine if LSB lidocaine is ineffective in relieving the for special protection. In a more restricted definition,
pain. Several parents express concerns that their children “vulnerability” in research on human subjects is often
may be subjected to the risks of general anesthesia and of applied to individuals who are unable to give informed
lumbar catheter placement, but not receive the benefit of consent or more likely to be exploited.5 National and
pain relief. They want assurances that their children will international regulations are based on this sort of def-
receive lidocaine and not placebo. inition: vulnerability is usually linked either to con-
What are the ethical considerations in human subjects sent or to the risk of harm.
research when the patients who are being studied belong to One way to synthesize these different definitions is
vulnerable groups, such as children? Should human sub- to consider that vulnerability as a claim to special pro-
jects research be conducted in vulnerable populations?
tection is an identifiably increased likelihood of being
Vulnerable persons enrolled as research participants wronged.6 It encompasses any wrongs, including those
require special protection. This is recognized in a num- we incur when something to which we have a valid claim
ber of international and national regulations, including is denied us. Defining vulnerability in this way means
the US federal regulations on research with human sub- that we start by identifying the sorts of wrongs likely to
jects (see Table 31.1). When designing and conducting a occur in the conduct of research, then identify those
research study, it is important to know which potential more likely to suffer these wrongs. Many individuals
participants are vulnerable, which studies do or do not are vulnerable in this way; but this definition makes the
justify their inclusion, and what protections are neces- identification of different kinds of ­vulnerability, and
sary when they do participate in research. the development of targeted protections, easier.

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
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 Section 4. Research and publication

Table 31.1. Vulnerability in research according to international guidelines

Belmont report •  Racial minorities

•  The economically disadvantaged
•  The very sick
•  The institutionalized
U.S. – Department of Health and •  Children
Human Services (DHHS) •  Prisoners
45 CFR 46 •  Pregnant women and foetuses
Declaration of Helsinki •  Incompetent persons
•  Persons susceptible to coercion
•  Persons who will not derive direct benefits from participation
•  Persons for whom research is mixed with clinical care
CIOMS •  Thosewith limited capacity or freedom to consent or to decline to consent…
[including] children, and persons who because of mental or behavioural disorders
are incapable of giving informed consent,
•  Junioror subordinate members of a hierarchical group…[such as] medical and
nursing students, subordinate hospital and laboratory personnel, employees of
pharmaceutical companies, and members of the armed forces or police,
•  Elderly persons,
•  Residents of nursing homes,
•  People receiving welfare benefits or social assistance and other poor people,
•  The unemployed,
•  Patients in emergency rooms,
•  Some ethnic and racial minority groups,
•  Homeless persons,
•  Nomads,
•  Refugees or displaced persons
•  Prisoners
•  Patients with incurable disease
•  Individuals who are politically powerless
•  Members of communities unfamiliar with modern medical concepts
ICH tripartite guidelines •  Membersof a group with a hierarchical structure such as medical, pharmacy, dental,
and nursing students, subordinate hospital and laboratory personnel, employees
in the pharmaceutical industry, members of the armed forces, and persons kept in
detention
•  Patients with incurable diseases
•  Persons in nursing homes
•  Unemployed or impoverished persons
•  Patients in emergency situations,
•  Ethnic minority groups,
•  Homeless persons
•  Nomads,
•  Refugees,
•  Minors,
•  Those incapable of giving consent

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 Chapter 31. Research with vulnerable persons

Protecting vulnerable persons in research known as the subsidiarity principle. A study that,
although it could be conducted enrolling only non-
Necessary protections have two components: fair sub-
vulnerable subjects, could be designed in a way to
ject selection, and the specific care required to minim-
give sufficient extra protection for vulnerable sub-
ize wrongs to vulnerable persons once they are enrolled
jects. When such studies offer prospective benefit
in research. Recruitment of research subjects should
to research subjects, excluding vulnerable popula-
respect fairness in the distribution of research-related
tions rather than providing protections to allow their
risks and benefits. It is not justifiable to conduct research
recruitment can itself be harmful. If a subject in a
on an “easily available” population – for example, the
research protocol with prospective benefit is impris-
rural poor in developing countries – ­simply because
oned during the study, for example, terminating his
the study will be easier to conduct with them than
participation may not be in his interest. In the rest
with persons living in better circumstances. Neither is
of this chapter, we focus on two specific populations
it defensible to reserve access to potentially beneficial
of individuals often vulnerable in the conduct of
research to the socially privileged. The rationale for
research: children and prisoners.
the planned recruitment strategy must be based on the
balance of potential harms and benefits and the need
to obtain generalisable results, and discussed in the Research involving children
protocol.
Why are children vulnerable?
Specific care requires that the risks and needs of
those more likely to suffer wrongs in the conduct of Going from the state of being a child to that of being
research be identified, and targeted special protections an adult is a continuous process, during which socie-
outlined. Protecting vulnerability in clinical research ties identify varying points as the threshold marking
starts with a good grasp of criteria for ethical research, the passage from one state to the other. Children are
in general. Investigators designing research with vul- considered vulnerable because, during much of their
nerable subjects, and ERCs reviewing such research, development, they are incapable of decision-making
should ask themselves the following questions: regarding medical intervention. Even when they are
capable of decision-making for clinical care, consent
(1) In which ways are potential research subjects at
for research requires something more: research-related
risk of being wronged in this research?
risks are born for the benefits of others, a fact potential
(2) Are some potential subjects identifiably more
subjects are at risk of misunderstanding even in the
likely than other persons to incur this wrong, or
best of cases. Although minors who are mature adoles-
likely to incur it to a greater degree?
cents can often understand the consequences of their
(3) Am I/are we among those who share in the duty to choice regarding medical interventions and then pro-
minimize, or avoid, this wrong? vide informed consent for clinical care, this is not con-
(4) If yes, what should we do to avoid this wrong or sidered sufficient in the case of research. Additionally,
minimize its increased likelihood or degree, or we are more reluctant to expose children to research-
ensure it is compensated in ethically justifiable related harms, in part again because the risks under-
ways? gone in this context cannot be consented to by the
Based on the sorts of wrongs that can occur in clin- child herself, but also because we recognize a general
ical research, examples of vulnerability are outlined responsibility of protection towards children beyond
in Table 31.2; examples of protections tailored to the that which their parents endorse.
wrongs involved are outlined in the Table 31.3. In
some cases, excluding vulnerable persons from par-
What follows from the vulnerability of children
ticipation in a research project will be an appropriate for research ethics?
way to minimize the risk of harm or other wrongs. Fair subject selection requires that children be enrolled
Sometimes, however, it won’t be. A study designed only when the research question cannot be answered
to address health problems specific to a vulnerable by conducting the study with adults  – for example,
population, such as research on advanced dementia, because the targeted condition is specific to children
could benefit the same population of vulnerable per- or because the research question regards the situation
sons from which subjects are recruited, and cannot of children specifically. When children are recruited
be conducted on nonvulnerable subjects: a condition in research, protections are required to circumscribe
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 Section 4. Research and publication

Table 31.2. Vulnerability as a greater likelihood of being wronged

Requirements* Examples of vulnerability

Social or scientific value •  Lack of access to either benefit or knowledge derived from research
Scientific validity •  Raredisease, leading to difficulties in reaching statistical power to
demonstrate therapeutic effectiveness
Fair subjects selection •  All persons likely to be victims of discrimination
Favorable risk-benefit ratio •  Potentiallyhigher risks: unstable patients, emergency research, foetuses,
pregnant women
•  Potentially lower benefits: subjects in phase I studies, terminally ill patients
•  Subjectswhose risk-benefit ratio might sometimes be the object of
lesser concern to those responsible for protection: terminally ill patients,
disenfranchised persons, poor subjects in developing countries, subjects
without access to health care outside of research.
Independent review •  Allpersons likely to be victims of discrimination, if those responsible for
review share discriminatory views.
Informed consent •  Difficultiesin receiving or understanding the relevant information: not
knowing the language used, or how to read
•  Lackof decision-making capacity: some children, some patients with
mental disorders, comatose patients.
•  Lack of freedom to make a voluntary choice
•  Through limited freedom: prisoners
•  Through social weakness: minorities, refugees, sometimes women
•  Through hierarchical weakness: lab employees, students
Respect for potential and enrolled •  Healthcare providers, researchers and students close to the study team
subjects who are at increased risk of faulty confidentiality
•  Groupsand communities at risk of stigmatisation in the interpretation of
study results
* With permission from Emanuel, E. J., Wendler, D. and Grady, C. (2000). What makes clinical research ethical? JAMA, 283(20), 2701–11.

acceptable risks and to compensate the lack of consent criticism for conflating risks acceptable in therapy and
by the children. in research, and allowing healthy children to undergo
Limiting risks to children has implications for the greater research-related risk than those accepted in
timing of a protocol. Interventions relevant to both the case of sick children. An alternative proposed by
children and adults should undergo at least initial test- Wendler is based on the “net risks test.”7 As any assess-
ing on adults in order to minimize unknown risks at ment of risk in research, it should focus on the research-
the time when children will be recruited to assess ques- related risk: risks that potential research subjects would
tions more specific to them. Other implications regard not run outside the protocol. Sick children enrolled in
the design of a protocol. Under US regulations, ERCs research will often undergo standard therapy as well as
may approve research involving children under three experimental interventions, and risks inherent to the
sets of circumstances: “minimal risk,” “prospect of dir- standard therapy are not research-related. The assess-
ect benefit,” and “minor increase over minimal risk.” A ment should further focus on the net risk: risks that are
prospect of direct benefit is defined as a research situ- not balanced by the prospect of direct benefit to the
ation where risks are justified by the anticipated benefit child. Paediatric pharmacokinetic studies, for example,
to the subjects and where the relation of the anticipated hold no prospect of direct benefit: their entire risk is a
benefit to the risk is at least as favourable as that of net risk. A phase III study of a novel therapy proven
alternatives available to potential subjects. effective in adults, however, does hold a prospect of
Linking the acceptable risk threshold to the pro- direct benefit for sick children. Such a study can still
spect of direct benefit in this manner has come under have a net risk, however, especially if the expected
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 Chapter 31. Research with vulnerable persons

Table 31.3. Protection of vulnerable subjects by Ethics Review Committees*

Are potential research subjects Example 1: breach of •  Health care providers are at greater risk.
at risk of being wronged by this confidentiality •  IRBs share in the duty of protection
research project? •  Minimization: could require specific anonymisation
of data to limit colleagues’ access to their personal
information
Are some potential subject Example •  Ifthey stand to benefit less, terminally ill patients
identifiably more likely than 2: unfavourable risk/ may be at greater risk.
other persons to incur this benefit ratio •  IRBs share in the duty of protection.
wrong, or likely to incur it to a •  Theirrisk/benefit ratio should be specifically
greater degree? examined by researchers and IRBs rather than
assumed to be the same as for other potential
subjects.
Is our IRB among those who Example 3: being •  Subjectsof emergency research lack time to think
share in the duty to minimize, enrolled without valid through the options.
or avoid, this wrong? consent •  IRBs share in the duty of protection.
•  Thiscan be minimized if consent is asked at that
time only for those parts of the protocol that are
truly urgent.
•  Theremaining problems with consent at
that time can be compensated by including
a requirement that an independent clinician
confirm that enrolment is not contrary to the
potential subject’s interest.
If yes, what should we do to Example 4: being •  Patientsin developing countries who lack access
avoid this wrong, or minimize denied the benefit of to care are excluded from an important part of the
this increased likelihood research social benefits of research.
or degree, or ensure it is •  AlthoughIRBs are not alone in bearing some
compensated in ethically responsibility for this, it is among the points they
justifiable ways? should examine in general, and thus also for the
purposes of protecting the vulnerable
•  Minimization: reasonable availability (World
Medical Association 2008) aims to minimize this
problem
•  Compensation: fair benefits (Participants in the
2001 Conference 2002) aim to compensate it.
* With permission from Hurst 2008.

benefit is modest. Finally, ERCs should assess this net or living in circumstances such as war-torn countries,
research-related risk and accept it if it is no greater than whose risks in daily life far exceed what is acceptable
“those associated with routine medical and psycho- in research.
logical examination”8 or “those ordinarily encoun- Because children are unable to provide consent for
tered in daily life.”9 US regulations combine these two their own participation in research, permission must
thresholds. Comparison of the net research-related be sought from their parents or other legal guardians.
risks posed by a study should be with “the level of risk US regulations specify that the permission of both
average children face in daily life (or during routine parents is required unless: (1) the investigational pro-
examinations),”10 or the level “normally encountered cedure involves no more than minimal risk; (2) there
in the daily lives of people in a stable society”11,12 in is a prospect of direct benefit to the child; or (3) “one
order to avoid placing an excessive burden on children parent is deceased, unknown, incompetent, or not
suffering from diseases requiring invasive treatment reasonably available” or “only one parent has legal
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 Section 4. Research and publication

responsibility for the care and custody of the child.” mentally ill, and  – in many countries  – foreigners
EU directive 2001/20/EC specifies that research can who do not understand or speak the local language
only be conducted on minors if “the informed con- sufficiently to understand explanations regarding
sent of the parents or legal representative has been research.
obtained,”13 apparently requiring the agreement of As a group, prisoners are vulnerable due to their
both parents. particular situation: being detained and therefore being
Regulations also require that older children and deprived of the freedom to move freely, which implies
adolescents should be informed to the level they can that they are, possibly, under the influence of differ-
understand, and that they should provide assent  – ent kinds of pressures. Several prison-related factors
defined as “affirmative agreement” in US regulations are relevant for ethical considerations about research
and provided in writing  – when they are capable of involving prisoners.
doing so.14 Determining when assent should be sought First, prisoners are vulnerable because they have
is delicate as children’s ability to understand research limited choices: they cannot freely choose and consult
participation varies across, but also within, age groups. their own physician. Their access to healthcare depends
While it is usually found that children under 7 years on the available health structures. Prisoners might not
of age are not capable of giving assent, and those over have access to alternative healthcare or adequate and
14  years often are, this requires specific assessment, independent clinical advice when a research study is
especially in the intermediate age group. Letting fam- carried out in a prison.
ilies decide when children are old enough to be involved Second, prisoners are vulnerable because the pres-
in a decision to enroll in research is one possibility, but sures from prison officers and co-detainees, as well as
it should be applied with caution; data suggest that pressures resulting from their living conditions, could
considerable disagreements can arise within families interfere with free informed consent. Prisoners might
on this point, including reluctance on the part of the accept participation in research because they fear pun-
parents of capable children to involve them.15 Children ishment if they do not participate. Hierarchical struc-
sometimes wish their parents to decide for them, and tures are strong among prison inmates and leaders
this, of course, should be respected. might force others to participate or, on the contrary,
Protections provided by parental permission and could force inmates not to participate. Prisoners are also
children’s assent are further complemented by require- vulnerable to real or perceived incentives to become a
ments that explicit refusal by children be respected.8 research subject, especially if they think that participa-
EU directive 2001/20/EC further specifies that “par- tion could be advantageous because research subjects
ental consent must represent the minor’s presumed obtain better living conditions or shorter prison terms
will,”13 and that no financial incentive may be offered. than other prisoners.
Children who are unable to assent to research may Among ethics scholars and researchers, contro-
become able to do so, especially in long-term studies. versy exists as to whether prisoners should be con-
In such cases, their assent (or consent as the case may sidered competent to give informed consent. At one
be), must be sought at that time. extreme are those who, based on the principle of ben-
With such protections in place, a (small) net risk eficence, claim that, since studies are lacking which
in research involving children is acceptable. Allowing prove prisoners’ capacity to give truly informed con-
such studies is not only necessary to allow the conduct sent, one should not let them decide on their own. At
of research needed by children themselves, it is also the other extreme is the opinion that prisoners should
compatible with motivations of altruism for research not be treated differently from other potential research
participation, a reason accepted by many parents as subjects, since their mental faculties are not funda-
well as children. mentally changed by detention. A part of this question
is empirical: there has been insufficient exploration of
Research involving prisoners whether prisoners have a tendency to make different
decisions while in prison from those they would make
Why are prisonersa vulnerable? if they were not detained. A second argument refers to
Prisoners are not a homogenous group. Statistically, the right to respect autonomy: being deprived of lib-
they include a higher percentage of members from erty does not include deprivation of the autonomy to
other vulnerable groups, such as the poor, illiterate, decide about one’s body and ­healthcare-related issues.
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 Chapter 31. Research with vulnerable persons

Treating prisoners, by definition, as ­incompetent including a prisoner representative who has experi-
­concerning health-related matters is a violation of ence with prison healthcare. RECs should receive clear
their human rights. indications how to evaluate specific ethical issues con-
cerning research with prisoners such as the principle of
What follows from the vulnerability of prisoners subsidiarity and issues of distributive justice: prisoners
for research ethics? should not bear a disproportionate burden of research
The vulnerability of prisoners has triggered various risks, and research should be carried out inside pris-
strategies for their protection against research risks ons only if results of comparable efficiency and mean-
and abuse.16,17 Strategies are used either alone or cumu- ing cannot be obtained with nonprisoners. Stricter
latively by different guidelines and legislations. oversight mechanisms might include the obligation
The first is characterized by different forms of to visit the prison before, during, and after the study
restrictions. The most extreme form is general pro- to control whether confidentiality, informed consent,
hibition of all forms of research with prisoners as is and other ethical requirements are respected.
the case in some of the US. Others, such as US fed- A fourth strategy is to require special ethical train-
eral regulations, allow only certain categories of ing for researchers carrying out research with prison-
research to be carried out with prisoners. Categories ers to assure that they are aware of ethical issues and
are allowed either because they imply only minimal specific risks related to research with prisoners, and
risk or because their benefits are particularly import- engage themselves in the protection of prisoners from
ant and outweigh the (limited) risks.18 The Council abuse through research.
of Europe varies restrictions according to the type of Such strategies are important to protect prisoners
benefit. It restricts only research that does not prom- from the risk of abuse, and preferable to their exclu-
ise direct benefit to prisoners. If research is expected sion from research entirely. Empirical studies inside
to produce indirect benefit, i.e., benefit only to pris- prisons can be beneficial and are necessary to obtain
oners as a group, it is allowed only if three conditions evidence-based answers to some research questions
are fulfilled: “(i) Research of comparable effectiveness that need to be addressed in order to improve prison-
cannot be carried out without the participation of per- ers’ healthcare.
sons deprived of liberty; (ii) The research has the aim
of contributing to the ultimate attainment of results
capable of conferring benefit to persons deprived of Key points
liberty; (iii) The research entails only minimal risk and • With children, prisoners, and other vulnerable
minimal burden”. Research without at least indirect populations, the challenge is to find the right
benefit is prohibited.16,17 balance between protection from abuse and
A second strategy is to require higher efforts than the need to grant vulnerable populations
with nonprisoners to assure informed consent and access to participation in research.
freedom of choice. This could imply that prisoners • Although the exclusion of vulnerable subjects
should be informed several times and particular tests from a specific study will sometimes be an
could be indicated to ensure that they have understood appropriate way to minimize their risk of
the information. It could also mean to provide prison- being wronged in the conduct of research, this
ers with more time than nonprisoners to consider their will not always be true.
decisions. Most regulations prohibit incentives in the • Studies designed to address health problems
form of money or better living conditions or influence specific to a vulnerable population are needed
on prison terms. Other means to ensure that prison- to improve care for this very population, and
ers’ choices are in line with their best medical interest often cannot be conducted on others.
is to grant them access to an independent and qualified • Participation in research can hold a prospect
doctor who is not part of the research team who could of benefit from which it is sometimes wrong
advise prisoner patients impartially. to exclude vulnerable persons. In such cases,
A third strategy is to increase oversight mecha- enrollment with special protections tailored
nisms by research ethics committees (RECs) or ERCs.b to the sort of wrong to be avoided is ethically
In the US, for example, ERCs that approve research preferable to exclusion.
with prisoners need to have a particular composition

191
 Section 4. Research and publication

Notes European Parliament and the Council on medicinal

products for paediatric use. Published in the Official
Journal of the European Union on 27/12/2006 (L 378/20).
a
 In this text, the term “prisoner” is meant to include any kind of
Available at: http://www.eortc.be/Services/Doc/clinical-
detained person, in any kind of detention facility. The term prison
is used in its British meaning all kinds of detention facilities, such EU-directive-04-April-01.pdf Accessed August 15th 2009.
as jails, federal prisons or other places of detention. 14  Whittle, A., Shah, S., Wilfond, B., Gensler, G., and
b
 Institutional review boards (terminology used in the US). In Wendler, D. (2004). Institutional Review Board
this chapter we do not make any difference between the termin­ Practices Regarding Assent in Pediatric Research.
ology: both REC and IRB refers to the competent body of research Pediatrics, 113, 1747–52.
oversight in a given country.
15  Varma S., Jenkins T., and D. Wendler. (2008) “How do
Children and Parents Make Decisions About Pediatric
References Clinical Research? “J Pediatr Hematol Oncol 30(11),
1* Ruof, M. C. (2004). Vulnerability, vulnerable popula­ 823–8.
tions, and policy. Kennedy Inst Ethics J, 14(4), 411–25. 16  Council of Europe (2005). Additional Protocol to
2* Rendtorff, J. D. (2002). Basic ethical principles in the Convention on Human Rights and Biomedicine,
European bioethics and biolaw: autonomy, dignity, concerning Biomedical Research. Strasbourg,
integrity and vulnerability – towards a foundation of 25.I.2005: http://conventions.coe.int/Treaty/EN/
bioethics and biolaw. Med Health Care Philos, 5(3), Treaties/Html/195.htm
235–44.
17*  Gostin, L. O., C. Vanchieri, A. Pope and IOM
3* Callahan, D. (2000). The Vulnerability of the Committee on Ethical Considerations for Revisions
Human Condition. Bioethics and Biolaw, Volume to DHHS Regulations for Protection of Prisoners
II: Four Ethical Principles. P. Kemp, J. Rendtorff Involved in Research (2006). Ethical Considerations
and N. Mattsson Johansen. Copenhagen, Rhodos for Research Involving Prisoners. Washington, DC: The
International Science and Art Publishers; and Centre National Academies Press.
for Ethics and Law in Nature and Society.
18*  Branson, R. (1977). Prison research: National
4* Kottow, M. H. (2004). Vulnerability: what kind of
Commission says ‘no, unless…’ . Hastings Cent Rep,
principle is it? Med Health Care Philos, 7(3), 281–7.
7(1), 15–21.
5* Lott, J. P. (2005). Module three: vulnerable/special
participant populations. Dev World Bioeth, 5(1), 30–54.
6  Hurst, S. A. (2008). Vulnerability in research and Further reading
health care: describing the elephant in the room? Elger, B. S. (2008). Research involving prisoners: consensus
Bioethics, 22(4), 191–202. and controversies in international and European
7  Wendler, D. (2008). Is it possible to protect pediatric regulations. Bioethics, 22(4), 224–38.
research subjects without blocking appropriate Emanuel, E. J., Wendler, D., and Grady, C. (2000). What
research? J Pediatr, 152(4), 467–70. makes clinical research ethical? JAMA, 283(20),
8  CIOMS (2002). International Ethical Guidelines 2701–11.
for Biomedical Research Involving Human Subjects. Freedman, B., Fuks, A., and Wijer C, (1993). In loco
Geneva, Switzerland, CIOMS. parentis : Minimal Risk as an Ethical Threshold
9  DHHS. Department of Health and Human Services. Code for Research upon Children. Hastings Ctr Rep,
of Federal Regulations Title 45 Part 46. Federal Register. 23(2): 13–19.
56: 28012. http://www.hhs.gov/ohrp/humansubjects/ Meyer, C. R. (1999). “Unwitting consent: “Acres of
guidance/45cfr46.htm (accessed August 15th 2009) Skin: Human Experiments at Holmesburg Prison” tells
10  Wendler, D. (2006). Three steps to protecting pediatric the story of medical researchers who sacrificed the
research participants from excessive risks. PLoS Clin rights of their subjects for personal profit.” Minn Med,
Trials, 1(5), e25. 82(7), 53–4.
11  South African Medical Research Council Sammons, H. (2009). Ethical issues of clinical trials in
(2006) Guidelines on ethics in medical research. children: a European perspective. Arch Dis Child, 94,
Available: http://www.mrc.ac.za/ethics/ethics.htm. 474–7.
Accessed August 15th 2009. World Medical Association. (2008). Declaration of
12  Tangwa, G. B. (2009). Research with vulnerable Helsinki: Ethical Principles for Medical Research Involving
human beings. Acta Tropica, 112S, S16–S20. Human Subjects. Retrieved February 24th, 2009,
13  European Parliament and the Council of the European from http://www.wma.net/e/policy/b3.htm (accessed
Union (2006). Regulation (EC) No 1902/2006 of the October 3rd 2006).
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Section 4
1 Research and publication
Chapter

32
The ethics of research on pain and other
symptoms for which effective treatments
already exist
Monica Escher and Samia Hurst

The Case equally necessary, and each is relevant to research on

the management of pain and other symptoms, which
Dr. Smith is an anesthesia resident on the hospital “pain
requires the same ethical protections as any other form
service,” who has been asked to consult on a patient who
has been admitted for palliative care for terminal colon
of research with human subjects. Some aspects, how-
cancer. The patient has had breakthrough pain on max- ever, do present difficulties more specific to the context
imal oral therapy. He feels nauseous and limits his oral of symptom management studies. These include diffi-
intake. Subcutaneous (SQ) administration of morphine culties related to scientific methodology, fair subject
is initiated, and brings partial relief. The patient requests selection, obtaining a favorable risk/benefit ratio, and
epidural analgesia. The attending on the pain service is informed consent.
conducting a placebo-controlled crossover research study
evaluating the efficacy of administration of SQ recombin-
ant human hyaluronidase to improve the absorption of
Scientific methodology
SQ morphine in patients with terminal illness. Each study Although individual patients may benefit indirectly
subject will receive morphine via a different method on from research participation, the intention of research
each of 3 days: intravenous morphine, SQ morphine plus is to generate valid data to inform the care of future
placebo, and SQ morphine plus hyaluronidase. As part of patients. The research may involve delaying pain relief
her role on the pain service, Dr. Smith is supposed to help in participants. The investigator is responsible for
recruit clinical research subjects, but she is bothered by the minimizing risks and avoiding unnecessary harm for
fact that this patient is terminally ill, is in considerable the patients. He/she is also accountable for the scien-
pain, and is requesting a specific therapy that is not on the tific validity and clinical relevance of the experimen-
research protocol. Is it ethical for her to try to recruit him
tal question. Methodological issues in the design of
for this study?
symptom management trials, the collection of adverse
Research on the management of pain and other symp- effects, and the reporting of data, have ethical import-
toms is crucial to provide better care for acute, post- ance. Failure to give proper attention to these issues
operative, and chronic symptoms, as well as better can make the results of a trial difficult to interpret and
symptom management at the end of life. However, par- prevent comparisons. This limits usefulness in clinical
ticipation in clinical research places subjects at risk of practice, causing research to fall short of its purported
harm for the benefit of others. This tension is intrinsic goal and fail to fulfill its commitments towards patients
to all clinical research, and underlies the need for pro- and society. Risks to human subjects must be justified
tection of human subjects. A number of national and in part by the social benefit of research. Therefore any
international regulatory documents aim to protect par- risk, however small, in a study that cannot answer its
ticipants in research while also taking into account the research question is excessive.
interests of future patients by allowing research to be Randomized, double-blind trials have become
conducted1 All refer to similar basic principles, which standard in acute as well as in chronic pain trials. The
have been synthesized thus: social value, scientific val- inclusion of patients with moderate to severe pain at
idity, fair subject selection, favorable risk/benefit ratio, baseline may be crucial for sensitivity, i.e., the abil-
independent review, informed consent, and respect ity to detect the analgesic effect of the tested drug.
for enrolled participants. All of the requirements are Primary outcomes are usually a difference in pain

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
193
 Section 4. Research and publication

intensity and a measure of pain relief. Analgesic con- reporting results.2 In addition to absolute changes
sumption after a surgical procedure has also been in pain intensity, percent change provides valu-
used as a surrogate endpoint because it can prove able information, and correlates with patient global
more convenient to measure. Data other than pain satisfaction.3
intensity and pain relief are also useful in characteriz-
ing patients’ responses. In acute pain trials onset and
duration of analgesia, the time to rescue analgesia Fair subject recruitment
and the number of patients requiring a rescue dose at Potential subjects should be selected based on the
various time points all provide valuable information. potential for generalizability of study results, and to
Observation periods must be long enough to gather maximize the risk/benefit ratio for enrolled subjects.
relevant data. As chronic pain impacts different They should not be recruited on the basis of mislead-
aspects of the patient’s life, decreasing health-related ing expectations, lesser ability to defend themselves,
quality of life, chronic pain trials must address issues or because they are persons whose risk is somehow
considered important by patients, such as physical discounted.
and emotional functioning, sleep, relations to family,
and social activities. Whenever available, a standard The problem of misleading expectations
set of outcome measures should be used to assess these A major expectation of informed consent in clinical
dimensions. Studies should also assess what magni- research is to help patients understand the differ-
tude of change brings a meaningful difference for the ence between the goals of the research and those of
patient, as opposed to finding a statistical difference medical care – the research goal is to acquire gener-
only. Defining a “meaningful difference” is therefore alizable knowledge that will help improve the care of
necessary. Such an approach enables researchers to future patients, rather than providing the best care to
determine which patients benefit from treatment and individual patients. Chronic pain patients have often
to perform responder analyses. received treatments that did not satisfy them, and may
Overall patient satisfaction depends on treatment welcome access to a novel treatment they believe will
efficacy in alleviating pain, and on treatment adverse work better. This makes them particularly prone to
effects. Single-dose studies do not adequately charac- “therapeutic misconception.” Their hope for personal
terize drug toxicity because most side effects are dose benefit can also lead them to minimize or overlook
dependent and will occur only after repeated dosing. inconveniences and risks. Most chronic pain tri-
Careful monitoring of adverse effects is warranted in als involve fixed-schedule drug titration, prohibit or
all pain trials to assess the balance between risks and limit the use of other pain medication, and impose
benefits in the specific clinical context. It also helps constraints on nonpharmacological and alternative
interpret the results in trials where analgesic consump- treatments. Moreover, chronic pain patients often
tion is an outcome, as sedation, confusion, or nausea experience impaired physical, emotional and social
may all lead to reduced opioid use without achieve- functioning, all of which have been associated with the
ment of adequate pain relief. Whatever the method, the therapeutic misconception.4
type, frequency, and severity of adverse events should Therapeutic misconception is also ethically prob-
be recorded for placebo and active treatment, and the lematic because it represents misplaced trust, which
causal relationship between adverse events and the can endanger the physician–patient relationship.5
study drug should be evaluated. Participants may question the researcher’s competence
For results to be readily understandable, data and blame him if their expectations are not fulfilled.
must be reported in a way that relates to clinical This risk may be especially high with patients suffering
practice. Data on pain intensity and pain relief from chronic pain, as it is difficult to treat, with even the
do not have a normal distribution but are highly best treatments available providing only partial relief.
skewed, in acute pain as well as in chronic pain tri- Moreover, patients may experience the side effects of
als. Giving mean values does not reflect clinical real- medication without benefiting from its therapeutic
ity as some patients may benefit considerably from effect. Patients’ distrust towards physician investiga-
the intervention, while others do not experience tors can extend and impact on their relationship with
any improvement. Analysis of individual patient their own physician, thus possibly jeopardizing rou-
data has been proposed as a more relevant way of tine clinical care.

194
 Chapter 32. Research on pain and other symptoms

Is research at the end of life a special case? hand, giving a placebo to subjects randomized to the
control group deprives them of an effective treatment,
The exclusion of terminally ill patients from research
leading to recommendations against placebo controls
would not be easy to defend. Research is useful to
in such standards such as the Declaration of Helsinki.10
improve therapies at the end of life and thus help the
On the other hand, using a recognized treatment as a
very people whom such a ban would attempt to protect.
control can lead to methodological difficulties. A posi-
Terminally ill patients do enroll in studies, and research
tive noninferiority trial can mean three very different
has shown that, when given hypothetical scenarios, a
things: both treatments are equally effective, both are
majority of palliative care patients want to participate
equally ineffective, or the trial was underpowered to
in research6 with motives including the hope of per-
detect the difference. This tension was recognized in
sonal benefit, altruism towards patients going through
the 2008 Helsinki declaration, which states that pla-
the same ordeals7 and the wish to maintain hope.8
cebo controls can be used “where for compelling and
Moreover, terminal disease does not by itself invalidate
scientifically sound methodological reasons the use of
the capacity for informed consent. Were it so, we would
placebo is necessary to determine the efficacy or safety
not routinely respect the choices expressed by the ter-
of an intervention and the patients who receive placebo
minally ill in their wills.
or no treatment will not be subject to any risk of serious
The conduct of research with terminally ill patients
or irreversible harm.” It then adds that “Extreme care
is, however, often described as requiring special care
must be taken to avoid abuse of this option.”
due to risks of coercion or exploitation. Coercion is best
How do we tell the difference between those situa-
described as a credible and strong threat exerted by a
tions where a placebo control is acceptable, and those
person that limits the options in a negative way available
where it is not? Emanuel and Miller propose that this
to another person. Having limited options through no
be based on scientific rationale and a risk criterion.11
fault of anyone’s does not constitute coercion. Indeed,
Placebos should be excluded where this would deprive
the possibility of enrolling in a clinical trial actually
gives terminally ill patients an additional option. patients of “effective, life-saving, or at least life-pro-
Exploitation is the unfair distribution of the benefits longing treatment.” While it can be justifiable to con-
and burdens of a transaction. Research participation duct a placebo-controlled trial in cases where there is
always carries burdens. Although it can carry the pro- some potential harm to patients, the methodological
spect both of direct benefits to subjects and of benefits rationale must be compelling. Such rationale may exist
to their community from the social value of research, if the placebo response rate is high, the condition rare,
both are always uncertain in a given study. Are termin- variable or with frequent spontaneous remissions, or if
ally ill patients at greater risk during research, and/or existing therapies are only partly effective or have seri-
are they less likely to benefit from research participa- ous side effects.
tion than they should? Assessing risks and benefits of A scientific rationale is necessary, but not sufficient
participation in research for terminally ill patients is to make a placebo-controlled trial ethically justified. A
a complicated question. Effects deemed sufficient by placebo control should not increase the subjects’ risk
researchers – and which underlie the choice of research of death or irreversible morbidity, or disability. Nor
question and much of the methodology – may or may should it substantially increase their risk of other ser-
not reflect what terminally ill patients would consider ious harms or severe discomfort. Judging which trials
a clinically desirable effect.9 A patient’s evaluation of are acceptable on these criteria is a delicate balance
both risks and benefits may shift during terminal ill- and should be specifically addressed during the ethics
ness, and that shift will no doubt vary between indi- review. Such trials must exclude participants who are
viduals. At minimum, the risks incurred by terminally at increased risk, limit the period of placebo adminis-
ill patients should never be discounted, and the risk/ tration as much as possible, monitor subjects carefully,
benefit assessment must take into account the circum- provide rescue medication, and outline specific criteria
stances of terminal disease. for withdrawal from the study. The use of placebo, as
well as its risks and rationale, must be made clear to
potential subjects during informed consent.
A favorable risk/benefit ratio The question of placebo use is also relevant to
The use of a placebo control when a recognized effective research on invasive interventions like surgical treat-
treatment already exists is controversial. On the one ments, sometimes raising the question of placebo
195
 Section 4. Research and publication

surgery.12 Sham surgery is controversial; requires pla- The second aspect is that, in emergency situations,
cing control subjects at risk while additionally depriv- there is limited time for potential subjects to think
ing them of effective treatment. Trials including sham through a decision to participate in research. There are
interventions are, however, not always riskier than several potential solutions. First, the urgency might be
other accepted clinical trials, and can be important to reduced by the study design. If, for example, the emer-
protect future patients from the harms of ineffective gency is due to severe pain rather than the need for
interventions. immediate surgery, a protocol might allow treatment
In practice, they should be assessed with at least the to proceed as usual at first, with enrollment and ran-
same criteria used for placebo-controlled drug trials. domization only after the emergency has resolved. If
Particular care should be given to exploring alterna- this is not possible, care should be taken to separate
tives, minimizing risks, and assessing the risk/benefit those aspects of the trial that must be initiated dur-
ratio. Informed consent should be particularly care- ing the emergency and those which do not. Consent
ful, as potential subjects may be more likely to confuse should be sought at a later time for nonurgent aspects
research with clinical care in the case of an invasive of the trial. Finally, neutral supervision of enrollment
procedure. Some sham intervention trials may be jus- can be utilized: a clinician not involved in the trial is
tified, provided they have no valid safer alternative and given veto power on the enrollment of a patient if her
respect the criteria outlined above. considered judgment is that participation is against
the patient’s interests. Whichever strategy is chosen, it
should be described in detail in the protocol submitted
Consenting to research on symptom for ethics review.
management
Informed consent is particularly important in research, Case resolution
because it allow subjects to make an informed and vol- Several issues contribute to Dr. Smith’s discomfort in
untary choice to participate – or refuse to participate– our case scenario. (1) The patient is in pain, which she
in a project where they will take risks for the benefit of has an obligation to try to relieve. (2) The patient is ter-
others. minally ill, and therefore may be vulnerable to undue
Adequate informed consent requires that poten- pressure if he is under the therapeutic misconcep-
tial subjects understand the relevant aspects of their tion that the study will necessarily provide him with
choice, are capable of decision-making and are free to better pain relief. (3) Dr. Smith understands that for
accept or refuse participation. Assessment of each of portions, if not all, of the study, the patient may experi-
these elements requires a degree of judgment. In the ence deterioration in his pain control, depending on
case of research on the management of pain and other the efficacy of SQ and IV morphine compared to his
symptoms, some of these elements can be more diffi- oral medications, and depending on the efficacy of
cult to attain. Similarly, concerns could arise in emer- the study drug, hyaluronidase. She is torn between
gency situations, or in situations where consent might her desire to research pain in terminally ill patients to
be solicited during acute pain, or immediately follow- benefit others, and her obligation to offer this patient
ing acute administration of anesthetic agents. the best and most individualized care, which could be
Although none of these situations necessarily epidural analgesia.
represents an obstacle to informed consent, or to The solutions to some of these issues are relatively
enrollment in research, they do require special pre- straightforward. If the patient appears competent to
cautions. Two aspects are particularly relevant. The make medical decisions, he can certainly be informed
first one is the risk that decision-making capacity of the risks of poorer pain control, as well as the poten-
could be affected. Since chronic pain, and chronic tial benefit of better pain control for himself as well
administration of stable doses of analgesic medica- as other patients through participation in the study.
tion do not by themselves affect decision-making cap- Ultimately, he will have to determine if the clinical trial
acity, this question is most relevant in the presence of and its potential risks and benefits are acceptable to
acute pain or the acute administration of analgesia. him. As with many terminally ill patients, the oppor-
However, studies have shown that most patients per- tunity to benefit others by participating in research
ceive that they retain decision-making capacity in may have special meaning for him, and may also pro-
these circumstances.13 vide him with hope during his palliative care. While
196
 Chapter 32. Research on pain and other symptoms

he is a “vulnerable” patient, automatically excluding

him from being a clinical research subject solely on the • Even with explicit patient consent, the
basis of his diagnosis is arguably unethical, as long as researcher has the obligation to minimize risk
coercion is avoided, and careful attention is paid to cor- and discomfort to the patient.
recting therapeutic misconceptions he may have. Care • Particular attention to subject comfort and
should be taken if he agrees to be a subject to clearly safety is important in placebo-controlled trials.
outline the plans for “rescue” therapy if any, and allow • Research involving symptomatic relief at
for voluntary withdrawal from the study if/whenever the end of life is ethical, but requires special
the patient changes his mind. considerations. Patient assessment of benefits
However, for Dr. Smith, being both a researcher and burdens may shift during the trial and
and a primary treating physician for a subject of clin- require reconsideration.
ical research carries several risks. The patient may be
more likely to view the research study as medical care,
and be unable to overcome therapeutic misconception References
because of Dr. Smith’s dual role in his care, for example. 1*  The National Commission for the Protection of Human
If he is denied epidural analgesia in favor of partici- Subjects of Biomedical and Behavioral Research (1979);
pation in a research study, and his pain is poorly con- ICH Steering Committee (1996); CIOMS (2002); World
trolled, he may not only come to mistrust Dr. Smith, Medical Association (2008); Department of Health and
but transfer that mistrust to other physicians involved Human Services, (March 1983).
in his clinical care. While the study itself may be eth- 2   Moore, R. A., Edwards, J. E., and McQuay, H. J. (2005).
ical, and recruitment of terminally ill patients accept- Acute pain: individual patient meta-analysis shows the
able, Dr. Smith should consider either withdrawing impact of different ways of analysing and presenting
results. Pain, 116(3), 322–31.
from the medical team caring for the patient in favor of
doing the clinical research, or ask another physician to 3   Farrar, J. T., Young, J. P. Jr., LaMoreaux, L., et al.
(2001). Clinical importance of changes in chronic pain
obtain consent from the patient so that she can partici-
intensity measured on an 11-point numerical pain
pate solely in his clinical care and avoid the “dual” role rating scale. Pain, 94(2), 149–58.
of researcher and clinician.
4*  Appelbaum, P. S., Lidz, C. W., and Grisso, T.
(2004). Therapeutic misconception in clinical
research: frequency and risk factors. IRB, 26(2), 1–8.
Key points 5*  de Melo-Martin, I. and Ho, A. (2008). Beyond
• Subjects who participate in clinical research informed consent: the therapeutic misconception and
trust. J Med Ethics, 34(3), 202–5.
take risks for the benefit of future patients, and
may not realize personal benefits themselves. 6*  Pautex, S., Herrmann, F. R., and Zulian, G. B. (2005). Is
research really problematic in palliative care? A pilot
It is therefore an ethical obligation of clinical
study. J Pain Symptom Manage, 30(2), 109–11.
researchers to pay close attention to study
7*  Todd, A. M., Laird, B. J., Boyle, D., et al. (2009). A
design to fulfil the promise of research to
systematic review examining the literature on attitudes
patients and to society, and to justify the risks of patients with advanced cancer toward research. J
to which the subjects of research are subjected. Pain Symptom Manage, 37(6), 1078–85.
• Researchers always have the obligation to 8*  Agrawal, M., Grady, C., Fairlough, D. L., et al.
obtain informed consent from research (2006). Patients’ decision-making process regarding
subjects. This can require special precautions participation in phase I oncology research. J Clin
in emergency situations, or in situations Oncol, 24(27), 4479–84.
where consent might be solicited during 9*  Horrobin, D. F. (2003). Are large clinical trials in
acute pain, or immediately following acute rapidly lethal diseases usually unethical? Lancet,
administration of anaesthetic agents. 361(9358), 695–7.
• Patient subjects often confuse the intention 10  World Medical Association (2008). Declaration
of research trials and have the misleading of Helsinki: Ethical Principles for Medical Research
expectation that the research is intended to Involving Human Subjects. Retrieved February 24, 2009,
benefit them. from http: //www.wma.net/e/policy/b3.htm (accesed
October 3, 2006).
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11* Emanuel, E. J. and Miller, F. G. (2001). The ethics of Emanuel, E. J., Wendler, D., and Grady, C. (2000). What
placebo-controlled trials – a middle ground. N Engl J makes clinical research ethical? JAMA, 283(20),
Med, 345(12), 915–19. 2701–11.
12* Horng, S. and Miller, F. G. (2002). Is placebo surgery Faden, R. and Beauchamp, T. (1986). A History and Theory of
unethical? N Engl J Med, 347(2), 137–9. Informed Consent. Oxford, New York: Oxford University
13* Kay, R. and Siriwardena, A. K. (2001). The process of Press.
informed consent for urgent abdominal surgery. J Med Grisso, T. and Appelbaum, P. S. (1998). Assessing Competence
Ethics, 27(3), 157–61. to Consent to Treatment. A Guide for Physicians and Other
Health Care Professionals. New York: Oxford, Oxford
Further reading University Press.
CIOMS (2002). Guideline 4: Individual Informed Consent. Hawkins, J. S. and Emanuel, E. J. (2005). Clarifying
International Ethical Guidelines for Biomedical Research confusions about coercion. Hastings Cent Rep 35(5),
Involving Human Subjects. Geneva: CIOMS. 16–19.
Emanuel, E. J., Grady, C., Crouch, R. A., et al. (2008). The International Association for the Study of Pain. Ethical
Oxford Textbook of Clinical Research Ethics. Oxford, Guidelines for Pain Research in Humans. http://www.
New York: Oxford University Press. iasp-pain.org.

198
 Section 4
1 Research
section 1 and publication
Chapter

33
Quality improvement initiatives:
when is quality improvement actually
a form of human subjects research?
Michael A. Rie and  W. Andrew Kofke

The Case professional process review would translate into pro-

spective preventive improvements for future patients
Suarez et al. published an article in the Journal of Neuro­
within the department’s practice of anesthesia was sys-
surgery examining outcomes after human albumin (HA)
administration in patients with subarachnoid hemorrhage
tematically lacking.
(SAH).1 Because some believed that HA increased mortal- QI/QA has evolved from an informal retrospective
ity in critically ill patients, the authors’ hospital developed review of individual cases involving critical incidents,
an administrative policy restricting its use. The authors to large retrospective analyses and evaluation of physi-
examined patient outcomes and costs before and after the cians, departments, hospitals, and healthcare systems.
introduction of the restriction. They concluded that admin- Increasingly, the impetus for projects and data collec-
istration of human albumin after SAH probably improved tion has come from extramural demands to document
clinical outcomes and reduced hospital costs. accountability for care, safety, quality, efficiency, and
Critics argued that the decision to change the “stand- cost in all of medical care.
ard of care” with regard to human albumin administration The root cause of nonaccountability was evident.
failed to take into account animal data suggesting that albu-
The victim of a prior sentinel event had been possibly
min might be neuroprotective in patients with SAH. They
charged that patients had been subjected to a change in the
unintentionally injured or suffered a “near miss,” and
“standard of care” because of a corporate cost containment a negligence action in malpractice law was a possible
activity that could be “more accurately described as a system consequence. Systemic analysis of quality is now recog-
level ‘experiment’ with the dual hypothesis of no harm and nized as a management necessity to address and distin-
less cost.” Furthermore, it was an experiment “in which no guish system error from individual professional errors
disclosure occurred, nor was informed consent obtained in and/or patient idiosyncratic events. Thus, the incorp-
an institution receiving federal funds for both patient care oration of such study into “research subject protection
and clinical research. The critics questioned who would vol- ethics” became unavoidable.
untarily submit to an experiment with “the main depend- The regulatory structure in the CFR and the
ent variables being money saved and increased morbidity powers invested in the Office for Human Subjects
and death rate.”2,3
Research Protections (OHRP) inevitably came into
operational inquiry for QI projects. The realization
Quality assurance and quality that system errors could produce as many as 100 000
errors of preventable nature per year came to public
improvement attention.*5 Shortly thereafter the Joint Commission
In 1980, Donabedian defined the basic elements for Accreditation of Health Care Organizations
of healthcare quality to be structure, process and (JCAHO) published its first Sentinel Event Chapter for
outcome.*4 Early medical quality assurance (QA) was the accreditation standards for American hospitals.
handled in sentinel event case discussions as part of The stage was then set to revisit what QA and QI
anesthesia departmental conferences and possible patient subject protections might be. The world had
prospective prevention practice suggestions. The pro- moved before clinicians had from Phase I to Phases II
cess of quality improvement (QI) was informal, col- and III of quality improvement activities.6 These three
legial and educational. Accountability to assure that phases of QI are:

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
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(1)  Reactive or descriptive QI: react to sentinel events. Critical care professionals work in complex organ-
(2) Outcome improvement QI: improve an already izational environments in which documentation of
satisfactory outcome. negative outcome data for safety and quality purposes
(3) Cost containment QI: improve efficiency leading pose risk for public discovery of the cases, negligence
to a satisfactory/better outcome. malpractice litigation, and conflict with hospital cor-
porate management. In many academic hospitals,
A decade of conflicting OHRP interpretations of qual- there is a formal organizational structure in which the
ity improvement research leaves QI project directors medical faculty is employed by corporate entities dir-
and institutional review boards (IRBs) predictably con- ectly linked with hospital management and budget dir-
fused. When is patient consent prospectively necessary ectors, creating intractable conflicts of interest.
for a QI process? Can patients be potentially injured by Thus, there exists a culture of silence in advancing
delayed reporting of important data if medical publish- QI initiatives driven by cost containment. These pro-
ers reject reports for lack of IRB approvals? The com- fessionals are in an untenable master–servant relation-
bined federal definitions of generalizable knowledge ship when they want to report negative (as opposed to
and publication cover virtually all conceivable pro- positive) data necessary for the advancement of medi-
spective activities that a QI project might encompass cine, science, and the public welfare.
while leaving uncertain the nature of exempt “minimal
risk” projects. Is patient safety and professional integrity threatened
The practice of population-based cost containment
by state interests?
QI initiatives is widespread in healthcare. It is apparent
that lessons from the business model (e.g., widget fac- In the Suarez matter more than 25 years of animal exper-
tory) are also commonly applied to patient care. But, iments supported the use of human serum albumin to
unlike patients, widgets are not invested with contrac- diminish intracranial ischemia and stroke propaga-
tual healthcare rights. tion in patients with ruptured cerebral aneurysms. A
fundamental principle of the Nuremberg Code is that
human experimentation should be based on previous
Is patient safety and quality being compromised animal experiments, and that experiments that pose
by cost containment? risk of serious injury to human subjects cannot be eth-
In the situation described by Suarez, the hospital ically conducted. The publication by Suarez led to the
imposed clinical research on a population of patients awarding of an NIH research grant regarding the use of
presenting with SAH, with the primary goal of redu- human albumin in patients with ischemic stroke, and a
cing costs and the belief, but no proof, that no adverse national multi-center trial was initiated.
change in clinical outcome would occur. Unfortunately, The Suarez matter further reveals “the moral abuse
they have demonstrated the very nature of research of evidence-based medicine” (EBM) in the pursuit of
itself: a hypothesis cannot a priori state the outcome cost containment. The vast majority of treatments uti-
of the research in a specific group of patients until the lized in critical care medicine lack level I and II evi-
data are analyzed after the experiment is over. dence to support them. To suggest (via a pharmacy and
The publication and responses to the Suarez scen- therapeutics committee) that such a lack of evidence
ario command a unique position in academic medical may mandate banning of a pharmaceutical in contra-
publication morality. If negative outcomes occur by diction of what is thought to be an existent standard of
corporate actions, then how are critical care practi- care without evidence-based support is to use EBM in a
tioners able to speak and professionally publish such fashion antithetical to the welfare of patients and their
data? How do they assure that lessons learned from abilities to participate or decline cost-driven corporate
negative outcomes in one institution are promul- experimentation. Conversely, because there was insuf-
gated to prevent the same mistakes in other hospitals? ficient evidence to warrant the use of serum albumin,
One could argue that any information derived from policy makers might argue for albumin’s elimination
a negative outcome QI study should be mandated for and say that the patients were not given an appropriate
generalization as a matter of organizational ethics. A consent option to decline serum albumin because it was
similar public safety nondisclosure issue in publica- an unproven therapy. Generalization of this approach
tion occurred in aviation safety, resulting in an airliner throughout the healthcare system might drive a cost-
crash into a mountain.7 containment-driven wedge into the fiduciary trust
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relationships that are the legal and moral bases for the concerns for governmental control of professional free
delivery of individual healthcare. speech in publication by healthcare investigators and
QI data analysts. As Bosk et al.*8 point out, the art of
Should we simply eliminate therapies that do not have medicine will be more complex and costly in achieving
sufficient evidence-based support? true improvement than Gawande’s sensational exposé
It is quite a different matter to delay FDA approval for on checklists.9
new therapeutics that are of unproven benefit than to
proscribe historically based treatments until better What should be the responsibility of IRBs
ones are found. Were this a reality, digoxin might never
have entered the pharmacopeia and both the FDA and
with regard to QI initiatives?
physicians everywhere have been negligent in continu- Many cost-containment activities occasioned either by
ing to use it. professionals or hospital corporations constitute human
The Suarez matter was referred to the OHRP for experimentation by accidental but predictable intent.*10
review. Their response was: Such activities demand vigorous scientific peer review
“… it appears that the restriction on the administration and some form of independent extramural funded eth-
of the human albumin by the University Hospitals in ical oversight beyond hospital control under the exist-
Cleveland was not research as defined by federal regula- ing rule of law. Unfortunately, the most comprehensive
tions at 45CFR 46.102 … from the information submitted review on this subject proposes only an extension of the
to OHRP it appears that the hospital’s restrictions on the existent IRB structure called a QI-IRB to perform the
administration on human albumin was not a systematic determination of exempt or non-exempt study for con-
investigation and was designed to reduce hospital costs sent procedures.11 Keeping such activities within hos-
and perhaps reduce morbidity.” pital management that has a cost containment integrity
We interpreted this OHRP response in the Suarez conflict related to the care of individuals and its public
­matter to indicate that the federal government pres- mission is not likely to prove legally or morally accept-
ently has neither legal interest nor congressional man- able in the long run. In Sabin’s “Accountability for
date to ensure that a return to pre–Nuremberg Code Reasonableness” illustration, there is diminishing fidel-
practices does not develop in the practice of QI in the ity to individuals as decision-making occurs increas-
United States. ingly in boardrooms rather than exam rooms, and
As rationing becomes reality, the IRB will increas- diminishing stewardship of resources as the focus on
ingly be perceived to be under corporate economic individuals increases (Fig. 33.1).
pressure, although the converse may be as likely. This
would place upon the QI-IRB of the future an apparent The Electronic Medical Record (EMR), QI
moral and legal conflict of interest concerning human
subject protection. It seems that conflict for profession- initiatives and privacy issues
als, IRBs, and corporate officials will be unavoidable As the US prepares for healthcare reform, the 2009
if negative outcomes derived from cost containment Emergency Federal Relief Budget and The Health
quality improvement activities of the institution were Information Technology for Economic and Clinical
never subject to human subject protections by inde- Health Act allocated 19 billion dollars for electronic
pendent review. medical records (EMRs) for patients in every phys-
The OHRP has reduced the definition of research ician’s office and acute care hospital by 2014.12 Already,
for QI in such a fashion as to deputize itself as final 1.4 billion dollars have been spent to develop regional
arbiter of what systematic clinical observations may federal extension centers to assist providers in creating
be lawfully permitted publication. A former editor of the EMR and its local integrated development.
the Annals of Internal Medicine, Dr. Frank Davidoff, Defining a “recompensible EMR” and requirements
has stated publically, “you can be punished if you try to for integrated connectivity upon manufacturers of
publish the results of your QI work but you will avoid hardware and software for local and national databases
punishment if that same work goes unpublished.” is a first step to future QI evaluation projects using the
The coming of healthcare reform and height- EMR. QI analysts in the “reform era” and health system
ened concerns for patient privacy with the explosion leaders await these definitions to produce the “data-
of ­clinical information technology will now awaken driven cultural change” of healthcare delivery.

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 Section 4. Research and publication

A framework for applying decrements in the quality and accessibility of care?”

accountability for reasonableness
Contemporary EMRs provide major cost savings and
Individual Exam revenue enhancements for billing and coding sys-
focus room
tems integrated into provider payments.13 Physicians
Fidelity clearly see computers as helpful when they facilitate
rapid access to laboratory data and imaging diagnos-
tic results. What has proved burdensome to patients
and professionals is the time needed to properly enter
Population Boardroom computerized physician order entry (CPOE) and the
Stewardship
focus nonmonetarized costs of added professional time.
Users of hospital computer information systems
Figure 33.1. Reproduced by permission from J. Sabin. Cost-containment ethics requires
fiduciary trust of both physicians and institutions to disclose their summative integrity for
need ongoing real-time transparent flowcharts for
patient care under rationing policies. ICU, emergency room, operating suites, and proced-
ure area patients on hospital-based computers. The
QI projects in this new world require new ethical/ records must fulfill the seamless availability of ongoing
legal regulatory architecture. If there is to be privacy minute-to-minute flow sheets to facilitate information
and confidentiality of shared information between transfer across shifts of individuals and nursing per-
patients and providers, then the Office of the National sonnel to physicians. If these flow records cannot meet
Coordinator for Health Care Information Technology these standards of clinical necessity, they should be
(ONC) should publish the specifics of lawfully main- accounted for as quality and safety decrements in per-
taining that privacy. QI activities requiring both col- formance evaluation.
lection and transparent data dissemination will be in Future QI ethics projects will be more easily under-
conflict with existent regulations of the OHRP placed stood and rewarded when efficiency is properly meas-
on present-day IRBs. ured and held financially accountable to maximize
Plans to define efficiency and quality value perform- professional quality/time inputs and outputs.
ance will be morally challenged if quality measures A primary care physician in a remote office will
defining payment of institutions and physicians are need the same enhanced EMR time maximizing effi-
recognized as social policy experimentation that vio- ciency. Leveraging system productivity requires funded
lates the existent Code of Federal Regulations (CFR). connectivity telemedicine applications in offices and
Such policy questions require review and revision of the patient residential sites that will permit physician
Belmont Report structure for QI organizational eth- extenders to leverage and maximize higher complexity
ics and law interpretations, since such issues were not decision-making activity by primary care physicians
existent when the Belmont Report was issued in 1979. liberated from present-day documentation inefficien-
Defining “meaningful usage” of the EMR in national cies. Primary care physicians will need swift telemedi-
health policy awaits the necessary regulatory revision. cine consultation with specialists when necessary to
These conceptual issues are the major unknowns for efficiently solve chronic disease management issues in
people conducting QI activities in anesthesiology and the home setting to prevent additional hospitalizations.
acute care hospital medicine. Resolving these unknowns Meaningful usage criteria here should carry the ability
are prerequisite to integrating primary care and acute of the EMR to produce demonstrable cost savings and
care databases under healthcare reform. efficiency, on the one hand, while providing negative
At the operational level, QI project design efficiency documentation of redundant functions not
needs concrete definitions of “meaningful usage.”12 captured in deficient EMR hardware and software on
Meaningful QI projects need meaningful end-point the other.
definitions of quality in order to define enhanced pay- Other nations have been implementing EMR
ments to providers to accomplish those endpoints and integration with direct caregivers for several years.
to determine what performance data will be deemed Successful smaller nations have required local integra-
of lower payment priority. Detailed definitional output tion. Vast data composites to assess the national prod-
from ONC is an urgent emerging national QI priority. uctivity or net aggregate costs are a political imperative
At the most basic clinical level, QI projects must ask but will not offer a delivery cultural transformation.
“Will EMRs truly cut costs and find efficiencies without Smaller QI projects undertaken by QI analysts going

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forward will offer the necessary guidance to effect real 4*  Donabedian, A. (1980). Definition of Quality
change in individual services, hospitals and communi- and Approaches to Its Assessment. Ann Arbor,
ties as a whole. Thus, the data-driven EMR, defined as Michigan: Health Administration Press.
“meaningful usage” will be fundamental in illuminat- 5*  To Err Is Human. (1999). A Report of the Institute of
ing the legislative revision of CFRs and OHRP’s legal Medicine. Washington, DC: National Academy Press.
accountability in advancing efficiency, safety, quality, 6   Bellin, E. and Dubler, N.N. (2001). The quality
and privacy in clinical medicine. improvement–research divide and the need for external
oversight. Am J Public Health, 91(9), 1512–17.
Key points 7   Aviation Safety Network. http://aviation-safety.net/
database/record.php?id=19741201–0.
• QI/QA has evolved from an informal 8*  Bosk, C.L., Goeschel, C.A., and Pronovost, P.J. (2009).
retrospective review of critical incidents to The art of medicine: reality for checklists. Lancet, 374,
large retrospective analyses and evaluation 444–5.
of physicians, departments, hospitals and 9   Gawande, A. (2007). A life saving checklist. Opinion,
healthcare systems. New York Times December 30. Available at www.
• These three phases of QI are: nytimes.com/2007/12/30/opinion/30gawande.html?/.
• Reactive or descriptive QI: react to sentinel 10* Kofke, W.A. and Rie, M.A. (2003). Research ethics and
events. law of healthcare system quality improvement: The
• Outcome improvement QI: improve an conflict of cost containment and quality. Crit Care Med,
31(Suppl), S143–52.
already satisfactory outcome.
11* Baily, M.A., Bottrell, M., Lynn, J., and Jennings, B.
• Cost containment QI: Improve efficiency
(2006). The ethics of using QI methods to improve
leading to a satisfactory/better outcome. quality and safety. Hastings Cent Rep, 36, S1–40.
• Some forms of QI activity actually represent 12   http://healthit.hhs.gov/.
human subjects research, with potential
13  Haig, S. Electronic records: will they really
for patient harm. As such, similar ethical cut costs?. http://www.time.com/time/health/
imperatives should apply in protecting patients article/0,8599,1883002,00.html/.
from unconsented research when QI initiatives
involve significant changes in patient care.
• As rationing and cost-containment efforts
Further reading
increase, IRBs may come under increasing Childress, J.F., Meslin, E.M., and Shapiro, H.T. (2005).
Belmont Revisited. Washington, DC: Georgetown
pressure, and therefore experience conflicts
University Press (p.vii).
of interest, with regard to evaluation of cost-
containment QI activities. Grady, C. (2007). Quality improvement and ethical
oversight. Ann Int Med, 146(9), 680–1.
• The Electronic Medical Record (EMR) carries
powerful potential as a tool in QI and cost- Miller, F. and Emanuel, E. (2008). Quality improvement
research and informed consent. NEJM, 358(8), 765–7.
containment efforts. Use of patient records
carries risk for future privacy conflicts Rie, M.A. and Kofke, W.A. (2007). Non-therapeutic
necessitating revision of the CFR and OHRP’s quality improvement: The conflict of organizational
ethics and societal rule of law. Crit Care Med,
regulatory authority in federal policy creation.
35 (Suppl), S66–84.
Rodwin, M.A. (1993). Medicine, Money and Morals:
Physicians’ Conflicts of Interest. New York:
References Oxford University Press.
1   Suarez, J.I., Shannon, L., Zaidat, O.O., et al. (2004). Effect Tapp, L., Edwards, A., Elwyn, G., et al. (2010). Quality
of human albumin administration on clinical outcome and improvement in general practice: enabling general
hospital cost in patients with subarachnoid hemorrhage. practitioners to judge ethical dilemmas. J Med Ethics,
J Neurosurg, 100, 585–90. 36(3), 184–8.
2   Heros, R. (2004). Fluid management. J Neurosurg, 100, US Department of Health Education and Welfare. (1979).
581–2. Protection of human subjects: Belmont Report. Ethical
3   Rie, M.A., Fahy, B.G., and Kofke, W.A. (2005). Human principles and guidelines for the protection of human
serum albumin. J Neurosurg, 101, 564–6; author reply 566. subjects of research. Fed Reg, 44, 23192–7.
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1 Research and publication section 1
Chapter

34
Conflicts of interest in research funding
Michael Nurok and Carl C. Hug, Jr.

The Case would have to dismiss members of her laboratory because

no other future funding is envisaged. The economy is slow
An academic physician has a long history of receiving and two members of her laboratory are the sole support of
industry support for clinical research on a medication that their families.
she had helped to develop. The university sold the patent
rights to a local biotechnology company. The company is The United States Institute of Medicine defined con­flict
small but rapidly growing, and the physician knows most of interest as:
of the founding members. She and her husband are friendly Circumstances that create a risk that professional judg-
with the Chief Executive Officer, and their children attend ments or actions regarding a primary interest will be unduly
the same school along with children of other company influenced by a secondary interest. 1
members.
The report defines primary interest as promoting and
To date, clinical reports have supported the new drug
protecting the integrity of research, the quality of med-
as superior to the much less costly and generically available
alternative. But data analysis from her recent clinical trial ical education, and the welfare of patients. Secondary
yields no statistical difference between the two products. interests are listed as financial, the pursuit of profes-
She discusses her findings with members of the sponsoring sional advancement and recognition, and the desire to
biotechnology company, and they suggest that she allow one do favors for friends, family, students, or colleagues.
of their statisticians to check the results. A number of different sources of potential conflicts
The company’s statistician segregates the study popula- of interest can be identified in the introductory case.
tion according to age and finds that there is greater vari- These can be divided between financial and non-finan-
ability in the group less than 40 years of age. He then repeats cial conflicts.
the standard statistical test after omitting the under 40 There is a risk that the physician’s professional judg-
group and shows a clear statistical difference in favor of the
ments or actions with respect to her duty to promote
new drug. Reanalysis of the data for the entire group with
and protect the integrity of research could be unduly
a novel statistical test also shows a definite benefit for the
new product compared to the generic drug. A statistician influenced by the following financial motivations:
at the university tells the physician that the novel statistical • Reliance on the company for partial support of her
test was done correctly, but points out that this is an unu- salary.
sual – but not incorrect – statistical test to apply to this body • Reliance on the company for financial support of
of data. Because it is very important to prospective inves- her laboratory.
tors, the company officers urge that the positive data based
only on the novel statistical method be published as soon Sources of non-financial conflict exist with respect to
as possible. this physician and include:
The investigator is an associate professor at the uni- • Desire for publication of positive findings to
versity and, with one additional peer-reviewed publica- facilitate academic promotion.
tion, feels confident that her promotion to professor will go • Personal and spousal relationships with members
through. She knows that her chances of publishing a paper
of the biotechnology firm and its CEO.
on the study are greatly increased if the study findings are
positive. In addition, she is in discussion with the biotech- • Children’s social relationships with company
nology company about funding a large project to develop members’ children.
another drug. Without this funding she would be required • Sense of responsibility towards members of her
to do more clinical work to support her salary and probably laboratory in regard to continued employment.

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
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 Chapter 34. Conflicts of interest: research funding

Discussions of financial conflicts of interest tend to be increase profits through various mechanisms such as
based on certain assumptions. Stossel2 describes these controlling the use of data concerning their products.3
as beliefs that: A 2003 meta-analysis found that industry-associated
(1)  Academic–industrial relationships promote clinical trials were significantly more likely to report
research misconduct. product-favorable results than those in which industry
(2)  Commercial intrusion leads to subtle or overt bias relationships did not exist.4
in the interpretation of research data, limitations Contracts between industry and academic institu-
of academic freedom, degradation of quality of tions have included restrictions on the publication and
research, and violation of important research other use of data without advance permission of the
values. sponsor. Examples of the various contractual provi-
(3)  If commercial intrusions even appear to sions related to publications of industry-sponsored tri-
compromise scientific integrity, public trust in als were published in 2005.5 A minority of institutions
and support for research will be eroded. allowed sponsors to decide whether a study should or
should not be published. Many institutions allowed
Stossel also points out that there is little empiric evi- contractual provisions to permit the sponsor to insert
dence to support these assumptions. Many point to the its own statistical analysis, and sometimes even to draft
positive effects on medical innovation that academic the manuscript.
relationships with industry have produced in contrast Conflicts of interest are not just limited to research-
to the often-noted theoretical effects of conflicts of ers. In a recent study, 94% of physicians reported
interest. Nevertheless, potential conflicts are apparent some sort of relationship with industry. Interestingly,
in the above scenario and are common in the practice anesthesiologists were less likely to have received
of academic medicine. The most concerning effect of a samples, reimbursements, or payments than were
financially motivated conflict of interest is that it may family practitioners, internists, pediatricians, car-
introduce bias into science and medicine. diologists or general surgeons who write more pre-
The clinician investigator in this case has a number scriptions for long-term use of drugs.6 Psychiatrists
of potent incentives to publish positive findings of have been a major focus of the investigations by US
the trial using the novel statistical test. She would Senator Charles E. Grassley (R-Iowa), a sponsor of
please the pharmaceutical company and enhance The Physician Payment Sunshine Act, 2009 (S.301).
her ability to receive further research funding from Despite evidence to support public concern regard-
the company. She would likely acquire the additional ing conflicts of interest, with the exception of isolated
publication needed to be promoted. The social prob- cases, little evidence points towards actual harm hav-
lems that may arise between her family members and ing been caused by conflicts.
their network of friends would be avoided. In addi- Physicians have multiple loyalties, interests, and
tion, if her laboratory is funded, all of her employees obligations that go beyond their professional role.
would retain their jobs. These relationships lead to the potential for competing
Disincentives to using the novel statistical test and interests that are non-financial in their nature. Non-
publishing the positive findings include the risk to her financial conflicts – although inherent to research and
reputation as an investigator and the increased costs of the practice of medicine – are more difficult to manage.
health care resulting from reliance on her study as sup- Critics who perceive the focus on financial conflicts to
port for prescribing the drug in question. More broadly, be overzealous, have argued that industry is subject
maintaining the public’s trust in research is critical to to scrutiny by the FDA and other regulatory bodies
ensuring participation in studies that may lead to new whereas academics are not.
medical breakthroughs and also to ensuring faith in Because the potential for nonfinancial conflicts
science and medicine. Using only the novel statistical is so ubiquitous, it is a challenging subject to study
test risks jeopardizing this trust. and there are far fewer data to assess their impact.
A number of facts support the concerns that finan- Ideally, nonfinancial conflicts should be disclosed and
cial conflicts influence the integrity of medical research. acknowledged. However, criteria for doing so have not
Corporations in general, and industry and drug com- been established, and further research is needed to
panies in particular, are focused on their responsibil- determine the magnitude of the problem and its con-
ity to stockholders and some have acted aggressively to sequent effects.7

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 Section 4. Research and publication

Recommendations powered clinical trial in an attempt to answer the ques-

tion definitively.
Several options are open to the academic clinician in
this case. Option 5
Option 1 The clinician may choose to publish using only data
from the over 40 groups which represent the vast
The clinician may chose to publish using only the novel
majority of people for whom the new drug would
statistical test and to make the raw data from her study
be prescribed. This approach is neither scientifically
available online. This puts any uncertainty about the
nor ethically appropriate because it is misleading and
findings into the public domain and renders it avail-
motivated by conflicting interests. It exposes the clini-
able for transparent discussion and debate in addition
cian to the lowest risk of adverse financial, social and
to allowing other statistical analysis based on the raw
professional consequences of all options at the cost of
data. The industry sponsor may not like this approach;
jeopardizing her professional reputation with respect
however, it would most likely be better received by
to the duty to promote and protect the integrity of
the company officers than Option 2. In addition, this
research.
approach would mitigate the social and professional
risks discussed previously. An ethically defensible
argument for this approach is that the novel statistical
Mitigating conflicts of interest
The potential for conflicts of interest can never be
test is not inaccurate, simply unusual.
eliminated, but conflicts of interest can be managed
Option 2 and, in some cases, reduced. Strategies for doing so are
The clinician may choose to use only the conventional most useful when they are matters of institutional and
statistical test and attempt to publish the negative find- editorial policies that are focused on preventing the
ings of her results along with the raw data from her adverse effects of conflict of interest and are not unduly
study. This approach may be difficult to achieve if the burdensome.
contract with the sponsor specifies limits on publi- The first and most common step in managing con-
cation without the sponsor’s approval. In addition, flicts involves disclosure. Following recent scandals in
this option may antagonize the industry sponsor and the United States, several institutions are voluntarily
expose the researcher to many of the social and pro- publishing information regarding conflicts of interest
fessional risks noted above. Another important risk of online.8 Agreement is needed on criteria and thresh-
this approach is that, if the conventional test is provid- olds for disclosure. Another mechanism for managing
ing a false-negative result, use of this test may lead to conflicts is monitoring of research by independent
the product being abandoned when it could provide a bodies, and public disclosure of raw scientific data.
clinically important benefit. Placing the raw data in the This step would help prevent (by functioning as a deter-
public domain may mitigate this risk. rent) or detect the most concerning effect of conflicts of
interest – the introduction of bias. Research on other
Option 3 mechanisms for preventing bias is needed.
The clinician may chose not to publish any results Managing financial and other types of conflicts
from her study. This is an ethically acceptable stance of interest extend beyond the individual investigator
provided that the clinician is motivated by genuine to the academic institutions themselves, because the
uncertainty regarding her results in the face of oppos- institutions have become dependent on research pro-
ing statistical interpretations. This stance is harder to ductivity, scientific, and medical advancements for
justify if it is motivated by avoiding the social and pro- their financial well-being and enhancement of their
fessional conflicts brought about by her predicament. reputations.9 The American Bayh-Dole Act of 1980
In addition, this approach means that data from her (pub L. No. 96–517) and the Federal Transfer Act of
study are not available in the public domain. 1986 (Pub L. No. 99–502) provided strong incentives
to investigators and institutions to patent findings of
Option 4 publicly funded research, and led to an explosion of
The clinician may choose to apply for additional fund- academic–industry interactions highlighting that
ing either (1) to expand the number of patients in academia and industry have different as well as com-
the under 40 group; or (2) to conduct another, better mon interests (Table 34.1).

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Table 34.1. Diverse and common interests of academic anesthesiology and industry

Academic Anesthesiology → Common Interests ←Industry

Incentives Professional recognition •  New knowledge •  Attract Customers
•  Promotion •  Researchand Development •  Attract Investors
•  Increased income •  Improved Quality of Life •  Increased Valuation
•  Increased resources •  ImprovedPatient Care and •  Pay Dividends and Bonuses
•  Research space Safety
•  Assistants
•  Increasedextracurricular
activities
•  Lectures
•  Consulting
•  Prestige
Methods •  Financial support •  Attract bright people •  Operations
•  Mentors •  Find experts •  Build facilities
•  Space, Staff •  Recognizeneed and find •  Hire Staff
•  Equipment, Supplies solution •  Obtain Approvals FDA
•  Travel, publications •  Develop products •  Advertise
•  Publication •  Collaboration •  Selling ideas and products
•  “Selling” ideas •  Promoteideas and •  Public media
products •  Annual reports
•  Journals
•  Meetings(CME and
social)
•  Mailings
•  Personal contacts
Resources •  Grants •  Investors
•  University •  Sales
•  Foundations
•  Industry
•  Government
Checks •  IRBs •  Ethics, morals •  Government regulations
and •  Research •  Individual •  Negative publicity
Balances •  Human, clinical •  Institutional •  Lawsuits
•  Animal •  Legal actions
•  Compliance, •  Public censure
regulations
•  Peer review
•  Grant applications
•  Publications
•  Misconduct Reports

Policies and guidance on conflicts of interest are Key points

changing rapidly. The United States the National
Institutes of Health10 and the Department of Health • One of the most harmful adverse
and Human Services Office of Human Research consequences of conflicts of interest in
Protection offer updated guidelines.11 In the United research is the potential introduction of
Kingdom, the General Medical Council offers such bias into the science of medicine and the
guidance.12
207
 Section 4. Research and publication

biomedical research: a systematic review. JAMA, 289,

denigration of the integrity of scientific
454–65.
research.
5*  Mello, M.M., Clarridge, B.R., and Studdert, D.M.
• The potential for conflicts of interest in (2005). Academic medical centers’ standards for
research can never be eliminated, but can be clinical-trial agreements with industry. N Engl J Med,
managed, and in many cases reduced. 352, 2202–10.
• Strategies for reducing conflicts of interest in 6*  Campbell, E.G., Gruen, R.L., Mountford, J., et al.
research are most effective if they involve clear (2007). A national survey of physician–industry
institutional and editorial policies. relationships. N Engl J Med, 356, 1742–50.
• Disclosure is the most common first step in 7*  The PLoS Medicine Editors. (2008). Making Sense
managing conflicts of interest. of Non-Financial Competing Interests. PLoS Med
• Public disclosure of raw scientific data and 5(9): e199. doi:10.1371/journal.pmed.0050199
independent monitoring of research are 8*  Steinbrook, R. (2009). Online disclosure of physician–
additional mechanisms for managing conflicts industry relationships. N Engl J Med, 360, 325–7.
of interest. 9*  Johns, M.M.E., Barnes, M., and Florencio, P.S. (2003).
Restoring balance to industry–academia relationships
in an era of institutional financial conflicts of interest.
Promoting research while maintaining trust. JAMA,
References 289 (6), 741–6.
10  NIH Guidelines. (Accessed 2 April 2009, at http://
1*  Institute of Medicine. (2009). Conflict of Interest in
grants.nih.gov/grants/policy/coi/.)
Medical Research, Education, and Practice. Washington,
DC: National Academies Press. 11  DHHS Guidelines. (Accessed 2 April 2009, at http://
www.dhhs.gov/ohrp/special/conflict.html.)
2*  Stossel, T.P. (2005). Regulating academic-industrial
research relationships – solving problems or stifling 12  GMC Guidelines. (Accessed 2 April 2009, at http://
progress? N Engl J Med, 353, 1060–5. www.gmc-uk.org/guidance/current/library/conflicts_
of_interest.asp#1.)
3*  Angell, M. (2004). The Truth about the Drug
Companies: How They Deceive Us and What to Do about
It. 1st edn. New York: Random House. Further reading
4*  Bekelman, J.E., Li, Y., and Gross, C.P. (2003). Scope Levinsky, N.G. (2002). Nonfinancial conflicts of interest in
and impact of financial conflicts of interest in research. N Engl J Med, 347, 759–61.

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 Section 4
1 Research and publication section 1
Chapter

35
Publication ethics: obligations of authors,
peer-reviewers, and editors
Gail A. Van Norman and Stephen Jackson

The Case ethical obligations on the part of reviewers, editors,

and publishers. Fraudulent research and publication
An anesthesia pain management researcher submits
practices divert the search for truth, and corrupt the
abstracts for two studies. It is discovered that he did not
obtain prior approval for human subjects research. In add-
medical literature.
ition, a colleague finds he is listed as a co-author on one of Publication also serves other critical processes in
the studies, although he did not participate in the research. promoting the integrity and efficacy of the medical
Investigation reveals that the anesthesiologist had fab- profession, and thereby in promoting patient well-
ricated data in some or all of 21 published studies dating being. Scientific enterprise is built on a foundation
back over 13 years. This uncovered what arguably is one of of trust. “If science is to flourish and attain its appro-
the most wide-ranging research fraud cases in history. His priate role in aiding human progress, it is incumbent
reports had been favorable to several drugs under investi- upon…the scientific community to help provide a
gation as “replacements” for postoperative narcotic therapy, research environment that, through its adherence to
and also had refuted animal studies suggesting that one of high ethical standards…will attract and retain individ-
these medications interfered with bone healing after ortho-
uals of outstanding intellect and character.”3 Synthesis,
pedic surgery.
Not only are all of this researcher’s findings now in
debate, and discussion are all integral to the intellectual
question, but also those of numerous studies by other process required for analyzing and validating the rele-
investigators that relied upon these findings for subsequent vancy of scientific findings in the context of medical
research design and comparisons. A medical journal editor care. Medical publications educate physicians through
remarked that “these retractions clearly raise the possibility reviews and synopses of complex research findings,
that we might be heading in the wrong directions or toward distilled for application in clinical practice.
blind ends in attempts to improve pain therapy.”1 A prom- Publication is a critical part of academic medicine,
inent academic anesthesiologist stated that the fraudulent and sets scholarly work apart from the practice of medi-
research had affected “millions of patients worldwide,” and cine. Authorship is integral to obtaining credit for one’s
possibly led to the sale of “billions of dollars worth of poten- research, creative thoughts, and educational efforts,
tially dangerous drugs.”2
and it is essential for achieving a successful academic
Ethical principles of beneficence and nonmaleficence career. Publications influence promotions and can
require that physicians strive to improve medical affect recruitment opportunities and future research
knowledge to improve patients’ lives (beneficence) funding. As the gatekeepers to publication, reviewers
and avoid harmful or ineffective treatments (non- and editors wield power over whether academic credit
maleficence). Medical research seeks to find truths is justly apportioned, and thereby can affect academic
that support these principles, and medical literature careers. They also determine which research is “rele-
should be a map illuminating that search. The integ- vant” enough to see the light of publication, and may
rity of research involves more than simply the just and thereby indirectly determine which patient groups
honest conduction of research, but also honest and fair benefit from research efforts.
reporting and analysis of results, peer review, and pub-
lication of research findings. Investigators and authors Investigation of scientific fraud
have primacy over the ethical conduct and reporting Scientific misconduct is internationally recognized as
of research, but the publication process also involves a serious problem, but few countries have regulatory

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
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 Section 4. Research and publication

systems in place to evaluate scientific fraud. Widely authorship (the acceptance of credit for publications
publicized cases of scientific misconduct led the US written by another or the assignment of credit to a non-
Congress to establish the Office of Scientific Integrity author); and (5) redundant publication (the submis-
(later named the Office of Research Integrity, or ORI) sion of the same study in more than one publication,
in 1989. Denmark, Norway, Finland, and Sweden all or the deliberate splitting of results from one study into
established formal review councils in the early 1990s several publications).
to investigate scientific fraud. In the UK, medical fraud
is reported to the General Medical Council (GMC). A Fabrication and falsification of data
voluntary organization, the Committee on Publication
The harm caused by falsification and fabrication of data
Ethics (COPE), which includes publishers and edi-
is self-evident. False information may cause practition-
tors of over 300 journals in Europe and Asia, reviews
ers to expose patients to ineffective, or worse, harmful
instances of misconduct. However, it functions as an
treatments. Other researchers may be diverted from
advisory body and cannot apply sanctions. Other coun-
productive paths of inquiry in the pursuit of fictional
tries calling for institutional or other reviews and sanc-
results. One study of researchers suggests that nearly
tions include Canada, Japan, India, Croatia, Germany,
2% admit to at least one career episode of fabricating,
and China, although none has regulatory agencies.4
falsifying or modifying data. However, when asked
In practice, the reporting, investigation, and (poten-
about the behavior of colleagues, about 14% admitted
tial) sanctioning of fraudulent research and publication
to knowing of falsifications. Medical and pharmaco-
practices falls largely to professional peers, individual
logical researchers more frequently report misconduct
institutions, and the actions of journal reviewers and
than other researchers.6 Another study confirmed
editors.
these discouraging results, finding that 4.7% of authors
surveyed stated they had participated in research that
Ethical obligations of authorship involved fabrication or misrepresentation. In only
about half of cases had the misconduct ever been dis-
and author misconduct covered. Over 17% of the authors indicated that they
The International Committee of Medical Journal knew of instances of falsification, fabrication or mis-
Editors (ICMJE) defines an author as one who has leading reporting involving other academics. In a large
made substantial contributions in all of the following proportion of these cases, the conduct also remains
areas: concept, design and acquisition of data or ana- undiscovered, suggesting that the authors themselves
lysis and interpretation of data, drafting or critical had not reported the misconduct.7
revision of the publication, and final approval of the
version that is published.5 Plagiarism: theft of intellectual property, or
Medical authors have ethical obligations of veracity,
or to be truthful and nonmanipulative, in the reporting the sincerest form of flattery?
of research results. In addition, authors have obliga- A basic definition of plagiarism is the appropriation
tions to be just in allocating credit for what often is a of someone else’s words and/or ideas as one’s own. It
collaborative effort among colleagues. Author miscon- is nearly always wrong,a because it damages the true
duct has the potential to cause detrimental treatment author (by denying credit and disrespecting their
of patients, as well as to mislead other researchers in the efforts), it harms readers (by deceiving them, and by
construction and implementation of their subsequent making it harder for them to trace the true route by
research designs. It also may harm academic colleagues which an idea was developed) and it accumulates ben-
by failing to properly credit their work, or by inappro- efits to the undeserving (the plagiarist). Plagiarism
priately crediting them with work they did not do. raises questions of trust in scholarly work: if an author
Types of author misconduct in research publica- copies some material, how do we know they didn’t copy
tion include, but are not limited to: (1) fabrication (the something else?
invention of false results); (2) falsification (the manipu- A review conducted at Harvard found that com-
lation or omission of critical data so as to inaccurately plaints over medical authorship, including the
represent the research record or results); (3) plagiarism ­plundering of noncredited work of junior academi-
(appropriation of another’s ideas, processes, results cians, had more than quadrupled over a period of one
or words without appropriate attribution); (4) ghost ­decade. A larger total proportion of complaints came

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 Chapter 35. Publication ethics

from females, although they represented a minority of use similar styles and wording in different venues
the academic population. There was also a trend toward to express particularly important concepts, sim-
more complaints from non-US citizens,8 suggesting ply because repetition also represents emphasis, and
that plagiarism may more often “victimize” academ- thereby underscores an idea’s importance.14 The self-
ically vulnerable populations. A notorious example of plagiarist is not stealing original ideas or words from
scientific plagiarism is the surreptitious acquisition by anyone else. Publishers have reason to expect that
Watson and Crick of unpublished data, “photograph their copyrights will be honored, but concerns about
51,” from Rosalind Franklin’s research on DNA struc- the integrity of the scholarly work itself appear to be
ture as well as of a confidential research progress report less serious in such cases.
about her work. Both elements were essential to their
development of the double helix model.9,10 Crick later Redundant publication
acknowledged that their work was based on Franklin’s
Redundant publication includes the practice of pub-
data in 1961, sadly 3 years after her death.11
lishing the same results in different journals, publish-
Plagiarism violates ethical principles of nonmalefi-
ing a review of those results nearly simultaneously in a
cence and justice. While it is easy to condemn plagiar-
different journal, or splitting a study into two or more
ism, it nonetheless is technically challenging to identify
parts to publish in separate journals. While the last
precisely what constitutes plagiarism. It also is ques-
practice may be acceptable when a study involves large
tionable whether all forms of plagiarism are equally
populations studied over many years, overlapping or
culpable.
split manuscripts are usually not justified.
Words versus ideas Redundant publication may be undertaken to dis-
tort academic accomplishments in a “publish or perish”
The verbatim copying of an entire thesis of another is
system. Almost 1 in 20 scientists admit to publishing the
easy to identify as plagiarism, because it steals both
same data in two or more sources in order to enhance
the words and ideas that comprise the creative work of
their curriculum vitae.15 Some authors claim that
the original author. But words and ideas do not in all
they merely were trying to reach different audiences.
instances have similar weight in determining original-
However, duplicate publication has detrimental effects
ity. For example, a great love poem is not great because
that may be visited on patients, and on colleagues try-
of an original concept (love), but is exceptional for its
ing to sort through a mass of information for meaning-
expression of the concept. Paraphrasing such a poem
ful results. Redundancy adds inconsequential material
would not constitute plagiarism because it is the ori-
to the medical literature, may wrongly emphasize the
ginal wording that makes it unique. Bouville points
importance of findings, and burdens an already over-
out that science and scholarship, on the other hand,
laden publication review system.
are about new knowledge and ideas. “An experimental
result that is described using different words is not a
different result.”12 Therefore, in medicine and science, Ghost authorship and honorary authorship
the wording might be less important than the ideas that “Ghost writing” and “honorary” authorship both
the words convey in determining if a scientific thesis involve the improper attribution of authorship or
has been plagiarized. credit to someone who did not actually participate in
the research or the review and synthesis of ideas on
Is all plagiarism equally wrong? which a publication is based. “Ghost writing” is the
Is self-plagiarism (when an author makes duplicate practice of failing to name an individual who sub-
statements in two different publications) ethically as stantially contributed to a publication. The term often
concerning as plagiarizing the work of another? Self- refers to the practice of attaching a researcher’s name to
plagiarizing original research results is the same as a paper that was written by a professional writer who
redundant or duplicate publication and it is harmful in is not named. In “honorary authorship,” the name of
ways that are discussed below. But what about schol- (often) a senior academic is included among the true
arly reviews, synthesis, and opinion publications? authors although that academician did not have a prin-
Ideas can only be expressed in so many ways. While ciple role in the publication. Both of these practices are
some have labeled the practice “intentional fraud,”13 common. In one study, approximately 29% of articles
Chalmers points out that an author may deliberately had honorary authors, ghost authors, or both.16 In the

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 Section 4. Research and publication

case of industry-related trials, one study demonstrated carefully reading the article, or making mistakes of fact
a prevalence of ghost authorship approaching 91%.17 or reasoning in the review.19
Improperly assigning or concealing authorship
violates ethical guidelines for authorship, and is harm- Confidentiality and trust
ful to the medical publication process in a number of Reviewers are in a position of trust, receiving advance
ways. It may falsely elevate the perceived significance notice of potentially important discoveries prior to
and reliability of a study if well-respected researchers their publication. Breach of confidentiality exposes
are inappropriately credited with the findings. Ghost the author to the risks of plagiarism, and also to the
writing can hide conflicts of interest that may affect risks that commercially sensitive information could
the balance and veracity of the material presented – as, be inappropriately released, either to the public or to
for example, when the writer is a pharmaceutical com- investor interests. Examples of plagiarism and theft by
pany employee discussing an important new drug that peer reviewers, while not common, are not very difficult
the company is developing. Knowing the identities of to find.20 One-tenth of researchers who were surveyed
the true author(s) of a study is important with respect indicated they believed that a reviewer had deliberately
to both accountability, and also to the ability to retro- delayed approval of one of their manuscripts so that the
spectively examine results in light of new data, such as reviewer could publish an article on the same topic.19
newly recognized adverse outcomes. Basic trial data
can be difficult to review after the fact, particularly Respect and protection of dignity of colleagues
if the authors of the record did not write the original No author relishes a poor review or rejection, but sur-
report and no longer have access to original trial data.18 prisingly, abusive reviews, that is ones in which the
An author who knowingly agrees to allow his or her author, and not the idea, comes under attack, are not
name to be attached to work in which he/she did not uncommon.19 One article reports abusive reviewer
participate is engaging in an act of fraud. comments that included an unsupported accusation
that a new primary investigator had submitted a senior
researcher’s ideas as their own, a statement that revi-
Ethical obligations of peer reviewers sions to a paper should “start by burning the entire
Peer review is encountered throughout medicine. It manuscript,” and actual name calling.21 Clearly, peer
is used to judge clinical performance and quality out- reviewers have obligations not only to confine their cri-
come measures, as well as to determine the allocation of tiques to the manuscript, but also to respect the dignity
research grants and the quality of research design. It is of their colleagues, lest the peer review process become
also a key process in medical publications. Peer review mired in personal attacks and retributive behavior.
satisfies the practical need to determine if research and
reviews are well-designed, ethically executed, and pre-
sent significant new information that will lead to bet- Ethical obligations of journal editors
ter patient care. Peer review also serves professional Editors have considerable power: their decisions about
interests in maintaining autonomy within the specialty what gets published – whether research results, reviews
to evaluate professional performance. Peer reviewers or editorial opinion  – significantly impact percep-
have the power not only to impact career advancement tions and practice in medicine and medical research.
among authors, but also to directly affect which studies They control what criticisms may be launched against
and opinions find their way into the medical literature authors, and how authors may respond when criti-
and thereafter influence the practice of medicine. cized. As the ultimate gatekeepers on publication, they
hold considerable sway over academic careers. Despite
Expertise such influence, the ethical responsibilities of editors
Although it seems self-evident that peer review- only recently have been considered in depth.
ers require appropriate expertise in the field being In parallel to authors and peer reviewers, editors
reviewed, incompetent review is one of the most com- have ethical obligations to assure as far as possible that
mon complaints among researchers. More than 60% published material is accurate and not fraudulent, that
of researchers polled in one study indicated that they research adheres to ethical guidelines with regard to
had experienced incompetent reviews, defined as the protection of human and animal subjects, that confi-
reviewer being unfamiliar with the subject matter, not dentiality of manuscript submissions is maintained,

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 Chapter 35. Publication ethics

Table 35.1. Responsibilities of journal editors*

General responsibilities
•  Strive to meet the needs of readers and authors
•  Constantly improve the journal
•  Ensure the quality of published material
•  Champion freedom of expression
•  Maintain the integrity of the academic record
•  Preclude business needs from compromising intellectual standards
•  Willingly publish corrections, clarifications, retractions and apologies when needed
Relations to readers
•  Inform readers about who had funded research and the role of the funders in the research
Relations with authors
•  Ensure the quality of published materials, recognizing that journal and sections within journals have different aims
and standards
•  Decisions to accept or reject a paper should be based only on the paper’s importance, originality, and clarity, and
the study’s relevance to the journal
•  A description of the review process should be published and any deviation from the published process justified
•  There should be a declared mechanism for author appeal
•  There should be published guidelines of expectations to authors that are regularly updated
•  Acceptance of submissions should not be reversed except in cases where serious problems are identified
•  New editors should not overturn acceptances by previous editors unless serious problems are identified
Relations with reviewers
•  There should be published guidelines to reviewers of what is expected of them; these guidelines should be
regularly updated
•  Editors should assure that reviewers’ identities are protected unless they have an open review system that is
declared to authors and reviewers
The peer-review process
•  Systems should be in place to assure that submitted materials remain confidential while under review
Complaints
•  Editors should follow the COPE flowchart
•  Editors should respond promptly to complaints. Mechanisms for further management of complaints should be
published, and unresolved matters referred to COPE
Encouraging debate
•  Cogent criticisms of published works should be published unless there are convincing reasons why they cannot be.
•  Authors of criticized material should be given opportunity to respond
* summarized from the Committee on Publication Ethics
http:www.publicationethics.org/files/u2/New_Code.pdf.

and that any potential personal conflicts of interest are are proven. This is especially important if the reliabil-
avoided or at least made transparent. ity of data is in question, since erroneous or fraudu-
COPE has outlined a code of conduct for jour- lent results has ramifications for both patient care and
nal editors, listing essential responsibilities (see Table future research. Although the COPE published code
35.1). While much of this effort concentrated on the of conduct for editors charges them with retraction
administrative duties and transparency of medical of fraudulent or unethical research (see Table 35.2),
editorship, the code included important responsibil- barriers to such retractions may include protracted
ities to assure that allegations of misconduct are prop- investigation processes, author disagreement, threats
erly investigated. of litigation, and misunderstandings by editors them-
A critically important, and difficult responsibility selves of appropriate actions to take. COPE emphasizes
of medical editors is one of “cleansing” the medical that the purpose of retraction should always be correc-
literature when instances of publishing misconduct tion of the literature, and not punishment of the author,
213
 Section 4. Research and publication

Table 35.2. Guidelines for retracting articles*

Editors should consider retraction when

•  There is clear evidence that the findings are unreliable, due to misconduct or honest error
•  Findings have been previously published elsewhere without proper reference, permission or justification
•  The publication is plagiarized
•  The study reports unethical research
Editors should consider an expression of concern when
•  There is inconclusive evidence of research or publication misconduct
•  There is evidence the findings are unreliable, but the authors’ institution will not investigate
•  They believe an investigation into misconduct has not been – or would not be – fair and impartial, or conclusive
•  An investigation is underway, but judgement will not be available for a considerable time
Editors should consider issuing a correction when
•  A small portion of an otherwise reliable publication proves to be misleading
•  The author/contributor list is incorrect
Retractions are NOT usually appropriate if
•  A change of authorship is needed, but there is no reason to doubt the findings
Notices of Retraction should
•  Be linked to the retracted article electronically
•  Clearly identify the retracted article
•  State clearly that it is a retraction (i.e. not a correction or comment)
•  Be published promptly to minimize harms
•  Be freely available to all readers (i.e. not only available to subscribers)
•  State who is retracting the article
•  State the reasons for the retraction
•  Avoid statements that are potentially defamatory or libellous
* summarized from the COPE guidelines on retracting articles
http: publicationethics.org.

because problems in publishing can occur due to hon- Key points

est mistakes as well as willful misconduct. Investigation
and punishment are best referred back to the author’s • Publication serves physicians’ ethical duties
institution for further action. to improve medical knowledge, provide
continuing benefits to patients, and avoid
Case resolution harmful or ineffective treatment.
The introductory case is an example of fabrication • Publication is an integral part of academic
of data. Moreover, the anesthesiologist improperly medicine – crediting research, creative
involved an unknowing colleague in the fraud by thoughts, and educational efforts.
attaching his name to the research. The concerns about • Few regulatory bodies exist globally to
the anesthesiologist’s research were raised at his home investigate scientific fraud.
institution, which then notified journals in which his • Authors have ethical obligations to be truthful
publications appeared. All of the researcher’s articles regarding credit for the work and outcomes of
were retracted. However, “scrubbing” the literature of research.
all citations of this research as well as managing deriva- • Fabrication and falsification of data, plagiarism,
tive publications from related research is an ongoing misleading assignment of authorship and
task that may never be complete. The effects on patients redundant publications all are detrimental to
are unknown. Because the research results encouraged the mission of medical publication.
the use of medications that may have had ­detrimental • Peer reviewers have obligations to be
effects on bone healing, both physical and financial competent, fair, and balanced, and free of
harms to patients on a large scale remain possible.
214
 Chapter 35. Publication ethics

11  Zallen, D.T. (2003). Despite Franklin’s work, Wilkins

conflicts of interest in reviewing medical
earned his Nobel. Nature, 425(6951), 15.
manuscripts. Breaches of confidentiality and
12* Bouville, M. (2008). Plagiarism: words and ideas. Sci
abusive review tactics are not consistent with
Eng Ethics, 14, 311–22.
ethical review.
13  Editorial: Self-plagiarism: unintentional, harmless, or
• Journal editors have parallel responsibilities to fraud? (2009). Lancet, 374(9691), 664.
assure accuracy in the medical literature. They
14  Chalmer, I. (2009). Intentional self-plagiarism. Lancet,
have additional responsibilities to try to assure 374(9699), 1422.
that appropriate investigation occurs if fraud
15* Khanyile, T.D., Duma, S., Fakude, L.P., et al. (2006).
is suspected, and to retract suspect material Research integrity and misconduct: a clarification of
when it is discovered. the concepts. Curationis, 29(1), 40–5.
16  Flanagin, A., Carey, L.A., Fontanarosa, P.B., et al.
Notes (1998). Prevalence of articles with honorary authors
and ghost authors in peer-reviewed medical journals.
a
Authors’ comment: plagiarism that is encouraged and condoned
JAMA, 280(3), 222–4.
by the original author may not always be wrong.
17  Gotzsche, P.C., Hrobjartsson, A., Johansen, H.K.
et al. (2007). Ghost authorship in industry-initiated
References randomized trials. PLoS Med, 4, e19.
1   Winstein, K.J. and Armstrong, D. Top pain scientist 18  Johansen, H.K. and Gotzsche, P.C. (1999). Problems in
fabricated data in studies, hospital says. The Wall Street the design and reporting of trials of antifungal agents
Journal. March 11, 2009. http://online.wsj.com/article/ encountered during meta-analysis. JAMA, 282, 1752–9.
SB123672510903888207.html. 19  Resnik, D.B., Gutierrez-Ford, C., and Peddada, S.
2   Borrell, B. A medical Madoff: anesthesiologist faked (2008). Perceptions of ethical problems with scientific
data in 21 studies. Scientific American, March 10, 2009. journal peer review: an exploratory study. Sci Eng
http://www.scientificamerican.com/article.cfm?id=a- Ethics, 14, 305–10.
medical-madoff-anesthesiologist-faked-data. 20  Dalton, R. (2001). Peers under pressure. Nature, 413,
3   Alberts, B. (2010). Promoting scientific standards. 102–4.
(Editorial). Science, 327, 12–3. 21  Hadjistavropoulos, T. and Bieling, P.J. (2000). When
4   Council of Science Editors. White paper on promoing reviewers attack: ethics, free speech, and the peer
integrity in scientific journal publications. Approved review process. Can Psychol, 41(3), 152–9.
by the CSE Board of Directors, March 29, 2009. http://
www.councilscienceeditors.org/editorial_policies/
whitepaper/3–2_international.cfm. Further reading
5   Uniform requirements for manuscripts submitted Committee on Publication Ethics (COPE) http://
to biomedical journals; ethical considerations in the publicationethics.org/ International Committee of
conduct and reporting of research: authorship and Medical Journal Editors http://www.icmje.org.
contributorship. International Committee of Medical Ross, J.S., Hill, K.P., Egilman, D.S., and Drumholz,
Journal Editors. ICMJE.org. http://www.ICMJE.org./ H.M. (2008). Guest authorship and ghost writing in
ethical_1author.html. publications related to rofecoxib. JAMA, 299(15),
6   Fanelli, D. (2009). How many scientists fabricate and 1800–12.
falsify research? A systematic review and metaanalysis Sox, H. and Rennie, D. (2006). Research misconduct:
of survey data. PLoS One, 4(5), e5738. retraction and cleansing the medical literature: lessons
7   Gardner, W., Lidz, C.W., and Hartwig, K.C. (2005). learned from the Poehlman case. Ann Int Med, 144(8),
Authors’ reports about research integrity problems in 609–13.
clinical trials. Contemp Clin Trials, 26(2), 244–51. Wager, E., Barbour, V., Yentis, S., and Kleinert, S., on behalf of
8   Wilcox, L. (1998). Authorship. The coin of the realm, COPE Council. Retractions: guidance from the Committee
the source of complaints. JAMA, 280(3), 216–17. on Publication Ethics. http://publicationethics.org/
9   Fuller, W. (2003). Who said ‘helix’? Nature, 424, 876–8. guidelines (accessed Dec 1, 2009).
10  Watson, J.D. (1968). The Double Helix: A Personal World Association of Medical Editors. Dalla Lana School of
Account of the Discovery of the Structure of DNA. Public Health, University of Toronto, Ontario, Canada
New York: Athenaeum. http://www.wame.org/.

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Section Practice issues

5
 Section 5
1 Practice issues
Chapter

36
The impaired anesthesiologist – addiction
Thomas Specht, Clarence Ward, and Stephen Jackson

The Case including healthcare professionals. Its lifetime preva-

lence in the physician population is estimated to be
A 43-year-old male anesthesiologist has been drug-free for
10%–12%, essentially the same as that of the general
6 years following initial treatment for his sufentanil addic-
tion and an extensive rehabilitation program administered
population.1 Among anesthesiologists, the prevalence
section
by his state medical board. 1 re-entered private prac-
He has appears to be even higher. However, support for this
tice with the support of his department and colleagues. His perception is based on diagnosis from treatment pro-
tightly monitored recovery program was considered to be grams for chemical dependence where the specialty of
a model of success. After 5 years, his monitoring intensity anesthesiology is over-represented in relation to most
was loosened, although he continued to take naltrexone other medical specialties, at least with regard to drugs
in a witnessed environment, regularly attended Narcotics other than alcohol. This may be because the specialty
Anonymous meetings, submitted witnessed random absti- of anesthesiology is particularly attuned to the issue,
nence-urines for testing when required, and met every 3 monitors its members more closely, and therefore
months with an addiction specialist who reported his find- detects chemical dependency more often than special-
ings to the medical staff impaired physician chair. During
ties that have lower vigilance.
the past 2 months, suspicion of relapse was raised by sev-
eral close colleagues, but no evidence for narcotic diversion
Furthermore, recent trends in prescription drug
could be substantiated. Shortly after his last urine test sub- abuse in the US suggest that perceptions regarding
mission, he was found unconscious in a bathroom with an drug abuse that are based on literature from past dec-
empty 20 ml syringe and ampoule of propofol. This relapse ades is no longer relevant.
was immediately followed by appropriate treatment for 18
months, once again serving as a “model” patient in recov- Outcomes
ery. He again expresses his desire to return to practice, but
this time there is sharp disagreement within his department
The historic approach to the addicted anesthesiolo-
and group over re-entry. gist has been to assume that those who complete treat-
ment for addiction should be returned to practice. But
Chemical dependence in the form of addiction is a a 1990 study of chemically dependent anesthesiology
chronic relapsing disease characterized by the over- residents indicated that prolonged abstinence follow-
whelming compulsion (both genetic and behavioral in ing treatment is unusual. Startlingly, 7% of those cases
origin) to use drugs in spite of adverse consequences. presented with death. Two-thirds of the residents who
Drug addiction, unless identified and treated skillfully, were allowed to reenter their programs after treatment
will lead to disability and often to death. The practice relapsed, and perhaps most frightening, in 16% of those
of anesthesiology provides the setting for a susceptible who relapsed, death was the presenting sign.2 However,
“host” by offering an environment in which powerfully this study was criticized because of its poor design and
addictive drugs are immediately available for abuse. inadequate inpatient treatment times. Nontheless, its
conclusion are likely to be valid, as a 2005 publication
Addiction in the specialty of anesthesiology found that less than half of anesthesiology residents
who attempted reentry successfully completed their
Prevalence residency, while 9% of those attempted reentrants died.3
Addictive disease in the form of chemical depend- Such statistics raise the question of whether reentry by
ency is present in all classes, cultures, and professions, residents after treatment for substance abuse should

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
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 Section 5. Practice issues

even be attempted, or whether there is an ethical obli- gradual inability to provide safe and competent care to
gation of anesthesia training programs to prohibit resi- the patient. Due to the progressive nature of drug addic-
dents from returning. This debate remains unresolved, tion, the anesthesiologist-patient becomes subservient
but hopefully will lead to the development of effective to the incessant demands of the disease. The addicted
standardized guidelines for appropriate evaluation, anesthesiologist may have tangential awareness of
treatment, monitoring and aftercare (monitoring if this fact, but the same rationalization that accepts or
returning to work) of the addicted anesthesiologist. excuses his/her diversion of drugs dims awareness of
the declining quality of patient care. Feeding addiction
Is addiction a disability? reorders a physician’s priorities, pushing honesty and
Addiction is approached from the perspective of a dis- patient responsibility into the background.
ease model in the United States, but it is not treated As the disease progresses, there eventually is a deg-
entirely as a disability. The Americans with Disabilities radation of the physician’s personal health, and the
Act of 1990 prohibits discrimination based on dis- physician commonly develops organic neuropsychi-
ability, defined as “physical or mental impairment that atric impairment that further clouds his/her ability to
substantially limits a major life activity.” While physi- provide competent and compassionate care. This fail-
cians who are in current treatment for substance abuse ure to place a patient’s interests foremost represents
are afforded some legal protections by the act, current a stark violation of the primary ethical obligation of
substance abuse is excluded as a protected condition. any physician. It frequently is only after diagnosis and
successful treatment that there is any direct awareness
or acknowledgment of this inverted priority by the
Ethical issues addicted physician.
The ASA Guidelines for the Ethical Practice of During the course of the disease, the development
Anesthesiology4 recognizes that anesthesiologists have of chemical (alcohol or drugs) tolerance demands
professional responsibilities to patients, to colleagues, ever-increasing doses and frequency of use. The pat-
to facilities at which they practice, to self (meaning the tern of use escalates, often rapidly, from off-duty occa-
duty to maintain physical, mental and emotional abil- sional use to consumption while directly involved
ities necessary to good patient care), and to community with patient care in the healthcare facility or operat-
and society. In the case of the addicted anesthesiologist, ing room. Chemical impairment of anesthesiologists
these obligations are further complicated by the fact while they are involved in direct patient care clearly
that the anesthesiologist is not only a healthcare pro- places patients at increased risk from cognitive errors
vider, but is also a patient, with ethical duties owed to in decision-making, diminished capacity for vigilance,
them by others. and chemically induced physical discoordination.
The incessant compulsion to obtain drugs is accom-
Anesthesiologists’ ethical responsibilities to patients panied by both the continuous stress of disguising the
and themselves addiction and the anxiety of impending withdrawal.
All physicians have as their primary ethical respon- In addition, the opiate-addicted anesthesiologist may
sibility the obligation to place their patients’ interests divert drugs from patient use, potentially leading to
foremost while providing competent medical care with inadequate postoperative pain control for patients.
compassion and respect for human dignity. This obliga- The potential for patient harm caused by the impaired
tion, in turn, invokes anesthesiologists’ ethical respon- anesthesiologist is the major impetus for prompt and
sibilities to themselves. According to the American effective action by the medical community.
Society of Anesthesiologists’ Guidelines for the Ethical
Practice of Anesthesiology, they are required to Anesthesiologists’ ethical responsibilities
“maintain their physical and mental health and special sen- to their colleagues
sory capabilities [and] if in doubt about their health … seek In the course of their disease, the addicted anesthe-
medical evaluation and care … [and further] during this siologist often violates many obligations to their col-
period of evaluation or treatment … should modify or cease
leagues. These include duties of honesty and fidelity to
their practice.”4
the profession. The addicted physician is induced by
The unethical and illegal behavior inherent to the self-interest to conceal their addiction (thus prevent-
impaired anesthesiologist’s addictive disease leads to a ing treatment), lest they be removed from the work

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 Chapter 36. Addiction

place – and in most cases, away from their drug sup- consideration over the fate of the colleague profession-
ply. In addition, the anesthesiologist abusing operating ally. Placing concerns for patients first is important,
room (OR) drugs (e.g., fentanyl, sufentanil, ketamine but the professional fate of the addicted provider is
or propofol) often turns to the theft of those drugs from also a legitimate ethical concern of their colleagues. If
the OR to maintain their supply. Alternatively, they the recovering anesthesiologist is not well respected
may obtain drugs using actual or forged prescriptions. or is thought to be professionally substandard, greedy,
Not only are such activities frankly illegal, but they are manipulative, or possessing a genuine personality dis-
a betrayal of the trust placed in physicians by society order, then it is almost impossible to expect that these
and by their colleagues, and thus a breach of duty. factors will not influence or even dominate group deci-
ASA guidelines also describe the ethical responsi- sion-making with respect to re-entry.
bilities of anesthesiologists to their colleagues.
“Anesthesiologists should advise colleagues whose ability
Anesthesiologists’ ethical obligations to
to practice medicine becomes temporarily or permanently healthcare facilities
impaired to appropriately modify or discontinue their prac- Anesthesiologists personally handle and have easy
tice. They should assist, to the extent of their own abilities, access to many controlled and potentially addictive
with the re-education or rehabilitation of a colleague who is substances. The ASA ethical guidelines declare that:
returning to practice.” 4 “Anesthesiologists personally handle many controlled and
These obligations by extrapolation include the detec- potentially dangerous substances and, therefore, have a spe-
tion of addiction, intervention, treatment, and even- cial responsibility to keep these substances secure from illicit
tually rehabilitation of a colleague who is returning to use. Anesthesiologists should work within their healthcare
facility to develop and maintain an adequate monitoring
practice. However, the response of an addicted physi-
system for controlled substances.”4
cian’s colleagues to addictive behavior, as in society,
reflects a wide range of understanding of the relevant Increased awareness of addiction and diversion of con-
issues. Even with the reported high incidence of addic- trolled substances in anesthesiology has been fostered
tion in the specialty of anesthesiology, individuals in by educational efforts, particularly during residency.
a department often are most influenced by their own All anesthesiologists, whether in training or not, have
personal experience with this problem, by the broader an ethical responsibility to learn to recognize the signs
view society takes, or even other factors such as reli- and symptoms of addiction in order to avert a pos-
gious beliefs, rather than by full understanding of the sible tragic outcome, either to that individual or one of
addictive disease process. his/her patients. Unfortunately, educational efforts to
Because chemical dependency is a disease, in the raise awareness of addiction among anesthesiologists
case of an impaired anesthesiologist there are actu- apparently have not resulted in a decreased incidence
ally two patients: the patient receiving anesthesia care, of the disease. Increased reporting and diagnosis may
and the anesthesiologist him or herself. Conflicts reflect an actual increase in addiction, or simply reflect
may arises among colleagues of the addicted provider, increased awareness, adding to the confusion.
between concern for the safe provision of care for
patients by the impaired anesthesiologist, and the sup- Ethical considerations regarding re-entry
port of the impaired anesthesiologist’s well-being in into the anesthesia workplace
the event of a relapse. For physician colleagues trained Addiction is not only a life-threatening, but also a
to view illness with compassion, this conflict can pre- career-threatening disease. Many are concerned about
sent difficult choices. whether the addicted anesthesiologist should return to
Further complicating this matter is the potential practice or training once treatment has been completed.
for bias in decision-making due to lack of acceptance Opioid abusers with co-morbid psychiatric conditions
of the disease model for addiction, and a perception (dual diagnosis) and/or a family history of drug addic-
of the issue as rather a moral problem or deficiency of tion/abuse present greater risk for at least one relapse.
willpower. Moral judgments of addictive behavior may Recidivism is a characteristic of addictive disease and
greatly influence the decision of whether or not to sup- focuses discussion of re-entry on the safety for both the
port the addicted colleague professionally. Concern recovering anesthesiologist and his/her patients.
may principally be for the care of the patient and, per- Post-residency addicted physicians have years,
haps, for the safety of the anesthesiologist, with little even decades, invested in professional training and

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 Section 5. Practice issues

practice. This intensifies the real dilemma of deciding Key points

whether or not to support and advocate for that col-
league’s return to practice. • Addiction to drugs is a chronic, relapsing
On the other hand, the impaired provider’s sub- disease best characterized by the
stantial investment also represents enormous lever- overwhelming compulsion to use drugs
age to “encourage” compliance in recovery. There is despite adverse personal and professional
much more literature regarding the addiction expe- consequences.
rience in academic training programs than that of • A major occupational hazard of
the majority of anesthesiologists who are in private anesthesiologists is the development of
practice. Furthermore, information from academic addictive disease, which, in the light of the
programs is almost exclusively concerned with train- specialty’s powerful drugs, often involves
ees, who have been in the profession for only a short a rapidly progressive, life- and career-
period of time and have the least substantial career threatening pattern of behavior.
investment. The differences in addiction and recovery • Addiction prevents the anesthesiologist
between trainees and those in long-time practice may from his/her primary ethical responsibility
be substantial, but are currently poorly understood of placing the interests of his/her patients
and under-studied. foremost, providing competent and
compassionate care.
Does a practicing anesthesiologist have an ethical • Anesthesiologists have an obligation to
obligation to inform patients about past addictive themselves as well as to their patients and
behavior? their health care facility to maintain their
Although this ethical issue has received little if any physical and mental health and special
comment, it certainly is a physician-impairment topic sensory capabilities.
worthy of discussion. Two court rulings in the United • Anesthesiologists have an ethical
States were divided in their legal opinions regarding responsibility to be knowledgeable about
such disclosure as an integral part of informed con- addiction, to detect it in its earliest stages, and
sent. Those who support informed consent disclos- to support the treatment, rehabilitation, and
ure by physicians who have been treated for chemical eventually, if appropriate, reentry into the
dependence build their argument on the apparent workplace of a recovering colleague.
“materiality” of the risk of relapse to informed treat-
ment decisions by patients. According to this line of
belief, when the personal health problems of an anes- References
thesiologist may endanger the welfare of the patient, 1*  Berge, K.H., Seppala, M.D., and Schipper, A.M. (2009).
this constitutes an identifiable material risk about Chemical dependency and the physician. Mayo Clin
which a patient would want to know when deciding Proc, 84(7), 625–31.
upon a decision about treatment. In fact, however, 2  Menk, E.J., Baumgarten, R.K., and Kingsley, C.P.
the probability is extremely remote that a properly (1990). Success of reentry into anesthesiology training
programs by residents with a history of substance abuse.
rehabilitated practicing anesthesiologist who is being
JAMA. 263, 3060–2.
appropriately monitored would relapse and injure
3  Collins, G.B., McAllister, M.S., Jensen, M., and Gooden,
a patient. Taken to the extreme, a mandate for such
T.A. (2005). Chemical dependency treatment outcomes
disclosure by a recovering anesthesiologist could be
of residents in anesthesiology: results of a survey. Anesth
extended to a multitude of other medical diagno- Analg, 101, 1457–62.
ses and personal situations that conceivably could
4*  Guidelines for the Ethical Practice of Anesthesiology
have a negative impact on quality of anesthesia care. (2008). American Society of Anesthesiologists, www.
Relevant to this discussion is the fact that a significant asahq.org.
pool of professionals with obvious impact on public
safety  – commercial airline pilots  – includes a sub-
set of several thousand aviators rehabilitated back to Further reading
work with little or no direct mention of this fact to the Ackerman, T. (1996). Chemically dependent physicians and
flying public. informed consent disclosure. J Addictive Dis, 15, 25–42.

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Baldisseri M. (2007). Impaired healthcare professional. Crit Domino, K., Hornbein, T., Pollisar, N., et al. (2005). Risk
Care Med, 35(No 2 suppl), S106–16. factors for relapse in health care professionals with
Berge, K., Seppala, M., and Lanier, W. (2008). The substance use disorders. JAMA, 293, 1453–60.
anesthesiology community’s approach to opioid- and Gallegos, K., Lubin, B., Boweres, C., et al. (1992). Relapse
anesthetic-abusing personnel: time to change course. and recovery: five to ten year follow-up study of
Anesthesiology, 109, 762–4. chemically dependent physicians: the Georgia
Booth, J., Grossman, D., Moore, J., et al. (2002). Substance experience. Md Med J, 41, 315–19.
abuse among physicians: A survey of academic Model Curriculum on Drug Abuse and Addiction for
anesthesiology programs. Anesth Analg, 95, 1024–30. Residents in Anesthesiology. (2003). Park Ridge,
Bryson, E. and Silverstein, J. (2008). Addiction and IL: American Society of Anesthesiologists.
substance abuse in anesthesiology. Anesthesiology, 109, Oreskovich, M. and Caldeiro, M. (2009). Anesthesiologists
905–17. recovering from chemical dependency: Can they safely
Chemical dependence in anesthesiologists: what return to the operating room? Mayo Clin Proc, 84,
you need to know and when you need to know 576–80.
it. (1998). Park Ridge, IL: American Society of Specht, T. (2009). Reentry after addiction treatment:
Anesthesiologists. Research or retrain? Anesthesiology, 110, 1423–4.

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 Section 5
1 Practice issues section 1
Chapter

37
The impaired anesthesiologist –
sleep deprivation
Steven K. Howard

The Case ­physiology. Specific strategies have been used in other

domains to mitigate the impairing affect of fatigue.
At 3 am, a first-year anesthesia resident was providing an
anesthetic to a young adult male undergoing exploratory
laparotomy for presumed appendicitis. The resident had Human error
started his shift 20 hours earlier at 7 am at this very busy In 1999, the Institute of Medicine (IOM) published a
county hospital. There were cases to follow and it was obvi-
treatise To Err is Human which uncovered a previously
ous that this resident would be busy until being relieved of
unappreciated level of patient mortality and morbidity
duty the following day. As the case was finishing, the resi-
dent was drawing up medications to reverse neuromuscu- associated with human error of health care providers.2
lar blockade. He drew up 3 mg of neostigmine. He intended Although the IOM report did not specifically address
to draw up 0.6 mg of glycopyrrolate but instead drew up 30 the issue of care provided by sleep-deprived practi-
mg of phenylephrine. The two drugs were in adjacent bins tioners, it is likely that a fraction of the preventable
in the drug cart and were packaged in similar appearing errors that occur are secondary to this performance
vials. Prior to administering the likely lethal concoction, the shaping variable. Error investigation in healthcare and
resident described feeling that “something was not right.” in other industries has shown that fatigued workers
Upon checking the empty vials on the anesthesia cart, the make errors, although exact rates are difficult to quan-
near miss was discovered and the syringe disposed of. The tify. Physicians are not able to withstand the impairing
intended reversal agents were then drawn up and admin-
effect of sleep deprivation. Even though sleep depriv-
istered to the patient without incident. The resident com-
ation and fatigue could not be proven to have contrib-
pleted two more cases during his call until being relieved the
following morning. This incident was not reported to the uted to the near miss in the case scenario, sophisticated
residents’ supervisor. In three years of anesthesia training, accident investigation performed in other industries
this resident was offered the opportunity to nap on call only would conclude that it played a role.3
once by faculty.
The ASA Guidelines for the Ethical Practice of Basic sleep physiology
Anesthesiology outline the ethical responsibilities of A basic primer in sleep physiology is important to
anesthesiologists. Section IV.2 states: understand the issues of sleep deprivation and its effect
The practice of quality anesthesia care requires that anesthe- on performance. Sleep is a reversible behavioral state of
siologists maintain their physical and mental health and perceptual disengagement from and unresponsiveness
special sensory capabilities. If in doubt about their health, to the environment, and it is vital to human survival. It
then anesthesiologists should seek medical evaluation is comprised of two states – non-rapid eye movement
and care. During this period of evaluation and treatment,
(NREM) and rapid eye movement (REM) sleep that
anesthesiologists should modify or cease their practice.1
cycle throughout the night and can be differentiated
Sleep deprivation has a negative impact on perform- electrophysiologically. Both NREM and REM sleep are
ance, including the “special sensory capabilities” required for optimal alertness, though the body will
mentioned in the ethical guidelines. Anesthesia care preferentially replete lost sleep with slow wave sleep
providers are required to care for patients around (NREM stages 3 and 4). REM sleep is the stage when
the clock, presenting special problems for human dreaming takes place. REM sleep periods get longer

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
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 Chapter 37. Sleep deprivation

as the sleep period extends – the longest REM periods An individual’s sleep need is genetically deter-
coming before awakening in the morning. mined and cannot be trained. As adults age, sleep need
remains constant but obtaining adequate quantity and
Physiologic sleepiness quality of sleep becomes more difficult. Sleep disorders
Sleep is a basic human need similar to eating and increase with age and other benign issues associated
drinking. When deprived of food or drink, we develop with aging (e.g., urinary frequency in males and meno-
hunger or thirst. Similarly, if we obtain less sleep than pausal symptoms in females) make sleep consolidation
we require, sleepiness becomes marked and our brain increasingly difficult.
becomes “pressured” to acquire sleep –extreme sleepi-
ness during hazardous activities can become manifest. The circadian pacemaker
In these situations the brain may shift uncontrollably A circadian pacemaker located in the suprachiasmatic
between wake and sleep with little or no awareness nucleus of the brain governs alertness. Humans are
from the individual. These short sleep episodes (called programmed for two nadirs of alertness between 2–6
microsleeps or attentional failures) create safety risks am and 2–6 pm and these times represent periods of
especially when envisioning them occurring in the increased vulnerability to performance impairment
operating room during patient care or upon driving due to pacemaker-induced sleepiness. The circadian
home after a long call period. This level of sleepiness clock is very resistant to alterations and does not adjust
occurs in all humans if pressed to extremes. rapidly. For healthcare providers, the clock’s resiliency
to change is best evidenced by those who work the
Subjective sleepiness night shift. It is often difficult to maintain alertness
during the night when the body’s clock is “turned off ”
Subjective sleepiness (how sleepy we feel) often under-
and similarly it is difficult to gain adequate sleep during
estimates the level of physiologic sleepiness. It is con-
the day when clock is “turned on” (e.g., attempting to
ceivable that this subjective – physiologic disconnect
sleep during the day after an on-call period). Working
makes critical decision making more challenging. This
in opposition to circadian physiology is necessary in
disconnect might help explain why the incidence of
the round-the-clock work of health care providers but
single vehicular automobile accidents is higher from
it comes at the risk of decreased alertness.
2–6 am, during times of increased physiologic vulner-
ability. Though we may think we are “OK” to perform,
we are often less than optimally alert. The two primary Fatigue affects performance
determinants of sleepiness are modulated by sleep Fatigue adversely affects performance.4 Examples
homeostasis and circadian rhythms. include slowing of cognition, increased performance
variability, and decreased motivation. The learning of
The homeostat new information slows, memory is impaired, and non-
Sleep homeostasis refers to the sleep–wake balance of essential activities are neglected. Picture the fatigued
an individual. This balance is a function of sleep need, anesthesiologist at 3 am after being awake for a num-
offset by the quantity and quality of sleep obtained. ber of hours trying to safely care for patients with these
An individual’s sleep propensity (i.e., sleep pressure) very real constraints of human physiology. These are
changes when this equilibrium is tipped in either dir- precisely the special sensory capabilities alluded to in
ection. For example, if an individual’s sleep need is the ASA’s Guidelines for Ethical Practice, and are crit-
8 hours per night but sleep achieved is 7 hours per night ical for safe provision of care.
a sleep debt develops and sleep propensity increases. Performance is proven to be altered in sleep-de-
Average adults require greater than 8 hours of sleep prived physicians. The Harvard Work Hours, Health
per 24-hour period to maintain optimal alertness and and Safety Group showed that reducing shift duration
function at peak levels. Population studies reveal that by interns from 30 to less than 17 hours decreased seri-
sleep need is normally distributed so that for every per- ous medical errors by 35.9%.5 Simulation research of
son who needs 6 hours of sleep for optimal alertness anesthesiologists supports the findings that a clinician’s
another will require 10 hours. Importantly, humans performance is negatively impacted by sleep depriva-
are notoriously poor at determining their true level of tion and that increasing sleep (either by prioritizing or
sleep need. napping) can improve performance.6

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 Section 5. Practice issues

A robust finding in similar studies is that mood routinely harming patients because of impaired deci-
is dramatically affected by sleep loss and fatigue. sion making due to sleep deprivation?
Negative moods (e.g., anger, depression, fatigue, ten- No direct link between fatigue due to sleep loss and
sion) increase and positive moods decrease as sleep patient morbidity and mortality has yet been made,
loss accrues.7 The impact of impaired mood on inter- and this is one reason for the maintenance of the status
personal interactions between health care providers quo. If 4 hours of sleep predict poor patient outcome
and between providers and patients has been inad- (or driving off the road after call) healthcare providers
equately studied but is likely to have an overall nega- would have to prioritize sleep as an important compo-
tive effect. nent of professionalism. Instead, in the current cul-
ture of health care, staying up all night on call, is still
thought of by many as a rite of passage and a badge of
Comparison of sleep deprivation honor. If anesthesiologists better recognized the level
to ethanol usage of impairment engendered by sleep loss, perhaps these
Results of research correlating the affect of sleep loss behaviors would change.
and alcohol consumption are alarming. Dawson
showed that after 17 hours of wakefulness that per- Ethical responsibilities of anesthesiologist
formance on a tracking task declined to a level of
impairment equivalent to a blood alcohol concentra- Responsibilities to patients
tion (BAC) of 0.05%.8 After 24 hours of wakefulness, Anesthesiologists have an ethical responsibility to be
the decline in performance was equivalent to a BAC of optimally prepared to safely care for patients and this
0.1% – over the legal level for driving everywhere in the includes avoidance of impairments from any cause.
US. This amount of wakefulness is commonly seen in Optimal performance in part depends on level of alert-
medical professionals who take “in house” call and cre- ness and this is largely under the control of the individ-
ates a source for systemic latent errors thus increasing ual. There is no BAC equivalent marker for sleepiness
system vulnerability.9 and no “sleep police” to deter poor sleep habits, so it
A study comparing the effects of sleep loss and is the individual’s responsibility to come to work opti-
alcohol consumption on performance of a simulated mally prepared – not impaired. Excellent sleep habits
driving task further supports the correlation.10 With form the most important strategy for each physician.
increasing blood alcohol concentration, simulated A variety of strategies have been proven to increase
driving performance became progressively impaired. alertness.
Speed variability, and off-road events increased, while
speed deviation decreased, the result of subjects driv- Recuperative sleep
ing faster. Wakefulness of 18.5 and 21 hours produced Average adults require at least 8 hours per 24-hour
changes of the same magnitude as 0.05 and 0.08% BAC, day. Sleep blocks less than this can be supplemented by
respectively. Finally, wakefulness prolonged by as little nap periods both at work and after work shifts. Every
as 3 h can produce decrements in the ability to main- attempt should be made to mitigate sleep debt prior to
tain speed and road position as serious as those found call periods by prioritizing sleep. The sleep environ-
at the legal limits of alcohol consumption. ment should be conducive to sleep by allowing control
Arendt and colleagues found that the neurobehav- over ambient light, noise, and temperature. Pre-sleep
ioral performance of residents after a “heavy” (every routines that give cues for relaxation and sleep should
fourth or fifth night) call was comparable to that of res- be employed and distractions such as electronic devices,
idents after alcohol ingestion to BAC of 0.04 to 0.05% pets, children, etc. should be minimized.
during “light call” conditions.11
Caring for patients while under the influence of Strategic napping
alcohol is not ethical and would be viewed as abhorrent Napping has been shown to improve alertness and
behavior. Professionals caring for patients “under the performance.12 As little as 10–15 minutes of sleep will
influence” of alcohol would likely lose their license to improve performance and longer sleep periods have
practice and be shunned by society. Threats to patient a more substantial effect. Naps address physiologic
safety would be clear. Yet similar levels of impairment sleep need by decreasing sleep debt. Unfortunately,
are now known to be caused by sleep loss. Are we naps are not utilized in our society for mostly cultural
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 Chapter 37. Sleep deprivation

reasons – the most common reason given is that nap- Modafinil – an alertness enhancing drug
ping is a sign of weakness or laziness. Strategic napping Modafinil is a non-amphetamine stimulant with low
has been piloted in a few healthcare facilities but have physiologic addictive potential.15 Its current FDA
not reached widespread use at the present time.13 approval is for excessive daytime sleepiness due to
narcolepsy, OSA, and shift work sleep disorder. Use
Strategic use of caffeine
of modafinil in these populations is associated with
Caffeine is the most widely used drug to improve alert- improvements in daytime alertness and small improve-
ness. Chronic use of caffeine limits its strategic use as ments in performance. The development of these types
tolerance develops to routine exposure. Strategic use of of drugs is creating controversy in the medical pro-
caffeine includes: (1) limiting chronic ingestion hence fession regarding the ethical use of such stimulants
tolerance; (2) ingesting when you have be awake (e.g., while performing patient care activities. Cephalon, the
during circadian low points); (3) knowing its onset maker of modafinil issued a statement that the drug is
(15–30 minutes) and duration of effect (3–4 hours); “not intended for use in helping residents work longer
and (4) avoiding its use if close to a sleep opportunity. hours.”
Combining the effect of a nap and caffeine can be used
to improve alertness.14
Physicians’ ethical responsibilities
Mindful intake of food and drugs to each other
Use of caffeine, alcohol, and nicotine close to sleep In an ideal world patients would not suffer conse-
opportunities will impair initiation, consolidation, and quences of care from impaired providers. Honest dia-
maintenance of sleep. Attempting to sleep either hun- logue between colleagues regarding coverage if sleep
gry or on a full stomach will negatively impact sleep. deprivation is present could improve system safety.
This type of discussion occurs infrequently, most
Exercise
likely because of ego and a lack of understanding of the
Regular exercise improves sleep, but exercise within a impairment caused by sleep loss and the consequent
few hours to the sleep period can impair sleep. It is best decrease in safety.
to complete exercise routines 2–3 hours before sleep to
avoid this. Rest breaks
Diagnose and treat sleep disorders Rest breaks are common in many anesthesia prac-
tices. These breaks interrupt the monotony of care,
There are more than 80 different sleep disorders, the
allow for personal time (food and bath room breaks)
most common of which is obstructive sleep apnea
and allow for brief physical activity. Rest breaks have
(OSA). Almost all of the disorders have impaired alert-
been shown to transiently improve alertness but they
ness as a common presenting finding. Anesthesiologists
do not alter sleep pressure.16 Longer rest breaks can be
with excessive daytime somnolence should consider
used for strategic napping. Strategically placed rest and
being evaluated by a sleep medicine professional.
nap breaks could improve alertness, performance and
Optimize scheduling likely morale and should be built into anesthesia prac-
tice when the situation allows.
The most contentious issue to attempt to change is
Work schedules should be created with homeostatic
that of individual work schedules. Monetary and time
and circadian processes in mind. Anesthesia groups
at work issues are central to most decisions regard-
should allow for flexibility to accommodate schedule
ing scheduling and often compete with what might
requests that the providers desire but also have this bal-
be “correct” for both physiological and patient safety
anced by the science of sleep medicine.
reasons. Important factors that need to be taken into
account are:
• Length of shift Hospital responsibilities to groups and
• Length of rest opportunities while off duty physicians
• Number of consecutive duty periods Hospitals have an important role in how providers
• Start and end time of shifts practice. Production pressure (case throughput) and
• Periodic days off of clinical work a culture of safety are important factors especially
227
 Section 5. Practice issues

in anesthesia practice. In hospitals where produc- 3   Rosekind, M.R., Gregory, K.B., Miller, D.L., et al.
tion pressure is high and a culture of safety is lacking, Aircraft Accident Report: Uncontrolled Collision
fatigue related problems are more likely be prevalent. with Terrain, American International Airways Flight
Pressure to perform elective surgery in the middle 808, Douglas DC-8, N814CK, US Naval Air Station,
Guantanamo Bay, Cuba, August 18, 1993. (Report
of the night is but one example of how a hospital can
#NTSB/AAR-94/04). Washington, D.C., National
increase the collective sleep pressure of all of its pro-
Transportation Safety Board, 1994.
viders – not just the anesthesiologists. Some hospitals
have acted proactively to address fatigue-related risk. 4   Philibert, I. (2005). Sleep loss and performance
in residents and nonphysicians: a meta-analytic
The Veteran’s Administration has piloted strategic nap-
examination. Sleep, 28, 1392–1402.
ping in the high acuity areas of its intensive care units
and operating rooms.13 5   Landrigan, C.P., Rothschild, J.M., Cronin, J.W., et al.
(2004). Effect of reducing interns’ work hours on
serious medical errors in intensive care units. N Engl J
Key points Med, 351, 1838–48.
• Professional (and ethical) behavior begins 6*  Howard, S.K., Gaba, D.M., Smith, B.E., et al. (2003).
with the practitioner who should come to work Simulation study of rested versus sleep-deprived
prepared and not impaired. Sleep deprivation anesthesiologists. Anesthesiology, 98, 1345–55.
is an important example of a common and 7   Howard, S.K., Gaba, D.M., Rosekind, M.R., and
preventable disorder negatively impacting the Zarcone, V.P. (2002). The risks and implications of
performance of anesthesiologists. excessive daytime sleepiness in resident physicians.
Acad Med, 77(10), 1019–25.
• Sleep is a basic human need. Sleep deprivation
causes increasing physiologic pressure to acquire 8*  Dawson, D. and Reid, K. (1997). Fatigue, alcohol and
sleep, and resultant uncontrollable “microsleeps” performance impairment [Scientific Correspondence].
Nature, 388: 235.
create the risk of performance lapses and safety
risks. In the case of anesthesiology practice, these 9   Reason, J. (1990). Human Error. Camridge, Great
risks are visited upon patients. Britain, Cambridge University Press.
• Fatigue has been shown to affect performance 10  Arnedt, J.T., Wilde, G., Munt, P., and MacLean, A.
to a similar degree that is associated with legal (2001). How do prolonged wakefulness and alcohol
intoxication with alcohol. compare in the decrements they produce on a
simulated driving task? Accid Anal Prev, 33, 337–44.
• Anesthesiologists have ethical obligations to
patients to obtain appropriate levels of sleep, 11* Arnedt, J.T., Owens, J., Crouch, M., et al. (2005).
and to work to optimize work schedules Neurobehavioral performance of residents after
heavy night call vs after alcohol ingestion. JAMA, 294,
within groups to minimize sleep-disordered
1025–33.
performance degradation.
12  Sallinen, M., Harma, M., Akerstedt, T., et al. (1998).
• Anesthesiologists have ethical obligations
Promoting alertness with a short nap during a night
to each other to promote work breaks,
shift. J Sleep Res, 7, 240–7.
and discourage sleep deprivation among
colleagues. 13  Joint Commission Resources: Strategies for Addressing
Health Care Worker Fatigue. (2008). Oakbrook
• Anesthesiologists also have obligations to Terrace, IL, The Joint Commission on Accreditation of
work with hospitals to promote a culture of Healthcare Organizations.
patient safety and proactively address fatigue-
14  Bonnet, M.H. and Arand, D.L. (1994). Impact of naps
related risks.
and caffeine on extended nocturnal performance.
Physiol Behav, 56, 103–9.
15  Czeisler, C.A., Walsh, J.K., Roth, T. et al. (2005).
References Modafinil for excessive sleepiness associated with
1  ASA Guidelines for Ethical Practice of Anesthesiology. shift-work sleep disorder. N Engl J Med, 353, 476–86.
HOD October 2008. www.asahq.org. 16  Neri, D.F., Oyung, R.L., Colletti, L.M., et al. (2002).
2* Kohn, L.T., Corrigan, J.M., and Donaldson, M.S. Controlled breaks as a fatigue countermeasure on
(1999). To Err is Human: Building a Safer Health System. the flight deck. Aviat Space Environ Med, 73,
Washington, D.C.: National Academy Press. 654–64.
228
 Chapter 37. Sleep deprivation

Further reading National Sleep Foundation: 2008 Sleep in America Poll,

2008 website: http://www.sleepfoundation.org/article/
Borbely, A.A. and Achermann, P. (2005) Sleep homeostasis press-release/sleep-america-poll-summary-findings.
and models of sleep regulation, in Principles and Accessed June 1, 2009
Practice of Sleep Medicine, 4th Edition. Edited by Kryger
Rosekind, M.R., Graeber, R.C., Dinges, D.F., et al. (1994).
MH, Roth T, Dement WC. Philadelphia, PA, Elsevier
Crew Factors in Flight Operations IX: Effects of Planned
Saunders. pp. 405–17.
Cockpit Rest on Crew Performance and Alertness in
Carskadon, M.A. and Dement, W.C. (2005). Normal Human Long-Haul Operations. NASA Technical Memorandum
Sleep: An Overview, in Principles and Practice of Sleep #108839. Moffett Field, CA, NASA Ames Research
Medicine, 4th Edition. Edited by Kryger MH, Roth Center
T, Dement WC. Philadelphia, PA, Elsevier Saunders,
Van Dongen, H.P. and Dinges, D.F. (2005). Circadian
pp. 13–23.
rhythms in sleepiness, alertness, and performance,
Lockley, S.W., Cronin, J.W., Evans, E.E., et al. (2004). in Principles and Practice of Sleep Medicine, 4th
Harvard Work Hours H, and Safety Group: Effect of Edition. Edited by Kryger MH, Roth T, Dement WC.
reducing interns’ weekly work hours on sleep and Philadelphia, PA, Elsevier Saunders, pp. 435–43.
attentional failures. N Engl J Med, 351, 1829–37.

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 Section 5
1 Practice issues
Chapter

38
Ethical considerations regarding
the disabled anesthesiologist
Jonathan D. Katz

The Case Definitions

Dr. X is a 63-year-old right-handed, previously healthy, Impairment is “any loss, loss of use, or derangement
male anesthesiologist who suffered a stroke, resulting in a of any body part, organ system, or organ function.”
mild speech deficit and right-sided weakness. He under- The degree of impairment is an objective determina-
section with
went intensive rehabilitation 1 90% recovery of his
tion that is based upon both physical and psychological
speech and other motor functions. However, as his physical
loss.3
status improved, a personality change became apparent,
marked by uncharacteristic emotional swings and sub- Disability is “an alteration of an individual’s capac-
tle errors in cognition and judgment. He was placed on ity to meet personal, social, or occupational demands,
a course of anti-depressants, which narrowed the mood because of impairment.” Disabling conditions result
swings and further improved his cognitive function suffi- from physical, mental, emotional, sensory, or develop-
ciently so that his physician declared him fully recovered. mental etiologies. Disabilities can have an acute onset,
Family members and close friends, however, remained as occurs with injury or acute illness, or a more pro-
aware of cognitive deficits that manifested as forgetfulness gressive onset, as occurs with many chronic diseases.3
and faulty decision making. Work disability is a subgroup in which an indi-
Dr. X claimed that he was “100%” back to his pre- vidual’s ability to perform his/ her expected work role
stroke status. His close friends and family believed oth-
is compromised as a result of impairment. Work dis-
erwise. Three months after his stroke he notified his
ability is the result of a complex interaction between
partners of his intention to return to the full time practice
of anesthesiology. individual characteristics and behavior and the work
environment.
All individuals, if they live long enough, will suffer a An impaired physician is one who is unable to
disability for some period during their life. Physicians practice medicine with reasonable skill and safety
are no exception. At least one-third of all physicians because of mental illness, physical illness or condition,
will experience a disabling illness or injury during their or the habitual or excessive use or abuse of alcohol or
professional careers.1 At any given time, 2%–10% of other substances that would adversely affect cognitive,
practicing physicians are suffering from some degree motor, or perceptive skills.4
of disability.2 An incompetent physician is one who lacks the
Identifying an individual as “disabled” is a complex minimally acceptable levels of knowledge and skills
diagnosis with profound personal, professional, and needed to practice medicine. One can be incompetent
societal ramifications. Similar degrees of impairment without being impaired or impaired without being
can result in significant disability to one individual or incompetent.
a mere inconvenience to another or even to the same
individual in different circumstances. For example,
many wheel-chair users do not consider themselves Legal considerations
disabled. And many deaf individuals consider them- There are several, often conflicting, principles that
selves advantaged by possessing unique communica- frame the legal environment in which an impaired
tion skills. It can require a ruling by the Supreme Court physician finds him/herself.
to determine ultimately whether or not an individual A physician who accepts the privileges afforded by
is “disabled.” a state license to practice medicine also accepts many

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
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 Chapter 38. Disability

legal responsibilities. Paramount among these is the from any government program, such as medical licen-
responsibility to remain physically, mentally and emo- sure or renewal. Title III of the ADA further extends
tionally competent in his/her profession. The medical the law to protect applicants to both public and private
practice acts in most states include a requirement that institutions, for example, medical schools.
physicians self-report if they become aware that their There are notable exceptions to protections
professional skills may be compromised. Most states afforded by the ADA. Most important for this discus-
also include a provision that provides certain protec- sion is that an individual who poses a direct threat
tions to physician–patients who voluntarily enter into to the health and safety of others is not considered a
an appropriate program of rehabilitation. If a physi- “qualified person” with a disability.
cian-patient successfully completes the prescribed In addition to the legal obligation to self-report
rehabilitation program all information surrounding if medical competence is compromised, the medical
the episode of impairment remains confidential and practice acts in many states also require that a physi-
protected from public disclosure. cian report his or her colleague who they suspect of
The treating physician of an impaired physician-pa- incompetent practice. The requirements and details of
tient also has potentially conflicting legal obligations. reporting vary from state to state and most states pro-
To the extent that the disabled physician is a patient, vide a framework to permit confidential reporting with
he or she is entitled to the same rights and protections immunity from civil lawsuits.
of privacy that are provided to non-physician patients.
The confidentiality of the physician-patient’s medical Ethical considerations
history is recognized by federal and most state laws. The medical profession is a moral community that is
The sanctity of medical records is also recognized by charged by society with the ethical duty to treat disease
the American Medical Association (AMA) and most in such a manner as “to help, or at least to do no harm”
state medical societies. (primum non nocere). Each of the individual compo-
On the other hand, considerations of patient confi- nents of the medical community must fulfill specific
dentiality are superseded in situations where a patient ethical duties in order to meet that public trust.
poses a threat to him/herself, or to others. In many
states there is an affirmative “duty to report” that would Ethical obligations of the physician
require a treating physician to report to the state licens- The ethical responsibility of each physician to main-
ing board any physician who is considered impaired tain the highest standards of professional conduct is
for any reason. In many cases failure to report is poten- deeply ingrained in all ethical constructs for physi-
tially grounds for disciplinary action. cians. Thomas Percival articulated this obligation and
Disability law can impact the future practice deci- the remedy that must be applied to those who do not
sions of an anesthesiologist who has suffered a disabling meet it:  “Let both the Physician and Surgeon never
illness. Disability is one of the protected classes under forget that their professions are public trusts, properly
United States federal nondiscrimination law. The most rendered lucrative whilst they fulfill them, but which
important of these statutes that directly bear on disabled they are bound by honor and probity to relinquish as
anesthesiologists are the Rehabilitation Act of 1973,5 soon as they find themselves unequal to their adequate
the Americans with Disabilities Act of 1990 (ADA),6 and faithful execution.”8
and the Family and Medical Leave Act.7 These laws pro- The ethical codes of virtually all medical societies
hibit covered employers from discriminating against contain language that requires that members maintain
applicants and employees solely because of disability. mental and physical fitness in order to enable them to
All aspects of employment are encompassed, including meet their ethical obligation of providing competent
hiring and firing, training, advancement, compensa- medical care. For example, the Code of Medical Ethics
tion, and benefits. The laws go further by requiring that of the AMA specifies that physicians have an obliga-
employers proactively offer equal opportunity to disa- tion to maintain their own health and wellness, by
bled employees by providing reasonable accommoda- preventing and/or treating diseases including mental
tions that do not cause them “undue hardship.” illness, disabilities, and occupational stress. The Code
Title II of the ADA pertains specifically to medical further explains that the effectiveness and safety of
licensure. It prohibits state and local governments and the medical care that is rendered is likely to be com-
their agencies from excluding a disabled individual promised if the health of the physician is in question.

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 Section 5. Practice issues

Finally, “[P]hysicians whose health or wellness is com- ­colleagues to modify or discontinue their practice/
promised should take measures to mitigate the prob- Section III.2 declares that anesthesiologists have the
lem, seek appropriate help as necessary, and engage in ethical obligation to “observe and report to appropriate
an honest self-assessment of their ability to continue authorities any negligent practices or conditions which
practicing.” 9 may present a hazard to patients or healthcare facility
The Ethics Manual of the American College of personnel.”11
Physicians (ACP) makes a similar assertion that any Hand in hand with their duty to report, physicians
impaired physician must refrain from assuming patient also have a moral obligation to aid their colleagues
responsibilities. If there is any doubt of a physician’s in seeking help with disabling conditions. For exam-
capabilities he or she is required to seek assistance in ple, the ASA guidelines include the additional ethical
caring for his or her patients.10 responsibility of assisting with the re-education or
The Guidelines for the Ethical Practice of rehabilitation of a colleague who is returning to prac-
Anesthesiology of the American Society of Anesthesi­ tice. This is an important moral duty that demonstrates
ologists (ASA) (Section IV.2) also specifically addresses respect and compassion for disabled colleagues and
this obligation to maintain physical and mental health facilitates their ability to continue contributing to their
and “special sensory capabilities” as a prerequisite to profession and society. This duty was clearly articu-
providing quality anesthesia care.11 The guideline lated by Dr. Ulla Nielsen, of the Canadian Association
continues by encouraging anesthesiologists to seek of Physicians with Disabilities in a presentation to the
medical care if there is any doubt about their health. Federation of Medical Licensing Authorities of Canada
Moreover, during the period of medical evaluation and in June 2001:
treatment, anesthesiologists are urged to modify or It is easy to say “It’s (the problem of disability among physi-
cease practice. cians) not a big problem.” “It’s not my problem.” The prob-
lem is easy to ignore – out of sight, out of mind. But these are
Ethical obligations to colleagues your colleagues. They deserve the respect you give to your
Physicians have an ethical obligation beyond the legal other colleagues. They deserve to hear the questions, “What
requirement to intervene if they believe a colleague’s CAN you do? What can we do to help? How can we keep
you involved? The worse disrespect of all is the ignoring,
performance is impaired. This duty to report in part
the dismissal, of the person. It could be you in those shoes
stems from each physician’s obligation to protect tomorrow.”13
patients from harm – in this case at the hands of an
impaired colleague. This requirement is also grounded In practice, intervention with an impaired colleague
in professionalism and the physician’s responsibility to can be a daunting task. Although it is widely recognized
self-regulate. This has been clearly articulated in the that competence and self- regulation are cornerstones
AMA’s written positions on physician impairment of professionalism, little has been written on how to
wherein all physicians are reminded of their ethi- implement these lofty goals on a day-to-day basis. When
cal responsibility to “take cognizance of a colleague’s a physician is treating a colleague, the ethical mandate
inability to practice medicine adequately” if that col- to report can come into direct conflict with the treating
league is compromised by physical or mental illness.*12 physician’s obligation to protect the ­physician–patient’s
The AMA’s Code of Ethics further reminds physicians confidentiality. On the one hand, the AMA Code of
of their ethical duty to report impaired, incompe- Medical Ethics asserts that some form of interven-
tent, and/or unethical colleagues and to ensure that tion or reporting to a licensing or disciplinary board is
these physicians cease practice and seek appropriate required if the physician is impaired, incompetent or
treatment. behaving unethically. On the other hand, the treating
Similarly, the code of ethics of the ACP states that physician is bound by contract to secrecy and may not
it is the obligation of each physician to protect patients disclose any aspects of the physician-patient’s medical
from any impaired colleague.10 There is a clear ethical care, except as required by law or when essential to pro-
imperative to report a physician who shows evidence of tect patients from harm. Even when required by law, the
impairment to an appropriate authority. treating physician is bound to only reveal the minimum
The Guidelines for the Ethical Practice of amount of information that is required.
Anesthesiology of the ASA (Section II.4) also requires The ACP code also addresses this conflict between
of anesthesiologists that they advise impaired the dueling obligations to protect confidentiality and

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 Chapter 38. Disability

to report. The code makes the recommendation that • Physicians have obligations of respect and
a third party, independent of the treating physician, compassion for disabled colleagues; to
should monitor the impaired physician’s fitness for intervene if a colleague’s performance is
duty.10 impaired, and to engage disabled colleagues
to the degree that they can in continued
Ethical duties of professional organizations contribution to the profession.
Professional and specialty societies have a duty to • Professional organizations have duties to
ensure that their members are capable of providing safe ensure that their members are capable of
medical care. The AMA Code of Ethics specifies that providing safe medical care.
this obligation is discharged by promoting health and
wellness among physicians and intervening promptly
when a colleague’s health or wellness is compromised. References
The Code also calls for the establishment of physician 1   Leape, L.L. and J.A. Fromson. (2006). Problem
health programs. The importance of this obligation to doctors: is there a system-level solution? Ann Intern
ASA is evidenced by the fact that the Ethical Guidelines Med, 144(2), 107–15.
are the only ASA documents that are binding upon all 2   DeLisa, J.A. and Thomas, P. (2005). Physicians with
of its members. disabilities and the physician workforce: a need to
reassess our policies. Am J Phys Med Rehabil, 84(1),
Case resolution 5–11.
3*  American Medical Association. (2001). Guides to
Dr. X has suffered a significant illness with residual dis-
the Evaluation of Permanent Impairment. 5th edn.
ability that threatens to compromise his ability to pro-
Chicago: American Medical Association.
vide safe anesthetic care. The burden of proof is on Dr.
4*  Federation of the State Medical Boards of the United
X to demonstrate that his skills are once again adequate
States, Inc. (1995) Report of the Ad Hoc Committee on
to the challenging tasks of providing a safe anesthetic. Physician Impairment. [cited 2009 5/27]; Available
His professional obligations to his patients require that from: http://www.fsmb.org/pdf/1995_grpol_
he discontinue or at least curtail his practice until such Physician_Impairment.pdf.
time as it is clear to himself and to his advisors that he is 5   29 U.S.C. § 701 et seq.
once again capable of providing competent care. 6   42 U.S.C. § 12101 et seq
If Dr. X is incapable or unwilling to accept an objec-
7   29 U.S.C. § 2601 et seq
tive assessment of his limitations, his colleagues and
8*  Percival, T. (1803). Medical Ethics; Or, a Code of
the organizations of medicine share a duty to ensure
Institutes and Precepts, Adapted to the Professional
that he does not return to practice until his level of Conduct of Physicians and Surgeons. London: Johnson
competence is assured. This obligation might have to and Bickerstaff
be exercised through legal channels. 9*  American Medical Association. (2008) Code of Medical
Ethics: Current Opinions with Annotations, 2008–2009.
Key points [cited 2009 5/28]; Available from: http://www.ama-
assn.org/ama/pub/physician-resources/medical-ethics/
• Up to one-third of physicians will suffer code-medical-ethics.shtml.
from a disabling injury or illness during their 10* Snyder, L. and Leffler, C. (2005). Ethics manual: fifth
professional careers. edition. Ann Int Med, 142(7), 560–82.
• Medical licensure carries ethical and legal 11* American Society of Anesthesiologists. (2009).
responsibilities to maintain physical, mental Guidelines for the ethical practice of Anesthesiology [cited
and emotional abilities necessary to the safe 2009 5/27]; Available from: http://www.asahq.org/
practice of medicine. publicationsAndServices/standards/10.pdf.
• Physicians have ethical obligations to self-report 12* The sick physician. Impairment by psychiatric
problems that may compromise their ability to disorders, including alcoholism and drug dependence.
practice, and to take measures to mitigate the (1973). JAMA, 223(6), 684–712.
problem, seek appropriate help and honestly 13  Nielsen, U.D. How big is the problem of disability among
assess their ability to continue practice. physicians? June, 2001 [cuted 2010 1/06]; Available
from: http://www.capd.ca/How_BIG_is....htm.

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housestaff training: a qualitative study. Am J Med,

Further reading 116(6), 402–7.
Rich, C.F. (1999). Physician licensing and the Americans
Steinberg, A.G., Lezzoni, L.I., Conill, A., and Stineman, M.
with Disabilities Act. An update on the Minnesota
(2002). Reasonable accommodations for medical faculty
Board of Medical Practice. Minn Med, 82(1), 30–1, 43.
with disabilities. JAMA, 288(24), 3147–54.
Rosenbaum, J.R., Bradley, E.H, Holmboe, E.S., et al.
(2004). Sources of ethical conflict in medical

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 Section 5
1 Practice issues
Chapter

39 The abusive and disruptive physician

section 1

Stephen Jackson

A hospital’s busiest surgeon is universally disliked because of this chapter, however, is mean, abusive, and disrup-
of his persistent negative demeanor, punctuated by harsh tive (MAD) behavior of medical professionals in the
and abusive outbursts that spare no category of healthcare workplace.
provider, and often upset the efficient functioning of patient The importance of respect and civility in assur-
care areas. Over the years, this behavior has been tolerated
ing good patient care is a foundation of the American
without any effective attempt at correction or control by the
Medical Association’s Code of Medical Ethics.1 MAD
medical staff. His list of surgeries has been delayed because
the preceding surgeon (who is slow and marginally com- behavior subverts the ethical obligation of healthcare
petent) took 2 hours longer than anticipated. The surgeon professionals from consistently placing the interests of
berates the OR secretary, technician and circulating nurse. the patient foremost, by interfering with the norma-
Then as the anesthesiologist is transferring his patient to the tive processes of collegiality, cooperation, communi-
recovery department, the surgeon demands that his case get cation, and teamwork. This sabotages the viability of
started in short order. an effective and efficient institutional culture of safety
The surgeon has stated in his workup that his patient is and quality care. Indeed, there is ample evidence of the
having a right inguinal herniorrhaphy – but the patient has linkage of MAD behavior to adverse events, medical
related to the admitting nurse that she has left-sided symp- errors and compromise of patient safety.2
toms and was told by the surgeon in his office that she has a
left-sided hernia. In the preoperative unit the surgeon marks
the right side as the operative site and convinces a some- MAD behavior – definition and
what recalcitrant  – but otherwise timid  – patient to sign
an informed consent for a right-sided herniorrhaphy. The
consequences
preoperative nurse, known herself for harsh verbal attacks MAD behavior encompasses an extreme degree of
against physicians and co-workers, calls the anesthesiolo- uncivil and unprofessional demeanor. It violates ethi-
gist to warn him of this potential for wrong-site surgery, and cal standards of practice and impedes patient safety
rails against the head nurse for assigning her to this surgeon’s and quality improvement. It is a pattern of personality
patients. In the background the anesthesiologist can hear the flaws and traits that interferes with a physician’s effec-
surgeon berating her for making the phone call to him. tive clinical performance and can be directed at any
The behavior described in this scenario is experienced member of the healthcare team, as well as patients and/
by many physicians during their professional careers. It or their family and friends. Manifestations include, but
is termed abusive and disruptive, and adversely impacts are not limited to:
the ethical practice of medicine. Abusive behavior sig- (1) Verbal abuse – threats; intimidation; insults;
nals the treatment of others harshly, cruelly and unre- degrading, demeaning, or foul language; or
morsefully. Disruptive behavior indicates interference unwarranted yelling, tone or innuendo.
with the integrity and continuity of functions neces- (2) Physical abuse – inappropriate physical contact
sary for the provision of quality care. One may encoun- that is threatening, humiliating or intimidating,
ter nonabusive but disruptive behavior, represented by or actual physical violence (from finger poking to
the slow surgeon in our case. Or, one may encounter battery).
abusive but nondisruptive behavior, represented by (3) Invasion of the space or boundaries of others,
the preoperative nurse in the case scenario. The focus physically and/or psychologically.

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
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(4) Visual abuse – threatening or humiliating diagnosis may play a contributing role. But, because
movements; or inappropriate writings, they suffer from lack of insight, the MAD physician is
drawings or photographs, including electronic impervious to psychotherapy. The only potential treat-
transmissions. ment is to hold the MAD physician to strict limits of
(5) Harassment or discrimination against any acceptable behavior. Unfortunately, the medical com-
individual on the basis of race, religion, color, munity’s history has been one of impotence, permis-
ethnicity, national origin, ancestry or culture, siveness, frustration and a collective unwillingness to
socioeconomic status, physical, mental or other act decisively to address these antics.
medical disability, marital status, gender or sexual
orientation. Quelling MAD behavior – a standard
The MAD physician controls others through intimi- for assuring quality of care
dation, bullying, belittling, berating, and condescend- The Joint Commission has declared that MAD behav-
ence. They manifest impulsive and unexpected anger, ior constitutes a “Sentinel Event Alert” because of
behave with arrogance, inconsideration and inflex- the potential to “foster medical errors, contribute to
ibility, blame others rather than accepting respon- poor patient satisfaction and to preventable adverse
sibility, and are intolerant of those they deem to be outcomes.”3 Indeed, in the new “Leadership Standard”
“incompetent.” requirements, they state that
MAD behavior’s harmful impact on workplace staff “The hospital [must have] a code of conduct that defines
increases the risk for substandard care and adverse acceptable and disruptive and inappropriate behavior
patient consequences. It amplifies stress; diminishes … [and that] … leaders [should] create and implement
productivity; lowers self-esteem and morale; increases a process for managing disruptive and inappropriate
absenteeism, turnover, “sick” leave and worker com- behaviors.”4
pensation claims; and impedes the hiring of new staff.
Two of the six core competencies for which The Joint
MAD behavior encourages failures to follow policies
Commission and the Accreditation Council for
and procedures – for example by causing fear, disincli-
Graduate Medical Education (ACGME) want every
nation or disinterest in questioning a MAD physician’s
physician to be regularly appraised relate to MAD
orders no matter how illegible, inappropriate or incor-
behavior:  “interpersonal and communication skills …
rect they may appear to be. MAD behavior decreases
that enable [physicians] to establish and maintain pro-
or aborts normative communication regarding patient
fessional relationships with patients families, and other
care and polarizes staff into those who are deemed as
members of the healthcare team;” and professionalism,
“favored” versus “not favored.” The adverse impact
especially for “behaviors that reflect a commitment to
on healthcare institutions includes time-consuming,
continuous professional development, ethical practice,
unpleasant, and frustrating medical staff investiga-
and understanding and sensitivity to diversity, and a
tions; malpractice claims; and legal suits because of
responsible attitude towards their patients, their pro-
creation of a hostile work environment.
fession, and society.”4

The aberrant personality of the MAD Ethics, morals, and professionalism

physician Moral precepts and dilemmas involve actions that may
MAD behavior is an Axis II psychiatric classification harm or benefit others. Ethics is the study of society’s
(which is not a psychiatric diagnosis or illness) char- moral challenges, precepts and codes  – a scholarly
acterized by an underlying personality with maladap- effort to analyze rules, customs and beliefs, and how to
tive behaviors that deviate markedly from normative achieve the moral good. Ethics focuses on the study of
expectations. This behavior poses a direct danger to intentional human actions that we choose to carry out
patients as well as an indirect one by disrupting insti- with sufficient knowledge with respect to their being
tutional and professional cultures of safety. This per- right or wrong.
sonality disorder is one of enduring traits, that is, it is In Western literature concerning morality, some
part of the person’s innate character, and not merely a philosophers describe the qualities of character that
response to environmental factors. Cultural factors, lead to praise or blame. Others reflect on the duties
concomitant substance abuse, or a dual psychiatric and obligations that bind humans to perform certain
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actions and to refrain from performing others. Still the American Society of Anesthesiologists’ Guidelines
others consider how the existence of communities for the Ethical Practice of Anesthesiology,7 which also
is related to the purpose of individuals. These three incorporate the American Medical Association’s
themes  – character, duty and social responsibility  – Principles of Medical Ethics. The ASA Guidelines speak
are recurrent topics of ethical reflection, serving as the to an anesthesiologist’s ethical responsibilities to their
threads that also bind medicine and morality. patients, themselves, their colleagues, their healthcare
The writings ascribed to the School of Hippocrates institutions, and society.
describe characteristics of the “good physician.”
Physicians should be gentle, pleasant, comforting,
discreet, and firm, and these qualities represent true
Curbing MAD behavior: an ethical
values. A more grave morality involves the injunctions responsibility
that define the duty of the good physician: to benefit Section I.1 of the ASA’s ethical guidelines addresses
the sick and do them no harm, to keep confidences, to an anesthesiologist’s primary ethical responsibility to
refrain from exploiting patients, and to show concern patients: “The patient–physician relationship involves
and caring, even at the cost to one’s own wealth and special obligations for the physician that include plac-
health. These duties are more profoundly linked to deep ing the patient’s interests foremost, faithfully caring for
moral beliefs than to the admonitions of decorum, and the patient and being truthful.” Because MAD behav-
the paradigm of these moral imperatives are embodied ior creates a practice atmosphere in which quality of
in the Hippocratic Oath. Finally, as ethical profession- patient care is threatened, it is not consistent with this
als, physicians must define their place in society, by primary ethical responsibility.
demonstrating their worthiness of social trust, social With respect to ethical responsibilities to col-
authority, and reward. leagues, Section II.1 declares “Anesthesiologists should
Becoming a physician involves the acceptance of promote a cooperative and respectful relationship with
specific moral responsibilities. Physicians are mem- their colleagues that facilitates quality medical care for
bers of a learned profession defined by its educational patients. This responsibility respects the efforts and
breadth, importance in satisfying fundamental human duties of other care providers including physicians,
needs, and society’s permission to use their special medical students, nurses, technicians and assistants.”
knowledge, powers, and privileges. In return, societies MAD behavior clearly fails to conform to this ethical
have expected that physicians will hold as their primary duty.
concern the welfare of their patients. The covenant of Anesthesiologists also have ethical responsibili-
trust established by physicians with patients serves as ties to themselves, as addressed in Section IV.2: “The
the basis for the physician’s privileged contract with practice of quality anesthesia requires that anesthesi-
society. The special claim of the medical profession lies ologists maintain their physical and mental health …
less in physicians’ knowledge and expertise, and more [,and] … if in doubt about their health, then anesthe-
in their altruistic dedication to something other than siologists should seek medical evaluation and care,…
self-interest or self-indulgence. The insistence on clini- [and furthermore,]… during this period of evaluation
cal competence, caring and trustworthiness define the or treatment, anesthesiologists should modify or cease
core of medicine’s professional responsibilities, but it is their practice.” A practical problem with MAD behav-
a physician’s unique commitment – his or her promise ior is that MAD physicians are largely incapable of
and dedication to the welfare of those who seek their acknowledging it, and equally unable to gain meaning-
help – that makes medicine a moral enterprise. ful understanding or insight through treatment.
As a structurally stabilizing, morally protective Finally, Section III.2 iterates that anesthesiologists
force in our society, professionalism protects vulnerable have ethical responsibilities to the health care facilities
persons and social values. The ideal of professionalism in which they practice and should “share with all med-
has succinctly been described as a “set of values, behav- ical staff members the responsibility to observe and
iors, and relationships that underpin the trust the public report … any potentially negligent practices or condi-
has in doctors.”5 The ACGME includes in its compella- tions which may present a hazard to patients or health
tion of the essence of professionalism the “adherence care facility personnel.”7 Detection and documentation
to ethical principles.”6 Indeed, the expectations of ethi- of a physician’s MAD behavior is the first of the requis-
cal behavior are stated in professional codes such as ite steps to curb this harmful institutional infestation.

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 Section 5. Practice issues

Civility and social capital verification of this report must be free of bias or preju-
dice, yet thorough. It should include interviewing the
Relationships with colleagues and staff involve overlap-
initiator of the report as well as any other relevant third
ping responsibilities and obligations centering on the
parties. The medical staff leadership must adhere to its
care of patients. Our diverse healthcare community is
bylaws, policies and procedures. The physician under
composed of a wide spectrum of personalities, knowl-
investigation must be treated with respect and in com-
edge bases, intelligences, competencies, motivations,
pliance with due process rights under relevant law. The
backgrounds, cultures, races, ethnicities, religions,
law protects medical staff review of actions that affect
and value systems. Given this reality, disagreement,
quality of care from discovery.
tension, and even conflict are not only anticipated,
When appropriate, intervention should incorpor­
but welcome when managed civilly, because they can
ate an attempt to resolve the allegations with simple
contribute to improving quality of care. Yet, no matter
solutions – first pursuing collegial steps without neces-
how well honed our coping skills may be, it is extremely
sarily progressing to disciplinary measures or facilita-
challenging to circumvent the distasteful aftermath of
tive rehabilitation. One example is an interview and
unprofessional and uncivil behavior.
counseling by the department chair. If that approach
Civil, the root word for civilization, connotes an
is impractical or impossible (there already exists an
advanced stage of social development.8 “Civil” is gen-
adverse relationship with the chair, or they are eco-
erally thought of as being “polite” or “courteous,” each
nomic competitors), then the medical staff president
synonym referring to behaving with manners neces-
with at least one other medical staff leader should con-
sary in social situations and interactions. Civil behavior
duct an interventional meeting. All conversations must
increases social capital, which is the well of interper-
be documented.
sonal trust, sense of obligation, strength of norms, and
For a first offense, depending on the tone and
unrestrained information pathways that accrue from
responses during the interventional meeting, the MAD
robust relationships among members of a ­community.9
physician might simply be warned that the process for
Social capital produces communities of cooperation,
the medical staff ’s abusive/disruptive policy will be
fosters communication, enhances achievement of
invoked upon another reported incident. However, if
common goals, and facilitates successful realization of
warranted by the severity of the initial incident and/
complex and dynamic relationships. MAD behavior,
or the response of the MAD physician in the first
on the other hand, weakens social capital and breaks
“interventional” meeting, then the full body of the
down cooperation, communication, and achievement
disruptive/abusive policy can and should be enforced
of common goals – the very essence of a well-function-
immediately. If particularly egregious, then the MAD
ing medical team.
physician should be placed on summary suspension.
The “repeat offender” would, upon judgment of
Managing MAD behavior leadership, have to enter a process of further investiga-
Accrediting authorities mandate that every medical tion, counseling and advice. Ultimately, the medical staff
staff have bylaws that delineate a credible and effective bylaws addressing repeated MAD deportment must
policy to deal with the MAD physician.3,4 Identification lead to a referral for evaluation and recommendation
and documentation of MAD behavior is the point of for treatment by a psychiatrist with experience in pro-
initiation of this process. This presupposes a work- viding a comprehensive “fitness-for-duty” evaluation
place educated about the endangerment to patient care or its equivalent. The full force of imminent suspension
wrought by such behavior and the ethical responsibil- of medical staff privileges – and its attendant report to
ity to respond to quell it. Personnel should be urged state and national authorities – may suffice to induce the
to bring allegations, concerns or complaints to the MAD physician to comply with this mandate. The MAD
attention of medical staff leadership. The entry point physician’s options, consequences for failure to comply,
for incident reports must be simple, easily accessible, and potential sanctions, must be made crystal clear.
and free of impediments. The complainant must be A contract for treatment and monitoring in accord-
fully protected, and fear of retaliation and/or retribu- ance with the recommendations of the evaluator must
tion dispelled. establish absolute boundaries for acceptable behav-
Investigation of the incident report is the ethical ior, and clear and meaningful consequences for their
responsibility of the medical staff. The review and violation. The institution’s Well Being Committee or

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 Chapter 39. The abusive and disruptive physician

its equivalent can be consulted for advice and assist-

institutions that are incompatible with MAD
ance. Anger management therapy often is one of the
behavior. In fact, it is the ethical obligation of
elements included in these recommendations. The goal
anesthesiologists to work to eradicate MAD
of therapy and monitoring is behavioral compliance, not
behavior from the workplace.
psychological insight. Expert legal counsel’s advice at
• Investigation of MAD behavior should be
each procedural step is prudent.
thorough, unbiased, and respectful of the
Constructive problem solving and avoidance of
accused physician.
future incidents can be achieved without a change of
attitude, by compelling compliant behavior. However, • The goal of intervention and monitoring of
some MAD physicians may not achieve substantial the MAD physician is behavioral compliance
changes in attitude or behavior, and even may retali- and not psychological insight.
ate, escalate MAD behavior or even pursue litigation. • In order for MAD physicians to continue
Despite this, there should be no laxity in applying to practice, they must be strictly be held
the expectations and limits of acceptable demeanor. to exert a sufficient degree of control over
Recidivism is not unusual and must be handled their behavior that precludes their adversely
according to its severity and frequency. Monitoring impacting the culture of safety.
adherence to behavior contracts is crucial to success: it
should include montoring attendance at “therapeutic”
sessions (individual or group), reviewing reports from References
therapists (or psychologist “coaches”), and requiring 1*  American Medical Association. Council on Ethical and
the physician to meet regularly with medical staff lead- Judicial Affairs. (2003). Code of Medical Ethics.
ership to review compliance with the contract. 2*  Rosenstein, A. and O’Daniel, M. (2006). Impact and
implications of disruptive behavior in the perioperative
Abuse of disruptive/abusive policies arena. J Am Coll Surg, 203, 96–105.
In the US, physicians may participate in business 3   The Joint Commission on Accreditation of Healthcare
arrangements that hospitals might view as unfair or Organizations. Sentinel Event Alert. Issue 40, July 9,
2008.
unwanted competition, such as physician-owned sur-
gery or procedural centers. Professional competition 4   The Joint Commission on Accreditation of Healthcare
Organizations. Hospital Accreditation Standards. 2009.
and animosity has, on occasion, created incentives for
LD.03.01.01; MS.06.01.03; PC.01.03.05.
hospital administrators to use the disruptive/abusive
5*  Wass, V. (2005). Doctors in society. Medical professiona­
label inappropriately in a ruse to remove such competi-
lism in a changing world. Clin Med, 5(Suppl 1), S5–40.
tors from the medical staff. Physicians should not be
6*  Accreditation Council on Graduate Medical Education.
labeled as MAD if they violate onerous, overly broad,
(2006). Outcome Project: Enhancing residency
or sham “codes of conduct” that are created to squelch education through outcomes assessment. Available at
medical advocacy, target competitors, or otherwise www.acgme.org.
have no nexus to improving patient care. 7*  American Society of Anesthesiologists. (2009).
Guidelines for the Ethical Practice of Anesthesiology.
Key points Available at www.asahq.org.
• MAD behavior violates ethical standards 8*  Jackson, S. (2005). Civility and professionalism in
of practice and impedes patient safety and anesthesia. In Principes de Reanimation Chirurgicale,
2nd edn. J-L Pourriat, C Martin, eds. Paris:
quality of care.
Arnette, pp. 1420–24.
• MAD behavior is a manifestation of a
9*  Waisel, D. (2005). Developing social capital in the
personality disorder that is characterized by
operating room: the use of population-based techniques.
maladaptive behavior and lack of personal Anesthesiology, 103, 1305–10.
insight. It is not amenable to psychotherapy.
• The American Society of Anesthesiologist’s
Guidelines for the Ethical Practice of Further reading
Anesthesiology outlines obligations to Jackson, S. (1999). The role of stress in anaesthetists’ health
patients, colleagues, self and health care and well-being. Acta Anaesthesiol Scand, 43, 583–602.

239
 Section 5
1 Practice issues
Chapter

40
Sexual harassment, discrimination,
and faculty–student intimate relationships
in anesthesia practice
Gail A. Van Norman

The author wishes to thank Rosemary Maddi MD for report sexual harassment or discrimination on the
her contributions to the author’s understanding of dis­ job.2 Sexual harassment and discrimination represent
crimination and harassment in the anesthesia workplace. only the tip of an iceberg of similar issues in the med-
Regretfully, due to illness Dr. Maddi
section 1 was unable to partici­ ical workplace that include discrimination based on
pate personally in the writing of this chapter, which is nev­
race and sexual orientations, and bullying.
ertheless a direct result of her previous writings, teaching,
and discussions with the author.
Sexual harassment
In the US, sexual harassment is considered sexual
The Case discrimination and violates the Civil Rights Act of
Dr. Frances K. Conley held a tenured professorship in 1964 – Title VII. Sexual harassment is anti-social and
Neurosurgery at Stanford University. She was the first
unacceptable behavior defined as unsolicited sexual
woman to complete a surgical internship at Stanford in
advances or requests for sexual favors, or any verbal
1966, and the first woman appointed to a tenured professor­
ship at any US medical school in 1986. In 1991 she abruptly or physical conduct of a sexual nature. Sexual harass-
resigned when a male colleague with a widely publicized ment is independent of the gender of the offender or
pattern of misogyny, harassment and disrespect of female the recipient. It can occur between members of the
physicians and staff members was appointed Acting Chair same or opposite sex, and between workers of any rank.
of her department. In a letter to the Los Angeles Times, Dr. The victim is defined as anyone who is offended by the
Conley described a workplace that was relentlessly hostile behavior, not just the person toward whom the behav-
and demeaning. She related stories from her own illustrious ior is directed. It can take the form of inappropriate
career: a male colleague who repeatedly suggested in front jokes or stories, touching, or subtle or overt pressure
of colleagues that she “go to bed” with him, professional for sexual activity. Sexual harassment is deemed to exist
presentations she had attended in which images of Playboy
if the victim’s job performance is adversely affected by
centerfolds “spiced up” the lectures, and male physicians
the behavior, or if an offensive, hostile, or intimidating
who groped female colleagues and staff members at will in
the operating room. She described finding that “any dev­ work environment results from it.
iation on my part from the majority view often was prom­ In the US, federal law recognizes two forms of
inently announced as being a manifestation of either PMS sexual harassment. The first is “quid pro quo” harass-
syndrome or being ‘on the rag.’ She ultimately rescinded her ment, in which the offender demands verbal or physi-
resignation, but not before her office had been rifled, her cal sexual behavior from an employee in return for job
name had been summarily removed from the university sta­ benefits or advancement. The second is the creation of
tionery (even before her resignation had taken effect), and “a hostile work environment” in which no quid pro quo
her research lab had been dismantled. Only 12 years ago exists.3 The law also recognizes retaliation against an
Dr. Conley wrote, “I have acquired a curious inner peace employee for resisting or complaining about offensive
… realizing, in my lifetime, I will not see women obtain the
conduct as unlawful.
equality that should be theirs.”1
In 2005, Great Britain amended the Sex
Frances Conley’s story is a sadly familiar one to the Discrimination Act of 1975 to include sexual harass-
more than 80% of female academic physicians who ment, defined as verbal, nonverbal, or physical conduct

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
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 Chapter 40. Sexual harassment

based on sex that has the effect of violating [her] dignity class have to choose their associates or their profes-
or creating a hostile, degrading, humiliating, or offen- sion  – discrimination reduces even their ability to
sive environment. British courts further recognize that acquire mentors who could advocate for them. The
women suing for sexual harassment need not show that oppressive environment increases stress and limits the
a man would have been treated differently in order to individual’s emotional ability to cope with bullying. In
prevail. The European Union defines sexual harass- extreme cases, some individuals may feel compelled to
ment as unwanted conduct of a sexual nature affecting engage in unwanted sexual acts to secure a benefit or
the dignity of women and men at work.4 promotion they desperately want or need.
Sexual discrimination is more commonly directed Tolerance of discrimination is harmful to patients
against women, but male students are not immune from as well as to the medical profession as a whole, while
mistreatment. In pediatrics, obstetrics, and gynecology, conferring few if any benefits. When talented future
for example, men report frequent discrimination with physicians are excluded from training or practice due
regard to mentoring, educational opportunities, and to discrimination, advancements for the profession
even general support for entering these specialties.5 that these individuals might have contributed are never
achieved. Physicians as a whole are less able to under-
How is this behavior harmful? stand and advocate for their patients when the profes-
sion is restricted to a sexually and ethnically narrow
Many ethical principles and values are breached,
group of individuals that is not reflective of the popula-
whether intentionally or not, when sexually charged
tion of patients they serve. Restriction of access to the
and discriminatory behavior is tolerated in the work-
profession gives everyone in the “privileged” group
place. Discrimination flies in the face of social princi-
the short-term gain of a larger share of “benefits,” but
ples that hold that all persons have intrinsic value, and
at the expense of long-term degradation of physician
that equals should be treated equally. It also violates
resources for patient care – the very reason for which
principles of justice, beneficence, nonmaleficence, and
the medical profession exists.
respect for individual autonomy.
Discrimination creates exclusionary classes of per- It has been shown that trainees who experience or
sons – unfairly bestowing benefits on some while harm- witness sexual harassment or discrimination in the
ing others – and thus violates the ethical principle of workplace become accepting of it, and more likely to
justice. Unfair benefits to a “privileged” group include a commit abuses themselves in the future.6 Thus the har-
greater sense of power and control, lower stress, greater asser of today not only harms today’s trainee, but the
access to educational and promotional opportunities, trainees of tomorrow as well. Physicians often justify
and by extension, professional and financial advance- the presence of hostile work elements as “routine” and
ment, job security, and greater social acceptability. By even a “rite of passage,” implying that mistreatment and
excluding some individuals, members of the privileged abuse of staff and trainees is not merely acceptable, but
class also proportionally increase the remaining ben- somehow necessary because it toughens the trainee to
efits to themselves. a demanding occupation. This further entrenches dis-
Exclusion from the privileged class assures lower criminatory behavior, even while being antithetical to
quality education, personal and professional insecu- the training of empathetic, compassionate physicians.
rity, higher stress secondary to bullying and harass- Furthermore, demeaning any victim who objects to
ment, lower rates of promotion and lower rates of pay. such treatment as “too sensitive” or “not able to play
In the case of Frances Conley, the “privileged” class was with the boys” violates the values of respect and pres-
male physicians, and the “excluded” class was women ervation of dignity of individuals – values that are inte-
on the healthcare team. But unfair discrimination can gral to the ethical practice of medicine.
just as well be described for any racial, ethnic, financial, These harms are not merely theoretical, and cer-
or social divisions in which professionally and intellec- tainly are not trivial. In one study,7 more than 80%
tually comparable persons are treated unequally due to of women medical students had heard jokes in the
qualities that are unrelated to their ability to perform workplace demeaning to women, 71% had experi-
the job required of them. enced subtle sexual comments, 62% had heard overtly
Discrimination restricts the individual autonomy sexual comments, 22% had received unwanted sexual
of members of the “excluded” class. They do not have advances, and 36% had seen printed sexual material
the same freedom that the members of the “privileged” such as magazines or “pin-up” images of women in
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 Section 5. Practice issues

sexual situations in the workplace. Such behaviors were from residency is in question. The resident tells her advisor
more common on surgical rotations (74%) and rare on that she is dating a male faculty member, who has assured
anesthesia rotations (2%). However, the specialty of her she is doing fine and will graduate. Her partner attends
anesthesia was not exempt: one student described an faculty evaluation meetings where her performance is
reviewed, and participates in performance evaluations of
attending anesthesiologist who asked her about “the
her. Although faculty evaluation meetings are confiden­
sexy things” she was wearing under her scrubs and
tial, he has revealed some of their confidential discussions
then told her to “lighten up” when she was offended. to her.
Another study found that anesthesiology residency
was fourth among specialties (following only surgery, Ethical boundaries in the medical student–teacher
internal medicine, and emergency medicine) in fre- relationship are complex. The participants are adults,
quency of sexual harassment of residents.8 and Western culture values freedom of choice for
Sexual harassment undermines the victim’s sense mature individuals. Freedom of association is a basic
of self-confidence and dignity. Female trainees report tenet of democracy and centers of higher learning.
feelings of confusion (“Did he really mean that?” “Did Romantic and/or sexual pairing is intensely private,
he touch me by accident?”), self-blaming (“I’m too sen- and scrutiny by governments and regulators of such
sitive”), and fear of reprisals (“They’ll say I’m a ‘bitch,’” relationships generally is discouraged in both the US
“They won’t work with me”).7 The belief that reporting and Europe. Regulatory interference in private rela-
harassment is a sign of weakness, and that a “strong” tionships is therefore usually restricted to those situ-
woman would put up with the behavior and “just go on,” ations in which behavior is perceived to clash with
undermines attempts to identify and punish offenders. critical social values, or when vulnerable persons may
Society tends to view “victims” in a negative light (as be exploited. Examples include domestic abuse, mari-
powerless outsiders or angry zealots), and it is often tal rape, and incest.
easier for individuals to ignore harassment or blame Although intimate relationships between teachers
themselves for the problem than report it. Failing to act and adult students are not illegal, they are problematic,
to prevent harassment grants legitimacy to the beliefs sharing some issues in common with sexual harass-
that such behavior is benign or innocuous. Frances ment. Such relationships may intentionally or unin-
Conley admitted that she may have herself contributed tentionally exploit unequal power dynamics. They run
to the problem when she “put up” with such behavior the risk of creating actual or perceived favoritism, and
and “shut up” rather than taking action against it. may cast doubt on the integrity of the faculty member
Research has shown that the perception of being or institution. Overt sexual harassment of either party
sexually harassed results in increased cynicism, less- can also occur. Such relationships are therefore risky
ened professional commitment, poor self-esteem, for both the student and the teacher, and are at mini-
depression, and increased risk of posttraumatic stress mum imprudent in most cases.
disorder. Psychological manifestations are seen in 90% Faculty–student consensual sexual relationships
of women who experience sexual harassment, although appear to be common. In one report, up to 17% of psy-
few seek professional help. In one study involving chology students admitted to engaging in “consensual”
European physicians, suicidal ideation among female sexual activity with teachers.10 Most students later
physicians was three times more commonplace among reported an impaired sense of well-being, and many
those who had experienced degrading or harassing took action to avoid certain teachers, even changing
experiences at work.9 specialties or dropping out of training as a consequence
of such relationships. Many students who engage in a
sexual relationship with a teacher report that they feel
Are consensual sexual relationships in the coerced to some degree, and such feelings increase over
workplace the same as sexual harassment? time.11 Importantly, many do not feel free to break off
the relationship while the teacher is in a position to
A third-year female anesthesia resident falls behind her
peers in clinical performance. Although her technical skills
supervise or evaluate them.
are average, she does not appear to be studying, is far below Deceiving someone  – such as promising positive
her peers in her objective knowledge, and regularly comes evaluations, or professing emotional commitment
to the operating room poorly prepared. Her faculty advisor where there is none  – in order to engage them in a
warns her that unless her performance improves, she will sexual relationship is a form of exploitation. Sexual
be put on academic probation, and ultimately graduation exploitation is wrong, because it is an example of one
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 Chapter 40. Sexual harassment

person using coercive or manipulative influence over they might reasonably expect in the future to be in their
another, thus violating their autonomy. Are consensual classes.12 Many universities now proscribe intimate
faculty student relationships truly “consensual” or are ­relationships between faculty members and students
they actually exploitative? so long as the supervisory relationship is intact or has
Many professionals argue that faculty–student rela- the potential to occur in the future. If an intimate rela-
tionships are never truly consensual if the teacher is in tionship develops between a student and instructor, the
a position to affect the student’s evaluations or future teacher has at minimum an ethical obligation to with-
career prospects. Even if the teacher does not intend draw from any supervisory and evaluation pro­cesses
to coerce or deceive, the student may believe that their involving their partner.
evaluations will suffer if they do not participate, or be
elevated if they do. The student may be desperate for a
particular benefit from a teacher, and therefore believe
Case resolution
they are not truly free to refuse a sexual advance. Even In the case example, the relationship between the stu-
if such relationships begin consensually, many stu- dent and faculty member presents several serious prob-
dents later report fear, regret and disproportionate lems. The student has developed an unrealistic faith in
guilt. Furthermore, studies show that when a student her partner’s reassurances, or she may believe that their
participates in such a relationship they are more likely sexual relationship “guarantees” her graduation. The
to commit future sexual misconduct with their own student is not learning what she needs to learn to per-
patients and future students.6 form her duties well, and may therefore harm future
Quid pro quo relationships between a teacher and patients. She may even fail to graduate by not attending
an adult student, even if voluntary, are clearly unethical to her studies, and her peers may discredit her if they
because they are unjust to other students who actually believe that she received academic favors in return for
perform the necessary academic work to receive the sex, regardless of her actual ability to do her job.
academic recognition. Favorable evaluations that are The faculty member has broken fidelity with his
awarded in return for sex corrupt the academic process faculty colleagues to keep confidences, and may be
by disconnecting academic evaluation from academic deceiving the resident about his intentions or ability to
performance. Furthermore, teachers may be uncon- guarantee her graduation. He is harmed by the negative
sciously unable to assign even “fair” grades to students impact these actions have on how others perceive his
with whom they are intimately involved, or from whom professional and personal integrity. The institution is
they have recently severed a sexual relationship. harmed if other trainees believe that such relationships
When a teacher agrees to pursue a “voluntary” are tolerated and can corrupt the integrity of the aca-
sexual relationship with a student, the “rightness” or demic process. The faculty member should withdraw
“wrongness” of that decision depends in part on how immediately from any role in his partner’s evaluations,
accurately they have assessed that the student is behav- and should observe the confidentiality of faculty meet-
ing in a truly “voluntary” manner. Self-deception may ings. The resident must be informed that her gradua-
prevent an instructor from being able to truly recog- tion is in jeopardy, and be held to the academic goals
nize problems of coercion and academic fairness. Even that must be met in order to graduate.
the perception of unfairness among colleagues and stu-
dents can cause institutional harm by casting doubt on Key points
the objectivity of the academic process. These issues • Sexual discrimination and harassment in the
can be difficult to judge from the “inside” of an inti- workplace are examples of a broader group
mate relationship, and ethical considerations therefore of antisocial and unethical behaviors that
weigh against faculty engaging in such relationships include discrimination on the basis of race
with students as a general rule. and sexual orientation, and general bullying.
In the 1990s, almost half of US 4-year academic
• Sexual harassment is antithetical to the
institutions had adopted or were considering adopting
values of medicine which promote respect
policies restricting intimate relationships between fac-
for autonomy, beneficence, nonmaleficence,
ulty and students. In 2003, the University of California
justice, respect for others, and promotion of
instituted a policy that prohibits teachers from dat-
human dignity.
ing either students in their classes, or students that

243
 Section 5. Practice issues

8*  Nagata-Kobayashi, S., Maeno, T., Yshizu, M., and Shimbo,

• Physicians have ethical obligations to avoid T. (2009). Universal problems during residency: abuse
discriminatory behavior as well as to take and harassment. Med Edu, 43(7), 628–36.
measures to banish it from the workplace 9*  Fridner, A., Belkic, K., Marini, M., et al. (2009). Survey
when it occurs. on recent suicidal ideation among female university
• Not all consensual sexual relationships in hospital physicians in Sweden and Italy (the HOUPE
the workplace are automatically unethical, study): cross-sectional associations with work stressors.
but all have the potential for harm through Gend Med, 6(1), 314–28.
exploitation of vulnerable persons and 10* Biaggio, M., Paget, T.L., and Chenoweth, M.S. (1997). A
degradation of the educational process. model for ethical management of faculty-student dual
relationships. Prof Psychol Res Prac, 28(2), 184–9.
The proven, harmful effects on students,
faculty and institutions suggest that such 11  Glaser, R.D., and Thorpe, J.S. (1986). Unethical
intimacy: a survey of sexual contact and advances
relationships are imprudent and generally
between psychology educators and female graduate
should be discouraged. students. Am Psychol, 41(1), 43–51.
• When a consensual sexual or romantic 12  Paulson A. (2004). Student/teacher romances: off
relationship develops between a teacher limits. Christian Science Monitor, February 17.
and student, the teacher is ethically obliged
to withdraw from any process involving
evaluation or promotion/demotion of the
Further reading
student. Bumiller, K. (1988). The Civil Rights Society: The Social
Construction of Victims. Baltimore MD: The Johns
Hopkins University Press.
Changing the Face of Medicine: Dr. Frances K. Conley.
References shttp://www.nlm.nih.gov/changingthefaceofmedicine/
1*  Conley, F. (1998). Walking Out on the Boys. physicians/biography_68.html
New York: Farrar, Straus and Giroux. Conley F. Why I’m leaving Stanford: I wanted my dignity
2   Carr, P.L., Ash, A.S., Friedman, R.H., et al. (2000). back – sexism: a brain surgeon gives up her teaching job in
Faculty perceptions of gender discriminatin and sexual protest over a system that reinforces men’s ideas that they
harassment in academic medicine. Ann Intern Med, are superior beings. The Los Angeles Times, June 9, 1991.
132(11), 889–96. Maddi, R. (2000). Sexual Harassment. In The ASA
3   Title VII, Civil Rights Act of 1964. Syllabus on Ethics. Park Ridge, IL: American Society of
4   Directive 2002/73/EC of the European Parliament and Anesthesiologists.
of the Council of 23 Sept 2002. Robinson, G.E. and Stewart, D.E. (1996). A curriculum
5*  Stratton, T.D., McLaughlin, M.A., Witte, F.M., et al. on physician–patient sexual misconduct and teacher–
(2005). Does students’ exposure to gender discrimination learner mistreatment Part 2: Teaching method. CMAJ,
and sexual harassment in medical school affect specialty 154, 1021–5.
choice and residency program selection? Acad Med, Witte, F.M., Stratton, T.D., and Nora, L.M. (2006). Stories
80(4), 400–8. from the field: students’ descriptions of gender
6*  Robinson, G.E. and Stewart, D.E. (1996). A curriculum discrimination and sexual harassment during medical
on physician-patient sexual misconduct and teacher- school. Acad Med, 81(7), 648–54.
learner mistreatment Part 1: Content. CMAJ, 154, 643–9. Zippel, K.S. (2006). The Politics of Sexual Harassment: A
7*  Hinze, S.W. (2004). Am I being too sensitive? Women’s Comparative Study of the United States, the European
experience of sexual harassment during medical Union, and Germany. Cambridge, UK: Cambridge
training. Health (London), 8(1), 101–27. University Press.

244
 Section 5
1 Practice issues
Chapter

41 Conflicts of interest –section
industry gifts
1

to physicians
Murali Sivarajan

The Case And he provides his own answers

Dr. Daniel Carlat, a practicing psychiatrist, published an Maybe. I’m sure I persuaded many physicians to prescribe
article entitled, ‘Dr. Drug Rep’ in the New York Times Effexor®, potentially contributing to blood-pressure prob-
Sunday Magazine in November, 2007.*1 In it, he wrote of lems and withdrawal symptoms.
his experience acting more or less as a drug company detail
man going to physicians’ offices and giving lunch-time talks Dr. Carlat’s ethical lapses are obvious; misrepresent-
to primary care physicians and psychiatrists extolling the ing and evading the truth, prevarication if not outright
virtues of Effexor®, an antidepressant, while the audience lying. One could argue that there was no conflict of
feasted on gourmet luncheons supplied by the maker of interest because Dr. Carlat did not misrepresent him-
Effexor®. Wyeth Pharmaceuticals had recruited him to do self as any one other than a speaker for Wyeth paid to
this by inviting him and his wife to attend a conference in
promote its product. However, a conflict resides in a
New York City, plying them with expensive dinners and
­theater tickets and, in addition, paying him an honorarium
general sense because the payments he accepted from
of $750.00. He was given a set of slides on Effexor® prepared the drug company to sustain or increase its market
by Wyeth to use for his talks and he was promised a fee for share were against the interests of patients he is sworn
each talk that he delivered. He admits to being somewhat to protect as a physician. In his confessional, Dr. Carlat
uneasy about this arrangement but nevertheless decided to acknowledges his own ethical lapse in “dancing around
participate. the truth…,” but he ignored the larger problem of drug
In his talks, Dr. Carlat pitched Effexor® as a better anti- companies trying to influence physicians by plying
depressant than other drugs on the market. This was based on them with gifts.
a meta-analysis presented at the conference by an esteemed As part of promotion aimed at physicians, drug
academic psychiatrist who was a paid consultant to Wyeth. companies have always given out gifts. In 1985, this
The co-authors were Wyeth employees. As the year went by,
author observed that these gifts were “no longer cheap
new data emerged showing that Effexor® was only marginally
better than other drugs in improving depression. It also had a
ball-point pens but something moderately priced, such
significant side effect – a 50% greater incidence of hyperten- as a document case, with the name of the company
sion than with other antidepressants – and serious withdrawal emblazoned on it.”*2 Subsequently, the gifts became
effects as well. Dr. Carlat realized that these undesirable prop- even more extravagant. Expensive dinners at local res-
erties of Effexor® had been downplayed at the conference but taurants, all-expenses-paid trips to resorts to attend
he still continued to pitch the drug to his audiences because he quasi-scientific meetings where the company’s prod-
was “concerned that the reps would not invite him to give talks ucts were heavily promoted, and cash offerings to sit
if he divulged any negative information.” He came to the real- through promotional presentations became common-
ization that he was just a “drug rep with an MD” when he was place. In response to concern expressed in the peer-
challenged by one of the psychiatrists in the audience on the reviewed literature about drug companies’ influences
incidence of hypertension with Effexor®. After a year of giving
on physician practice and behavior, the American
an average of one talk a week, earning him a supplemental
income of $30 000.00, he quit being a drug rep. At the end of
College of Physicians*3 and The American Medical
the article, he raised several questions: Association*4 published position papers that sought to
Did I contribute to faulty medical decision-making? limit, but not eliminate, drug companies’ gifts to physi-
Did my advice lead doctors to make inappropriate drug cians. They found trivial gifts such as pens and calen-
choices, and did their patients suffer needlessly? dars, modest dinners, drinks and hospitality related to

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
245
 Section 5. Practice issues

an educational event, even trips to educational meet- without reciprocating assumes an inferior or depend-
ings chosen for their convenience and not for recre- ent relationship.7 The desire to reciprocate is a powerful
ation still acceptable. It was suggested that whether a emotional response to maintain an equal relationship
gift is acceptable or not may be guided by the answer to with the giver. Partaking of food in the company of
the question, “would you be willing to have these gifts others is a social event that most enjoy; therefore gifts
generally known?”3 of food, in particular are more entangling because of
In spite of position papers and guidelines, the the camaraderie and the good feelings that accompany
practice of feting physicians with expensive gifts it. It has been said that food is “the most commonly
continued unabated. The print media began to take used technique to derail the judgment aspect of deci-
note. Numerous articles, editorials and Op-Ed com- sion making.”8 Obviously, the doctor who accepts a
mentaries in major newspapers and magazines led drug company gift is not expected to respond by giving
the Pharmaceutical Research and Manufacturers of a gift to the drug rep. Physicians’ desire to reciprocate
America (PhRMA) to publish a voluntary code of con- results in their favoring the company’s product when
duct for interactions with health professionals in July prescribing from a bewildering formulary of similar,
2008.5 It prohibits small gifts (e.g., logo-embossed pens equally effective drugs.
and coffee mugs), and recreational and entertainment Empirical evidence supports the contention that
gifts, (e.g., tickets to shows and sporting events that physicians favor the products of the company that
have no educational value). But it does not prohibit provided gifts to them. One study examined the pre-
drug reps from providing office-based and hospital- scribing patterns of 20 physicians before and after
based meals and educational material less than $100.00 their attendance at a drug company sponsored semi-
in value. Does the acceptance of these gifts, such as the nar. They found that prescription for the index drug
office-based meals that Dr. Carlat presided over, con- increased after the drug company sponsored event
stitute conflicts of interest? Do these gifts influence compared with that before the event and also compared
physicians’ practices and potentially harm patients? with national trend at the same time. All but one of the
physicians denied that the seminar would affect their
The obligation of gifts behavior.9 A critical analysis of the studies on the influ-
ence of drug company interactions with physicians on
Most physicians who accept gifts from drug compan-
their practice patterns demonstrated that:  (1) physi-
ies deny that they are influenced to prescribe that com­
cians’ meetings with drug company representatives are
pany’s drug over other, or generic, drugs of equal merit.
associated with increased requests for adding the drugs
But to expect them to admit being influenced by gifts
promoted by the drug reps to the hospital formulary;
is unrealistic. Their natural and instinctive response is
(2) continuing medical education (CME) programs
denial because admission reflects poorly on their char-
sponsored by a drug company preferentially promoted
acter or professionalism. In behavioral psychology this
the sponsor’s drug compared to non-sponsored CME
response is attributed to “self-serving bias” that tends
programs; (3) physicians who attended drug company
to favor one’s own self interests:6 an individual’s judg-
sponsored CME programs and accepted travel funds
ments of appropriate behavior are biased in favor of
from sponsors were more likely to write prescriptions
their own actions. Yet, in fact, both philosophical rea-
for the drug(s) made by the sponsor and less likely to
soning and empirical evidence do implicate drug com-
prescribe generic drugs; and (4) resident physicians
pany gifts in influencing the prescribing behavior of
attending drug company sponsored luncheon lectures
physicians.
were more likely to have inaccurate information about
A reasonable body of enquiry in moral philosophy
the sponsor’s and the competitor’s products.10
has defined the obligation that gifts impose.7 In some
Social science and marketing research support the
Native American tribes, gifts entail no reciprocal obli-
view that the insidious obligation that gifts impose is
gation on the part of the recipient. However, gifts in our
not related to the size and cost of gifts. Studies show that
society have a more personal meaning. The giver offers
even trinkets with brand names etched on them, such
a personal relationship and the receiver in accepting
as key chains, ball-point pens, refrigerator magnets and
the gift, accepts the relationship that carries an obli-
coffee mugs, increase sales of the brand products.6 A
gation to reciprocate. Camenisch also describes the
simple indication of their effectiveness is the fact that
tension between the giver and the receiver if the gift
the drug companies would not be doing it if the resulting
is not reciprocated; the recipient in accepting the gift
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 Chapter 41. Industry gifts

increase in sales did not warrant the cost of these pro- The moral cost of the obligation of gifts is the ero-
motions. From a behavioral perspective, small gifts with sion of the physician’s professional image. The drug
brand logos create brand-awareness and implicit asso- companies declare these expenses as legitimate mar-
ciations in memory. This results in their name being keting, but there is a crucial moral difference between
recalled when purchasing a product or writing a pre- the marketing of pharmaceuticals to physicians and the
scription. Another study demonstrated that two small marketing of consumer products such soaps, cosmet-
pharmaceutical promotional items, namely a clipboard ics and cars directly to consumers. In pharmaceutical
and a notepad with brand logos, skewed the treatment marketing to physicians, gifts are given to physicians to
preferences of medical students who were exposed to influence their practices while the patients, who are the
them when compared to students who were not.11 consumers, pick up the tab. In stark mercenary terms,
physicians decide the medicine or treatment for which
the patients pay and then receive tax free gifts for those
The cost of the obligation created by decisions. There is the injustice of redistribution of
accepting gifts wealth from the patients, some of whom are least able
The financial costs of these obligations are impres- to afford it, to doctors, who are considerably better off.
sive. Annual marketing expenditures by pharmaceut- Anesthesiologists are less likely to write prescriptions
ical companies are approximately $ 20 billion, 90% of than other physicians but are still the target of drug com-
which is directed at physicians.12 In 2004, Blumenthal panies and medical equipment manufacturers. A survey
reported that drug companies spent $8 000 to $15 000 of physicians in the US revealed that, on the average,
per physician every year to promote their products.13 anesthesiologists met with drug and equipment sales
The money to pay for such promotions comes from the representatives about two times a month. They were
sale of products, paid for by patients in one way or the as likely to have received gifts – such as free meals and
other. During this decade, when inflation was approxi- entertainment tickets – as surgeons, internists, pediatri-
mately 1%–3%, drug company profits increased by cians, family practitioners, and cardiologists. In general,
double-digit percentages every year, and over 30% of anesthesiologists were less likely to have received travel
their budgets were spent on marketing. Inevitably, this reimbursement and payment for consulting than cardi-
adds to the cost of healthcare overall. ologists, internists, and family practitioners.14

Cartoon by Paul Noth, published in the July 7, 2008 edition

of The New Yorker. Reproduced with permission.

247
 Section 5. Practice issues

Physician obligations to the Key points

profession • Drug companies exert influence on
Voluntary guidelines and policy statements pub- physicians’ practice behaviors by bestowing a
lished over the last 15 years have had some effect in wide variety of gifts on them, from trinkets to
curbing some of the practices, such as all-expenses gourmet dinners and travel reimbursements
paid vacation in luxury resorts, that could be seen as to attend company sponsored meetings.
blatant bribes. But, by pharmaceutical industry’s own • Even inexpensive gifts influence physician
guidelines, gifts will continue to be given especially in behavior by creating “brand awareness” and
professional meetings in which the company’s prod- implicit associations with the products of the
ucts are promoted. Because voluntary guidelines have companies that provide the gifts.
had only limited success, a group of academic phy- • Accepting gifts creates obligations for
sicians and representatives from the Association of physicians that are in direct conflict with their
American Medical Colleges have called on academic obligations to patients.
medical centers to take a leadership role in abolishing • Company gifts are funded from the sale
potential sources of unwanted influence by drug com- of companies’ products to patients. Hence
panies.12 The hope is that academic medical centers, patients suffer additionally by having to pay
which have responsibility for educating and training for these gifts.
physicians, will have an influence in shaping the atti- • Voluntary guidelines by professional medical
tude of future physicians toward these conflicts of organizations have had very little effect
interests. There is some validity to this assumption. in curbing drug companies’ influences on
A recent study reported that students at a medical physician practices.
school that had policies prohibiting gifts from drug • Academic medical centers might have a role
companies were less likely to be influenced by drug in shaping the attitudes of future physicians
company promotional items than students from med- to drug industry influence on physician
ical schools that had no restriction on gifts from drug behavior.
companies.11 • Individual resolve is essential if physicians
Some years ago, the Marketing Executive of a large are to preserve their professional image and
drug company was invited by the author’s institution dignity.
to debate their promotional activities. He declined the
invitation but confided that there were two reasons for
their gift program: (1) that the rival companies were
doing it in a fierce competitive market, and (2) that References
without some gifts to catch their attention, doctors 1*  Carlat D. (2007). Dr. Drug Rep. New York Times,
would not give them their time of day. Surveys of resi- November 25. http://www.nytimes.com/2007/11/25/
dent physicians confirm the view that without meals magazine/25memo-t.html?_r=1&emc=etal Accessed
October 27, 2009.
as inducement they were less likely to attend drug
company sponsored CME meetings.13 Physicians are 2*  Sivarajan, M. (1985). Tarnishing the medical profession’s
image. N Engl J Med, 312, 1132.
therefore at least somewhat complicit with the drug
companies in perpetuating these activities. But physi- 3*  Physicians and the pharmaceutical industry: A position
paper of the American College of Physicians. (1990).
cians’ obligations to the medical profession demand
Ann Intern Med, 112, 624–6.
that they put patients’ interest ahead of material gain
4*  Gifts to physicians from industry (editorial). (1991).
outside of regular remuneration. If physicians rejected
JAMA, 265, 501.
the overtures of commercial medical companies with
5*  Pharmaceutical Research and Manufacturers of
as much indignation as they display when accused of
America. (2008). Code on interactions with healthcare
being influenced by them, then these practices and professionals. http://www.phrma.org/files/PhRMA%20
conflicts of interest would probably cease. In the words Marketing%20Code%202008.pdf Accessed October 27,
of Goldfinger, “In this world of medical commerce, it 2009.
still takes two to tango”.15

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 Chapter 41. Industry gifts

6*  Dana, J. and Lowenstein, G.A. (2003). Social science 12* Brennan, T.A., Rothman, D.J., Blank, L., et al. (2006).
perspectives on gifts to physicians from industry. Health industry practices that create conflicts of
JAMA, 290, 252–5. interest: a policy proposal for academic medical
7*  Camenisch, P.F. (1981). Gift and gratitude in ethics. centers. JAMA, 295, 429–33.
J Religious Ethics, 9, 1–33. 13* Blumenthal, D. (2004). Doctors and drug companies. N
8*  Katz, D., Caplan, A.L. and Merz, J.F. (2003). All gifts Engl J Med, 351, 1885–9.
large and small: towards an understanding of the ethics 14* Campbell, E.G., Gruen, R.L., Mountford, J., et al.
of pharmaceutical industry gift-giving. Am J Bioeth, 3, (2007). A national survey of physician-industry
39–46. relationships. N Engl J Med, 356, 1742–50.
9*  Orlowski, J.P. and Wateska, L. (1992). The effects 15* Goldfinger, S.E. A matter of influence. (1987). N Engl J
of pharmaceutical firm enticements on physician Med, 316, 1408–9.
prescribing patterns: there is no such thing as a free
lunch. Chest, 102, 270–3.
10* Wazana, A. (2000). Physicians and the pharmaceutical
industry: is the gift ever a gift? JAMA, 283, 373–80. Further reading
11* Grande, D., Frosch, D.L., Perkins, A.W., and Kahn, Brody, H. (2010). Drug detailers, professionalism, and
B.E. (2009). Effect of exposure to small pharmaceutical prudence. Am J Bioeth, 10(1), 9–10.
promotional items on treatment preferences. Arch
Intern Med, 169, 887–93.

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 Section 5
1 Practice issues
Chapter

42
Disclosure of medicalsection
errors
1
in
anesthesiology practice
Karen Souter

The Case Ethical principles involved in disclosure

A 45-year-old woman presents for laparoscopic of medical errors
­cholecystectomy. She is healthy apart from symptoms related
If this incident had happened prior to the modern era,
to her cholelithiasis. As is normal practice in this institu-
tion, the antibiotics to be administered by the anesthesiolo- it would be easy to imagine the patient being told that
gist are hanging on the IV pole on the patient’s stretcher. The she had experienced a “complication” related to her
anesthesiologist notices the antibiotic that has been sent is anesthetic, and perhaps very little else. This reflects
cefazolin, despite the fact that the patient’s allergy to cefazo- the paternalist approach by physicians that dominated
lin is clearly documented in the chart. He asks the nurse to medicine until the last half of the twentieth century,
replace the cefazolin with an alternative antibiotic. As he is and summed up by Oliver Wendell Holmes, the dean
about to take the patient to the operating room, one of his of Harvard Medical school from 1847–1853. “The
colleagues interrupts him to ask if he will take late call that patient has no more right to the truth than he has to all
night. A brief discussion ensues. He is now late bringing the the medicine in the physician’s saddlebag”.1 Many physi-
patient into the operating room and the surgeon is mak-
cians believed it was right to deny the patient the truth
ing his impatience obvious. The anesthesiologist induces
for a number of seemingly good reasons.
anesthesia and starts the antibiotic infusion.
Fifteen minutes later he notices a rash covering the Modern medical ethics emphasizes four guiding
patient’s body. The airway pressures have increased and the principles; respect for patient autonomy, beneficence,
patient is wheezing. The blood pressure falls precipitously. nonmaleficence, and justice. Autonomy refers to the
To his dismay he sees that, in his haste to get the patient right of an individual to make decisions about one’s life
anesthetized he failed to confirm that the antibiotic had and body without coercion by others. When applied to
been replaced and he has accidentally administered the the disclosure of medical errors, autonomy refers to the
cefazolin. He diagnoses acute anaphylaxis and initiates patient’s right to possess all the available information
treatment. The patient responds and her condition stabi- about their health necessary to making decisions. In
lizes, surgery is abandoned and the patient is admitted to our case, the patient required admission to the intensive
the ICU for further care.
care unit, escalation of medical care, and investigation
“To err is human; to forgive, divine” Alexander Pope
of the anaphylactic reaction. She also needed to have
1688–1744.
her surgery rescheduled. The patient must understand
A competent anesthesiologist would instantly recog- all the facts related to the case in order to be able to con-
nize the classic signs of anaphylaxis. Once diagnosed, sent to extra treatment. Respect for patient autonomy
prompt treatment of anaphylaxis usually results in a therefore requires the open and timely disclosure of all
complete recovery. the facts, including an admission that the wrong anti-
In contrast to the medical management of this error, biotic was delivered.
disclosure of the error resulting in the anaphylactic The American Medical Association (AMA) Code
reaction is not straightforward; layers of hospital pol- of Medical Ethics is clear about the ethical duty of phy-
icies, legal precedents, ethical codes and personal biases sicians to disclose errors:
complicate the correct course of action. A thorough It is a fundamental ethical requirement that a physi-
understanding of the issues involved in disclosure of cian should at all times deal honestly and openly with
medical errors is important to every anesthesiologist. patients.… Situations occasionally occur in which a patient

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
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 Chapter 42. Disclosure of medical errors

suffers significant medical complications that may have timeframe as the cefazolin. Without investigation of
resulted from the physician’s mistake or judgment. In these the error, the flaws in the system or the true nature of
situations, the physician is ethically required to inform the the patient’s allergy may not be completely revealed. A
patient of all the facts necessary to ensure understanding of common response by patients who are the victims of
what has occurred. Only through full disclosure is a patient
medical errors is a desire that the same thing doesn’t
able to make informed decisions regarding future medical
happen again to someone else. The premise of the pol-
care. .….. Concern regarding legal liability which might
result following truthful disclosure should not affect the icies put in place by the quality and safety organizations
physician’s honesty with a patient.2 is that, by encouraging reporting, a greater openness
and understanding of medical errors will develop
Likewise, the General Medical Council of the UK has and measures to prevent them can be determined.
stated that doctors should: Hospitals have much in common with the airline and
…offer an apology and explain fully and promptly to the nuclear power industries which are also complex sys-
patient what has happened, and the likely short-term and tems in which individuals are rarely solely responsible
long-term effects.3
for serious errors.
In 2009, the National Health Service of the UK In our case, the anesthesiologist clearly has an
announced a new “Being Open” framework as the best ethical duty to disclose the error to the patient. The
practice guide for healthcare staff concerning commu- implementation of patient safety and quality policies
nication with patients, their families and their caregiv- reinforces this duty. Disclosure respects the patient’s
ers following harm.4 autonomy to be fully informed about their medical
care. From a systems perspective, the disclosure of
National policies and standards for errors allows healthcare systems to identify and elimi-
nate system errors, thereby improving safety for all
disclosure of medical errors patients. The ethical principle of justice requires that
In 1999, The Head of the Clinical Risk Unit at the patients be treated equally, thus patients are entitled
University College London reported that an estimated to the truth regardless of the views of their physicians
40 000 patients die annually in Britain due to med- or the policies of the institution in which they receive
ical errors.5 Shortly thereafter in the US, the Institute care.
of Medicine published a landmark report “To Err is
Human” making the startling revelation that medical Barriers to effective error disclosure
errors accounted for an estimated 44 000 to 98 000 pre- Studies show significant discrepancies between what
ventable deaths ­annually.6 This report heralded a signifi- physicians say they would do and what they actually do
cant re-structuring of US healthcare systems aimed at when it comes to reporting medical errors and disclos-
improving patient safety. In 2001 the Joint Commission ing them to patients.7 Patients report both concerns
for Accreditation of Health Care Organizations that their doctors have withheld the truth concern-
(JCAHO) in the US issued the first nationwide dis- ing medical errors, and dissatisfaction with the way in
closure standard that required patients to be informed which errors are disclosed.8
about all outcomes of care, including “unanticipated There are many barriers to effective error disclo-
outcomes.” Since then, guidelines for disclosure have sure. To begin with, which errors need to be disclosed?
increasingly been used by institutions as well as pay-for- When ethical standards and policies are examined
performance programs to promote safer patient care. closely, they are not as clear as they might be. The AMA
code of ethics refers to “significant” events and JCAHO
A systems-based approach to medical error to “unanticipated outcomes.” Neither of these terms is
It is apparent that a number of problems within the well defined.
system may have contributed to the error described Fear of litigation is a major reason why physi-
in our case. These include the delivery of the wrong cians have avoided open error disclosure.9 In the US,
antibiotic to the patient’s bedside, the distraction by JCAHO recognizes that this “wall of silence” attribut-
a colleague, and the failure of the anesthesiologist to able to the medical liability system impedes the course
identify the drug prior to administration. There is of open disclosure and error reporting, and that these
also a small chance that the anaphylactic response was conceptions (or in many cases misconceptions) will
due to another drug administered within the same not easily be solved without re-structuring the legal
251
 Section 5. Practice issues

system.10 Evidence that error disclosure may decrease When physicians disclose an error, feelings of guilt
the incidence of litigation and liability costs is largely are often alleviated, and this may call into question the
unknown or ignored by doctors.11 Physicians in the US physician’s motives for apologizing. Is the physician
greatly overestimate the percentage of adverse events apologizing for an error out of concern for telling the
that result in lawsuits. Medical malpractice lawsuits truth, or is he motivated to seek forgiveness or absolu-
represent a prolonged period of emotional trauma, tion from his own feelings of guilt and shame? Berlinger
and perhaps even permanent harm to one’s reputation and Wu have used the term “cheap grace” to describe
and livelihood, and physicians are likely to attempt to the situation when a physician expects forgiveness for
avoid them. an error which harms a patient without first disclosing,
Advocates of patient safety have called for removal apologizing for and making amends for his mistakes.14
of blame and shame from the discussion of medical A similar criticism has been leveled at apology laws,
errors, recognizing that most medical errors are the where the apology may be made to “make the doctor
result of a systems failure involving multiple events look good in the eyes of a jury”.12
with the physician often being the last “nail in the cof- Placing the patient’s interest foremost and being
fin.” Patients on the other hand often want someone truthful respects patient autonomy and upholds the
to blame and surveys show that the public want to see ethical principles of beneficence and nonmaleficence.
doctors punished for errors.12 Beneficence results when the physician puts aside his
In our scenario it is clear that a systems error caused own fear of personal harm and provides the patient with
the wrong antibiotic to be delivered to the patient and an honest explanation. Such an account helps the patient
also that the interruption by a colleague distracted the understand what has happened and allows him or her
anesthesiologist at a time when he needed full concen- to engage in further treatment decisions fully informed.
tration. However, it is the anesthesiologist who must In a similar way, the principle of nonmaleficence is
face the patient and her family, apologize and rightly or upheld when the doctor spares the patient harm, both
wrongly be blamed for the error. physically and emotionally, that could result from not
The introduction of apology laws in many of the knowing about the error. The doctor also spares other
US has helped physicians by providing a safe harbor patients harm if an erroneous system is identified and
from admission in court for expressions of sorrow and corrected as a result of proper error reporting.
apologies made after a medical error.12 In the end, however, the physician must understand
A lack or perceived lack of institutional support can and accept that he or she may not receive the patient’s
prevent physicians from embracing full error disclos- absolution from blame. Some patients and families may
ure. In a well-publicized case, an anesthesiologist was never be able to forgive the injury, or want any contact
actively discouraged from any contact with his patient with those responsible for harming them.
after she had suffered an adverse reaction. The insti-
tution forbade contact on the grounds that this would
increase the risk of litigation. Eventually, the anesthe- Should the physician disclose medical
siologist was able to communicate with his patient and errors that do not cause harm?
much of the emotional pain, guilt, and misunderstand-
In the case of an obvious medical error that has caused
ing on both sides were reconciled.13
harm, disclosure and apology on the part of the physi-
cian is the right thing to do, even though physicians
Ethical considerations in apologizing may struggle to achieve this. In the case where an error
has not harmed a patient the correct course of action
and telling the truth is much less clear. Let us consider an alternative case
It is difficult for physicians to acknowledge their mis- scenario. This time the anesthesiologist notices a rash
takes when the duty to “first do no harm” (nonmalefi- spreading up the arm, but nothing else happens and by
cence) is a basic tenant upon which medical training is the end of the case the rash has disappeared. What is
based. A medical error violates this professional norm. the correct course of action for the anesthesiologist?
The emotional impact for the physician dealing with There are ethical arguments both for disclosing this
the guilt and shame of causing a medical error is con- error to the patient and for not disclosing it. These can
siderable and physicians will often avoid seeking help be approached from a consequence-based perspective,
because of this. or from a deontological or duty-based perspective.
252
 Chapter 42. Disclosure of medical errors

In the alternative scenario the patient would have

disclosure, will help to improve error
no knowledge that she received the wrong antibiotic.
disclosure practices and enhance patient safety.
In a consequence-based approach, there is little rea-
• The correct ethical path for physicians
son for a patient to ask her anesthesiologist “did you
involved in medical errors that do not cause
give me cefazolin?” and in the absence of this ques-
harm and particularly the case where an
tion, the anesthesiologist is not guilty of lying to
anesthesiologist delivers the wrong drug
the patient. Voluntary disclosure of the error by the
without obvious adverse effects can be
anesthesiologist could conceivably be harmful if the
debated from different ethical stand points.
patient suffers emotionally from knowing that she
Currently, there is no generalized consensus
had been placed at risk. Alternatively, one could argue
as to the correct procedure in these cases.
that the patient may not be truly allergic to cefazolin
and this serendipitous event in which she did not suf-
fer a major reaction should trigger re-evaluation of
her supposed “allergy.” In this case it would be right to References
inform the patient and suggest further investigations. 1   Oliver Wendell Holmes, addressing the graduating
Finally, if the event were not disclosed to the patient, class of Bellevue Hospital Medical College, New York,
she may later notice that she was charged for cefazolin March 2, 1871.
on her medical bill and question this. The discovery 2   American Medical Association. (1994). Code of
that some facts related to her case had been withheld Medical Ethics: Opinion 8.12. Council on Ethical and
could result in loss of confidence in the healthcare Judicial Affairs. Chicago, IL.
system. 3*  General Medical Council, GB. (2006). Good medical
The deontological, or duty-based approach is practice. London; GMC.
based on the works of Emmanual Kant. His main the- 4*  Being Open; Communicating with Patients, Their
sis was that the moral worth of an act is not related Families, and Carers Following a Patient Safety
to the outcome, but whether or not it is done from a Incident. National Patient Safety Agency, London UK.
November 19, 2009. Accessible on line at: http://www.
sense of duty or obligation.15 A duty-based argument
nrls.npsa.nhs.uk/rsources/?entryid45=65077.
would determine that the consequences are irrelevant
5*  Blundering Hospitals ‘Kill 40,000 a year’. The Times,
and the patient should be told the truth regardless
London. August 14, 2004. http://thetimesonline.co.uk/
of the outcome. In the case of a near miss or an error
tol/news/uk/article468980ece.
with no adverse outcomes, the patient still should be
6*  Koln, L.T., Corrigan, J.M. and Donaldson, M.S. (1999).
informed.
To Err is Human: Building a Safer Health System.
The correct procedure in the case of near misses and Washington, DC: National Academy Press.
errors with no harm is yet to be defined in the policies
7*  Kaldjian, L.C., Jones, E.W., Wu, B.J., et al. (2007).
and practices of institutional risk management depart- Disclosing medical errors to patients: attitudes and
ments. Currently, most would investigate these errors practices of physicians and trainees. J Gen Intern Med,
to help better understand systems issues, but may not 22, 988–96.
disclose all the information to the patient. 8*  Gallagher, T.H., Waterman, A.D., Ebers, A.G., et al.
(2003). Patients’ and physicians’ attitudes regarding the
Key points disclosure of medical errors. JAMA, 289, 1001–7.
9*  Kachalia, A., Shojania, K.G., Hofer, T.P., et al. (2003).
• Adherence to established ethical principles Does full disclosure of medical errors affect malpractice
and the strong arguments in favor of open, liability? The jury is still out. Jt Comm J Qual Saf, 29,
transparent medical error disclosure are 503–11.
hindered by physicians’ fears and mistrust of 10  Joint Commission on Accreditation of Healthcare
the legal system. Organizations. (2005). Health Care at the
• Raising awareness amongst anesthesiologists Crossroads: Strategies for Improving the Medical
of the ethical arguments involved in error Liability System and Preventing Patient Injury.
disclosure, as well as the provision of strong 11* Kraman, S.S. and Hamm, G. (1999). Risk management:
institutional support and training in error extreme honesty may be the best policy. Ann Intern
Med, 131(12), 963–7.

253
 Section 5. Practice issues

12* Wei, M. (2007). Doctors, apologies, and the law: an

analysis and critique of apology laws. J Health Law,
Further reading
40(1), 107–9. Bismark, M.M. (2009). The power of apology. NZ Med J,
122(1304), 96–106.
13   “Patient and doctor reconcile for the greater good.”
(2006). Anesthesia Patients Safety Foundation Center for Compassion in Health Care. http://www.
Newletter, Spring, 21(1), compassioninhealthcare.org.
14* Berlinger, N. and Wu, A.W. (2005). Subtracting insult Lazare, A. (2004). On Apology. New York: Oxford University
from injury: addressing cultural expectations in the Press.
disclosure of medical error. J Med Ethics, 31, 106–8. Medical Malpractice: an International Perspective of Tort
15* Bernstein, M. and Brown, B. (2004). Doctors’ duty System Reform. The Hon Justice Michael Kirby AC
to disclose error: a deontological or Kantian ethical CMG. http://www.hcourt.gov.au/speeches/kirbyj/
analysis. Can J Neurol Sci, 31, 169–74. kirbyj_med11sep.htm.

254
Section Anesthesiologists, the state,

6 and society
 Section 6
1 Anesthesiologists, the state, and society
Chapter

43 Physician conscientious objection in

section 1

anesthesiology practice
Cynthiane J. Morgenweck and Stephen Jackson

The Case and anesthesiologist does not take hold until the
agreement between them actually has occurred. It
An anesthesiologist learns of an assignment in an isolated,
off-campus location on the day of the procedure, which is a is reasonable for the patient to expect unimpeded
transvaginal oocyte retrieval. During conversation with care by a team of physicians led by her infertility
the patient in the preanesthesia area, he learns that she is obstetrician.
having pre-implantation genetic diagnostic studies of any The anesthesiologist in this case has unwittingly
fertilized eggs, and that these results will determine future been placed in the position of being expected to pro-
options, which include deciding to reject and discard any vide anesthesia for a procedure that could lead to
that would test positive for rare inheritable diseases such events that are in violation of his deeply held moral
as cystic fibrosis. The anesthesiologist believes that this convictions. Perhaps the most common example of
case should not have been assigned to him as he previously conscientious objection for anesthesiologists in the
had stated to his department that he has a conscientious
US is that of anesthetizing a patient who is having an
objection to participating in certain reproductive proce-
dures. Time is of the essence as the infertility obstetrician
abortion. Indeed, the federal government has prom-
indicates that the timing of the retrieval must take place ulgated healthcare workers’ right-to-conscience pro-
within the next hour. tection laws, rules, and regulations. However, federal
employment laws require the balancing of reasonable
Perhaps the most fundamental political ideal in the accommodation for employees who have religious,
US is that one should be free to pursue whatever ethical, or moral objections to specific aspects of their
conceptions of “the good” one desires (autonomy), jobs with the resultant hardships that would burden
but subject to the limitation of avoiding acts that are employers given their accommodations of the employ-
harmful to others (nonmaleficence). As such, there is ees’ beliefs. The needed delay to rectify our anesthesi-
general acceptance of rights-of-conscience, which in ologist’s assignment, given the extremely tight window
this chapter we shall refer to as conscientious objec- of opportunity for the success of this infertility process
tion – a refusal by a physician to act in a way that is (retrieval of high quality oocytes) has the potential to
not in accord with deeply valued personal beliefs. In violate the contract between the infertility obstetrician
the scenario above, however, insistence on withdrawal and the patient.
from providing care not only could result in harm to The following discussion is limited to requested
the patient, but will disrupt the efficiency of institu- medical services that have been deemed medically
tional operational functions (with attendant adverse appropriate and to which there is legal entitlement. The
economic consequences), potentially incurring the focus will be on why conscientious objection (refusal)
wrath of unsympathetic coworkers (including those of by physicians is generally considered ethical behavior;
the anesthesiology department). The potential to cre- however, there are controversial caveats.
ate not only physiologic but also psychological harm
to this patient is ethically preeminent.
In this case the infertility obstetrician already Validity of conscientious objection
has “contracted” for services with the patient, In the US, citizens are permitted significant latitude
and, per routine has “arranged” for anesthesia ser- in defining the personal beliefs and values they adopt
vices. However, the “contract” between patient for themselves. Furthermore, in developing a lifestyle

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
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 Section 6. Anesthesiologists, state, and society

that is congruent with their moral convictions, they inappropriate application of personal beliefs to the
need not be concerned with personal safety because physician–­patient relationship. Indeed, invocation
their beliefs might be construed as those of a minority. of a conscience clause could serve as a subterfuge for
When claiming conscientious objection, individuals discrimination against patients based on characteris-
endeavor to preserve a sense of self, their integrity or tics of the patient such as race, gender, religion, sexual
wholeness that enables their human spirit to flourish. orientation and so forth.
Americans value the diversity of its citizenship and its Refusal by a physician to perform a service based
attendant disparate convictions and lifestyles. Because on conscientious objection may constitute only part of
respect for conscientious objection is based, at least what is entailed in an objection. The generally accepted
in part on respect for personal integrity, some under- obligation of a physician after refusal is to facilitate the
standing of integrity is in order. referral and orderly transfer of the patient to another
Personal integrity includes a set of coherent prin- physician willing to perform the procedure. However,
ciples that have been expressed verbally (or in writ- the objecting physician may strongly believe that
ing), and manifest conduct that is consistent with those even making such a referral constitutes complicity in
stated principles. “One’s words and deeds generally the objectionable procedure. Others, however, con-
[should] be true to a substantive, coherent and rela- strue such conscience-based refusal to refer as patient
tively stable set of values and principles to which one abandonment.
is genuinely and freely committed.”1 These core values The possibility always exists that referral to a quali-
are arrived at over time – and even may change over a fied nonobjector may not be feasible. Referral even
lifetime – as each member of society decides how to live may create new problems:  the receiving physician is
an individually satisfying life within the framework of physically at a considerable distance; or the service
common social goals. Yet, there may be tension among in question is of an urgent nature and further delay
competing principles as problems can arise that are is harmful to the patient; or a health insurance plan
impossible to resolve by adherence to one principle refuses to reimburse the services of the receiving phys-
without violation of another. For individuals to retain ician and/or institution not contracted with that plan.
their integrity, their values and actions ought to be rela- Recently, the Constitutional Court of the country of
tively constant over time. Columbia issued a ruling that limited the claim of con-
Moral distress may occur when an individual is scientious objection by institutions although objection
manipulated or coerced into performance of actions by an individual physician is to be honored.2 The rul-
contrary to core values. A person’s conscience must ing stated that an institution does not have such a safe
assess whether or not such behavior is permissible harbor, and further, it must provide a means of access
within the context of those core values. If deemed for legally sanctioned services. Lynch takes a similar
impermissible, then it is reasonable to refuse to per- stance, suggesting that state licensing boards should be
form otherwise socially acceptable – or even expected –
tasked with assuring timely patient access to physicians
actions, particularly if that individual is willing to
and services by directing areas of practice for physi-
accept the consequences – even harm – of such refusal.
cians based on their conscientious objections.3
Society has codified that an individual’s core values,
It is suggested that there are degrees of immorality,
should they fail to coincide with established societal
and in general, physicians who conscientiously object
core values, are, nonetheless, potentially socially per-
do so when they judge that the process in which they
missible. Witness certain of the more common types of
would participate is sufficiently immoral. The phys-
conscientious objection, such as refusal of vaccinations
ician has judged that participation is immoral because
and military service. Indeed, for healthcare providers,
the physician will facilitate the ability of the patient to
there are legal precedents and protections afforded to
engage in immoral activity. Note that the statutory con-
those who conscientiously object to participation in
science clause protections are directed at physicians
services to which the patient is legally entitled, therein
and other healthcare workers. There is no protection
setting the stage for ethical debate.
for the patient’s fundamental medical entitlement to
the procedure: it is the patient who is powerless. Many
Concerns with conscientious objection argue that, in an emergency situation, this powerless-
There are concerns with the potential abuse of ness creates an ethical obligation for the objecting
conscience clauses as they could involve the physician to provide the services if there is no other
258
 Chapter 43. Physician conscientious objection

physician to perform the service, referral and trans-

fer are not possible, or delay would further imperil the
“Preventive” ethics
By the completion of one’s residency, an anesthesi-
patient’s life.
ologist should have a thorough understanding of what
procedures, if any, he/she will not perform based on
The social contract conscientious objection. The knowledge should be
Becoming a physician is a voluntary act and one in which translated into requests for policies to address con-
physicians enter into an informal contract with society scientious objection concerns before there is a case
at large. Society bestows benefits attendant to the prac- such as the one introducing this chapter. Physicians
tice of medicine in return for which the physician has should not choose specialties that constitute moral
an obligation to perform according to the medical pro- minefields for them. Anesthesiologists interface with
fession’s mores and standards. In essence, society gives many other physicians in the medical field. They are
physicians significant control of their work in exchange likely to encounter moral dilemmas not only in the
for their placing foremost the best interests of society field of reproductive biology, but also in transplant
and its citizens. Physicians as a group, therefore, decide medicine, critical care medicine (especially end-of-
who will be admitted to the profession, how they will be life issues) and pain management. A practice situation
educated and credentialed, what standards of care are should be chosen that likely would lead to few, if any,
appropriate, and what constitutes appropriate research. scenarios calling for conscientious objection, unless
There are, of course, external controls (laws), but medi- the practice is able to support and accommodate that
cine – as other professions – is given significant latitude anesthesiologist’s personal values. If the lay community
in deciding how to conduct its work. expects to have access to procedures that are contrary
This social contract between society and the medical to the anesthesiologist’s deeply held values, then there
profession is characterized by a continuous discourse should be concern that the practice is not a proper fit.
between parties, with corrections and redirections. If an anesthesiologist chooses to invoke conscientious
Indeed, conceived as a shift toward patient autonomy objection, then it ought not to be at the last moment,
within the past half century, society has urged physi- but rather with ample time for deliberation, discourse
cians to have their patients become more fully partici- and planning to avoid the potential contentions and
patory in medical decision-making. The preeminence troublesome consequences pursuant to a last minute
of informed consent signifies this radical ethical shift objection. The reason for such objections should be
pursuant to the demise of physician paternalism. constant over time so as to preclude the loss of support
The issue of conscientious objection by a physician from colleagues and accusations of discrimination or
enters center stage here: although physicians do have unwillingness to carry one’s share of the workload.
personal core values that guide the conduct of their It should be noted that the American Medical
practice, these generally ought not take precedence Association’s Principles of Medical Ethics,4 recognized
over professional standards of practice and respect for as a basic guide to ethical conduct, are included in the
patient self-determination. The professional role of a American Society of Anesthesiologists’ Guidelines
physician requires provision of care (appropriate to for the Ethical Practice of Anesthesiology.5 Specifically,
his/her skill set) for all who suffer, not just those with AMA Principle VI declares:
coinciding belief systems. A patient’s expectation of A physician shall, in the provision of appropriate patient
receiving an unwavering standard of competent care care except in emergencies, be free to choose whom to serve,
from those with the expertise and license to practice with whom to associate and the environment in which to
is a fundamental element of the social contract. The provide medical care.
patient–physician relationship is, in part, based upon Whereas these guidelines do not address conscien-
the physician’s specialized knowledge and skills, and tious objection, conflict resolution is offered for the
therein places the physician in a position of power conscientious objector in the American Society of
to usurp the moral convictions of the patient. In the Anesthesiologists’ Ethical Guidelines for the Anesthesia
introductory case, the power dynamic between phys- Care of Patients with Do-Not-Resuscitate Orders or
ician and patient is skewed toward the physician, Other Directives that Limit Treatment:
and the time pressure is so urgent that there is little When an anesthesiologist finds the patient’s or surgeon’s
time for any discussion of conflicting values, no less limitations of intervention decisions to be irreconcilable
negotiation. with one’s own moral views, then the anesthesiologist
259
 Section 6. Anesthesiologists, state, and society

should withdraw in a nonjudgmental fashion, providing an 3*  Lynch, H. (2008). Conflicts of Conscience: An Institutional
alternative for care in a timely fashion.6 Compromise. MA: MIT Press.
4   Accessible at the American Medical Association
website: www.ama-assn.org.
Key points 5   Accessible at the American Society of
• Our society supports an individual’s right to Anesthesiologists website at: http://www.asahq.org/
conscientious objection, to refuse an action publicationsAndServices/standards/10.pdf.
that is not in accordance with one’s deeply 6   Accessible at the American Society of
held moral convictions. Anesthesiologists website at:http://www.asahq.org/
publicationsAndServices/standards/09.pdf.
• A sense of personal integrity is based on
conduct that is consistent with an expressed
set of coherent principles and values.
• There are legal protections for physicians who
Further reading
American Academy of Pediatrics, Committee on Bioethics.
conscientiously refuse to participate in medical (2009). Physician refusal to provide information
services to which the patient is legally entitled. or treatment on the basis of claims of conscience.
• There is a potential for abuse of statutory Pediatrics, 124(6), 1689–93.
conscience clauses protecting physicians Brock, D.W. (2008). Conscientious refusal by physicians
should they inappropriately apply their and pharmacists: who is obligated to do what, and why?
personal moral convictions to the physician– Theor Med Bioeth, 29, 187–200.
patient relationship. Cantor, J. (2009). Conscientious objection gone awry –
• Most ethical dilemmas raised by conscientious restoring selfless professionalism in medicine. NEJM,
refusal can be prevented by forethought, 360, 1484–5.
communication, planning and accommodation. Davis, J.K. (2004). Conscientious refusal and a doctors’ right
• Pursuant to the social contract between to quit. J Med Phil, 29, 75–91.
society and the profession of medicine, Fjellstrom, R. (2005). Respect for persons, respect for
physicians should provide appropriate care integrity. Med Health Care Phil, 8, 231–42.
for all patients, not just those with coinciding Lawrence, R.E. and Curlin, F.A. (2007). Clash of
belief systems. definitions: controversies about conscience in medicine.
• When feasible, and excepting emergencies, the AJOB, 7, 10–14.
refusing physician’s ethical duty is to facilitate May, T. and Aulisio, M.P. (2009). Personal morality and
referral and orderly transfer to a competent professional obligations. Persp Bio Med, 52, 30–8.
physician willing to perform the service that Pelligrino, E.D. (2002). The physician’s conscience,
was requested of the conscientious objector. conscience clauses, and religious belief: a catholic
perspective, Fordham Urban Law Journal. http://
Such referral and transfer do not equate to
www.thefreelibrary.com/The physician’s conscience,
complicity. conscience clauses and religious belief:…-a097823705.
(Accessed November 5, 2008).
References Savulescu, J. (2007). Conscientious objection in medicine.
BMJ, 332, 294–7.
1*  Benjamin, M. (1990). Splitting the Difference. Kansas:
Lawrence University Press. Sulmasy, D.P. (2008). What is conscience and why is respect
for it so important? Theor Med Bioeth, 29, 135–49.
2*  Cook, R.J., Olaya, M.A., and Dickens, B.M. (2009).
Healthcare responsibilities and conscientious objection. Wardle, L.D. (2005). Five reasons why rights of conscience
Internat J Gyn and Obstet, 104, 249–52. must be protected. Linacre Quarterly, 72, 158–63.

260
 Section 6
1 Anesthesiologists, the state, andsection
society
1
Chapter

44
The ethics of expert testimony
Louise B. Andrew

The Case (2) The physician should be board certified in anesthesi-

ology or hold an equivalent specialist qualification, and
Dr. X is contacted by an attorney in a plaintiff ’s firm with (3) The physician should have been actively involved in
which he has worked frequently on prior cases. The attorney the clinical practice of anesthesiology at the time of the
requests that he provide expert testimony in a malpractice event.”1
case involving a patient who died intraoperatively following
pacemaker placement by an anesthesiologist during car- The legal qualification of a witness as an expert in court
diac surgery. Although Dr. X is well known and respected in is determined by the judge on a case-by-case basis.
the specialty for his expertise in regional anesthesia and has Judges have broad discretion for such determinations,
written several respected textbooks, he is not board certified but for practical purposes are usually limited to con-
in anesthesiology. He does not practice cardiac anesthesia. sideration of those “experts” brought to them by the
He has never placed a pacemaker himself. Despite misgiv- parties to the case.
ings, he agrees to review the case. Expertise in the subject matter forming the basis of
After chart review, Dr. X identifies no obvious breach in
any legal case is the sine qua non of an ethical expert
the standard of care by the defendant anesthesiologist, and
informs the attorney. However, after he has read selected
witness. Such expertise is established on the basis
reference materials provided by the attorney, and following of: (1) knowledge of the field; and (2) relevant clinical
a discussion during which a significant fee is discussed, he experience. In medicine, board preparation and cur-
decides that he might testify that the death resulted from rent certification are the best indicators of knowledge
improper pacemaker placement. of a specialty. Relevant experience is established by a
period of active clinical practice beyond training, as
Because judges and juries generally are not knowledge-
well as practice during the time frame of the incident in
able about medicine, the integrity and credibility of the
question. An ethical expert witness should be actively
litigation process in the United States and elsewhere
practicing within his/her field in order to be aware of
depends on expert witnesses who help them to under-
the current standard of care. Holding an active and
stand technicalities and decide complex cases by artic-
unrestricted license to practice medicine constitutes a
ulating the applicable standard of care and rendering
bare minimum qualification for expert testimony.a
an opinion as to whether or not it was met. To protect
patients and physicians and uphold the highest stand-
ards of medical care, it is morally and ethically appro- ASA guidelines for expert witness
priate for anesthesiologists with sufficient expertise to testimony
testify in medical malpractice claims. The ASA ethical guidelines include six explicit points:
(1) “The physician’s review of the medical facts should
Qualifications of an expert witness be truthful, thorough and impartial and should not
The American Society of Anesthesiologists (ASA) has exclude any relevant information to create a view
established guidelines regarding expert witness testi- favoring either the plaintiff or the defendant.”1
mony to guide members in providing such service.1 The As an expert witness, the anesthesiologist has
guidelines state that to qualify to act in this capacity, an ethical responsibility to be truthful, thorough,
“(1) The physician (expert witness) should have a current, and impartial when evaluating a case for adherence
valid and unrestricted license to practice medicine, to the standard of care. An expert witness’ primary

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
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responsibility must always be to discernment of the and even institution-specific and resource based vari-
truth2. Truthfulness is a fairly self evident concept; but ations in practice.
in expert testimony based on case analysis, truthful- The legal principle of the medical “standard of care”
ness carries several other ethical obligations. One obli- is usually defined by case law or statute for each jur-
gation is that the analysis must be thorough, including isdiction and entails some version of “that degree of
all sources of possible information, even if the infor- care which would be rendered by a reasonably com-
mation initially provided is insufficient or might be petent physician practicing under the same or similar
misleading in light of further relevant details. Before circumstances.”3 In their zeal for advocacy, attorneys do
forming any opinion, the physician must familiarize not always clearly define this concept for their experts.
him or herself with all aspects of the case. Every relevant Even the pivotal concept of “standard of care” is not
medical record must be accessed, as well as imaging or well understood by many who agree to serve as expert
other ancillary studies if potentially germane to the witnesses, though most believe that they both under-
medical issues. The witness has an obligation to review stand it and can accurately describe the specific stand-
these materials even if they are difficult to obtain and ard applicable in a given case. Legal scholars believe
are not volunteered by the attorney requesting expert that medical expert testimony regarding what consti-
consultation. This is important – an unscrupulous or tutes the standard of care is more apt to reflect what
incompetent attorney may provide selective informa- experts think that they and their immediate colleagues
tion favoring the side for which he or she is an advocate. would do rather than what most physicians actually
Failure to review all potentially relevant materials can do.4 Research suggests medical expert witnesses share
render any expert susceptible to unwitting partiality, with all of us the tendency to have selectively optimistic
just as selective exclusion of mitigating data, facts, or recall of how well they themselves typically handle clin-
circumstances may render an expert opinion unethical ical situations.5 This means that well intended experts
for partiality. will tend to overestimate the applicable standard of
“... the ultimate test for accuracy and impartial- care. As a fundamental principle, however, it is import-
ity is a willingness to prepare testimony that could be ant to understand that the legal standard requires
presented unchanged for use by either the plaintiff or only that the physician acted reasonably under the
defendant.”1 circumstances.
This is a valid and useful concept, though it An ethical witness must be careful in differentiating
could prove difficult to apply. In some instances, two between a widely utilized standard of care, and ideal
blinded experts could examine the same set of facts care that might be provided by the most astute clinician
and circumstances and ethically render opinions practicing under optimum circumstances. Application
that are opposite in their conclusions, thus rendering of an “ideal” standard (sometimes called “counsel of
either opinion useful to one party and damning for perfection”) may be a particular hazard for clinicians
the other. whose only practice experience has been in a tertiary
(2) “The physician’s testimony should reflect care facility, such as a medical school faculty, or newly
an evaluation of performance in light of generally graduated residents.
accepted standards, reflected in relevant literature, It is easier to define what the standard is not, than
neither condemning performance that clearly falls what it is. The legally required standard of care is
within generally accepted practice standards nor not perfect care, or care that creates a perfect result.
endorsing or condoning performance that clearly falls Although such care would presumably meet the stand-
outside accepted medical practice.”1 ard, it would in many if not most instances, exceed the
The expert witness must review time-appropriate actual standard required under the law. The standard
literature to substantiate the existing standard, or to of care is also not necessarily what “I do in my prac-
identify alternative acceptable approaches to care. tice, which I assume others also do.” It is also not neces-
Testimony should reflect knowledge of, and compari- sarily what “I was taught to do in training,” what the
son with, applicable and generally accepted standards textbooks recommend, or even what clinical policies/
of care. Though not explicit in the ASA guidelines, the guidelines say it is (although these may be good indi-
expert must be aware of and apply the standard of care cators of things which peers believe to represent opti-
that existed at the time of the incident giving rise to the mal care, best practices, or recommended practices
claim, and should also take into consideration regional according to the best available evidence). Each of these

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sources can provide information as to what constitutes opinion may be proffered during expert testimony,
good or excellent care for a given condition, but they do but should be clearly designated as such. The ethical
not define the legal standard of care. witness will recognize that with respect to medical
An expert must be able to help the jury to under- management, in most cases differences of opinion
stand the difference between the type of care that is between competent medical practitioners will exist.
most commonly rendered for a particular condition, The ethical expert will acknowledge that the ideal
and an equally acceptable method (the “two schools of course of events is almost always clearer when viewed
thought” or “respectable minority” test) which is not retrospectively in light of a less than optimal out-
often rendered, but is also medically valid or theoreti- come. Because it is impossible to avoid knowledge of
cally sound. The expert must also be able to assess and the ultimate outcome of a case, an ethical expert must
to clearly delineate the difference between reasonably be vigilant in analyzing the facts of a case as if the out-
competent care, and care which would be considered come is unknown, and limit standard of care opinion
substandard by an average practitioner under any testimony to the adequacy of care provided.
circumstances. (5) “The physician’s fee for expert testimony should
(3) “The physician should make a clear distinction relate to the time spent and in no circumstances should
between medical malpractice and adverse outcomes be contingent upon the outcome of the claim.”1
not necessarily related to negligent practice.” Financial remuneration must never be the key
(4) “The physician should make every effort to motivation behind expert witness work. Compensation
assess the relationship of the alleged substandard for time expended in analysis or testimony should
practice to the patient’s outcome. Deviation from a be commensurate with compensation that would be
practice standard is not always causally related to a earned during the same amount of time devoted to
poor outcome.”1 medical practice, and not indexed to the “market rate”
In a typical malpractice case, one of the most for expert testimony.b
important roles of a medical expert witness is to help For a physician to earn more through work as an
a judge and jury to understand the difference between expert witness than as a practicing physician is mor-
maloccurrence (an adverse patient experience or ally questionable if not unethical. Expert testimony by
outcome), and malpractice (an adverse experience physicians can be useful to juries, the profession, and
or outcome that more likely than not resulted from society, but exorbitant fees charged for such review and
substandard care or negligence). Causation is defined testimony will predictably increase the cost of malprac-
as being the “proximate cause,” or that which brings tice defense, and therefore threaten liability insurance
about injury as a direct result, and without which the premiums and availability, and ultimately the availabil-
injury would not have taken place. An expert may not ity and affordability of healthcare.
be asked to render an opinion as to “causation,” b or Under no circumstances is it appropriate for an
may be asked to render an opinion only as to caus- expert’s professional remuneration to be contingent on
ation of an adverse outcome by negligence or sub- the outcome of a case. All medical professional ethics
standard care. If asked to render an opinion as to codes and legal codes of professional responsibility pro-
causation, an ethical expert must carefully consider hibit this practice, because it immediately casts doubt
whether the adverse outcome could have occurred in on the objectivity of an expert witness. In general, an
the absence of any substandard care, and be able to ethical expert would be wise to establish a fee schedule
explain why this is or is not likely in this particular at the beginning of any case and require payment at the
case. In addition to a thorough review of all relevant time service is commenced – not at the conclusion of
case materials for possible confounding influences, the case – to avoid even the appearance of contingency
such an opinion also should be informed by personal billing and attendant bias. Experts must also acknow-
experience, literature, and an assessment of prob- ledge that there is an unspoken inherent contingency
abilities. An expert who cannot reach a conclusion in every consultation for an attorney, because repeat
regarding the relationship of an adverse outcome to engagement is less likely when an expert is unable to
the degree of care that was provided, should ethically provide the opinion or the testimony sought by that
decline to testify as to causation. attorney.6
Representation of one’s personal opinion as abso- (6) “The physician should be willing to submit such
lute truth is misleading and unethical. Personal testimony for peer review.”1

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 Section 6. Anesthesiologists, state, and society

Ideally, medical expert testimony would be rou- are replete with testimony by “hired guns” who earn a
tinely peer reviewed to ensure it meets the ethical significant portion or even the majority of their income
standards of medical professional societies. In some of from testifying in malpractice cases. Some such physi-
the US expert testimony has been subject to Medical cians have not practiced for years or may have restricted
Board peer review and disciplinary action by under the their practice to a very small subspecialty area, then
authority of the state Medical Practice Act. A few states falsify their current practice experience, or practice
are moving towards requiring a limited state license in just enough to maintain their medical licenses. Some
order to testify in the state. Although several states have so-called “experts” have been barred by judges from
issued discipline based on falsification of credentials by acting as expert witnesses in some states, yet continue
those acting as medical experts, none has yet success- to do so in others. Some witnesses use past credentials
fully disciplined a medical expert for giving unethical or academic accomplishments as evidence of current
testimony. Many professional societies, including the expertise.
American Society of Anesthesiology have followed Although some physicians believe themselves to
the lead of the American Association of Neurological be eminently qualified to testify after retirement from
Surgeons in reviewing the testimony of members act- clinical practice because of their knowledge of the basic
ing as expert witnesses upon complaint by another precepts of the specialty and the breadth of their expe-
member.7 rience, the fact is, that what the courts need – education
The US Supreme Court has upheld the right of a about currently prevailing standards of clinical prac-
professional society to discipline a member for inap- tice – cannot honestly be provided by a person who no
propriate expert testimony in the Austin case.6 The longer practices clinically. An ethical expert witness
American Association of Neurological Surgeons sus- should be actively practicing within his field at the time
pended a member for giving improper expert witness of the incident involved in a claim in order to be aware
testimony at a medical malpractice trial. Judge Posner of the actual applicable standard of care in effect as of
speaking for the 7th court of appeals applauded the that date. A retired physician might ethically be able
association for increasing the accountability of experts to render opinion about causation, as opposed to the
from its ranks. This precedent was an important vic- prevailing standard of care.
tory for those professional societies that include eth- Some witnesses testify almost exclusively for either
ics review of expert witness testimony in their policies the defense or the plaintiff. This practice in itself calls
and disciplinary procedures. A member who believes into question the objectivity of the witness. Federal
that an expert has acted unethically while giving testi- court rules now require that an expert keep detailed
mony has standing to request a review of the testimony records about parties on whose behalf they have testi-
by their specialty society (if the witness is a member). fied for the purpose of exposing such potential sources
Not all societies, however, have a mechanism in place of bias.
to perform this function, and ethics reviews are not
without attendant costs and liability to the professional
society. Case resolution
Medical association sanctions in the event of proven In the introductory case, several obvious potential
false or unethical testimony are generally limited to ethical violations are apparent. Dr. X does not meet
those affecting the expert’s membership in that soci- the ASA’s minimal qualification for expert witness
ety. Unfortunately, not all “experts” belong to medical testimony of board certification or preparation in
societies, or are even eligible for membership. Further, the specialty. Although he still practices part time,
if the expert is from a different specialty than that of the it is in a subspecialty area that is far removed from
defendant, the expert’s specialty society has no obliga- the subspecialty that is the basis of the case. It is dif-
tion to respond to a nonmember complainant from ficult to assess whether he could even know what
another specialty. Parenthetically, there is an inherent additional data could be relevant in determining the
selection bias in such reviews, rightfully noted by plain- standard of care in the case, since he may have relied
tiff ’s bar, that members are extremely unlikely to report upon selected references provided by the attorney
questionable testimony on behalf of a defense witness. to form even a basic understanding of this area of
Acting as an expert witness has become a second subspecialization. It could be argued that he may
career for some physicians. Medical legal case reports have allowed financial considerations to influence

264
 Chapter 44. Expert testimony

his willingness to provide a favorable opinion/

testimony.
References
1*  Guideline for Expert Witness Qualifications and
Dr. X’s testimony was submitted to his professional
Testimony. (2008). American Society of Anesthesiologistst.
association for peer review, and he was judged to have http://www.asahq.org/publicationsAndServices/
breached the ethical guidelines and thus was disci- standards/07.pdf accessed May 19, 2009 (Fig 1).
plined by the society. 2*  Bucy, P.C. (1975). The medical expert witness in
malpractice suits. JAMA, 232, 1352–3.
Key points 3   Shilkret v Annapolis Hospital Emergency Association,
349 A 2d 245, 249–250 (Md 1975)
• Those who take part in expert medical 4   Peters, P.G. (2002). “Empirical Evidence and Mal­
testimony should make every attempt to give practice Litigation”, 37 Wake Forest Law Review, 2002,
fully informed, truthful, non-biased opinion 757, at 759.
about the care that the patient received and 5   Meadow and Sunstein, (2001). “Statistics, not Experts”,
the relationship between that care and the 51 Duke Law Journal 629, at 630–31. 2001
outcome of the case. 6   Moss, S., Opinion for Sale: Confessions of an Expert
• The opinion of the expert witness should Witness http://www.legalaffairs.org/issues/March-April-
never be influenced by the outcome of the 2003/review_marapr03_moss.html#, accessed May 19,
case, the party that retains the expert, or the 2009.
remuneration which is offered. 7   Maryland, DC, New York, and on other grounds in WA.
• An expert should be willing for their 8   Donald C. Austin v AANS, 253F3d 967 (2001).
testimony to be subjected to peer review when
requested. Further reading
• The hallmark of the ethical expert witness is Andrew, L.B. (2006). Expert witness testimony: the ethics of
conscientious, objective, thorough, truthful, being a medical expert witness. Emerg Med Clin North
and impartial evaluation and testimony, Am, 24(3), 715–31.
signifying an unswerving dedication to the Baldas, T. (2005). Nonexperts taking the Stand. National
integrity of the process. Law Journal March 21. http://www.law.com/jsp/article.
jsp?id=1111572309683 accessed May 19, 2009.
Crosby, E. (2007). Medical malpractie and anesthesiology:
literature review and role of the expert witness. Can J
Notes Anaesth, 54(3), 227–41.
a
Yet surprisingly, in a number of states there is no legal requirement
that an expert witness testifying about the standard of care of phy- Meadow, W. and Lantos, J.D. (1996). Expert testimony,
sicians be qualified as a physician. legal reasoning, and justice. The case for adopting a
b
Defined by Black’s law dictionary as the fact of being the “proxi- data-based standard of care in allegations of medical
mate cause”, or “that which produces injury as a direct result, and negligence in the NICU. Clin Perinatol, 23(3), 583–95.
without which the result would not have occurred”. Rabeinerson, D. and Green, Y. (2007). The problem of
c
Which is increasing dramatically in recent years, and can
double loyalty: medical expert opinion and its cost.
­reportedly reach $600–1000 per hour in some specialties. Baldas,
“Nonexperts taking the Stand”, National Law Journal March 21,
Harefuah, 146(7), 539–43.
2005 http://www.law.com/jsp/article.jsp?id=1111572309683 Weinstein, J.B. (1999). Expert witness testimony: a trial
accessed May 19, 2009. judge’s perspective. Neurol Clin, 17(2), 355–62.

265
 Section 6
1 Anesthesiologists, the state, andsection
society
1
Chapter

45
Ethical principles regarding physician
response to disasters: pandemics, natural
disasters, and terrorism
Susan K. Palmer

The Case particularly desirable as early emergency responders.

Anesthesiologists sometimes serve in pre-hospital
During morning rush hour, a subway station in a major
treatment, including in-field airway management
metropolitan area is rocked by a sudden explosion. The
train platforms and several cars that were in the station
and administration of anesthesia to facilitate victim
at the time of the explosion are severely damaged, and extrication,3 in early hospital triage of victims accord-
the structural integrity of the underground system is com- ing to available resources, and in the management of
promised. The scene is chaotic. There is concern that the intensive care patients and patients who need immedi-
subway tunnel may collapse. The cause of the explosion is ate surgical intervention.
unknown – the smell of gas may indicate a potential cause,
or may be the result of gas leakage after the explosion. There
is concern that if this is a terrorist attack, there may be add-
Physician’s ethical obligations to respond
itional bombs awaiting detonation timed to kill rescuers. in public health emergencies
A live victim cannot be extricated from one of the trains
because her leg is entrapped in the wreckage. Her injuries General and special positive duties
appear otherwise not life-threatening. An anesthesiologist Common moral theory holds that we all, by virtue of
is requested by rescuers to provide airway support and being a part of humanity, have a duty to help others
analgesia for an immediate on-site amputation in order to in peril  – particularly if we can do so without great
free the victim.
risks to ourselves. For example, we should all prevent
The idea that physicians have ethical duties during a toddler on the sidewalk from running out in traf-
mass casualty incidents is a relatively modern one. fic, and we should all call 911 if possible when we wit-
During episodes of the plague in Europe, for example, ness an accident. These are termed “positive” duties,
clergy and magistrates were expected to remain in the since they require us to take an action, rather than to
cities to minister to the sick, but physicians generally refrain from taking an action. An example of a negative
were not. Most did in fact leave the cities, arguing that duty – in which there is an ethical obligation to refrain
they needed to live to serve the greater good by taking from an action–is a general duty not to kill. Malm and
care of survivors.1 Ideas about the ethical duties of phy- colleagues*4 differentiate general positive moral duties,
sicians during pandemics, natural disasters and other which morally bind all persons, from special posi-
mass casualty incidents have changed, now that mod- tive moral duties, which require a special relationship
ern medical practice can positively impact survival. between the actor and the recipient of their actions.
But contemporary studies indicate that physicians as a They use the example of the relationship between a
group continue to be reluctant to respond to “societal” lifeguard and swimmer as a special relationship. The
medical emergencies. In one study, 45% of surveyed lifeguard has a special positive duty to rescue, based on
physicians felt that it would be ethical to abandon their their skills and the general expectations of their work.
workplace in the event of an influenza pandemic.2 Such special positive duties also exist between physi-
The unique skills of anesthesiologists as experts cians and victims of disaster who require medical care.
in airway management, fluid and blood resusci- The special positive duties of physicians are gen-
tation, and intraoperative anesthesia make them erally argued to exist based on several considerations.

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
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First, physicians freely choose to enter a profession The AMA opinion goes on to say that physicians are
whose primary function is to serve the sick; they there- a limited resource, and the physician should balance
fore agree to some degree of exposure to illness and the the immediate benefits to individual patients against
resulting personal risk. The medical profession enjoys the ability to care for future patients. Similar duties are
a privileged position in society. In order to enjoy those stated by the UK’s General Medical Council, which
privileges, physicians must accept certain responsi- states:
bilities that go with them. Second, special skills are Doctors must not refuse to treat patients because their
needed in mass casualty incidents, and physicians are medical condition may put the doctor at risk. The balance
members of a restricted group that have those skills. between protecting individual doctors and their families
Third, physicians owe a debt to patients and to soci- from harm, and ensuring patients are not put at unneces-
ety. Not everyone can be trained to be a physician. The sary risk is best addressed at the local level, taking into
account the principle that those who place themselves at
resources needed to teach physicians are both limited
additional risk should be supported in doing so and the
and expensive. Training every physician involves the
risks and burdens minimized as far as possible.9
consent/cooperation of the hundreds of patients who
allow trainees to work with them. There is therefore a
societal contract which obligates physicians to recipro-
cate by serving both patients and societal needs.5,6
The limits of risk
Although physicians enter the medical profes- Military physicians have a duty to put the requirements
sion of their own free will, it is nevertheless difficult to of the military “mission” ahead of the interests of them-
convincingly argue that they therefore are obliged to selves or of individual patients. Physicians serving
assume unlimited risks. Such an argument relies on an in the military can be ordered to assume almost any
“implied consent” of all physicians to a strong duty to level of risk and even be expected to serve in situations
treat – but actual evidence that implied consent exists where they will likely die. Civilian physicians, however,
is lacking. Only about 55% of physicians now believe are not obligated in the way soldiers may be to take
there is such a “profession-wide duty to treat patients unlimited risks.
despite risk to one’s health.”7 In general, risks are more acceptable if they are pro-
The idea that physicians have special abilities that portionate to the benefits expected. When HIV/AIDS
increase their obligation to respond in emergencies has was becoming epidemic, some surgeons and anesthesi-
more traction. While people with special skills may not ologists refused to provide care for infected patients or
be ethically obliged to serve the public good all the time, to treat them equitably in other ways. But actual risks
communitarian principles do acquire more authority to healthcare providers who take care of HIV positive
in times of emergency. As Sawicki points out: patients are now known to be very low. It is therefore
unethical for physicians to refuse to treat HIV/AIDS
“As the risk of harm grows more imminent, as the gap
between harm to the rescuer and harm to the public widens, patients on the basis of maintaining their own safety.
and as the pool of available and qualified rescuers shrinks On the other hand, infections with the SARS virus
(particularly where state regulations preclude unlicensed are not only extremely contagious, but are associated
individuals from developing special abilities to rescue), with high mortality. In order to obligate physicians to
potential rescuers may indeed find themselves obliged to be exposed, there must be a proportionate expectation
subvert their own interests for the public good.”7 that their response will result in significantly better
This type of argument is based on rights-based, or overall patient outcomes, and/or in significantly better
deontologic, theories in which one generally should act societal outcomes through containment of the disease.
in a manner that promotes beneficence and respect for The ethical obligations of physicians to respond in
the lives and autonomy of others. Such duties, however, natural disasters or terrorist attacks, as well as what
are not restricted to the medical profession itself. manner of response can be required of them, must be
The American Medical Association’s Code of balanced between the probability that such participa-
Medical Ethics states that: tion will improve survival for more casualties, and
Because of their commitment to care for the sick and
the risks of mortality to the physicians themselves.
injured, physicians have an obligation to provide urgent Risks to casualties may be obvious early on, but the
medical care during disasters. This ethical obligation benefits of intervention unknown. Assessing the
holds even in the face of greater than usual risks to their risks to physicians in such situations is complicated;
own safety, health or life.8 routes of contamination during an epidemic and toxic
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 Section 6. Anesthesiologists, state, and society

exposure during natural or man-made disasters may … It is perhaps pertinent for the community and Hong
be unknown, at least initially. The means of reducing Kong healthcare authorities to ask some poignant questions,
risks to healthcare workers may not be fully under- however, about their commitment to people that work on
stood, and the equipment to reduce such risks not the front line to safeguard our right to life. Is adequate care
being taken to safeguard their lives by providing the neces-
readily available.
sary protection for them in a timely manner, for instance?
Supererogatory actions This is a vexing question that needs to be answered if our
appreciation of their efforts is to make any sense.11
In general, it is not an ethical obligation to risk one’s
own life to save another. Acts involving such risks are Emergency response workers have rights to adequate
usually termed “supererogatory”– literally “payment rest, updated information, and to participate in deci-
beyond that which is owed or asked.” Many examples of sion-making throughout the crisis. This not only
supererogatory – or heroic – acts can be found among assures their well-being, but enhances their ability
physicians responding to emergencies.10 Tse Yuen- to perform. Society has obligations to provide ade-
man was the first physician volunteer in the SARS epi- quate housing and other basic needs for emergency
demic in Hong Kong in 2003 to die of SARS. She had responders.
volunteered knowing that SARS is highly contagious Healthcare workers are on “the front lines” and
and very deadly. Anesthesiologists have been early should be among the first to receive effective pre-
responders in stabilizing patients in earthquakes and ventative treatment, such as vaccines in the event of
terrorist bombings, even at times providing on-site pandemics or bioterrorism situations. Additionally,
anesthesia when amputations are required for victim society has obligations to provide physicians made ill,
extrication. Structural instability, possible toxic con- injured or disabled during emergency response with
tamination, and the risk of being injured or killed in appropriate medical care and social support, much as
aftershocks of an earthquake or additional terrorist it has an obligation to provide such things for wounded
bombs detonated in order to kill the rescuers present soldiers.
imminent danger for early responders.
Case resolution
What does society owe to physicians The situation in the introductory case presents extreme
in mass casualty situations? potential risk to rescuers. An anesthesiologist who
responds performs an act that is “above and beyond the
Society and hospitals have interests in having compe-
call of duty,” i.e., one that cannot be required of him or
tent, seasoned and responsive physicians, and therefore
her. No rules, moral or legislative, can obligate a civil-
have obligations to physicians, e.g., to provide physi-
ian to risk sacrificing their life for another.
cians with personal protection, training and logistical
On the other hand, the broader context of
support to minimize their risk while maximizing the
this emergency will require responses that do not
potential benefit of physicians’ service to patients. Dr.
ne­cessarily place physicians at great personal risk.
Tse Yuen-man, for example, did not have protective
Anesthesiologists will be needed at the hospital, both
gloves to wear when she responded to an emergency
to triage and to care for patients who may require
resuscitation of a SARS patient. The Asian Human
immediate surgical intervention. Reporting for duty
Rights Commission offered the following words of
at the local healthcare facility may present an indi-
condolence, and appreciation for Dr. Yuen-man’s sac-
vidual healthcare provider with personal challenges,
rifice, and called upon healthcare authorities to recog-
such as making alternative arrangements to fulfill
nize their own obligations to physicians responding to
family obligations, as well as personal discomfort,
emergencies:
such as prolonged work hours to manage multiple
The right to life is at the centre of all human rights, and all
casualties. The “special” positive duties incurred by
efforts of the community should be geared toward its protec-
entering the medical profession and acquiring special
tion and promotion…The people in the medical profession,
particularly those that work to save life, are at the centre of skills impose greater obligations of response. Even
safeguarding people’s right to life. They become living wit- if unwilling to go into the subway to help extricate
nesses of the commitment of human beings to the life of oth- the trapped victim, the anesthesiologist is ethically
ers, living symbols of the tremendous respect with which the obliged to respond to the general call for help and
supremacy of life and its dignity are upheld. report for duty.

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2   Ehrenstein, B., Hanses, F., and Salzberger, B. (2006).

Key points
Influenza pandemic and professional duty: family or
• Ethical obligations of physicians to respond to patients first? A survey of hospital employees. BMC
mass casualty incidents have arisen in modern Public Health, 311.
times, as medical care has developed the 3   Mahoney, P.F. and Carney, C.J. (1996). Entrapment,
potential to improve outcomes of casualties. extrication, and immobilization. Eur J Emer Med, 3,
• The unique skills of anesthesiologists make 244–6.
them valuable in early emergency response – 4*  Malm, H., May, T., Francis, L.P., et al. (2008). Ethics,
for in-the-field management of casualties, pandemics, and the duty to treat. Am J Bioeth, 8(8),
4–19.
triage, and intensive care unit and operating
room management of victims. 5   Anantham, D., McHugh, W., O’Neill, S., and Forrow,
L. (2008). Clinical review: influenza pandemic –
• Everyone has general positive moral duties to physicians and their obligations. Crit Care, 12, 217–21.
help others in peril, particularly if there is low
6   Bostick, N., Levine, M., and Sade, R. (2008). Ethical
personal risk in doing so. obligations of physicians participating in public health
• Special positive moral duties occur when quarantine and isolation measures. Public Health Rep,
certain “relationships” exist between the 123, 3–8.
actor and the recipient of action: one 7*  Sawicki, N.N. (2008). Without consent: moral
such relationship is the physician–patient imperatives, special abilities, and the duty to treat. Am J
relationship. Bioeth, 8(8), 33–5.
• Physician ethical duties in disaster are based 8*  American Medical Association. Opinion 9.067 –
in part on the special skills they acquire that Physician Obligation in Disaster Preparedness and
are needed in emergency situations. Those Response. Adopted June, 2004. AMA. Council on
duties are strengthened by the restricted pool Ethical and Judicial Affairs. Chicago, Il. http://www.
of qualified responders, due to the limitations ama-assn.org/ama/pub/physician-resources/medical-
on who can be trained in the medical ethics/code-medical-ethics.shtml.
profession. 9* General Medical Council. (2009). Good Medical
Practice. Pandemic Influenza: Responsibilities of
• Physicians are not ethically obliged to risk
Doctors in a National Pandemic. London, General
their lives in emergency situations, but do Medical Council.
have ethical duties to respond and perform
10  Tai, D.Y. (2006). SARS plague; duty of care, or medical
non-life-threatening duties. heroism? Ann Acad Med Singapore, 35(5), 374–8.
• Society has obligations to physician 11  A Statement of the Asian Human Rights Commission
emergency responders, such as providing Offering Condolences and Deep Appreciation for the
appropriate protective equipment, first line Life and Work of Dr. Tse Yuen-man, 2003.
therapies such as vaccines, and treatment
when illness or injury results from emergency
response actions. Further reading
Simonds, A.K. and Sokol, D.K. (2009). Lives on the line?
Ethics and practicalities of duty of care in pandemics
References and disasters. Eur Respir J, 34, 3003–9.
1  Wallis, P. (2006). Plagues, morality and the place of Trotter, G. (2007). The Ethics of Coercion in Mass Casualty
medicine in early modern England. Eng Hist Rev, CXXI Medicine. Baltimore: The Johns Hopkins University
(490), 1–24. Press.

269
 Section 6
1 Anesthesiologists, the state, and society
section 1
Chapter

46
Triage in civilian mass casualty situations
Susan K. Palmer

The Case Principles of civilian versus military triage

A small community hospital located several hundred miles Military triage is an example of a situation in which
from any other hospital gets word that it is about to receive limited medical resources must be allocated among
100 casualties from a F-5 tornado that touched down five multiple casualties. The goals of combat medicine are
miles away. All elective surgeries are cancelled, and sur-
to return the greatest number of soldiers to combat,
geons are encouraged to quickly complete ongoing proce-
and then to preserve life. Seriously wounded soldiers
dures. An anesthesiologist is assigned to perform “front
door triage” – deciding which casualties go directly to the may be quickly stabilized, but then wait while atten-
OR, which can wait for treatment, and which can probably tion turns to returning less seriously wounded soldiers
not be saved. At least 20 casualties are expected to need crit- to the battlefield. (For a discussion of military triage
ical care or urgent surgery. There are five operating rooms. principles, see Chapter 47.) Combat triage principles
The ICU consists of eight beds, and is full. The local blood do not appropriately address civilian mass casualty
supply consists of 20 units of RBCs, including only four O situations in which survival, not combat-readiness, is
negative units. Resupply of blood and other critical provi- the main goal of medical treatment.
sions is several hours away.
The American Medical Association’s Code of Medical
Ethics states:
Ethical principles of civilian triage
Individual physicians should take appropriate advance Consequentialism
measures to ensure their ability to provide medical serv- Traditional medical ethics teaches that a physi-
ices at the time of disasters, including the acquisition and
cian should put their patients’ interests ahead of his
maintenance of relevant knowledge.1
or her own interests or preferences and also ahead
In medical triage, a “disaster” is defined as an incident of the interests of any other patients. In mass casu-
in which local response resources are overwhelmed by alty situations traditional patient-centered ethical
patient needs. Recent terrorist attacks, catastrophic principles of medicine may have to yield temporar-
earthquakes, and potential global pandemics have ily to the consequentialist (or utilitarian) principle
resulted in more discussion and effort towards plan- of “doing the most good for the greatest number.”
ning for the next mass casualty situation. Consequentialism was described by the British phi-
General principles of civilian triage should be losopher and socialist, Jeremy Benthamand, and was
familiar to all physicians. Isolated instances of mass further developed by James Mill and his son John
casualties can happen in a region with only one small Stuart Mill. Consequentialism does not value an
hospital, and any physician may be called upon to individual as much as the collective group of people
act as a triage officer. Anesthesiologists in particu- affected in a mass casualty situation. Individuals may
lar have special knowledge useful in triage  – air- even be viewed as a “means to an end” when applying
way assessment and management, fluid and blood consequentialist principles in practice. In the words of
resuscitation, intensive care expertise and knowl- Jonsen and Edwards,
edge of surgical treatment and local operating room This [disaster] is one of the few places where a “utilitar-
capabilities. ian rule” governs medicine; the greater good of the greater

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
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 Chapter 46. Triage of civilian mass casualties

Table 46.1. Catagories and color-coding for casualties in civilian disasters

Priority Color-code (for General description of injury Specific examples

tagging casualties) category
(1)Emergent Red Critical; may survive with simple Airway obstruction,
life-saving measures. hemorrhage, cardiorespiratory
Allocated to immediate care failure, shock
(2) Urgent Yellow Likely to survive if care is Penetrating abd wound,
provided within hours severe eye injury,
Allocated to delayed care, fractures, avascular limb
next priority
(3)Nonurgent Green “Walking wounded.” Injuries Lacerations, contusion,
generally minor and can be superficial or partial
delayed thickness burns < 20%
Allocated to delayed care, body surface area,
low priority uncomplicated fractures
(4) Catastrophic or Blue (dying) Catastrophically wounded Head injury – Glasgow
dead (sometimes Black (dead) patients who are unlikely to Coma Scale < 8, burns
divided into 2 survive if they don’t receive > 85% of body surface
groups to identify care within minutes, or area, multisystem trauma,
those in need of patients who have already signs of impending death
comfort care died
Allocated to comfort care
only if still alive.

number rather than the particular good of the patients at social worth, patient contribution to their illness/
hand. This rule is justified only because of the clear necessity injury, or the patient’s ability to pay for care. No patient
of general public welfare in a crisis.2 group should receive special consideration in a disaster
situation, other than that dictated by their physiology –
Justice including children.
Such principles of justice may be difficult to strictly
Patients’ trust in the medical profession is based heav-
follow, however, since judgments of social worth are
ily on the belief that physicians will do what is best for
nearly inevitable sometimes. For example, if some of
them individually. Utilitarian decision-making has the
the survivors of a tsunami are healthcare workers with
potential to erode that trust, if it is perceived that such
minor injuries, they might be given priority for treat-
decisions are made capriciously or are based on sub-
ment because of their value in then being able to help
jective judgments. Therefore, decisions about which
others. Physicians might be given the first doses of
patients will receive limited medical care resources
protective vaccine in a pandemic, so that they will not
in a disaster must be based on thoughtful criteria that
become infected and will be able to care for those who
are agreed upon and transparent to the community
are. Such decisions amount to prioritization based on
of patients. A number of models of medical triage in
social worth, but may be justified in this very restricted
civilian mass casualty situations are available. For one
context if the individual’s abilities are indispensable to
example of triage criteria, see Table 46.1.
the larger goal of this disaster’s containment. The deci-
The principle of justice dictates that criteria for tri-
sions should be strictly limited to only those skills that
age of civilian patients must be based on their medical
are essential to the successful management of the disas-
condition and not on their social connections. Ethically
ter, and not to general social assessments.3
acceptable criteria for withholding or withdrawing care
from patients could include the likelihood of benefit
from medical care, the urgency of need for care, and The risks of consequentialism
the availability of the resources needed to care for a When physicians are forced into mass casualty situa-
particular patient. Unacceptable criteria might include tions where they must temporarily abandon the usual

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 Section 6. Anesthesiologists, state, and society

ethical principles of medicine, then they must rec- and the capacity to “create” available beds, among other
ognize that what they are doing is distinctly different things.
from what would be acceptable in the normal course One consideration is the re-allocation of hospital
of patient care. Consequentialism, especially when it is beds from current inpatients to future ones, in a proc-
not recognized as distinctly different from usual medi- ess sometimes called “reverse triage.” In reverse triage,
cal ethics, can subvert the patient-centered values that patients who are capable of being cared for in lower
form the bedrock of medical professionalism. acuity beds or at home are discharged to make room
A historical example of the subversion of patient- for incoming casualties.
centered ethical values by consequentialist arguments The primary principle in disaster triage is utili-
can be found in the “Nazification” of the medical pro- tarian in aiming to provide the most benefit for the
fession in pre-WWII Germany.4 In a decades-long most people. Therefore reassignment of resources
process, German physicians were gradually con- away from existing patients must meet a test of
vinced to adopt consequentialist principles in medical proportionality – there should be at least as much,
decision-making in order to serve the interests of the and preferably significantly more potential benefit
“state” as the highest “good” and to bring the “great- expected for the incoming casualties, than there is
est happiness” to the greatest number of people. The potential for harm to those hospital patients who
process began with the replacement of academic phy- are reassigned. Kraus and colleagues describe such
sicians at universities with patriotic doctors who were considerations as “lifeboat ethics.” The needs of all –
not qualified as teachers or researchers and were less those in the lifeboats and those still in the water – are
likely to question the shift in ethical decision-making. treated equally.5
Physicians were promoted to positions of power on the Lifeboat ethics create concerns about breach of
basis of their political beliefs, and became increasingly expectations to existing patients. Inpatients expect that
involved in judgments regarding the “social worth” of they are benefiting from the hospitalization, and may
certain groups of patients. They were then recruited to therefore be harmed by early discharge. Some argue
research “humane” methods of killing persons whose that in a public health disaster, all patients are equal,
social worth was questioned. Consequentialist-type and therefore the priority of any existing patient, in
reasoning was offered to convince physicians that they the lifeboat or outside of it, is re-triaged in the setting
were doing what was best for the “greatest number” of of the mass casualty event. By this reasoning, it might
Germans. Ultimately, refusal by physicians to partici- be ethical to balance the likelihood that discontinuing
pate in these activities was branded as “unpatriotic,” “futile” care to an inpatient and reallocating resources
and therefore harmful to society. to a “more salvageable” casualty will result in greater
Consequentialism may be a legitimate ethical benefits than continuing critical care to a moribund
framework in which to make decisions regarding how patient while the casualty is denied the resource. Thus,
resources should be allocated when mass casualties a terminally ill ICU patient might be transferred to
overwhelm the traditional delivery of medical care, comfort care measures – in much the same way as a
but is not the ethical framework applied to usual medi- “black” listed pre-morbid casualty might be – so that
cal care. another injured patient whose survival is more likely
can occupy the bed.
As with other forms of triage, “lifeboat” triage
Lifeboat Ethics should be transparent, and based on empirical data and
Once initial triage is performed to decide which community approval. In promoting disaster prepared-
patients do not need immediate care (the walking ness, hospital administrators who consider developing
wounded, and the dead or near-dead), another set of lifeboat triage policies should do so with considerable
decisions face providers in facilities to which the sur- community input.
vivors are evacuated. During public health disasters,
hospitals perform as “lifeboats,” with finite capacity to
“surge” to meet the medical needs of arriving casual- Case resolution
ties. The extent of a hospital’s ability to “surge in place” Several measures have already been taken to prepare
depends on ability to acutely increase staff, the current for the arriving casualties. An assessment of the cur-
status of critical supplies, the number of available beds, rent status of all operating rooms has been made, and

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 Chapter 46. Triage of civilian mass casualties

the operating rooms are being freed as soon as possible

individual patients as a means to achieve
to accept casualties. All available staff have been con-
certain ends for others.
tacted and asked to report to the hospital. The hospi-
• Triage in mass casualty events should be based
tal, in other words, is preparing to “surge” as much as
on principles of justice that treat all patients
possible. The available blood has been inventoried, as
equally, and from the perspective of their
well as an assessment of when resupply is likely to be
medical condition rather than social worth.
possible. All of this information is helpful to the triage
officer in allocating resources. • However, “social worth” may be applicable
When casualties arrive, all patients who do not in very limited interpretations, when the
need immediate attention, either because they are not particular skills of the individual are critical
seriously injured, or because they are not expected to to managing the disaster itself. One example
survive their injuries, should wait for resource-inten- is allocation of vaccines to physicians in
sive treatment. Seriously and critically injured patients pandemics so that they remain well and
who have a potential to survive will receive first inten- continue to treat victims.
sive treatment. The anesthesiologist should continue to • “Lifeboat” ethics may lead to decisions to
reassess casualties even after they arrive, to “re-triage” reallocate resources away from existing
if they later fit a different triage category, or as supplies hospital patients in order to provide capacity
arrive and more resources become available and can be to treat disaster victims.
extended to them. An assessment should also be made • Triage should be based on ethically sound
regarding how many hospital beds are available, and principles, should be transparent, should
whether any inpatients can be allocated to lower acuity include public input, and should be developed
beds, or discharged home. before disaster strikes.
The recent earthquakes in Haiti and Chile under-
score the need for physician and hospital preparedness
should a natural disaster strike. Merin and colleagues References
describe the process of inventorying and managing lim- 1   American Medical Association Code of Medical
ited resource, including the formation of triage consult Ethics, Opinion 9.067. Physician obligations in disaster
preparedness and response. Adopted June, 2004. AMA,
committees to aid in difficult on the ground decision-
Chicago, IL.
making. Knowledgeable and prepared physicians are
2   Jonsen, A. and Edwards, K. Resource allocation in
desperately needed in times of mass casualties, to have
Ethics in Medicine, University of Washington School
the best chance of providing life-saving care to as many
of Medicine. http://eduserv.hscer.washington.edu/
people as possible.6 bioethics/topics/resall.thml.
3*  Beauchamp, T.L. and Childress, J.F. (1994). Justice in
Key points Principles of Biomedical Ethics, 4th edn. NY: Oxford
University Press, pp. 386–7.
• During mass casualty situations, the goals
4*  Lifton, R. J. (1986). The Nazi Doctors, Medical Killing and
of medical management change from those
the Psychology of Genocide. New York, NY: Basic Books.
focusing on individual patient benefit, to more
5*  Kraus, C.K., Levy, F., and Gabor, K. (2007). Lifeboat
utilitarian principles of “doing the most good
ethics; considerations in the discharge of inpatients for
for the most people.” the creation of hospital surge capacity. Disaster Med
• Civilian casualty triage differs from military Public Health Prep, 1(1), 51–6.
triage. In military triage, a primary goal 6*  Merin, O., Nashman, A., Levy, G., et al. (2010). The Israeli
is returning the less severely wounded to field hospital in Haiti – ethical dilemmas in early disaster
combat. In civilian triage the goal is overall triage. New Eng J Med, published online, March 3.
survival. Thus, victims not expected to survive
may be allocated to lower treatment priority Further reading
than those who have survivable injuries.
Code of Medical Ethics of the American Medical
• Consequentialism is not philosophically Association. (2006). Council on Ethical and Judicial
supportable as an ethical basis for the best Affairs, current opinions with annotations 2006–2007
medical care because it approves of using edition. AMA, USA.

273
 Section 6. Anesthesiologists, state, and society

Devereaux, A.V., Dichter, J.R., Christian, M.D., et al. (2008). Trotter, G. (2007). The Ethics of Coercion in Mass Casualty
Definitive care for the critically ill during a disaster: a Medicine. Baltimore: The Johns Hopkins University Press.
framework for allocation of scarce resources in mass VA Office of Public Health and Environmental
critical care. Chest, 133, 51S–66S. Hazards: www.vethealth.cio.med.va.gov/
Moreno, J.D. (2004). In the Wake of Terror. Medicine and Veterans Health Administration – Central Office:Pandemic
Morality in a Time of Crisis. The Cambridge, MA: MIT influenza in general, www.pandemicflu.gov.
Press. National Center for Ethics in HealthCare.www.ethics.va.gov.

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 Section 6
1 Anesthesiologists, the state, and society
Chapter

47
Triage and treatment of wounded
during armed conflict
Craig D. McClain and David B. Waisel

The Case The underlying discrepancy between civilian

and military medical ethics can be attributed to their
The triage physician at a forward clearing station receives
two wounded enemy enlisted men, an injured local villa- respective goals and how they are to be achieved.
ger, and a wounded friendly solider. The enemy soldiers Civilian physicians, in most circumstances, concen-
appear to have serious section
but not1 life-threatening internal trate on primary medical goals, while military physi-
bleeding and may require blood transfusion. The triage cians must adhere to the organizational objective of
physician estimates that short operations will stabilize defeating the enemy. As such, military physicians must
both enemy soldiers. It is unlikely they have any useful occasionally subordinate other values to achieve defeat
military intelligence. The villager’s open femur fracture of the enemy.
will require surgical treatment and a blood transfusion This is the origin of the core ethical quandary with
under normal circumstances. He has a hematocrit of 25% which military physicians must wrestle: finding a bal-
and a compression dressing has effectively limited his rate
ance between giving absolute priority to the principle
of bleeding. The friendly soldier has a vascular injury in
his groin. He is conscious, mildly hypotensive and his
of military necessity – and its attendant obligations as
hematocrit is 18%. The triage physician is concerned that a military officer – with that of lending moral weight
this operation will consume extensive resources both dur- to their patients’ interests according to the traditional
ing the operation and postoperatively. Many additional principles of civilian medical ethics. Indeed, mili-
casualties will arrive within the hour. The triage physician tary physicians may have to choose to sacrifice their
estimates that treating all four patients will deplete the patients’ autonomy and best interests when required
unit’s blood supply, and she is aware that no further per- to fulfill the military mission of protecting their soci-
sonnel or material resources are expected. ety. Physicians trained within modern medical ethics
in which an individual patient’s rights are paramount
“It is forbidden to kill; therefore all murderers are may have difficulty balancing those views with their
punished unless they kill in large numbers and to the duty to place the needs of the military before those of
sound of trumpets.”(Voltaire)
his/her patients.
Military medicine intertwines the military and medical Triage is a system of sorting patients according to
professions. Under most circumstances, the military need when resources are insufficient for all wounded to
physician serves primarily as a physician, and to a lesser be treated. Military medical ethics becomes even more
extent as a member of the military. However, on occa- complex and challenging in the arena of armed conflict
sion, the two positions can battle each other for ascend- when triage of the wounded involves friendly soldiers,
ency. In Greek mythology the sons of Asclepius were “enlisted” enemy soldiers, and local civilians.
both healers and warriors. However, in modern times,
military physicians do not take up arms to confront the
enemy unless their own lives – or those of their patients –
International guidelines for ethical conduct
are under threat. In fact, many of the ethical challenges of physicians engaged in armed conflict
met by the modern military physician are not encoun- In response to wartime outrages, international
tered in civilian settings, and as such, it may not always organizations codified the conduct of armed con-
be appropriate – or practicable – to apply the principles flict. Statements from the Geneva Conventions,a
of civilian medical ethics to military medicine. International Committee of the Red Cross, the United

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
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 Section 6. Anesthesiologists, state, and society

Nations, and the US military1 have proposed that war The goals of combat medicine are to return the great-
can be conducted in an orderly fashion by adhering to est possible number of wounded soldiers to combat
certain guidelines. The World Medical Association’s and to preserve life. These sometimes conflicting goals
(WMA’s) resolution entitled “Regulations in Times of necessitate tough decisions. Faced with an impending
Armed Conflict” typifies these statements2*: attack, physicians may try to quickly stabilize critically
Medical ethics in times of armed conflict is identi- wounded soldiers while focusing most resources on
cal to medical ethics in times of peace, as stated in the returning the less seriously wounded soldiers to fight-
International Code of Medical Ethics of the WMA. If, in ing. If speedily returning soldiers to combat is less
performing their professional duty, physicians have con- essential, then combat physicians may devote most of
flicting loyalties, then their primary obligation is to their their resources to treating the critically wounded.
patients; in all their professional activities, physicians
Soldiers may receive care during triage that they
should adhere to international conventions on human
would not receive in a resource-rich environment. For
rights, international humanitarian law and WMA decla-
rations on medical ethics. example, rather than performing limb salvage surgery
The primary task of the medical profession is to pre- on a soldier with a neurovascular injury, the physician
serve health and save life. Hence it is deemed unethical for may amputate the arm in order to conserve time and
physicians to … give advice or perform prophylactic, diag- other resources. In his article, Gross crystallizes the
nostic or therapeutic procedures that are not justifiable for sacrifices soldiers accept in regard to triage:
the patient’s health care. … (military) medical personnel bear an obligation to sal-
vage soldiers and return as many to duty as quickly as pos-
While codifying wartime behavior sounds ironic,
sible. Salvage speaks to a specific and objective measure
these principles are accepted by most of the interna- of quality of life distinct from the patient’s own subjective
tional community. Indeed, modern bioethical prior- evaluation. Salvageable soldiers may not invoke quality of
ity of respect for autonomy is promoted by the WMA’s life to refuse treatment, however painful or onerous, if it
prohibition against performing procedures that would will return them to military duty. Those beyond salvage, on
not benefit the soldier-patient. Both independence the other hand, may not appeal to any right to life to secure
from controlling influence and capacity for intentional medical care when resources are scarce.3
action are essential for making an informed choice Clashing demands of patient and state may cause cog-
regarding medical treatment. nitive dissonance in the physician, requiring mindful
During state-sponsored armed conflict, however, attention to balancing loyalty to the state with loyalty
the goals and needs of the state often supersede the to the patient.
rights of individuals. Combatants, by definition, are
members of a state-controlled military force actively Enemy non-combatants
participating in armed conflict. By joining the mili-
Enemy combatants pose a direct and dangerous threat
tary, soldiers have willingly accepted some level of con-
to the security and stability of the state. In war, active
trolling influence from the state, particularly during
enemy combatants have no intrinsic right to life or
combat. Using this standard, it may be necessary for
medical care. Wounded enemies are no longer a sig-
individuals to make willing or unwilling sacrifices  –
nificant threat and are reclassified as non-combatants,
including that of their health and survival  – for the
thereby regaining their rights to life, medical care and
benefit of the state.
humane treatment. The Geneva Convention states, “All
wounded, sick and shipwrecked, to whichever Party
Triage they belong, shall be respected and protected…shall be
Triage is the dynamic process of prioritizing treatment treated humanely and shall receive, to the fullest possible
for casualties in a resource-poor environment. Tables extent and with the least possible delay, the medical care
47.1 and 47.2 illustrate the complexity and imprecision and attention required by their condition. There shall be
of triage. Table 47.1 describes theoretical and practical no distinction between them on any other grounds.”1
triage categorization. Table 47.2 describes the multiple There is a theoretical and practical basis for treat-
known and unknown factors that affect the otherwise ing wounded enemy non-combatants the same as
discrete categorization of the wounded. But this over- wounded friendly soldiers. It is consistent with the
simplification is belied by the demand for in-the-mo- training of physicians that all patients are equally
ment functional use of these categories.b deserving of treatment. Supporting this belief may

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 Chapter 47. Triage of casualties in armed conflict

Table 47.1. Traditional wartime triage categories

Traditional Practical
Immediate Critical
•  Lifesaving intervention •  Urgentintervention needed to avoid death or major
•  Brief disability
•  High chances of survival •  Examples
•  Examples •  Airway obstruction / compromise (actual or potential)
•  Respiratory obstruction •  Uncontrolled bleeding
•  Pneumothorax •  Shock
•  Amputation •  Systolic BP < 90 mm Hg
•  Unstablecasualties with chest or abdominal injuries •  Decreased mental status without head injury
•  Unstablepenetrating or blunt injuries of the trunk, neck,
head, and pelvis
•  Threatened loss of limb or eyesight
•  Multiple long-bone fractures
Delayed Noncritical
•  Can delay surgery without increasing risk •  May require surgery
•  Time-consuming surgery •  Does not require emergent attention
•  Sustainingtreatment required (e.g. IV fluids, •  Lackssignificant potential for loss of life, limb, or
splinting, antibiotics, gastric decompression, and eyesight
pain relief ) •  Examples
•  Examples •  Single long-bone fractures
•  Large muscle wounds •  Closed fractures
•  Fractures of major bones •  Soft tissue injuries without significant bleeding
•  Abdominal and thoracic wounds •  Facial fractures without airway compromise
•  Burns less than 50% of total body surface area
Minimal
•  Treatable by non-medical personal
•  Examples
•  Minor lacerations and abrasions
•  Fractures of small bones
•  Minor burns
Comfort Care Comfort Care
•  Survival unlikely in the best of circumstances •  Survivalunlikely given the situation and resource
•  Provide comfort care constraints
•  Examples •  Examples
•  Unresponsivepatients with penetrating head •  Novital signs or signs of life, regardless of mechanism
wounds of injury
•  High spinal cord injuries •  Transcranial gunshot wound
•  Mutilatingexplosive wounds involving multiple •  Openpelvic injuries with uncontrolled bleeding; in
anatomical sites and organs shock with decreased mental status
•  Secondand third degree burns in excess of 60% •  Massive burns
total body surface area
•  Profound shock with multiple injuries
•  Agonal respiration
The traditional column represents the standard wartime triage. The practical column suggests a more ­functional approach to triage.

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 Section 6. Anesthesiologists, state, and society

Table 47.2. Factors influencing discrete categorization of the wounded

•  The tactical situation and mission

•  Current supply of consumable resources and anticipated resupply, if any
•  Currentstatus of static resources and capabilities: the number of operating rooms, holding and
ward capacity and diagnostic equipment
•  Opportunitycosts of individual casualties, i.e. one overwhelming patient can limit available
resources (particularly operating room tables, which is often the choke point) for other patients
•  Evacuationintervals of wounded to a main treatment facility; e.g. shorter evacuation intervals
may lead to more treatment for more complex patients, because they will not consume as many
resources post-operatively
•  The status of personnel resource
•  Professional capability (type and experience of individual physician/ nurse/medic)
•  Perishable resources
•  Emotional stability of personnel
•  Sleep status of personnel
•  Stress (degrades individual and unit capability)

help protect (or at least not breach) the internal mor- The case emphasizes the murkiness of triage. One
ality of military physicians, whose behavior by virtue could imagine prioritizing the friendly soldier given his
of formal and informal authority influences others. more tenuous state and the realization that resources
Treating enemy non-combatants the same as wounded may diminish after the others receive care and other
friendly soldiers emphasizes the enemy’s humanity wounded arrive. On the other hand, repairing a vascu-
and may prevent abuses rooted in the dehumanization lar injury could be time and material consuming and
of the enemy. Practically, physicians hope that follow- more pressing demands eventually may require intra-
ing this agreement will incent their enemies to do the operative abandonment and re-categorization of the
same. soldier to expectant.
If all the wounded men were treated as equals, then
Civilian non-combatants one could imagine starting with the patients with inter-
Civilian non-combatants are those taking no active nal bleeding (on the theory that an easily fixable prob-
part in hostilities such as the local civilians, aid work- lem now may turn into a more costly problem later),
ers, displaced persons, and media. Similar to enemy temporizing the femur fracture and delaying work on
non-combatants, civilian noncombatants are to be the patient with the vascular wound until the next wave
triaged akin to friendly soldiers. Noncombatants may of wounded and more resources arrive.
have involuntarily diminished autonomy due to the
hegemony of the armed conflict. Despite the humani- Key points
tarian imperative and the public relations boon of
• During state-sponsored armed conflict,
treating civilian noncombatants, access to care may be
military physicians will be placed in situations
hindered in a resource-poor environment.
where they need to triage honorably.
Principled triaging • Knowledge of some of the ethical
Principled triaging is arduous. It would be easy for underpinnings of the decision-making
honorable physicians to be unconsciously influenced process would aid in making these difficult
during triage. One can also imagine physicians con- decisions in a tense situation.
sciously overcorrecting to inappropriately prioritize • Close examination of the nature of the
enemy noncombatants out of a fear of being unfair. differences between bioethical principles in
On the other hand, it takes courageous physicians to peacetime as well as wartime will ultimately
choose appropriately to spend limited resources on lead to a better understanding of the difficulties
enemy noncombatants instead of countrymen. faced by physicians during armed conflict.

278
 Chapter 47. Triage of casualties in armed conflict

Notes 173rd Council Session, Divonne-les-Bains, France,

May 2006.
a
Rules relating to the conduct of combatants and the protection
of prisoners of war, 1988 extract from “Basic Rules of the Geneva 3*  Gross, M.L. (2004). Bioethics and Armed Conflict:
Conventions and their Additional Protocols”; Geneva:  ICRC, Mapping the Moral Dimensions of Medicine and War.
2nd edn. Hastings Cen Rep, 34(6), 22–30.
b
Rules relating to the conduct of combatants and the protec-
tion of prisoners of war, extract from “Basic rules of the Geneva
Conventions and their Additional Protocols”; ICRC, Geneva,
1988; 2nd edn.
Further reading
Emergency War Surgery (2004). 3rd United States Revision.
Department of Defense, United States of America.
References International Dual Loyalty Working Group (2003). Dual
1*  Beam, T. and Howe, E. (2003) A proposed ethic for Loyalty & Human Rights in Health Professional
military medicine. Military Medical Ethics: Volume 2. Practice. Physicians for Human Rights 2003.
Peligrino, E.G., Hartle, A.E. and Howe, E.G., eds.
Department of Defense, Borden Institute, Washington, Repine, T.B., Lisagor, P., and Cohen, D.J. (2005). The
DC, USA. dynamics and ethics of triage: rationing care in hard
times. Mil Med, 170, 505–9.
2*  The World Medical Association Regulations in Times
of Armed Conflict. Originally adopted by the 10th Rubenstein, L.S. (2004). Medicine and War. Hastings Cen
World Medical Assembly, Havana, Cuba, October Rep, 34(6), 3.
1956, most recently amended by The WMA General Singh, J.A. (2003). American physicians and dual loyalty
Assembly, Tokyo 2004 and editorially revised at the obligations in the “war on terror.” BMC Med Ethics, 4, E4.

279
 Section 6
1 Anesthesiologists, the state, and society
Chapter

4 8
Physician facilitation of torture and
coercive interrogation
David B. Waisel

The Case to develop their interrogative approaches, falsifying

medical records and death certificates, and failing to
A suspect informs police that he has buried a 5 year-old girl
in a box with a limited air supply. Standard interrogation provide even basic healthcare.2
techniques have failed to ascertain the girl’s location and it All mainstream medical ethicists unwaveringly
section
is believed she may have 1 hours to live. A judge
only several reject torture as an affront to the fundamental and
authorizes torturing the suspect to obtain the girl’s location. absolute right of all humans to dignity. We shall con-
The proposed method of torture is to have an anesthesi- sider the morally impermissible nature of torture (as
ologist administer a paralytic drug to the awake prisoner, well as of coercive interrogation), the ethical prohi-
and then allow the prisoner to experience periods of awake bition of physician participation in torture, and the
paralysis without respiratory support. This will result in dilemma of dual loyalties facing physicians requested
acute hypercarbia, severe dyspnea, and an experience of or mandated to participate in such universally con-
awake suffocation. After a period of time, time the anesthe-
demned activities.
siologist will be instructed to ventilate him with a bag and
mask, reverse the paralytic, and allow him to answer ques-
tions. The technique will leave no lasting physical disfigure- International statements banning
ment or disabilities.
This type of scenario, known as the “ticking time bomb
torture
scenario” is often proposed as one in which torture might Arguments prohibiting torture are straightforward
be justified. Some authors suggest that in cases of “ticking and powerful. Perhaps the most potent argument is
time bomb scenarios,” not only is torture possibly justified, the psychological, emotional, cultural and legal pro-
but that it should be regulated by judicial warrant and hibition to treat people inhumanely. For that reason,
oversight.1 a number of agreements and statements ban torture.3
Torture is the deliberate infliction of mental and For example, the 1984 Convention Against Torture
physical suffering in order to overcome resistance or and Other Cruel, Inhuman or Degrading Treatment or
to sufficiently disorient prisoners so that the torturer Punishment from the United Nations4 states:
can intimidate, extract information, and obtain con- Torture and other cruel, inhuman or degrading treat-
fessions. Methods of physical torture include, but are ment or punishment are particularly serious violations
of human rights and, as such, are strictly condemned by
by no means limited to, beating, choking, stressful
international law.
positioning, “simulated drowning”a and use of electric
shock. Methods of psychological torture involve sen- The Convention declared that no “exceptional circum-
sory manipulation, sleep deprivation, exploitation of stances” and no legal authority may supersede this
phobias, and humiliation. Torture is performed during absolute prohibition.
peace and wartime – by state policy or by individual For long periods of history, torture was legal, and
decision. “Participation in torture” is not necessarily physician participation was common. Following rev-
confined to administration of the coercive technique elations about atrocities during World War II, Western
itself. Historically, medical personnel have partici- nations condemned torture through documents such
pated in torture by evaluating prisoners for interro- as the Geneva Conventions and statements from the
gation, monitoring coercive interrogation, allowing international medical tribunal at Nuremberg. In 1982,
interrogators access to medical records of the prisoners the United Nations reiterated the foundational ethical

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
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 Chapter 48. Torture and coercive interrogation

medical principle of nonmaleficence (primum non the information is accurate and the potential benefits
nocere  – first do no harm), imploring physicians to such as lives saved from the information.
adhere to this dictum when requested – or ordered – No studies confirm or deny the relative accuracy
to participate in medical interventions that are not of torture in extracting accurate information, or how
intended to be beneficial: often information obtained from torture has saved
It is a great contravention of medical ethics, as well as lives. Many experienced interrogators believe that tor-
an offence under applicable international instruments, ture is less likely to lead to accurate information than
for health personnel, particularly physicians, to engage, other techniques such as relationship building. If the
actively or passively, in acts which constitute participa- rate of success is relevant in deciding whether to tor-
tion in, complicity in, incitement to, or attempts to commit ture, however, this implies that the decision to torture
torture or other cruel, inhuman or degrading treatment or
should be based on risks and benefits. From an ethics
punishment.5
point of view, if torture is wrong because it is an affront
The World Medical Association has repeatedly made to human rights and dignity, then it is always wrong,
declarations against physician participation in torture regardless of the rate of success.
as well as in other cruel, inhumane or degrading prac- Returning to the case example at the beginning of
tices. In particular, it iterated that: this chapter, we find that the kidnapped girl in the box
Medical ethics in times of armed conflict is identical to is an example of a scenario that fulfills many of these
medical ethics in times of peace … [and that] … if, in per- aforementioned requirements. The confessed perpe-
forming their professional duty, physicians have conflict- trator has provided sufficient evidence to prove his par-
ing [dual] loyalties, their primary obligation is to their ticipation and knowledge of the crime (to help rule out
patients. coerced confession), less invasive methods have failed,
The American Medical Association lends even further and time-sensitive results will immediately benefit the
support by calling upon physicians to support victims kidnapped girl. Presumably acting in good faith, inter-
of torture, reject the use of torture, and endeavor to rogators desired to avoid torture, but feel compelled by
change situations in which torture is practiced.6 their obligation to help the girl. Importantly, the judge,
Treaties and statements prohibiting torture a formal authority operating within her jurisdiction of
encourage states not to torture so that their enemies protecting others, has approved proceeding, so there is
also will not torture. For example, the prohibition on no legal impediment. False leads will not cause a mis-
gas warfare was effective in World War II because each allocation of limited resources that otherwise might
side feared that initiating gas warfare would result in expose society to other harms, and the information can
a similar enemy response. The moral clarity provided be quickly confirmed or disproven.
by statements may enable states to refrain from torture While there may be no tangible losses in this case,
regardless of enemy actions. In addition, torture rents there may be meaningful societal losses. Torturing that
the fabric of both the torturer and the community. If leads to rescuing the girl may nudge society toward
torture were to become acceptable within society, it being more accepting of torture. If society were to
may become psychologically easier to permit other choose to sanction torture, then the policy and process
immoral acts. ideally would be wholly transparent, inviting public
Some commentators suggest that torture may be discussion and review. But, no matter what precautions
acceptable under certain conditions,7 but that torture are taken, permitting torture – even under limited cir-
should be a last resort only after other less intrusive cumstances  – likely will lead to abuses. Moreover, a
measures have failed. They further declare that inter- declaration removing the taboo of the unethical nature
rogators would need robust reasons for believing that of torture would give other countries (and terrorists) a
the prisoner has the desired information, and that such public relation’s safe harbor to perform torture.b
information must have immediate benefits for redu-
cing or preventing imminent harm. Under these spe- Should physicians participate in torture?
cific conditions, they contend, torture may be worth The American Medical Association (AMA) Opinion
its associated harms. However, these authors further on Torture states, “Physicians must oppose and must
opine that torture should not be used to force confes- not participate in torture for any reason.”8 The argu-
sions or to uncover unspecified, future crimes. Other ment, in part, is that torture is antithetical to the phy-
gross considerations may include the likelihood that sician’s primary responsibility to help patients as they
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 Section 6. Anesthesiologists, state, and society

define help. Moreover, the AMA’s Code of Medical adversaries, but whether hostile “stress and duress” tac-
Ethics states, “Physicians may treat prisoners or tics are tantamount to torture is debatable. The military
detainees if doing so is in their best interest, but physi- further argues that the physicians assisting in devising
cians should not treat individuals to verify their health or performing coercive interrogation strategies do not
so that torture can begin or continue.” This “best inter- have doctor–patient relationships with the prisoners
est” phrase has laid the basis for a distinct minority because other physicians not participating in coercive
of commentators who believe that traditional medical interrogation provide the medical care for the pris-
values mandate at least minimal physician participa- oners. In fact, they argue, physicians participating in
tion in hostile interrogation even though this theoreti- coercive interrogation are using medical skills outside
cally could prepare the prisoners to undergo further of functioning in the role of a physician. Many con-
hostile interrogation. However, the AMA condemns sider this interpretation as a dubious one, arguing that
coercive interrogation as well as torture. physicians are, indeed, acting as physicians by virtue of
Countervailing the argument that physicals should using medical knowledge and skills in their interaction
only act in the patients interest is that number of physi- with the prisoners.
cians work for the public good and do not prioritize Military physicians are faced with balancing what
helping individual patients. Consider, for example, is simplistically known as “dual loyalty” when decid-
the specialties of forensic psychiatry, public health ing whether they have an obligation to participate in
and occupational health in which physicians often coercive interrogation as part of their military and
incorporate an investigative component when pro- societal obligation.11 Military medicine is a mingling of
viding services to the public. In this sense, it has been the military and the medical professions. Under most
suggested that legally sanctioned torture is similar in circumstances, the military physician serves primarily
that it would claim that it serves the public good. This as a physician, and to a lesser degree as a member of
specious argument ignores the critical factual differ- the military. However, on occasion, the two positions
ence that forensic psychiatrists and public health and can be contradictory. On one hand, military physicians
occupational health physicians do not directly physic- have obligations to fellow soldiers, the military and the
ally or psychologically harm individual patients, either. nation’s military units to perform what is necessary to
Furthermore, although physicians may make it easier achieve the goals of the military and their country. On
to accomplish torture, their participation is in fact not the other hand, these physicians have an obligation
necessary for torture to happen. Torture can be accom- to honor personal values and beliefs as well as their
plished in many other ways.9 obligation to society of not harming the image of the
physician. To advise military physicians, commenta-
The military physician tors mostly declare that one of the two obligations has
A newly deployed physician must decide whether to post absolute hegemony over the other. While dogma may
physician assistants and medics behind a one-way mirror be helpful to some physicians, others appreciate having
during interrogations. A military police commander tells a process to resolve these dilemmas.
the physician that “the way this worked with the unit here The International Dual Loyalty Working Group
before was: We’d capture a guy; the medic would screen him (IDLWG) guidelines call for education of physicians
and ensure he was fit for interrogation. If he had questions to recognize dual loyalty situations involving human
he’d check with the supervising doctor. The medic would get rights and international law. They suggest that an
his screening signed by the doc. After that, the medic would independent group should set standards for behavior
watch over the interrogation from behind the glass.”10 in dual loyalty situations, and, additionally, that a for-
In this scenario, coercive interrogation is designed to mal appeals process and whistle-blower protections be
find general information, not specific, time-sensitive instituted. Their proposals center on the premise that
information. Moreover, there would be a limited abil- population-based interventions of standards through
ity to immediately validate the confession, leading to oversight and statements of professional organizations
a much higher likelihood of wasting resources while will change behavior and provide support for the indi-
pursuing false leads. vidual physician.
The US military has stated that they perform coer- Notwithstanding the recommendations of the
cive interrogation but not torture. Military conflicts IDLWG, commentators generally insist that military
usually lead to the detention and interrogation of and civilian physicians must hew to the same standards

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 Chapter 48. Torture and coercive interrogation

of ethical behavior because medical ethics are univer-

sal.12 In addition, they argue, the military benefits by • There is similar disagreement about
adhering to civilian standards because it is more con- distinctions between when a physician is
sistent with the mindsets of physicians. Both argu- acting as a physician and when a military
ments, however, have been challenged. While possibly officer, who happens to be a physician, is not
true in theory, in reality medical ethics are not univer- acting as a physician.
sal. And given that the unique experiences and obliga- • Nearly all commentators prohibit any
tions of military physicians are not often encountered physician participation in any aspect of
in civilian settings, the ethical principles of the civilian coercive interrogation or torture.
physician may not always be appropriate – or practic- • Dual loyalty decisions by physicians about
able – to apply to military medical standards. torture and interrogation are emotionally
A danger in excusing the military physician lies in charged and highly stressful, and should not
the possibility that torture for the purposes of the state be made by the individual in the moment, but
may be viewed without the same critical eye as torture by rather based on central policies with fervent
law enforcement agencies within a state. Furthermore, oversight.
participation in torture leads to degradation of the
physician, whether civilian or military, by allowing
him or her to become “socialized to atrocity.”13 Notes
a
As Annas stated: It should be noted that in this usage, “simulated drowning” refers to
the creation of a sensation of drowning, often through the submer-
Preventing torture is everyone’s business – but three pro- sion in and aspiration of water.
fessions seem to be especially well suited to prevent tor- b
Author’s note: If a judge were to come to me as a physician and ask
ture: medicine, law and the military. Each profession has me to torture a confessed suspect in order to try to save the little
particular obligations. Physicians have the obligations girl’s life in a time-limited situation, then I would find it difficult to
of the universally recognized and respected role of heal- refuse to participate. If the girl were a child I knew, then I suspect
ers. Lawyers have the obligations to respect and uphold that I might even find it quite easy to torture the suspect. While
the law, including international humanitarian law. And emotions in the heat of the moment are understandable, such
military officers have the obligation to follow the interna- emotionally based behaviors are precisely why society prohibits
tional laws of war, including the Geneva Conventions.14 vigilante justice. I want to convey that we should not leave emo-
tional, stressful, and even dual loyalty decisions about torture or
Physician participation in torture harms the integrity of coercive interrogation to the individual (in this case, a physician)
the medical profession and societal trust in physicians, in the moment. These decisions should be based on central policies
and physicians must consider the societal consequences guarded with fervent oversight.
of such behavior. Statements by organized medicine
provide some reflection of the potential for such public References
harm. The ethical analysis of statements written during 1   Dershowitz, A.M. (2002). Why Terrorism
peacetime is often superior to the impromptu analysis Works: Understanding the Threat, Responding to the
made in the heat of battle. Physicians under consider- Challenge. New Haven, CT: Yale University Press
able stress may want to consider the limitations of their 2   Miles, S.H. (2004). Abu Ghraib: its legacy for military
ability to perform ethical analysis and may want to medicine. Lancet, 364, 725–9
defter to such statements. 3*  World Medical Association Declaration Concerning
Support for Medical Doctors Refusing to Participate in,
or to Condone, the Use of Torture or Other Forms of
Key points Cruel, Inhuman or Degrading Treatment. 1997.
• Every treaty, international agreement, 4   Convention against Torture and Other Cruel, Inhuman
national policy, and medical association code or Degrading Treatment or Punishment. United
of ethics declares that torture is not morally Nations. 1984.
permissible and that physicians should not be 5   United Nations General Assembly resolution 37/194,
involved in coercive interrogations. Principle 2. 111th plenary session, 18 December 1982
www.un.org/documents/ga/res/37/a37r194.htm
• Commentators disagree about distinctions
6   Council on Ethical and Judicial Affairs, American
between torture and coercive interrogation.
Medical Association. E-2.067-Torture.

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 Section 6. Anesthesiologists, state, and society

7*  Kennedy, R.G. (2003). Can interrogatory torture be 12* Annas, G.J. (2008). Military medical ethics – physician
morally legitimate? Presented at JSCOPE 2003: A Joint first, last, always. N Engl J Med, 359, 1087–90.
Services Conference on Professional Ethics 13* Lifton, R.J. (2004). Doctors and torture. N Engl J Med,
8   Council on Ethical and Judicial Affairs, American 351, 415–6.
Medical Association. E-2.067-Torture. 14  Annas, G.J. (2005). Unspeakably cruel – torture,
9*  Benatar, S.R. and Upshur, R.E. (2008). Dual loyalty medical ethics and the law. New Eng J Med, 352:
of physicians in the military and in civilian life. Am J 2127–32
Public Health, 98, 2161–7.
10* Singh, J.A. (2003). American physicians and dual
loyalty obligations in the “war on terror.” BMC Med Further reading
Ethics, 4, E4. Bloche, M.G. and Marks, J.H. (2005). When doctors go to
11  International Dual Loyalty Working Group. Dual war. N Engl J Med, 352, 3–6.
Loyalty and Human Rights in Health Professional Silove, D.M., and Rees, S.J. (2010). Interrogating the role of
Practice: Proposed Guidelines and Institutional mental health professionals in assessing torture. BMJ,
Mechanisms. New York and Cape Town, South 340, c124.
Africa: Physicians for Human Rights and the School of Walzer, M. (2006). Just and Unjust Wars: A Moral Argu­
Public Health and Primary Health Care, University of ment with Historical Allusions. 3rd ed. New York: Basic
Cape Town, Health Sciences Faculty; 2002. Books

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1 Anesthesiologists, the state, and society
Chapter

49
Physician participation in executions
Gail A. Van Norman

The Case “religious” overtones were intentionally incorporated

into the execution process by the state in order to unite
RB, a 53-year-old US prison inmate is scheduled for execu-
tion by lethal injection. His crime is heinous: the abduc- the community in virtue. Until several hundred years
tion, rape, and stabbing death of a 14-year-old girl. There ago, executions also often incorporated protracted
section
is no doubt of his guilt. 1
DNA profiling confirms he is the torture (drawing and quartering, impaling, breaking
murderer. on the wheel), intended to exact retribution from the
On execution day, after several hours’ administrative prisoner, and to inspire horror as a means of criminal
delay, the execution team commences placement of intra- deterrence.
venous catheters, which is complicated by the prisoner’s Since 1608, around 20 000 judicial executions have
long history of IV heroin use. The session drags on for more been carried out in territories now known as the US,2
than 2 hours. Members of the prison team take turns, mak- which remains one of the very few Westernized coun-
ing more than two dozen unsuccessful insertions. After the
tries that still wields the death penalty. Until the mid-
only successful acquisition of a vein, the IV infiltrates. Team
members take multiple breaks due to stress. The prisoner at
nineteenth century, US executions were conducted as
times appears to be crying, and offers to “help” the IV team, public spectacles. With the development of “mechan-
requesting at one point to place his own IV. He moves tour- istic” forms of execution such as electrocution and the
niquets, attempting to locate veins himself. gas chamber, the public spectacle all but disappeared,
Eventually, all attempts are terminated and the and the concept of execution acquired a detached and
exhausted execution team retires for the day. The prisoner is almost “civilized” tone.
returned to his cell with a promise that his execution will be Recent execution methods evolved largely at the
resumed one day the following week. Internet commentary hands of physicians, who developed increasingly
regarding the botched execution includes a renewed call for “humane” methods of killing, including the guillo-
anesthesiologists to provide execution services. tine (Drs. Antoine Louis and Joseph Ignace-Gillotin),
In the US, physician organizations have consistently hanging (Dr. Samuel Haughton) and the gas cham-
held that physician participation in executions is uneth- ber (Dr. Allen McLean Hamilton). The inventor of
ical, yet up to 41% of physicians state they would agree the electric chair, to be complete, was a dentist. When
to participate in executions.1 Physician involvement in macabre aspects of many modern execution meth-
euthanasia and executions concerns anesthesiologists ods rendered them repugnant to public sensibilities,
in particular; their skills appear to make them ideal Jay Chapman, a medical examiner, and Dr. Stanley
candidates for duties that involve killing. To date, there Deutsch, an anesthesiologist, introduced a recipe for
are no reported cases of disciplinary action against a “humane” executions via intravenous injection of a
physician or expulsion from a professional society for cocktail consisting of a hypnotic, a paralytic agent,
such involvement. and high-dose potassium. This concoction was first
used in 1982 and has become the preferred method
of execution in most of the US. With lethal injection,
Medicine, retribution, and executions capital punishment has acquired a sterile, almost
For much of human history, executions have been benign, medical veneer, and physicians have increas-
designed to extract humiliation, remorse and dread ingly been seen by judicial authorities to be its logical
in addition to the life of the prisoner. Ritual and even administrators.

Clinical Ethics in Anesthesiology: A Case-Based Textbook, ed. Gail A. Van Norman, Stephen Jackson, Stanley H. Rosenbaum
and Susan K. Palmer. Published by Cambridge University Press. © Cambridge University Press 2011.
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 Section 6. Anesthesiologists, state, and society

In weighing whether physicians should ethically from the chrysalis of an ancient shaman. It repre-
be involved in executions, we should consider several sents, quite literally, the defining moment of The
questions: (1) Is it consistent to accept that physician Physician. Any challenge to the principles of that
aid-in-dying may be within the scope of professional oath therefore redefines what it means to be a phys-
integrity, but that physician participation in executions ician, and should not be undertaken without solemn
is not; (2) does respect for autonomy support physician consideration.
participation in executions; (3) do harms outweigh the
benefits if physicians become executioners; and (4) Autonomy, beneficence, and
should the moral acceptability of physician involve-
ment in executions take into account the moral accept- nonmaleficence
ability of the death penalty itself – in other words, can Arguments for physician involvement in execution
actions ever be legitimately separated from the context often invoke principles of beneficence (relieving or
in which they are carried out? preventing suffering during execution) and respect
for autonomy (of a prisoner who requests death by
lethal injection). Arguments against invoke principles
Physicians, the Hippocratic Oath, of nonmaleficence (harms to persons and the profes-
and the question of killing sion) and professionalism (erosion of trust in physi-
cians and corruption of the physician in the execution
Ethical arguments against physician participation in
process).
killing usually begin with a recitation of one of the
many versions of the Hippocratic Oath: “I will nei-
ther give a deadly drug to anybody if asked for it, Beneficence
nor give advice to that effect.”3 Interestingly, this is Anesthesiologists Truog and Waisel use the principle
not an argument based in principles of beneficence of beneficence to argue that physician participation in
or nonmaleficence, but one centered in profession- execution is acceptable because it prevents prisoners’
alism – an argument that killing violates behavioral suffering.*5 But Caplan points out that announcing a
standards that distinguish physicians from other duty to alleviate the suffering of condemned prisoners
professionals. is nonsensical if we don’t also acknowledge a duty to
The ancient oath must now be reconciled against minimize their suffering prior to execution. 6 In order
a modern culture. Physicians participate in abor- to accept a beneficence argument even in the narrow
tions, physician-assisted suicide, and in some cases context of preventing suffering only during the execu-
even euthanasia. We no longer restrict teaching the tion, we must first believe two critical assumptions: (1)
discipline of medicine to only our teachers’ sons. that suffering is indeed prevented or relieved by lethal
Some of us have become surgeons All of these were injection; and (2) that such relief or prevention can
forbidden by the Hippocratic Oath. In the context of only be accomplished by physicians, and that therefore
modern medicine, why is the Hippocratic Oath still physicians’ professional skills are uniquely necessary to
so compelling? humane executions.
Margaret Mead observed that the Hippocratic As with other methods of execution invented by
Oath, apart from being one of the first statements of well-meaning physicians, lethal injection has its own
moral conduct for physicians, represented a break- set of complications that cause considerable docu-
through from primitive concepts in which physicians mented physical suffering in a substantial number of
and sorcerers were one and the same. cases. Ironically, these complications are familiar to
He with the power to kill had the power to cure … He with most anesthesiologists because they also occur during
the power to cure would necessarily have the power to anesthesia care: complications of obtaining IV access,
kill….With the Greeks, the distinction was made clear. One unintended awareness, and suffocation due to respira-
profession, the followers of Asclepius, were to be dedicated tory muscle paralysis in the absence of adequate airway
completely to life…regardless of rank, age or intellect – the support.
life of a slave, the life of the Emperor, the life of a foreign
Many condemned prisoners have poor options for
man, the life of a defective child.4
intravenous (IV) access because of prior drug abuse,
The Oath of Hippocrates is compelling, because it obesity, and terror. Attempts to establish IV access
describes the emergence of the modern physician have sometimes persisted for hours, and at times have

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 Chapter 49. Physician participation in executions

had to be terminated because of lack of success, with

the prisoner thereafter returning to his cell to dread
Respect for autonomy at end of life
Physicians now embrace the promotion of the comfort
future execution attempts. At least one study demon-
and dignity of patients during the dying process – even
strated that, in 43% of executed prisoners, inadequate
if such comfort measures might hasten death. But in
blood levels of the hypnotic were achieved to guaran-
order for physicians to use their skills to enable death
tee unconsciousness throughout the duration of the
and yet not violate the professional distinctions that
execution.7 A legal review in California showed that a
set physicians apart, there must be clear, compelling,
majority of prisoners were not apneic when the para-
and distinguishing ethical criteria that tell us when and
lytic agent was administered,8 raising questions about
why such actions are acceptable.
the depth of anesthesia achieved. Many prisoners may
Brody and others suggest that the (rare) legitim-
have regained consciousness after administration of
acy of a physician’s role in physician aid-in-dying or
the paralytic agent, and it is likely that at least some
euthanasia has two critical elements, both of which
have suffered an agonizing death of suffocation while
must be preserved in order that the physician does not
being paralyzed and aware. It is worthy of note that the
violate the integrity of his or her professional ethic: (1)
American Veterinary Medical Association considers
the request for aid-in-dying must be autonomous;
the administration of paralytic agents during animal
and (2) the physician must have no realistic means to
euthanasia to be unethical because it might cause or
reduce or relieve the suffering from which the patient
mask suffering.9
seeks release.10
Both legal and medical authorities have argued
Some argue that participation in lethal injection
that “botched” executions are proof that physicians
fulfills a prisoner’s “autonomous” request for aid-in-
are needed to prevent these complications. But there dying, analogous to patients’ requests for physician-as-
is no evidence that many if not most “botched” execu- sisted suicide. But this argument confuses the presence
tions would not also occur in the hands of physicians, of a “choice” for the presence of “autonomy.” Many
particularly since similar complications occur in the choices are made in the presence of manipulation
course of anesthetic administration. Physicians do and coercion, but are then not “autonomous,” because
not have a monopoly on skills in accessing veins and autonomy requires absence of coercion or manipula-
administering IV substances, and lethal doses of the tion. Picture a robbery victim, for example, who is told
agents involved are not a “trade secret.” Inadequate to hand over her purse or be killed. Presumably, she
training or experience among non-physicians can be considers both options to be bad and would not choose
remedied by appropriate training, and is therefore not between them if she were not forced to do so. The rob-
a compelling argument for physician involvement. The ber coerces her and makes a choice, but her choice is
special training of anesthesiologists is not needed, nor not an autonomous one.
even appropriate, if the goal is to produce unconscious- A dying patient differs from the robbery victim
ness and subsequent death. in that no one is intentionally “forcing” the choice.
Clearly, current execution methods cannot be Strictly speaking, disease cannot “force” or “manipu-
guaranteed to be “humane.” But suppose we could late.” Disease is merely a set of circumstances, within
eliminate all of the complications of lethal injection – the framework of which human beings make choices,
would that be sufficient to vacate ethical objections to such as whether to pursue or forgo therapy. However,
physician participation in executions? Oral adminis- a prisoner choosing between methods of execution
tration of lethal medicinal cocktails has been closely is being forced to do so by the state, which represents
studied and is highly effective as well as virtually com- human intentions. The prisoner can’t simply “not
plication free in places where physician-assisted sui- choose,” because refusal to make a choice results in
cide is legal. Can we eliminate ethical objections to “default” to an execution method that is predetermined.
physician participation in executions by simply using In this case, the prisoner is more like the robbery vic-
the same method that is considered ethically and tim than a patient. The “choice” does not represent an
legally acceptable by many at the end-of-life due to act of autonomy and is not ethically analogous to an
disease? Or are there important ethical distinctions end-of-life decision by a dying patient. In fact, when
between physician-assisted suicide and participa- prisoners seek the death penalty, it is usually argued
tion in state-sponsored executions that transcend that they suffer from limited capacity due to mental ill-
methodology? ness and therefore they cannot be autonomous.
287
 Section 6. Anesthesiologists, state, and society

Nonmaleficence – are physicians harmed Concerns regarding the moral legitimacy

of the death penalty
by participation in executions? While physician professional organizations have care-
Moral disengagement among participants in executions fully avoided making pronouncements about the
Moral disengagement is a process by which individ- morality of the death penalty itself, ethicists are not as
uals “turn off ” aspects of moral self-regulation while silent on the issue. In the words of Caplan, when phy-
participating in activities that may violate some of sicians participate in executions that are carried out
their internal moral standards. Mechanisms of disen- “capriciously” or for “immoral reasons”, even if their
gagement occur at four sites in an action: (1) charac- personal motivation is one of mercy, “[they] grant
terization of the action (the “locus of behavior”); (2) such systems ethical legitimacy and are complicit in the
minimizing the responsibility of the actor (the “agent” unethical killing of sometimes helpless, hapless, and vul-
of the action); (3) minimizing the outcomes of the nerable persons.”12 Physicians, in other words, have an
action; and (4) recharacterization of the recipient of obligation to examine the morality of a process before
the action. Some specific mechanisms include moral becoming a part of it.
justification, minimizing consequences, dehuman- How is the death penalty applied? Globally, the
ization of victims, and displacement or diffusion of death penalty has been all but eliminated in Western
responsibility (Table 49.1). nations, and it is prohibited throughout the European
Moral disengagement plays a facilitative role in Union. The five countries carrying out the most exe-
injurious conduct by individuals and groups, and cutions in the world in 2008 were China, Iran, Saudi
is systematically used to manage adverse psycho- Arabia, Pakistan and the US. In addition to “heinous
logical consequences to the participants as well as crimes,” the death penalty is imposed for reasons as
to maintain loyalty. Examples of situations in which varied as tax fraud, political protest, bribery, homo-
moral disengagement is used include antisocial sexuality, adultery, minor drug offenses, and the
pursuits (crime), international terrorism, and sup- importation of alcohol. Six nations permit the execu-
port for military action in international conflicts. tion of children (defined as persons under 18 years of
The penal system formally and intentionally incor- age).13
porates methods of moral disengagement (such as Capital punishment is unevenly applied across
diffusion of responsibility) to decrease guilt among race and social groups in the US.14 Almost all stud-
participants in executions and to enable members ies demonstrate that the death penalty does not deter
of the execution team to carry out future executions crime.15 Capital punishment is more expensive in the
(Table 49.2). US than lifelong incarceration, largely due to a pro-
A study of moral disengagement during executions tracted and costly appeals process. This fact has fueled
among prison guards, support personnel (persons pro- objectionable proposals to curtail existing judicial
viding support and spiritual guidance to the prisoner “safeguards” – the appeals process – to cut such costs.16
and family members) and the actual executioners at There is no evidence that it provides emotional “clos-
several US penitentiaries found moral disengagement ure” to victims’ families.17 To date, 139 condemned US
at all levels.*11 Executioners were found to have the prisoners have been freed from death row by DNA or
highest levels of moral disengagement, and support other evidence, suggesting that innocent victims have
personnel the lowest. Most disturbing was the fact that almost certainly been wrongly executed by the state.18
participation in more executions not only progres- Finally, the death penalty in the US is seen by many to
sively inured executioners to their actions, but had be an impediment to foreign relations.19
even more marked effects on support personnel, con-
verting them from “moral engagers” to “moral disen- Professional statements
gagers.” Behaviors of moral disengagement that were The American Medical Association (AMA) states
demonstrated in the study, such as demonizing and that physician participation in executions is uneth-
dehumanizing the prisoner and deflecting personal ical. Physician participation includes, but is not lim-
responsibility to others would appear to be particularly ited to:
antithetical to the professional ethics and demeanor of Prescribing or administering tranquilizers and other
physicians. ­psychotropic agents and medications that are part of

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 Chapter 49. Physician participation in executions

Table 49.1. Mechanisms of moral disengagement

Mechanisms of moral disengagement and examples of

Locus of moral disengagement reasoning applied in capital punishment
Locus of behavior (characterizing the action) Moral justification
•  Deters crime
•  Provides closure to victims and their families
•  Is justified by religious precepts (“an eye for an eye”)
•  Is necessary for law and order to prevail and for society to survive
Euphemistic language
•  “Capital punishment is just the legal penalty for murder.”
Exonerative (or advantageous) comparisons
•  Lethal injection is more humane than a murder
•  The murderer’s victims did not have the benefit of a trial
Locus of the agent (diffusing responsibility of •  Sentencingrequirements forced the jury to impose the death
the person or persons carrying out the action) penalty
•  The decision involved 12 jurors, and no one juror is responsible
•  Thecriminal will still have the decision reviewed on appeal,
therefore the jury is not ultimately the decision-maker
•  Iam not the one who made the decision, it is just my job to
carry out the sentence
Locus of the outcomes (minimizing or •  The death penalty is humane and the murdered doesn’t suffer
mischaracterizing the outcomes of the action) •  The murderer suffered less than the victims
Locus of the recipient (characterizing the •  The murderer is to blame for being put to death
recipient as deserving of the action) •  Murderers forfeit their rights to be treated as human beings
Moral disengagement occurs at several “loci” in an action, in order to prevent the actors from experiencing ­self-condemnation.

Table 49.2. Fractionalization of responsibility during executions to diffuse responsibility

•  Lethal injection “recipe” is determined by someone who will not be involved in injection
•  The lethal cocktail is drawn up by someone who will not be involved in injection
•  Guards who care for the prisoner awaiting execution are not involved in the death chamber activities

•  Taskssuch as tying straps on the prisoner, taking vital signs, and finding sites of intravenous cannulation are all assigned to
different persons, none of whom will be involved in injection of lethal drugs
•  Person involved in ordering the execution to commence does not inject the drugs
•  Person involved in checking vital signs did not inject the drugs
•  Inmany cases, physicians are allowed to “confirm” death, but not “declare” death, to avoid the appearance of ordering an
execution if the prisoner is still alive and requires another dose
•  Multipledrug lines run from the prisoner to a blind screen: several persons “inject” drugs from behind the screen, but none
knows which of their lines is connected to the prisoner’s IV. This is analogous to firing squads, in which several executioners
will have weapons, but not all contain live ammunition. No one is entirely sure of whether their bullet contributes to the
prisoner’s death.
(Note: not all institutions have identical execution processes, so these examples may not be universal)

289
 Section 6. Anesthesiologists, state, and society

the execution procedure; monitoring vital signs on site

or remotely (including monitoring electrocardiograms); • Participation in executions leads to moral
attending or observing an execution as a physician; and disengagement by members of the execution
rendering of technical advice regarding execution. In the team; methods of moral disengagement such
case where the method of execution is lethal injection, as dehumanizing the prisoner or deflecting
the following actions by the physician would also con- responsibility for actions, are antithetical to
stitute physician participation in execution:  selecting the professional ethics of physicians.
injection sites; starting intravenous lines as a port for a
lethal injection device; prescribing, preparing, admin-
• The morality of participation in executions
istering, or supervising injection drugs or their doses or cannot be divorced from the morality of
types; inspecting, testing, or maintaining lethal injection capital punishment. Global characteristics
devices; and consulting with or supervising lethal injec- suggest that the death penalty is applied
tion personnel.20 capriciously, unequally, and does not fulfill
the public’s expectations for security and
The American Society of Anesthesiologists (ASA)
emotional closure.
also states that capital punishment in any form is
• Anesthesiologists who participate in lethal
not the practice of medicine, and agrees with the
injection in the US now risk professional
AMA’s position on physician involvement in capital
sanctions.
punishment.21
In February of 2010, the American Board of
Anesthesiology announced that an anesthesiologist’s
participation in an execution by lethal injection is
inconsistent with the ABA’s Professional Standing References
Policy, and diplomats of the ABA who participate 1   Farber, N.J., Aboff, B.M, Weiner, J., et al. (2001).
in lethal injection may be subject to disciplinary Physicians’ willingness to participate in the process
action including revocation of their ABA diplomate of lethal injection for capital punishment. Ann Intern
status.22 Med, 135, 884–8.
2   Espy, M.W. and Smykla, J.O. (2003). Executions in
the United States, 1608–1991: The Espy file. 2002.
Key points Retrieved from The Inter-University Consortium for
Political and Social Research. http://www.icpsr.umich.
• Physician professional organizations edu/icpsrweb/ICPSR/studies/8451?archive=ICPSR&
consistently state that it is unethical for q=espy
physicians to be involved in executions. 3   The Hippocratic Oath. http://en.wikipedia.org/wiki/
• Arguments for physician participation in Hippocratic_Oath.
lethal injection usually rely on principles of 4   Levine, M. (1972). Personal communication quoted
beneficence (relieving suffering) and respect in Psychiatry and Ethics, New York. George Braziller,
for autonomy (of the prisoner). p324.
• Lethal injection is plagued by complications 5*  Gawande, A., Denno, D.W., Truog, R. and Waisel, D.
that cause physical suffering in a substantial (2008). Physicians and execution – highlights form
number of cases. a discussion of lethal injection. New Eng J Med, 385,
• Arguments that lethal injection respects a 448–51.
prisoner’s “autonomy” are flawed, in that they 6*  Caplan, A.L. (2007). Should physicians participate in
confuse “choice” with “autonomy.” capital punishment? Mayo Clin Proc, 82(9), 1047–8.
• Physician aid-in-dying for patients suffering 7   Koniaris, L.G., Zimmers, T.A., Lubarsky, D.A., and
from medical disease, is ethically distinct from Sheldon, J.P, (2005). Inadequate anaeshtesia in lethal
execution of condemned prisoners. Dying injection for execution. Lancet, 365(9468), 1412–14.
patients suffer from adverse circumstances, 8   Gawande, A. (2006). When law and ethics collide – why
and are not manipulated by an intentional physicians participate in executions. New Eng J Med,
354, 1221–9.
third party. Condemned prisoners, on the
other hand are being coerced by human 9   American Veterinary Medical Association Guidelines
on Euthanasia. June 2007. http://www.avma.org/issues/
actors.
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10* Brody, H. and Wardlaw, M. (2008). Two gorillas in the ama-assn.org/ama/pub/physician-resources/medical-

death penalty room. Am J Bioethics, 8(10), 53–4. ethics/code-medical-ethics/opinion206.shtml.
11* Osofsky, M., Bandura, A., and Zimbardo, P. (2005). The 21  American Society of Anesthesiologists’ Statement
role of moral disengagement in the execution process. on Physician Nonparticipation in Legally
Law Human Behav, 29(4), 371–93. Authorized Executions. Approved by House of
12  Caplan, A. L. (2007). Should physicians participate in Delegates October 18, 2006. http://www.asahq.org/
capital punishment? Mayo Clin Proc, 82(9), 1074–8. publicationsAndServices/standards/41.pdf.
13  The Death Penalty Information Center. http://www. 22  Anesthesiologists and capital punishment; professional
deathpenaltyinfo.org/. standing. February 2010, American Board of
14  Phillips, S. (2008). Race disparities in the capital of Anesthesiology. Raleigh, NC. http://www.theaba.org/
capital punishment. Houston Law Rev, 45(3), 807–40. Home/notices#punishment.
15  Radelet, M.L. and LaCock, T. (2009). Recent
developments: do executions lower homicide rates? Further reading
The views of leading criminologists. J Criminal Law
Annas, G.J. (2008). Toxic tinkering – lethal injection
Criminology, 99(2), 489–508.
execution and the Constitution. New Eng J Med, 359,
16  In the Senate of the United States; 109th Congress, 1st 1512–18.
Session. 2005. S1088. “Streamlined Procedures Act of
Freedman, A.M. and Halpern, A.L. (1996). The erosion of
2005.”
ethics and morality in medicine: physician participation
17  Goldberg, M. (2003). The ‘closure’ myth. Salon.
in legal executions in the United States. NY Law Sch Rev,
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feature/2003/01/21/closure/index.html.
Osofsky, M. and Osofsky, H. (2002). The psychological
18  The Death Penalty Information Center. http://www.
experience of security officers who work with
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death-row, accessed Feb 15, 2010.
Ragon, S. (1994). A doctor’s dilemma: resolving the conflicts
19  Warren, M. (2004). Death, dissent, and diplomacy: the
between physician participation in executions and the
US death penalty as an obstacle to foreign relations.
AMA’s code of medical ethics. U. Dayton Law Rev, 20,
Wm and Mary Bill Rights J, 13, 309–38.
997–1008.
20  American Medical Association Code of Medical
Ethics. Opinion 2.06. Capital Punishment. http://www. Wilkinson, D.J. and Douglas, T. (2008). Consequentialism
and the death penalty. Am J Bioethics, 8(10), 56–8.

291
 Index

abandonment, patient, 42, 258 American Board of Anesthesiology Animal Welfare Act (AWA), 176, 177
abortion, 257 , 286 (ABA), 290 Animals (Scientific Procedures) Act
abusive behavior, See MAD (mean, American College of Obstetricians and (ASPA), 177
abusive and disruptive) behavior Gynecologists (ACOG) Annas, G.J., 283
Accreditation Council for Graduate maternal–fetal conflict guidance, 50 anterior capsulotomy, 56,
Medical Education Section
(ACGME),1 treatment refusal guidelines, 47 See also psychosurgery
section 1
236, 237 Chapter American College of Physicians (ACP) anxiety, temporary incapacity, 7
addiction (anesthesiologist) anesthesiologist disability guidance, apology, 250–3
case example, 219 232 Association of American Medical
current situation, 219–20 industry gifts guidance, 245 Colleges, 248
ethical issues, 220–2 American Medical Association (AMA) autonomy (patient)
key points, 222 anencephalic neonates guidance, capacity and competence, 4–7
addiction (patient) 111 conflict with beneficence, 58
misunderstandings in opioid anesthesiologist disability guidance, controlling influences and, 9–10
dependency, 150 231, 232, 233 cultural and religious issues, 3, 47
opioid therapy use in, 148–53, conscientious objection guidance, DNR orders and, 13
154–8 259 double effect (DE) principle, 88
prescription opioid abuse disaster response guidance, 267, 270 euthanasia and assisted suicide, 129,
prevalence, 155 euthanasia and physician aid-in- 130
advance directives dying attitudes, 131 female genital cutting (FGC), 71–2
birth plans, 44–6 execution, 288 information provision and, 8–9,
do-not-resuscitate (DNR) orders, industry gifts guidance, 245 75–6
See do-not-resuscitate (DNR) MAD (mean, abusive and intention and, 7–8
orders disruptive) behavior guidance, Jehovah’s Witness (JW) patients,
Durable Power of Attorney for 235 19–20
Healthcare, 27, 93 medical error disclosure guidance, key points, 11
European laws on surrogate 250, 251 laboring patient, 44–8
decision-making, 27 pain management, 137 medical error disclosure, 250
living wills, See living wills patient advocacy, 126 military medicine, 276
Patient Self-Determination Act statements on torture, 281 Native American culture, 75–6
requirements, 40 treatment refusal guidelines, 47 nonrecommended treatment, 50, 72
summary of patient rights by American Society of Anesthesiologists opioid use in addicted patients, 148
­country,5–13 (ASA) physician-assisted execution and,
surgical intervention decisions, anesthesiologist disability 287
93 guidelines, 232, 233 therapeutic privilege and, 10–11
Ulysses Directive, 45 capital punishment, 290 Uniform Anatomical Gift Act
advocacy, patient, 126 conscientious objection guidance, (UAGA) and, 124
aggression and violence, 57, 58 259 waiver of informed consent, 10–11
agitation, restraint therapy, 61–3 expert testimony guidelines, 261–4 autonomy (relational), 29
alcohol impairments to practice, 220, 221,
addiction and opioid therapy use, 224 Bayh-Dole Act, 206
148–53, 154–8 MAD (mean, abusive and Beecher, H.K., 181
anesthesiologist addiction, disruptive) behavior guidance, behavior
See addiction (anesthesiologist) 237 aggression and violence, 57, 58
consumption and sleep deprivation Americans with Disabilities Act MAD (mean, abusive and
comparison, 226 (ADA), 220, 231 disruptive), See MAD (mean,
alertness, 224–8 analgesia, See pain management abusive and disruptive)
alimentation, withdrawal of, 129, 132 anencephalic neonates, 111 behavior
Alvord, L.A., 76–7 angiography, cerebral, 110 Belmont Report, 181, 186, 202

292
 Index

beneficence cardiopulmonary resuscitation (CPR), conscientious objection

Cesarean delivery on maternal history of, 39 case example, 257, 259
request (CDMR) and, 51 Cardozo, B., 13 Cesarean delivery on maternal
conflict with autonomy, 46–8, 58 care standards, 262–3 request (CDMR), 52–3
euthanasia and assisted suicide, cerebral stimulation techniques, do-not-resuscitate (DNR) orders, 42
129 See also psychosurgery 56 female genital cutting (FGC), 72
female genital cutting (FGC) and, 72 Cesarean section Jehovah’s Witness informed refusal,
medical error disclosure, 252 Cesarean delivery on maternal 25
Native American communitarian request (CDMR), 49–53 key points, 260
values and, 74–5 refusal during labor, 46–8, 49 preventive ethics, 259–8
opioid therapy in addicted patients, Christian Science, 64–7 social contract and, 259
149 cingulotomy, 56, consequentialism
pain management, 138–9 See also psychosurgery animal rights, 171–3
physician-assisted execution and, Civil Rights Act, 240 civilian mass casualty triage, 270–2
286–7 civility, 238 medical error disclosure, 253
preoperative testing, 79–80 Code of Federal Regulations (CFR), Controlled Substances Act, 155
Uniform Anatomical Gift Act 199, 202, 203 Council for International
(UAGA) and, 125 coercion, 9 Organizations of Medical
best interests standard conscientious objection, 42 Sciences (CIOMS), 186
interrogation and torture, 282 faculty–student sexual cultural issues
meaning of, 29 relationships, 242–3 anesthesiologist’s responsibilities in
pediatric patients, 34, 37, 40 Jehovah’s Witness (JW) patients, 21 different cultural backgrounds,
bilimbic leucotomy, opioid therapy, 140 76
See also psychosurgery 56 physician-assisted execution, 287 animal subjects research, 174–5
birth plans, 44–6 physician-facilitated coercive cultural/moral relativism, 71
blood/blood product transfusion interrogation, 280–3 decision-making in ICU, 100
beliefs of Jehovah’s Witnesses research participation, 165 female genital cutting (FGC), 69–73
(JWs), 19, 21 cognitive impairment information provision, 75–6, 77
Jehovah’s Witness (JW) liver (anesthesiologist), See disability Native Americans, 74–8
transplantation case example, (anesthesiologist) neurological standard of death,
19, 20–5 Committee on Publication Ethics 110–11
brain death (COPE), 210, 213–14 patient autonomy, 3, 47
current neurological standards communication
for determination of death, cultural issues, 77 death
109–10 communitarianism determining time of, 108, 112
determining time of death, 108, Native Americans, 74–8 organ donation issues, 114–15,
112 organ donation and, 119–20 117–19
development of neurological competence, 4–7 death penalty
­standard of death,108 distinction from decision-making moral legitimacy of, 288
ethical foundations for neurological capacity, 33 physician participation in
standard of death, 110–12 pediatric patients, 33 execution, See execution
key points, 112–13 confidentiality/privacy (physician-assisted)
Uniform Determination of Death anesthesiologist’s medical history, Death with Dignity Acts, 89
Act (UDDA), 115 230–1 decision-making capacity
electronic medical record (EMR) assessment of, 31
Callahan, D., 120 issues, 201–3 factors affecting, 28
Canadian Anesthesiologists’ Society, Institutional Review Boards (IRBs), informed consent, 4–7
165 184, 189 Jehovah’s Witness patients, 20
cannabis (marijuana) use, 148, 152, pediatric patients, 37 pain and, 196
158 peer review and, 212 pediatric patients, 33–5, 36–7, 40
capacity, See decision-making capacity conflicts of interest surrogate decision-making,
capital punishment, See execution definitions of, 204 See surrogate decision-making
(physician-assisted) financial motivations, 204 temporary incapacity, 7
Caplan, A.L., 286, 288 industry gifts to physicians, 245 Declaration of Helsinki
cardiac arrest, irreversibility of, 118 mitigation of, 206–7 clinician–researcher dual role, 166
cardiac assist devices nonfinancial motivations, 204, evolution of, 181
disabling of, 103–6 205 placebo-controlled studies, 183, 195
distinguishing characteristics of, organ donation, 116–19 research publication, 166
104–5 pain management, 138–9 vulnerable persons research
cardiopulmonary bypass, 21 research, 165, 206–7 participation, 186

293
 Index

deontologic/Kantian theory disabling cardiac assist devices, 104 revision of Uniform Anatomical
animal rights, 169–70 medication use in palliative care, Gift Act (UAGA), 123–7
disaster response, 267 87–90 surgical intervention, 13–17, 92–5
medical error disclosure, 253 opioid therapy in addicted patient, epidural
organ donation issues, 118, 119, 149 consent in laboring patients, 44–6
120 organ donation, 118 pediatric patient refusal case, 33, 36
Department of Health and Human surgical intervention near end of equal consideration, principle of, 171
Services (DHHS), 186 life, 93 ethics consultation, 64–8
diagnosis-related group (DRG) withholding/withdrawing life European convention for the
treatment classification systems, support, 101 Protection of Animals used
144 drug addiction for Experimental and Other
disability (anesthesiologist) anesthesiologist, See addiction Scientific Purposes, 177
case example, 230, 233 (anesthesiologist) euthanasia
ethical issues, 231–3 misunderstandings in opioid attitudes and practices, 131
key points, 233 dependency, 150 case example, 128
legal issues, 230–1 opioid therapy in, 148–53, 154–8 disabling cardiac assist devices and,
terminology, 230 prescription opioid abuse 103, 104
disaster response prevalence, 155 double effect principle in palliative
anesthesiologists’ skills in, 266 dual loyalty, 282 care and, 87–90
case example, 266, 268 Durable Power of Attorney ethical arguments and legislation,
civilian mass casualty triage, 270–3 for Healthcare, 27, 93 129–31
historical context, 266 See also advance directives ethical issues, 128–9
key points, 269 Hippocratic Oath, 286
physicians’ obligations in, 266–7 electrocardiography (ECG), 80 key points, 132–3
risk limitation, 267–8 electroconvulsive therapy (ECT), physician-assisted execution and,
societal obligation to 58–9 287
physicians, 268 electroencephalography (EEG), 108, responding to requests for, 131–2
discrimination 109, 110 surgical intervention near end of
conscientious objection and, 258 electronic medical record (EMR), life and, 93
sexual, See sexual harrassment and 201–3 evidence-based medicine (EBM),
discrimination emancipated minor status, 36, 37 200–1
disruptive behavior, See MAD (mean, emergency care evoked potentials, 109
abusive and disruptive) behavior conscientious objection in, 258 execution (physician-assisted)
do-not-resuscitate (DNR) orders consent for research in, 196 background of, 285–6
anesthesiologist’s rights and disaster response, See disaster case example, 285
obligations guidelines, 25 response ethical principles and, 286–8
conscientious objection, 42 pediatric patients, 36–7 Hippocratic Oath and, 286
controlling influences, 9 pre-hospital DNR orders, 15 key points, 290
ethical and legal basis of, 13 end-of-life issues professional statements, 290
historical development of, 39 brain death, 108–13 expert testimony
increasing application of, 15 cardiac device therapy American Society of
medical futility and, 13–14, 15 discontinuation, 103–6 Anesthesiologists’ (ASA)
operating room (OR) issues, 133, demands for “everything” to be guidelines, 261–4
organ donation and, 114 done, 94–5 case example, 261, 264–5
pediatric patients, 39–42 do-not-resuscitate (DNR) order, key points, 265
pre-anesthesia, 15–17 See do-not-resuscitate (DNR) witness qualification requirements,
pre-hospital, 15 orders 261, 264
provision of other vital double effect principle in palliative
therapies, 14 care, 87–90 faculty–student sexual relationships,
reasons for patient request for, 14 ethical framework for decision- 242–3
required reconsideration, 16–17, 41 making, 97–8 fatigue, sleep deprivation issues,
slow/show code, 14, 39 life support withholding/ 224–8
surgery at end of life, 13–17 withdrawal, See life support Federal Transfer Act, 206
surgical intervention near end of withholding/withdrawal female genital cutting (FGC)
life and, 95 lifeboat ethics, 272 case example, 69, 72
terminology of, 14, 39–40 organ donation/transplantation, current situation, 69–70
vital function support See organ donation/ ethical issues, 70–2
discontinuation and, 94 transplantation key points, 73
Doppler, transcranial, 110 research participation, 193, 195, medical sequelae of, 70
double effect (DE) principle 196–7 fidelity, 79

294
 Index

financial issues during labor, 45–6 interpreter services, 47

Cesarean delivery on maternal in informed consent, 8–9 interrogation, physician facilitation of
request (CDMR), 51 Jehovah’s Witness patients, 20 coercive, 280–3
cost-containment quality insurance pediatric patients, 34, 36 interventional trials, 92–5
initiatives, 200, 201 informed consent intubation, self-extubation, 62
expert testimony fees, 263 DNR orders, 13
industry gifts to physicians, 247–8 double effect (DE) principle in Jehovah’s Witnesses (JWs)
industry–academia relationship, palliative care, 88 beliefs on transfusion of blood/
207 electroconvulsive therapy (ECT), blood products, 19, 21
pain management, 143, 144–6 58–9 ethical principles in decision-
research funding, 165, 204–8 ethics consultation, 64–8 making, 19–20
fraud information provision, 8–9 key points, 25–6
data fabrication/falsification, laboring patient, 44–8 legal precedents, 20
209–10, 214 Native American culture, 75–6 liver transplantation case example,
ghost and honorary authorship, 209, organ donation, 116–17 19, 20–5
211–12, 214 pediatric patient assent and, 33–7, Joint Commission for Accreditation
plagiarism, 210–11, 212 189–90 of Health Care Organizations
futility (medical), 13–14, 15, 98–9 preoperative testing, 79–83 (JCAHO), 251
psychosurgery, 55, 56–8 judgment, substituted, 29, 99
gender equality, female genital cutting research participation, 57, 58, justice
(FGC) and, 71 164–5, 166, 196 Cesarean delivery on maternal
General Medical Council (GMC) respecting patient autonomy, 3 request (CDMR) and
conscientious objection guidance, summary of patient rights by distributive, 51
53 country, 5–13 civilian mass casualty triage, 271
disaster response guidance, 267 therapeutic privilege and, 10–11 medical error disclosure, 251
fraud investigation, 210 vulnerable persons research opioid therapy in addicted patients,
medical error disclosure guidance, participation, 587, 189, 190–1 149
251 waiver of, 5–13 sexual harrassment/discrimination
Geneva Convention, 276, 280 written or verbal, 46 and, 241
Institutional Animal Care and Use Uniform Anatomical Gift Act
Harrison Narcotic Drug Act, 154 Committees (IACUCs), 177 (UAGA) and, 125–6
Harvard criteria for determination of Institutional Review Boards (IRBs)
brain death, 0397, 108 academia–industry relationship, 207 Kantian/deontologic theory
health insurance case example, 180, 182, 183 animal rights, 169–70
Health Insurance Portability and key points, 184 disaster response, 267
Accountability Act, 184 new issues facing, 184 medical error disclosure, 253
pain management issues, 137, obligations on risk, 182, 183 organ donation issues, 118, 119,
138–9, 143, 144–6 purpose and evolution of, 180–2 120
Hippocratic Oath, 286 quality improvement (QI)
HIV/AIDS initiatives, 200, 201 labor
preoperative testing, 80, 81 scientific review role, 182–3 fear of pain during, 52
refusal to treat, 267 vulnerable persons protection in information provision during, 45–6
honesty research participation, 189–93 informed consent during, 44–8
expert testimony, 261–2 integrity, personal, 257–6 maternal–fetal conflict, 46–7, 49–53
medical error disclosure, 250–3 intensive care unit (ICU) treatment refusal during, 46–8
human rights, female genital cutting end-of-life care shortcomings, 97 legislation (healthcare), physician’s role
(FGC) and, 71 ethical framework for end-of-life in revision of, 123–7
hydration, withdrawal of, 129, 132 decision-making, 97–8 life support withholding/withdrawal
family meetings, 99–101 euthanasia/assisted suicide and, 129,
ICH tripartite guidelines, 186 futility, 98–9 130
implantable cardioverter defibrillator patient transfer from, 94, 101 intensive care unit (ICU) practices,
(ICD), disabling, 103–4, 105–6 surrogate decision-making in, 97–102
Indian Health Service (IHS), 74 99–101 interventional trials, 93–4
individualism, 119 triage, 98 organ donation and, 114, 115, 117
industry withholding/withdrawing life lifeboat ethics, 272
academic–industrial relationships, support, 97, 100–2 living wills, See also advance directives
205, 206 intention, 7–8 surgical intervention decisions, 93
gifts to physicians, 245 double effect (DE) principle and, surrogate decision-making and, 27,
information provision 88, 93 30
autonomy and, 75–6 International Animal Care and Use Uniform Anatomical Gift Act
cultural issues, 75–6, 77 Committees (IACUC’s), 177 (UAGA) and, 124
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lobotomy, See also psychosurgery pain management, 138–9 pain

55–6 physician-assisted execution, 288 euthanasia/assisted suicide
loyalty, dual, 282 preoperative testing, 79–80 and, 130
torture and, 281 evaluation of, 138
MAD (mean, abusive and disruptive) Uniform Anatomical Gift Act informed consent in labor, 44–5
behavior (UAGA) and, 125 temporary incapacity, 7
aberrant personality and, 236 Nuremberg Code, the, 3, 181, 200 pain management
abuse of disruptive/abusive policies, Cesarean delivery on maternal
239 obsessive–compulsive disorder (OCD), request (CDMR) and, 52
case example, 235 56–7 conjoining palliative care and
civility and social capital, 238 Office for Human Subjects Research interventional, 143–6
consequences of, 235, 236 Protections (OHRP), 199–200, double effect principle in palliative
definition of, 235–6 201, 203 care, 87–90
key points, 239 Office of Research Integrity (ORI), 210 ethical considerations in
management of, 236, 237, 238–9 Office of Scientific Integrity, 210 interventional, 137–40, 141–2
professionalism and, 236–7 Office of the National Coordinator informed consent and effects of,
malpractice, maloccurence for Health Care Information 44–5
distinction, 263 Technology (ONC), 202 moral obligation in, 143–4
manipulation, 10 opioid addiction, See addiction multi-disciplinary pain centers
physician-assisted execution and, (anesthesiologist); addiction (MPCs), 145
287 (patient) neuromuscular blockade and, 62
marijuana (cannabis), 148, 152, opioid therapy opioid therapy, See opioid therapy
158 addicted patients, 148–53, 154–8 research issues, 193–7
maternal–fetal conflict, 46–7, 49–53 case example, 137, 141–2 treatment efficacy assessment, 139
mature minor status, 36, 37 coercion and, 140 palliative care, See also end-of-life
Mead, M., 286 double effect (DE) principle, 87–90, issues
mean behavior, See MAD (mean, 101 conjoining interventional pain
abusive and disruptive) behavior intraspinal therapy in palliative care, management and, 143–6
medical errors 143–6 double effect (DE) principle in,
disclosure of, 250–3 legal issues in prescribing, 140–1, 87–90
sleep deprivation and, 224 155–6 pandemics, See disaster response
systems-based approach to, 251, misunderstandings on dependency, paternalism
252 150 female genital cutting (FGC), 71–2
mental illness, consent issues,55–9 patient choice of, 156–7 patient capacity and competence, 4
See also decision-making capacity prevalence of prescription abuse, therapeutic privilege and, 10–11
See competency 155 patient abandonment, 42, 258
military medicine professional guidelines, 151 Patient Self-Determination Act, 15, 40
physician-facilitated torture/ UK prescribing, 149–51 pediatric patients, See also vulnerable
coercive interrogation, 280–1, organ donation/transplantation persons
282–3 basis of current program, 114 adolescent pregnancy testing, 80–1,
risk, 267 declaration of death timing, 117, 82–3
triage and treatment, 270, 275–8 118–19 children’s rights, 71
moral disengagement, 288 definition of death and, 114–15 confidentiality, 37
moral relativism, 71 donation after cardiac death (DCD) decision-making capacity, 33–5,
protocols, 115–16 36–7, 40
Native Americans, 74–8 donation case example, 114 disagreement in decision-making,
natural disasters, See disaster response ethical controversies, 116–19 33, 35–6
neuromuscular blockade, 62 ethical frameworks, 119–20 do-not-resuscitate (DNR) orders,
neurosurgery, functional, Jehovah’s Witness patient case 39–42
See also psychosurgery 56 example, 19, 20–5 emancipated minor status, 36, 37
nonmaleficence key points, 120 emergency care, 36–7
Cesarean delivery on maternal legal precedents, 116 engagement in decision-making,
request (CDMR) and, 51 neurological standard of death and, 35
disabling cardiac assist devices and, 108, 110 female genital cutting (FGC), 69–73
103 organ preservation and hastening informed consent and assent, 33–7,
female genital cutting (FGC) death, 117–18 189–90
and, 72 revision of Uniform Anatomical Gift mature minor status, 36, 37
medical error disclosure, 252 Act (UAGA), 123–7 parental non-disclosure requests,
opioid therapy in addicted patients, 36
149 pacemakers, disabling, 103–4, 105–6 research participation, 185, 187–90

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peer review case example, 209, 214 pain management, 139, 193–7
expert testimony, 263–4, 265 conflicts of interest, 204–5, 206 participation and organ donation
publication, 207, 212 industry–academia relationship, 207 comparison, 116
persistently vegetative states, 111 influence of, 209 placebo-controlled studies, 183,
personhood journal editors’ obligations, 212–14 195–6
animal rights and, 168–73 key points, 214–15 public perceptions and consensus on
loss of, 111, 112 peer review, 207, 212 animal, 176–7
persuasion, 9–10 quality improvement (QI) initiatives quality improvement initiatives and,
pharmaceutical companies, and, 201 199–203
See industry risk and, 166–7, 182–3, 187–90,
Pharmaceutical Research and quality improvement (QI) initiatives, 195–6
Manufacturers of America 199–201 scientific methodology, 193–4
(PhRMA), 246 electronic medical record (EMR) scientific review, 182–3
physician aid in dying and privacy issues, 201–3 studies on symptoms with pre-
attitudes and practices, 131 quality of life, patient-requested DNR existing effective treatment,
case example, 128 orders and, 14 193–7
definition of, 129 therapeutic misconception, 194,
disabling cardiac assist devices and, Rehabilitation Act, 231 197
103, 104 relational autonomy, 29 three R’s of humane animal
double effect (DE) principle, 89 religious issues experimentation, 177–8
ethical issues, 128–31 Amish, 65 uniqueness of anesthesiology
Hippocratic Oath, 286 animal subjects research, 174–5 ­research,164
key points, 132–3 Christian Science, 64–7 vulnerable person participation,
physician-assisted execution and, 287 decision-making in ICU, 100 See vulnerable persons
responding to requests for, 131–2 ethics consultation, 64–8 responsibility, diffusion of, 288
plagiarism, 210–11, 212 Jehovah’s Witnesses (JWs), 19–26 rest breaks, 227
power of attorney, 27, 93, neurological standard of death, restraint therapy, 61–3, 65
See also advance directives 27 110–11 resuscitation, history of, 39
practice impairment issues religious freedom and the state, risk
addiction, 219–22 64–5 disaster response risk limitation,
disability, 230–3 treatment refusal, 47 267–8
sleep deprivation, 224–8 research Institutional Review Boards (IRBs)
pregnancy testing, 79, 80–3 anesthesiologists’ obligations in, obligations regarding, 182, 183
preoperative testing 163–4 risk/benefit ratio, 182, 189, 195–6
general ethical issues and principles, animal rights issues, 168–73, 175 vulnerable persons research and,
79–80 animal subjects case examples, 168, 187–90
HIV, 80, 81 174
key points, 83 assessing benefits of animal, SARS virus, 267, 268
pregnancy, 79, 80–3 175–6 sedation, restraint therapy, 62, 65
preventive ethics, 105–6, 259–8 clinician-researcher dual role, self-discharge, 4
prisoners, See also vulnerable persons 165–6 Sex Discrimination Act, 240
research participation, 181, 189–90 conflicts of interest in, 204–8 sexual harrassment and discrimination
privacy, See confidentiality/privacy current issues in animal, 177–8 case example, 240, 241
professionalism denial of participation, 189 consensual sexual relationships in
MAD (mean, abusive and disruptive) dual role of clinician and researcher, workplace and, 242–3
behavior and, 236–7 197 effects of, 241–2
physician-assisted execution and, 286 end-of-life participation, 193, 195, forms of, 240–1
proportionality, double effect principle 196–7 key points, 243–4
and, 88 enrolment of human subjects, sexual relationships, workplace, 242–3
psychoneuroimmunology, 76 164–5 Shipman, H., 156
psychosurgery human subjects case example, 163, Singer, P., 170, 171–3
historical perspective, 55–6 166–7 sleep deprivation
indications for, 56–7 human subjects review boards, affect on performance, 225–6
informed consent, 55, 56–8 See Institutional Review Boards anesthesiologists’ responsibilities,
key points, 59 (IRBs) 226–7
techniques of, 56 informed consent, 57–8, 164–5, 166, case example, 224
publication 196 hospital’s responsibilities, 227–8
animal research studies, 177–8 key points on ethics in human human error and, 224
author misconduct, 209–12, 214 subject, 167 key points, 228
authors’ obligations, 210 moral justifications of animal, 174–6 sleep physiology background, 224–5

297
 Index

sleep disorders, 227 organ donation/transplantation, Uniform Determination of Death Act

social capital, 238 116, 124 (UDDA), 115
social contract, ^=259 259 267 situations requiring, 28 United States President’s Council on
standards of care, 262–3 Bioethics, 111–12
student–teacher sexual relationships, terrorism, See disaster response utilitarianism, organ donation, 119, 120
242–3 testimony, expert, See expert
subcaudate tractotomy, testimony ventilation
See also psychosurgery 56 therapeutic misconception, 194, 197 restraint therapy and, 62
subsidiarity principle, 187 therapeutic obstinacy, 130 withdrawal of, See life support
substituted judgment, 29, 99 therapeutic privilege, 5–13 withholding/withdrawal
suicide torture, physician facilitation, 280–3 ventricular assist devices (VADs),
assisted, See physician aid-in-dying treatment refusal disabling, 103–4, 105–6
opioid therapy and, 155 do-not-resuscitate (DNR) orders, vital function support discontinuation,
sexual harrassment and suicidal See do-not-resuscitate (DNR) See life support withholding/
ideation, 242 orders withdrawal
supererogatory actions, 268 during labor, 46–8 vulnerable persons
surrogate decision-making ethics consultation, 64–8 child participation in research, 185,
basis of decision-making process, 29 Jehovah’s Witnesses (JWs), 19–26 187–90
burden on surrogates, 30–1, 99 pediatric patients, 35 definitions of, 185
correlation with patient’s respecting patient autonomy, 4–7 general protection strategies in
preferences, 29–30 summary of patient rights by research, 187–8, 193
decision-making capacity ­country,5–13 pain management and, 140
assessment, 31 triage prisoner participation in research,
disagreement in, 100–1 civilian mass casualty situations, 181, 189–90
Durable Power of Attorney for 270–3 uniqueness of anesthesiology
Healthcare, 27 intensive care unit (ICU), 98 ­research,164
family meetings, 99–101 military, 270, 275–8
hierarchy of legal surrogates, 27 reverse, 272 work schedules, 227
intensive care unit (ICU), 99–101 Tuskeegee experiment, 181 World Medical Association (WMA)
Jehovah’s Witness (JW) patients, 21 military medicine guidelines, 276
key points, 31–2 Uniform Anatomical Gift Act (UAGA), statement on torture, 281
limits of, 29 114, 117, 120
living wills and, 27, 30 revision of, 123–7 Yuen-man, T., 268

298