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Dr Aman Ullah
B.Sc. MLT
Ph.D. Microbiology
Bioethics, born out of the rapidly expanding
technical environment of the 1900s
It is a specific domain of ethics focused on
moral issues in the field of health care
Introduction
Bioethics, a term that first appeared in the
literature in 1969
Belmont Report outlined three basic principles for all
human subjects research: respect for persons,
beneficence, and justice
The description of beneficence also included the rule
now commonly known as the principle of
nonmaleficence
Ethical In 1979, Beauchamp and Childress published the
Principles first edition of their book Principles of Biomedical
Ethics
This book featured four bioethical principles:
autonomy, nonmaleficence, beneficence, and justice
Doing ethics based on the use of principles—that
is, ethical principlism
It does not involve the use of a theory or a formal
decision-making model; rather, ethical principles
provide guidelines to make justified moral
Ethical decisions and to evaluate the morality of actions
Principles Ideally, when using the approach of principlism,
no one principle should automatically be
assumed to be superior to the other principles
Each principle is considered to be prima facie
binding
Autonomy is the freedom and ability to act in
a self-determined manner
It represents the right of a rational person to
express personal decisions independent of
outside interference and to have these
Autonomy decisions honored
The principle of autonomy sometimes is
described as respect for autonomy
In the domain of health care, respecting a
patient’s autonomy includes obtaining
informed consent for treatment;
Facilitating and supporting patients’ choices
regarding treatment options; allowing patients
to refuse treatments; disclosing comprehensive
and truthful information, diagnoses, and
treatment options to patients; and maintaining
privacy and confidentiality
Autonomy Restrictions on an individual’s autonomy
may occur in cases when a person presents a
potential threat for harming others
such as exposing other people to communicable
diseases or committing acts of violence
Informed consent in regard to a patient’s treatment
is a legal, and ethical, issue of autonomy
Informed consent is respecting a person’s autonomy
to make personal choices based on the appropriate
Informed appraisal of information about the actual or
potential circumstances of a situation
consent Though all conceptions of informed consent must
contain the same basic elements, the description of
these elements is presented differently by different
people
Beauchamp and Childress II. Information elements
(2013) outlined informed 3. Disclosure
consent according to seven (of material information)
4. Recommendation
elements (of a plan)
Informed I. Threshold elements 5. Understanding of disclosure
consent (preconditions) and recommendation
III. Consent elements
1. Competence 6. Decision
(to understand and decide) (in favor of a plan)
2. Voluntariness 7. Authorization
(of the chosen plan)
(in deciding)
Dempski (2009) presented three basic elements that are
necessary for informed consent to occur:
1. Receipt of information:
Receiving a description of the procedure, information about the
risks and benefits of having or not having the treatment,
reasonable alternatives to the treatment, probabilities about
Informed outcomes, and “the credentials of the person who will perform
consent the treatment”
It is too demanding to inform a patient of every possible risk or
benefit involved with every treatment or procedure
Information should be tailored specifically to a person’s
personal circumstances, including providing information in the
person’s spoken language
2. Consent for the treatment must be voluntary:
A person should not be under any influence or be
coerced to provide consent
Patients should not be asked to sign a consent form
when they are under the influence of mind-altering
Informed medications, such as narcotics
consent Depending on the circumstances, consent may be
verbalized, written, or implied by behavior
Silence does not convey consent when a reasonable
person would normally offer another sign of agreement
3. Persons must be competent:
Persons must be able to communicate consent
and to understand the information provided to
Informed them
If a person’s condition warrants transferring
consent
decision-making authority to a surrogate,
informed consent obligations must be met with
the surrogate
In the past, patient-care errors were something to be
swept under the rug, and care was taken to avoid patient
discovery of these errors
When healthcare leaders realized that huge numbers of
patients were dying from medical errors, the Institute of
Medicine (IOM) began a project to analyze medical errors
Intentional and try to reduce them
Nondisclosure One outcome of the project is the book To Err Is Human:
Building a Safer Health Care System (IOM, 2000)
The IOM project committee determined that to err really
is human, and good people working within unsafe systems
make the most errors
It is now expected that errors involving serious,
preventable adverse events be reported to patients and
other organizational reporting systems on a mandatory
basis
Reporting near misses (i.e., errors that cause no harm to
Intentional patients) are more controversial
Nondisclosure Some professionals tend to avoid telling patients about
near-miss errors since no harm was done to the patient
But ethicists recommend disclosure of these events
Being honest and forthright with patients promotes
trust, and secrecy is unethical
Intentionally not disclosing information to a patient or surrogate
is legal in situations of emergency or when patients waive their
right to be informed
Respecting a patient’s right not to be informed is especially
important in culturally sensitive care
Other more legally and ethically controversial circumstances of
Intentional intentionally not disclosing relevant information to a patient
Nondisclosure involve three healthcare circumstances
The first circumstance falls under therapeutic privilege
The second relates to therapeutically using placebos
The third involves withholding information from research
subjects to protect the integrity of the research
The Patient Self-Determination Act (PSDA), passed by the
U.S. Congress in 1990, is the first federal statute designed to
facilitate a patient’s autonomy through the knowledge and
use of advance directives
Patient Self- Healthcare providers and organizations must provide written
information to adult patients regarding state laws covering
Determination the right to make healthcare decisions, to refuse or withdraw
Act treatments, and to write advance directives
One of the underlying aims of the PSDA is to increase
meaningful dialogue about patients’ rights to make
autonomous choices about receiving or not receiving health
care
The HIPAA Privacy Rule is a federal regulation designed to
protect people from disclosure of their personal health
information other than for the provision of health care and
The Health for other need-to-know purposes on a minimum necessary
Insurance basis
Portability and The intent of the rule is to ensure privacy while facilitating the
Accountability Act flow of information necessary to meet the needs of patients
of 1996 (HIPAA) The Privacy Rule protects all “individually identifiable health
Privacy and information” held or transmitted by a covered entity, in any
Security Rules form or media, whether electronic, paper, or oral
The Privacy Rule calls this information “protected health
information
The Security Rules of the act operationalize the Privacy Rules
These rules contain standards addressing privacy safeguards
The Health for electronic protected health information
Insurance The rule is designed to “assure the confidentiality, integrity,
Portability and and availability of electronic protected health information”
Accountability All patient-identifiable protected health information is to be
Act of 1996 kept private unless it is being used for patient care, a patient
agrees to a release, or it is released according to legitimate,
(HIPAA) limited situations covered by the act
Privacy and It is incumbent on all healthcare professionals to be familiar
Security Rules with the content of the act
Question/Suggestion
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