HEALTHCARE ETHICS (NCM 108) MODULE 3

Module 3 Bioethics and Research Handouts/Materials

CIRP Introduction
The judgment by the war crimes tribunal at Nuremberg laid down 10 standards to which physicians must conform when
carrying out experiments on human subjects in a new code that is now accepted worldwide.
This judgment established a new standard of ethical medical behavior for the post World War II human rights era.
Amongst other requirements, this document enunciates the requirement of voluntary informed consent of the human
subject. The principle of voluntary informed consent protects the right of the individual to control his own body.
This code also recognizes that the risk must be weighed against the expected benefit, and that unnecessary pain and
suffering must be avoided.
This code recognizes that doctors should avoid actions that injure human patients.
The principles established by this code for medical practice now have been extended into general codes of medical
ethics.

The Nuremberg Code (1947)

Permissible Medical Experiments
The great weight of the evidence before us to effect that certain types of medical experiments on human beings, when
kept within reasonably well-defined bounds, conform to the ethics of the medical profession generally. The protagonists
of the practice of human experimentation justify their views on the basis that such experiments yield results for the
good of society that are unprocurable by other methods or means of study. All agree, however, that certain basic
principles must be observed in order to satisfy moral, ethical and legal concepts:

The voluntary consent of the human subject is absolutely essential. This means that the person involved should have
legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the
intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or
coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to
enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance
of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and
purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards
reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in
the experiment.

The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs,
or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with
impunity.
The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or
means of study, and not random and unnecessary in nature.
The experiment should be so designed and based on the results of animal experimentation and a knowledge of the
natural history of the disease or other problem under study that the anticipated results justify the performance of the
experiment.
The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur;
except, perhaps, in those experiments where the experimental physicians also serve as subjects.
The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to
be solved by the experiment.
Proper preparations should be made and adequate facilities provided to protect the experimental subject against even
remote possibilities of injury, disability or death.
The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should
be required through all stages of the experiment of those who conduct or engage in the experiment.
During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has
reached the physical or mental state where continuation of the experiment seems to him to be impossible.
During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage,
if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him,
that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

Ref: http://www.cirp.org/library/ethics/nuremberg/

How the Belmont Report clarified informed consent

FEBRUARY 8, 2019 BY DANIELLE KIRSH
Sandra Maddock, President & CEO, IMARC Research
Imagine being enrolled in a clinical trial without fully understanding the scope or the risks.
 HEALTHCARE ETHICS (NCM 108) MODULE 3

The Belmont Report marks an important milestone in the history of clinical research. It established guidelines for basic
ethical principles, as well as informed consent, the assessment of risks and benefits and subject selection

What is the Belmont Report?

The Belmont Report was written in response to the infamous Tuskegee Syphilis Study, in which African Americans with
syphilis were lied to and denied treatment for more than 40 years. Many people died as a result, infected others with
the disease, and passed congenital syphilis onto their children.

Following the Tuskegee study, Congress passed the National Research Act, creating the National Commission for the
Protection of Human Subjects of Biomedical and Behavioral Research. This commission met regularly for nearly four
years, culminating in a four-day discussion at the Smithsonian Institution’s Belmont Conference Center in February 1976.

The resulting Belmont Report summarized the three ethical principles the commission concluded should guide human
research:
 Respect for persons: All individuals should be treated as autonomous agents, and persons with diminished
autonomy are entitled to protection
 Beneficence: Researchers should maximize possible benefits and minimize possible harm
 Justice – All persons should be treated equally, and the selection of research subjects should be scrutinized so
that no one is systematically selected on the basis of race, ethnicity, class or other factors

How the Belmont Report defines informed consent

The Belmont Report addresses informed consent as a necessary part of showing respect for all persons. It states that all
subjects, to the degree that they are capable, should be given the opportunity to choose what shall or shall not happen
to them.
According to the report, informed consent requires three elements: information, comprehension and voluntariness.

Information

Research subjects “must be given sufficient information about the research procedure, their purposes, risks and
anticipated benefits and alternative procedures (where therapy is involved).” They should be given the opportunity to
ask questions and have the right to withdraw from the research at any time.

In cases where informing subjects about some pertinent aspect of the research is likely to impair the validity of the
research, the Belmont Report states withholding information is justified only if the following three criteria apply:
Incomplete disclosure is truly necessary to accomplish the goals of the research
There are no undisclosed risks to subjects that are more than minimal
There is an adequate plan for debriefing subjects, when appropriate, and for disseminating research results to them
Researchers should never withhold information about risks for the purpose of getting a subject to cooperate.

Comprehension

The Belmont Report states that “the manner and context in which information is conveyed is as important as the
information itself.” For instance, allowing too little time for the subject to consider the information could affect their
ability to make an informed choice.

That means researchers need to consider a subject’s maturity, capacity for understanding, language and literacy when
presenting information to obtain informed consent. In some cases, the report states, it may be appropriate to give oral
or written tests of comprehension.
Voluntariness

Informed consent means there is no coercion or undue influence. In other words, researchers cannot threaten harm or
offer an “excessive, unwarranted, inappropriate or improper reward” to obtain compliance.
That means researchers need to take special care when conducting clinical trials involving vulnerable people who are
under the authority of someone else, such as inmates or people who are ill.

Other considerations involving informed consent

On the surface, informed consent seems like a straightforward concept. However, the evolution of clinical research and
the introduction of new technologies continue to raise new questions about its application.

For instance:
What additional considerations apply when informed consent is obtained electronically?
How can researchers avoid overstating the potential benefits of a medical device?
How can researchers avoid undue influence when enrolling employees in a clinical trial?
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The FDA released its latest guidance on informed consent in 1998 and has drafted an update to that document that has
yet to be finalized. While it’s not likely we’ll ever see the “last word” on informed consent, the Belmont Report serves as
an important and timeless reminder of the fundamentals of informed consent.
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Ref: https://www.massdevice.com/how-the-belmont-report-clarified-informed-consent/
HEALTHCARE ETHICS (NCM 108) MODULE 3
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ref: https://www.who.int/bulletin/archives/79(4)373.pdf

Research ethics involve requirements on daily work, the protection of dignity of subjects and the publication of the
information in the research. However, when nurses participate in research, they have to cope with three value systems;
society; nursing and science which may be in conflict with the values of subjects, communities, and societies and create
tensions and dilemmas in nursing. Method and material: Using the Medline and the Nursing Cinahl data base, the most
important ethical issues which appear in bibliography, will be addressed. After a short description of the nature of
nursing, and the advocacy role of nurses, the writer will attempt to highlight the possible conflicts that nurses have to
deal with, when undertaking or participating in research. Results: The major ethical issues in conducting research are: a)
Informed consent, b) Beneficence- Do not harm c) Respect for anonymity and confidentiality d) Respect for privacy.
However, both the nature of nursing which focuses on caring, preventing harm and protecting dignity and the advocates
role of nurses which calls for defending the rights of subjects, are sometimes incongruent with the ethics in research.
Conclusions: Ethical issues, conflicting values, and ambiguity in decision making, are recurrently emerging from literature
review on nursing research. Because of lack of clarity in ethical standards, nurses must develop an awareness of these
issues and an effective framework to deal with problems involving human rights.
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Ethics is rooted in the ancient Greek philosophical inquiry of moral life. It refers to a system of principles which can
critically change previous considerations about choices and actions. It is said that ethics is the branch of philosophy
which deals with the dynamics of decision making concerning what is right and wrong. Scientific research work, as all
human activities, is governed by individual, community and social values. Research ethics involve requirements on daily
work, the protection of dignity of subjects and the publication of the information in the research.

However, when nurses participate in research, they have to cope with three value systems; society; nursing and science.
The societal values about human rights, the nursing culture based on the ethic of caring and the researcher's values
about scientific inquiry. According to Clarke these values may conflict with the values of subjects, communities, and
societies and create tensions and dilemmas in nursing.
Historical overview- Ethical codes
Human experimentation has been conducted even before 18th century. However, the ethical attitudes of researchers
drawn the interest of society only after 1940's because of human exploitation in several cases. Professional codes and
laws were introduced since then in order to prevent scientific abuses of human lives. The Nazi experiments led to the
Nuremberg Code (1947) which was the leading code for all subsequent codes made to protect human rights in research.
This code focuses on voluntary informed consent, liberty of withdrawal from research, protection from physical and
mental harm, or suffering and death. It also emphasizes the risk- benefit balance. The only weak point of this code was
the self regulation of researchers which can be abused in some research studies. All declarations followed, forbade
nontherapeutic research. It was only in 1964 with the declaration of Helsinki that the need for non therapeutic research
was initiated. The declaration emphasised the protection of subjects in this kind of research and strongly proclaimed
that the well being of individuals is more important than scientific and social interests.

In terms of Nursing the first inquiry was the "Nightingale Pledge" (1983). Since then there has been a significant
development of professional codes in conduct and research. The American Nurses' Association (ANA) Guidelines for
Research, the Human Rights Guidelines for nurses in clinical and other research (1985) and the Royal College of Nursing
Code for nurses in research (1977) provide a strong assistance to professional nurses as well as reassurance to patients,
the public and society, of professionals’ intentions.
Major ethical issues in conducting research
Informed consent

Informed consent is the major ethical issue in conducting research. According to Armiger: "it means that a person
knowingly, voluntarily and intelligently, and in a clear and manifest way, gives his consent" .

Informed consent is one of the means by which a patient's right to autonomy is protected. Beauchamp and Childress
define autonomy as the ability for self determination in action according to a personal plan. Informed consent seeks to
incorporate the rights of autonomous individuals through self- determination. It also seeks to prevent assaults on the
integrity of the patient and protect personal liberty and veracity. Of course individuals can make informed decisions in
order to participate in research voluntarily only if they have information on the possible risks and benefits of the
research. Free and informed consent needs to incorporate an introduction to the study and its purpose as well as an
explanation about the selection of the research subjects and the procedures that will be followed. It is essential to
describe any physical harm or discomfort, any invasion of privacy and any threat to dignity as well as how the subjects
will be compensated in that case. In addition the subjects need to know any expected benefits either to the subject or
to science by gaining new knowledge.A disclosure of alternatives is also required as for example in the Tuskegee study
about syphilis. In this study, rural black men were chosen as subjects in a study of syphilis. Although a cure for syphilis
was found after the start of the study, it was decided not to treat them and they had not been told that penicillin was
effective to their disease. The researcher must inform the subjects about the methods which will be used to protect
anonymity and confidentiality and indicate a person with whom they can discuss the study. He must also provide a
"Noncoersive Disclaimer" which states that participation is voluntary and no penalties are involved in refusal to
participate. ] Moreover, the subject must be told that some information has been deliberately withheld in order to avoid
altered behaviours. The researcher must also take into account that persons with physical, cultural and emotional
barriers may require a very simple language in order to understand him. Finally, the freedom to withdraw must be
explained.This is very important but raises the issue of how difficult the subjects can withdraw after developing a
personal and sometimes friendly relationship with the researcher. With regard to withdrawal a researcher may be in a
dilemma in case many subjects choose to withdraw at an advanced stage of the study, because this can affect the
validity of the results. The Declaration of Helsinki provide some help as it declares that the interest of the subject must
always prevail over the interests of society and science. According to this, the will of the subject must be respected at
any cost for the research.

Another major ethical issue is obtaining an informed consent from groups with diminished autonomy which will be
further discussed later. From what has been discussed, it becomes clear that disclosure, comprehension, competency
and voluntariness are the four essential parts of a consent.

Beneficence- Do not harm

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The ethical principle of beneficence refers to the Hippocratic "be of benefit, do not harm". Beauchamp and Childress,
suggest that

"the principle of beneficence includes the professional mandate to do effective and significant research so as to better
serve and promote the welfare of our constituents".

Beneficence is sometimes difficult to predict when creating a hypothesis especially in qualitative research. Carr says that
if the research findings prove that it was not beneficial as it s expected, this can raise immense ethical considerations
especially for nurses. [16] Ford and Reutter say that "beneficence relates to the benefits of the research, while non-
malificence relates to the potential risks of participation". Nonmalificence requires a high level of sensitivity from the
researcher about what constitutes "harm". According to Burns and Grove "discomfort and harm can be physiological,
emotional, social and economic in nature".

When a researcher tries to learn intimate details of the participants lives he has to deal with opening old wounds
Nonmalificence dictates both preventing intentional harm and minimising potential harm. A researcher must consider all
possible consequences of the research and balance the risks with proportionate benefit. The type, degree, and number
of potential risks must be assessed as well as the patients value system which ranks various harms. The risk benefit ratio
can only be achieved by identifying these factors. If the risks outweigh the benefits, the study should be revised.

Last, debriefing at the end of a study, should be mentioned. Treece and Treece say that debriefing refers to explaining
the exact aim of the study and why the disclosure was not full. Treece and Treece suggest that subjects should feel as
much at ease as possible and express their feelings. In addition, Burns and Grove suggest that if the subjects experienced
a high level of discomfort, they should be debriefed or referred to appropriate professional intervention as necessary.

Respect for anonymity and confidentiality

The issue of confidentiality and anonymity is closely connected with the rights of beneficence, respect for the dignity
and fidelity. ANA suggests anonymity is protected when the subject's identity can not be linked with personal responses.
If the researcher is not able to promise anonymity he has to address confidentiality, which is the management of private
information by the researcher in order to protect the subject's identity. Levine advocates that confidentiality means that
individuals are free to give and withhold as much information as they wish to the person they choose. [The researcher is
responsible to "maintain confidentiality that goes beyond ordinary loyalty". Clarke addresses the ethical dilemma of the
researcher when confidentiality must be broken because of the moral duty to protect society.

According to the utilitarian theory, which focuses on the best interest of all involved, the happiness of society is of
greater importance. On the other hand, the deontological theory which ignores the result implies that the moral duty is
what really matters. If a researcher, though, acts deontologically he may feel that he has not protected society. Another
issue is that the researcher may have to report confidential information to courts which can also cause

moral dilemmas. In that cases it can be argued that the moral duty and personal ethos can be stronger than legal
requirements.Even if there are no duty conflicts, the researcher faces several problems with respect to maintaining
confidentiality especially in qualitative research where conduct is personal, the sample is smaller and the reports display
quotations of interviews. Ford and Reutter suggest using pseudonyms and distorting identifying details of interviews
when transcribing the tapes used.

In situations that are particularly complex, sensitive, and in which the participants are extremely vulnerable, a Certificate
of Confidentiality issued by the U.S. Department of Health and Human Services (DHHS) may be useful to help ensure the
privacy of research participants especially in studies in which participants and researchers may be exposed to compelled
legal disclosure of research data.

The researchers must always bear in mind all psychological and social implications that a breach of confidentiality may
have on subjects. In order to protect participants, they have to inform them on their rights, and use all possible coding
systems that they regard appropriate in each case.

Respect for privacy

The fifth principle of the entitled "A Patient's Bill of rights" document published in 1975 by the American Hospital
Association (AHA), affirm the patient's right of privacy. [21] According to Levine : "privacy is the freedom an individual
has to determine the time, extent, and general circumstances under which private information will be shared with or
withheld from others ". [20]

Kelman believes that an invasion of privacy happens when private information such as beliefs, attitudes, opinions and
records, is shared with others, without the patients knowledge or consent. [22] However, the American Nurses
Association says that different persons may held different opinions about when privacy is invaded. A researcher cannot
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decide on behalf of other persons on those delicate issues. All aims, instruments and methodology must be discussed
with the prospective subject and the research workers prior to the investigation.

Treece and Treece suggest that whenever subjects refuse to report personal information as they regard it an invasion of
privacy, the researcher ought to respect their views. This may even apply to report of age, income, marital status, and
other details that the subject may regard intimate. They also imply that privacy can be invaded when researchers study
certain groups without their knowledge and without identifying themselves. An example of such a study that the
researcher hid his identity, was Humphrie's study "Impersonal Sex in public places" in which, he observed homosexuals
during sexual activities in public men's rooms. Health care practitioners need to be aware that "an invasion of privacy
may cause loss of dignity, friendship or employment, or create feelings of anxiety, guilt, embarrassment or shame". In
conclusion, all possible measures have to be taken in order to protect subjects from potential physical, psychological or
social damage during the research or after circulation of the results.

Vulnerable groups of people

Nowadays, there is an increased concern about vulnerable groups and whether it is ethical or not for them to be used as
research subjects." Fisher classifies vulnerability as one characteristic of people unable to protect their own rights and
welfare". So, vulnerable groups include captive populations (prisoners, institutionalised, students etc), mentally ill
persons, aged people, children, critically ill or dying, poor, with learning disabilities, sedated or unconscious.

The different opinions about their participation in research can be attributed to their inability to give an informed
consent and also to their need for further protection and sensitivity from the researcher as they are in a greater risk of
being deceived, threatened or forced to participate. Many are in favour of the use of such subjects in research whilst
others would argue strongly against it. Most condition their responses according to the seriousness of the research, the
level of potential risk and the availability of alternatives. According to Burns and Grove vulnerability increases the need
for justification for the use of such subjects.An intense analysis of potential risks and benefits should be the first step of
starting such a research and careful approach should exist both in acquiring consent and during the research procedure
itself. Persons with diminished autonomy are also more vulnerable to invasion of privacy, since their right to privacy is
limited in contrast to other's right to know. In the case of mentally ill, family as well as employers and colleagues have
the right to know while patients may not be able to see the testimony of others in their own record. In the case of
mentally ill patients, it is important to measure comprehension and develop valid tools for it, before obtaining informed
consent to participate in a research study. In a descriptive study of Beebe and Smith the Evaluation to Sign Consent (ESC)
form was used in order to document comprehension in 29 schizophrenia outpatients. [24] Participants living in
supervised housing were significantly more likely to require prompts than those living alone. Participants prescribed two
antipsychotic medications were significantly more likely to require a prompt than those prescribed only one
antipsychotic.

According to Lasagna there are strong feelings among professionals who disagree with experimentation on vulnerable
groups. However, the potential improvement of their nursing care raises the issue of careful consideration before
rejecting or accepting this kind of research.

Skills of the researcher

Jameton declares that in research the three more important elements are the competency of the researcher, the careful
design, and worthwhile expected outcomes. The Royal College of Nurses declares that nurse researchers should have
the necessary skills and knowledge for the specific investigation to be carried out and be aware of the limits of personal
competence in research. Any lack of knowledge in the area under research must be clearly stated. Inexperienced
researchers should work under qualified supervision which has to be reviewed by an ethics committee

What is more, careful choice of method for data collection, to ensure validity and reliability, are two main requirements
that must be met in all kinds of research. The choice depends on the object of the study. When human beings are
involved, all the ethical issues, discussed above, must be taken into account.

The nature of Nursing

The nature and essence of nursing reflects on human beings and their relationship with health. Mckenna states that the
primary scope of nursing is to help persons to adapt in different stages of illness which is a rather task-orientated and
behaviouralistic approach. On the other hand, Swanson notes that nursing views persons as a whole and health as a
subjective and meaningful experience of integrating with the environment. Mckenna views nursing's main elements as
interpersonal interactions which involve practical actions but Chinn and Jacobs make hints on holism as well. Literature
contains diversed nursing definitions which indicates the complicate and uncertain nature of it. However, most authors
reflect on caring as the most important part of nursing. Raya focuses on the unique element of caring in nursing while
Swanson views Nursing in the same scope as "informed caring for the wellbeing of others". The ANA policy statement
declares that "Nurses diagnose and treat human responses to actual or potential health problems". This is quite
 HEALTHCARE ETHICS (NCM 108) MODULE 3

indicative of the nurses' role, but it does not reflect the values, experience and passion of nursing. Swanson suggests
that nursing has to do with "science, concern for humanity and caring.

What exactly does it mean to care? Mayeroff describes caring as an interaction which offers space for personal growth
for both the carer and the cared. Roach says that caring describes precious moments when participants realise their
common base of humanity". Burnard and Chapman suggest that the most important elements of caring are:
"knowledge, alternating rhythms in relationships and continuous changes in reactions to others, patience, honesty,
trust, humility, hope and courage".

In Nursing however, the element of caring is undervalued because the profession was viewed as "women’s work" in
which, care is governed by sentiment and not by logic. Nursing was perceived by society as an extension of medicine
while curing is regarded more important than "enhancing life quality" and preserving human dignity". On the other
hand, Roach says that the curecare dichotomy used to distinguish nursing from medicine is an artificial one.

As McNeil et al say, "care is the basis and precondition of all cure".Swanson proposes a structure for caring which
includes maintaining belief in persons, knowing the other person, being with, doing for, and enabling. The last two are
the most important parts related to research. Doing for, means predicting individual needs, encouraging, performing
tasks with adequate skills and competence, protecting the patient from harm and preserving the dignity. On the other
hand, enabling, means enhancing self-care by training, informing and explaining to the patient as well as assisting with
finding alternatives. Leininger supports the thesis that:"there is no discipline that is so directly and intimately involved
with caring needs and behaviours than the discipline of Nursing".

However, caring is not unique in nursing. Other professions can also claim that caring is an important part of their
practice. It can not be stated either that all nursing procedures include caring. What is more, can nursing today be a
synonym of caring? The vulnerability of the sick and the lack of patient participation in health care, creates a danger of
patient exploitation by nurses. The rapid change and development of nursing emerged the need for a code of
professional conduct to guide nurses in their practice.

Advocacy in nursing
Advocacy primarily used in legal contexts, refers to the protection of human rights of people who cannot defend them
for themselves. The role of nurses as advocates is closely related to the purpose of nursing, the nurse’s views about
humans and the needs of persons in health care. In literature advocacy is described in three different models: The rights
protection model implies that nurses helps persons to understand and exercise their rights. They also aim to protect and
enhance personal autonomy. The value based decision model suggests that nurses should not impose decisions but
assist persons to decide which choices are most consistent with their values. They should also support the patients'
confidence in their own decisions and prevent limitations of their freedom. This model is considered by Gadow in the
"existential advocacy" which focuses on the clarification and reconsideration of the values of the patients by self
examination. According to Fowler and Arrif this thesis is distinct from both "paternalistic and consumer rights
protection" and declares the fundamental rights of self determination. However according to Johnstone, Gadow does
not provide adequate reasoning why self-determination is the most important value or why the human rights claim to
selfdetermination are quite different from a patients rights claim to self-determination. Last, the respect for persons
model focuses on human dignity, privacy and selfdetermined choices that the nurse has to protect if the person is not
autonomous or self-determining. Murphy argues that this model which she calls the advocate model of the nurse-
patient relationship, reflects the basic value of nursing which is the best possible care for patients. However, nurses
should not be considered as being in a solely position to act as patients advocates.

According to Johnstone all professions with a morally significant relationship with a patient ought to fulfil the role of the
advocate. The ANA Code for nurses though, refers to the nursing role of advocate in safeguarding the well being of the
client and the society. However, both the nature of nursing which focuses on caring, preventing harm and protecting
dignity and the advocates role of nurses which calls for defending the rights of subjects, are sometimes incongruent with
the ethics in research.

Conflicts in nurses
Beneficence-Non malificence

A common feature in professional conduct codes and those specific to research is the principle of non-malificence. The
ANA Code of conduct declares that the nurse protects the clients and the public from unethical, incompetent or illegal
practice of any person. This statement raises the issue of advocacy when nurses have to protect patients from the
researchers’ incompetence or unethical behaviour. Even if nurses are certain about the incompetence of the
investigator, which is usually very difficult, they have to deal with serious dilemmas. First they have to consider the fact
that if patient learn that they are exposed to professional misconduct, they may lose faith in health care. Jameton
though, believes that patient should be informed as they will appreciate the trust shown to him by frankness. If the
researcher does not inform or compensate patient then nurses have to decide between the duty to safeguard the well-
being of patient and be loyal to them, and the loyalty to colleagues.
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However, even if nurses decide that their duty of caring and being loyal to the patient is more important, they may have
to deal with the hierarchical and bureaucratic systems of institutions which demand loyalty to subordinates to the
institution. In case the incompetent researcher is a higher status professional, nurses may be obliged to show loyalty,
but this can conflict with loyalty to patients. Consequently, nurses may feel that their patients are vulnerable and
exposed and that they can not prevent it because they do not have a voice or power to resist. This is merely why many
authors believe that it may not be possible for nurses to act as advocates of subjects in research. Many support the idea
that the prohibition from the advocacy role comes from the origins and development of nursing as a women’s
occupation dominated by medicine in a bureaucratic system.

Another possible issue of conflict is that the caring nature of nursing with regard to the right of patients to the best
treatment/care is sometimes conflicting with the aim of research in non therapeutic studies. According to the Belmond
commission the general aim of practice is to enhance the well being of individuals while the purpose of research is to
contribute to general knowledge. This distinction highlights the differences in the aims of a nurse practitioner and a
researcher. It is therefore very difficult for nurses to be engaged in studies whose aim is not directly beneficial to the
subject. They must though, consider that these studies may generate and refine nursing knowledge.

Another problem that nurses may have to face is taking part in randomised control trials. According to Brink and Wood
dedicated nurses are finding themselves under pressure when they are asked to exclude some patients from an obvious
beneficial treatment such as relaxation techniques for relief of post operative painSo, they suggest that whenever it is
possible to predict such problems for nurses, the control data should be colle.cted before introducing the beneficial
variable. Skodol Wilson implies that there should be some provisions for alternative effective care. Finally, Brink and
Wood recommend that withholding benefits can be rectified at the end of an experiment. This compensation must be
planned in advance so that enough money and time will be available.

In order to prevent human exploitation, ethics committees were introduced. The criteria on which the proposals are to
be judged are the physical and mental discomfort or harm of subject, the qualifications and experience of the
supervisor, the scientific value, the adequate consent procedures and the adequate information given to subjects. Clark
warns that there is a danger that the members may have vested interests in a research. The success of any ethics
committee will always depend on the commitment and moral competency of its members. If instead of the patient and
his needs, the central aims of the committee are personal interests, profits and academic prestige, then nurses will have
none to share their concerns with, and deal with their dilemmas in research. Nurses, need a greater accessibility to
committees and demand a multidisciplinary synthesis in order to deal with very difficult cases. Moreover, the
committees should be less strict so as not to prevent knowledge development in nursing.

Confidentiality

The issue of confidentiality which is stated as very important in the Hippocratic oath, is another possible issue of conflict
for nurses either as practitioners or researchers. Clause 10 of the ICN Code for nurses emphasises that all information
obtained during nursing practice should be kept secret apart from cases that it should be reported in a court, or in cases
that the interests of society are important. On the other hand the ICN Code for nurses in research states that: "Nurses
acting as data collectors must recognise that they are now committed to two separate roles ".]

According to the professional code they can not reveal confidential information not even to the members of the
research team. It is important therefore, to seek advice in ethics committees to get approval for disseminating the
results of the data collection including an account of what happened. In addition, they have to deal with the issue of
anonymity when some features of the research make the subjects easy to identify. It is very important that nurses
always bear in mind that they should protect the privacy of the patient. The trust showed to them must not be
jeopardised. Patients reveal information concerning their body and mind and expect them to be used only in a
therapeutic manner. When dilemmas according to confidentiality arise, trust as a basic element of a therapeutic
relationship should be considered and maintained.

Informed consent

Nurses involved in research, have to consider many ethical problems relating to the issue of informed consent. The ICN
code for nurses in research, states that nurses as practitioners may be called upon to witness that informed and
voluntary consent has been obtained from the subjects of research. It suggests that they should make sure that patients
have fully understood what has been proposed, which means that they are aware of potential risks or discomforts.
Nurses who spend more time with patients are in a good position to judge it. In addition, they must ascertain that
patients have understood their right to withdraw at any time. In order to maintain the self-determination of patients,
nurses must be fully informed themselves about the study and its purpose. The patient's consent should be obtained
freely, with full awareness of implications. If nurses find out that it was not obtained in an appropriate manner, they
should inform patient and refuse co-operation. Webb suggests that the informed consent is an obligation of the
researcher and no nurse should obtain it on behalf of another professional, nor agree to give the explanation as a
substitute. [40] If a nurse tries to get a consent, then the persons will feel obliged to participate, either because
 HEALTHCARE ETHICS (NCM 108) MODULE 3

information is coming from their carer that they trust and depend on, or, because they feel grateful for the care they are
receiving.

Another conflicting issue is that giving information to patients is accepted as a major role of the nurse; but if for the sake
of a research, nurses have to withhold information, this may create conflicts when they have to decide whether to
participate or not. Hurst suggests that if nurses cannot tell patients about the true research objectives, they should
provide a full explanation at the end of data collection. Provided, of course, that a supervisor body has decided that
disclosure should not be full in order not to invalidate the research outcome.

Consent, can however, be a major ethical issue for nurses when it involves persons with diminished autonomy, such as
children, aged, mentally ill etc. Nurses should ascertain that consent has been obtained either from the individual, when
possible, or, by relatives or guardians. They must also protect the dignity and privacy of such groups who are more
vulnerable to loss of dignity and privacy. Nurses taking part in research on children should be alert, in order to notice any
verbal or non verbal dissent which warrants exclusion of the child from the study (even if this creates conflicts with the
researcher. In the same prospect, nurses must act as advocates when vulnerable groups are used in research, and not
prevent it. According to Levine, restricting these groups from research could end in disadvantaging those populations,
even further, especially when research involves no risk and a high potential for benefit.

Researcher role conflict

With regard to nurse researchers, the International Council of Nurses declares that they are not responsible for the care
of patients. They should only intervene in case that "a harmful situation appears imminent". This statement is not
congruent with the culture of nursing which is "intertwined with the ethic of caring". The commitment of nurses to
caring, may create dilemmas according to the conflict between the researcher's and clinician's role.

If a researcher nurse provides physical or psychological care during an interview, the results will be biased and
generalisation will be difficult. Another issue raised from the ICN statement, is to determine when a "harmful situation
appears imminent" and the intervention of the researcher is required. The declaration of Helsinki says that the interest
of the individual should prevail over the interests of society of science. This can solve some of the ethical dilemmas of
the nurse, but in case the situation is not lifethreatening, the conflict remains. Burns and Grove suggest that in case that
support from the researcher is required, then, it should be given, but the subjects should be excluded from the research.
sThey also recommend that another alternative, is to seek help in other professionals to proceed with the data
collection. Nevertheless, most health professionals, no matter how skilled they are in supportive techniques will provide
some care if they feel that it is needed in a certain case.

Conclusion
Ethical issues, conflicting values, and ambiguity in decision making, are recurrently emerging from literature review on
nursing research. Because of lack of clarity in ethical standards, nurses must develop an awareness of these issues and
an effective framework to deal with problems involving human rights. This is necessary in order to come into terms with
the issue of the researcher's values relative to the individual's rights versus the interests of society. Professional codes,
laws, regulations, and ethics committees can provide some guidance but the final determinant of how research is
performed, rests with the researcher's value system and moral code. To prepare future nurses, ethics in research, must
receive special attention in nursing curricula. The criticism and uncertainties that arise, should be rather encouraged
than suppressed in nursing education. Hunt suggests that in order to liberate nursing from its "technocratic impasse"
ethics should be broadly interpreted as an arena of new ideas which can change professional hierarchies, to open cross-
disciplinary discussions, and question the concepts "abnormality", "patient" and " illness". He also declares that nursing,
not as a biomedical branch, but as a science and art of caring, is able to start the redefinition of research in health care
which was in the recent history dominated by the biomedical "paradigm".

Ref: https://www.hsj.gr/medicine/what-are-the-major-ethical-issues-in-conducting-research-is-there-a-conflict-
between-the-research-ethics-and-the-nature-of-nursing.php?aid=3485

Clinical Significance
Ethical values are essential for all healthcare workers. Ethical practice is a foundation for nurses, who deal with ethical
issues daily. Ethical dilemmas arise as nurses care for patients. These dilemmas may, at times, conflict with the Code of
Ethics or with the nurse's ethical values. Nurses are advocates for patients and must find a balance while delivering
patient care. There are four main principles of ethics: autonomy, beneficence, justice, and non-maleficence.

Each patient has the right to make their own decisions based on their own beliefs and values. This is known as
autonomy. A patient's need for autonomy may conflict with care guidelines or suggestions that nurses or other
healthcare workers believe is best. A person has a right to refuse medications, treatment, surgery, or other medical
interventions regardless of what benefit may come from it. If a patient chooses not to receive a treatment that could
potentially provide a benefit, the nurse must respect that choice.