Introduction to

Nursing Research
Unit 1
Ethical Issues in Nursing
S. Kendley & H. Williams
Department of Nursing
NCU
Objectives
At the end of this interactive session
students will be able to:

• Discuss the historical background that led

to the creation of various codes of ethics

• Understand the potential for ethical

dilemmas stemming from conflicts
between ethics and research demands

• Identify the three primary ethical

principles articulated in the Belmont
Report and the important dimensions
encompassed by each
• Identify procedures for adhering to ethical
principles and protecting study
participants

• evaluate the ethical dimensions of a

research report
HISTORICAL BACKGROUND (I)

• In any research with human beings or animals,

researchers must address ethical issues.

• Ethical concerns are especially prominent in

nursing research because the line between
what constitutes the expected practice of
nursing and the collection of research data
sometimes gets blurred.

• We might like to think that violations of moral

principles among researchers occurred
centuries ago rather than recently, but this is
not the case.
(Nieswiadomy, 2011)
• The Nazi medical experiments of the1930s and
1940s are the most famous example of recent
disregard for ethical conduct.
• The Nazi program of research involved using
prisoners of war and racial “enemies” in
experiments designed to test human endurance
and reactions to untested drugs.
• The studies were unethical not only because they
exposed people to harm and even death, but
because subjects could not refuse participation.
• Similar wartime experiments that raised ethical
concerns were conducted in Japan and Australia.

(Nieswiadomy, 2011)
• There are more recent examples. For instance,
between 1932 and 1972, the Tuskegee Syphilis Study,
sponsored by the U.S. Public Health Service,
investigated the effects of syphilis among 400 poor
African-American men.

• Medical treatment was deliberately withheld to study

the course of the untreated disease.

• Similarly, Dr. Herbert Green in Auckland, New

Zealand, studied women with cervical cancer in the
1980s; patients with carcinoma in situ were not given
treatment so that researchers could study the natural
progression of the disease.
• Other examples of studies with ethical transgressions
have emerged to give ethical concerns the high
visibility they have today (Nieswiadomy, 2011)
CODE OF ETHICS
• In response to human rights violations, various codes
of ethics have been developed.
• One of the first international set of ethical standards
was the Nuremberg Code, developed in 1949 in
response to the Nazi atrocities.
• Several other international standards have
subsequently been developed, including the
Declaration of Helsinki, which was adopted in 1964 by
the World Medical Association and most recently
revised in 2008.
• Most disciplines, such as medicine and psychology,
have established their own code of ethics.
• Nurses also have developed ethical guidelines In
the United States, the American
• Nurses Association (ANA) issued Ethical
Guidelines in the Conduct, Dissemination, and
Implementation of Nursing Research in 1995
(Silva, 1995).
• ANA (2001) also published a revised Code of
Ethics for Nurses with Interpretive Statements, a
document that covers ethical issues for practicing
nurses primarily but also includes principles that
apply to nurse researchers.
• In Canada, the Canadian Nurses Association
published its Ethical Research Guidelines for
Registered Nurses in 2002. And, the International
Council of Nurses (ICN) has developed the ICN
Code of Ethics for Nurses, which was most
recently updated in 2006.
(Polit & Beck, 2014; Rebar et al, 2011)
Ethical Dilemmas in Conducting Research
(II)
• Research that violates ethical principles
typically occurs out of a researcher’s
conviction that knowledge is potentially
life-saving or beneficial in the long run.
• There are research problems in which
participants’ rights and study demands
are put in direct conflict, posing ethical
dilemmas for researchers.
• Here is an example of research problems
in which the desire for rigor conflicts with
ethical considerations:
• Research question: Are nurses equally
empathic in their treatment of ICU patients
from different ethnic backgrounds?
• Ethical dilemma: Ethics require that
participants be informed of their role in a
study.
• Yet if the researcher tells participating nurses
that their degree of empathy in treating
different patients will be scrutinized, will their
behavior be “normal?”
• If the nurses’ usual behavior is altered
because of the presence of research
observers, then the findings will not be valid.

(Polit & Beck, 2014)

• As this example suggest, researchers are
sometimes in a bind.
• Their goal is develop high-quality evidence for
practice, but they must also adhere to rules for
protecting human rights.
• Another type of dilemma may arise if nurse
researchers face conflict of- interest situations,
in which their expected behavior as nurses
conflicts with standard research behavior (e.g.,
deviating from a research protocol to assist a
patient).
• It is precisely because of such dilemmas that
codes of ethics have been developed to guide
researchers’ efforts
(Polit & Beck, 2014)
 ETHICAL PRINCIPLES FOR PROTECTING
PARTICIPANTS

• The Belmont Report articulated three primary ethical

principles on which standards of ethical research
conduct are based: beneficence, respect for human
dignity, and justice.

• It is a code of ethics issued in 1978 In the United

States, and adopted by the National Commission for
the Protection of Human Subjects of Biomedical and
Behavioral Research.

• It provided a model for many guidelines adopted by

disciplinary organizations worldwide (Polit & Beck, 2014).
Beneficence
• A fundamental ethical principle in research is
that of beneficence, the duty to minimize harm
and maximize benefits.
• Human research should produce benefits for
participants themselves or—a situation that is
more common—for other individuals or society
as a whole.

• The Right to Freedom From Harm and

Discomfort - Researchers have an obligation to
prevent or minimize harm in studies with
humans.

(Polit & Beck, 2014).

• Participants must not be subjected to
unnecessary risks of harm or discomfort,
and their participation in research must be
essential to achieving societally important
aims.

• In research with humans, harm and

discomfort can be physical (e.g., injury),
emotional (e.g., stress), social (e.g., loss of
social support), or financial (e.g., loss of
wages).

• Ethical researchers must use strategies to

minimize all types of harms and
discomforts, even ones that are temporary.
• The Right to Protection From Exploitation -
Involvement in a study should not place
participants at a disadvantage.

• Participants need to be assured that their

participation, or information they provide, will
not be used against them in any way.

• For example, people describing their economic

situation should not risk loss of public health
benefits; people reporting drug abuse should not
fear exposure to criminal authorities.

(Polit & Beck, 2014).

• Study participants enter into a special relationship with
researchers, and this relationship should not
be exploited.

• Exploitation may be overt and malicious (e.g.,

sexual exploitation), but it might also be more
subtle (e.g., getting people to complete a 1-
year follow-up interview, without having
warned them of this possibility at the outset).

• Because nurse researchers may have a

nurse–patient (in addition to a researcher–
participant) relationship, special care may be
needed to avoid exploiting that bond.
• Patients’ consent to participate in a
study may result from their
understanding of the researcher’s role as
nurse, not as researcher

(Polit & Beck, 2014)

Respect for Human Dignity
• Respect for human dignity is the second
ethical principle articulated in the Belmont
Report.
• This principle includes the right to self-
determination and the right to full disclosure.

• The Right to Self-Determination - The principle

of self-determination means that prospective
participants have the right to decide
voluntarily whether to participate in a study,
without risking penalty or prejudicial
treatment.

(Polit & Beck, 2014; Burns , Grove & Gray 2013)

• It also means that people have the right to
ask questions, to refuse to give information,
and to withdraw from the study.

• A person’s right to self-determination

includes freedom from coercion.

• Coercion involves explicit or implicit threats

of penalty from failing to participate in a
study or excessive rewards from agreeing to
participate

(Polit & Beck, 2014; Burns et al., 2013)

• The Right to Full Disclosure - Respect for human
dignity encompasses people’s right to make
informed, voluntary decisions about study
participation, which requires full disclosure.
• Full disclosure means that the researcher has
fully described the study, the person’s right to
refuse participation, and possible risks and
benefits.
• The right to self-determination and the right to
full disclosure are the two major elements on
which informed consent are based
• Full disclosure maybe problematic is issue
being studied is sensitive
(Polit & Beck, 2014; Burns et al., 2013)
Justice III
• The third broad principle articulated in the
Belmont Report concerns justice, which
includes participants’ right to fair treatment
and their right to privacy.

• The Right to Fair Treatment

• One aspect of justice concerns the
equitable distribution of benefits and
burdens of research.

• The selection of participants should be

based on research requirements and not on
people’s vulnerabilities.
(Polit & Beck, 2014; Burns et al., 2013; Rebar et al, 2011)
• Historically, subject selection has been a key
ethical concern, with many researchers
selecting groups deemed to have lower social
standing (e.g., poor people, prisoners, the
mentally disabled) as study participants.
• The principle of justice imposes particular
obligations toward individuals who are unable
to protect their own interests (e.g., dying
patients) to ensure that they are not exploited
for the advancement of knowledge.
• The right to fair treatment encompasses other
obligations.
(Polit & Beck, 2014; Burns et al., 2013; Rebar et al, 2011)
• For example, researchers must treat people who
decline to participate in a study or who withdraw from
it in a non-prejudicial manner; they must honor all
agreements made with participants; they must show
respect for the beliefs and lifestyles of people from
different backgrounds; and they must treat participants
courteously and tactfully at all times
• The Right to Privacy - Virtually all research
with humans involves intruding into
personal lives.

• Researchers should ensure that their

research is not more intrusive than it
needs to be and that privacy is maintained.

• Participants have the right to expect that

any data they provide will be kept in strict
confidence.

(Polit & Beck, 2014)

INFORMED CONSENT
• An important procedure for safeguarding
participants involves obtaining their informed
consent.
• Informed consent means that participants
have adequate information about the study,
comprehend the information, and have the
power of free choice, enabling them to
consent to or decline participation voluntarily.
• Researchers usually document informed
consent by having participants sign a consent
form.

(Polit & Beck, 2014; Burns et al., 2013; Rebar et al, 2011)
• The consent includes information about the
study purpose, specific expectations regarding
participation (e.g., how much time will be
required), the voluntary nature of
participation, and potential costs and benefits.
• Researchers may not obtain written informed
consent when data collection is through self
administered questionnaires.
• Researchers often assume implied consent
(i.e., the return of a completed questionnaire
reflects the person’s voluntary consent to
participate).
(Polit & Beck, 2014; Burns et al., 2013; Rebar et al, 2011)
ELEMENTS OF INFORMED CONSENT IN
RESEARCH

• Show copy of informed consent with

various elements
ISSUES RELATING TO CONFIDENTIALITY
• Study participants have the right to expect that any
data they provide will be kept in strict confidence
(disclosed unwittingly).
• Participants’ right to privacy is protected through
confidentiality procedures.
• Anonymity - the most secure means of protecting
confidentiality, occurs when the researcher cannot
link participants to their data.
• For example, if questionnaires were distributed to a
group of nursing home residents and were returned
without any identifying information, responses would
be anonymous

(Polit & Beck, 2014; Burns et al., 2013; Rebar et al, 2011)
• Treatment of Vulnerable Groups
• Adherence to ethical standards is often
straightforward.

• The rights of special vulnerable groups,

however, may need extra protections.

• Vulnerable populations may be

incapable of giving fully informed
consent (e.g., developmentally delayed
people) or may be at high risk of
unintended side effects (e.g., pregnant
women).
• Attention should be payed to the ethical
dimensions of a study when people who
are vulnerable are involved.

• Among the groups that should be

considered as being vulnerable are the
following:

• Children - Legally and ethically, children do

not have the competence to give informed
consent and so the consent of children’s
parents or guardians should be obtained.

(Polit & Beck, 2014; Burns et al., 2013; Rebar et al, 2011)
• Mentally or emotionally disabled people
- Individuals whose disability makes it
impossible for them to make informed
decisions (e.g., people affected by
cognitive impairment, coma, and so on)
also cannot legally provide informed
consent.

• In such cases, researchers should

obtain the written consent of a legal
guardian.
• Severely ill or physically disabled people - For
patients who are very ill or undergoing certain
treatments (e.g., mechanical ventilation), it
might be necessary to assess their ability to
make reasoned decisions about study
participation.

• For certain disabilities, special consent

procedures may be required.

• For example, with people who cannot read or

who have a physical impairment preventing
them from writing, alternative procedures for
documenting informed consent (e.g.,
videotaping) should be used.
(Polit & Beck, 2014; Burns et al., 2013; Rebar et al, 2011)
• Terminally ill - Terminally ill people can seldom
expect to benefit personally from research, and
thus the risk/benefit ratio needs to be carefully
assessed.

• Institutionalized people - Nurses often conduct

studies with hospitalized or institutionalized
people who might feel that their care would be
jeopardized by failure to cooperate.

• Inmates of prisons and correctional facilities

may similarly feel constrained in their ability to
give free consent.
• Researchers studying institutionalized groups
need to emphasize the voluntary nature of
participation.
CRITIQUING THE ETHICAL ASPECTS OF A
STUDY

• Members of an Internal Review Board (IRB) or

human subjects or ethics committee are
provided with sufficient information to answer
all these questions, but research articles do not
always include detailed information about
ethics because of space constraints in journals.
• Thus, it may be difficult to critique researchers’
adherence to ethical guidelines.
• Nevertheless, we offer a few suggestions for
considering ethical issues.
• Many research reports do acknowledge
that the study procedures were reviewed
by an IRB or human subjects committee.

• When a report mentions a formal review, it

is usually safe to assume that a panel of
concerned people thoroughly reviewed
ethical issues raised by the study.

• Was the study approved and monitored by

an Institutional Review Board, Research
Ethics Board, or other similar ethics
review committee?
• Were study participants subjected to any physical
harm, discomfort, or psychological distress? Did the
researchers take appropriate steps to remove or
prevent harm?

• Did the benefits to participants outweigh any potential

risks or actual discomfort they experienced? Did the
benefits to society outweigh the costs to participants?

• Was any type of coercion or undue influence used to

recruit participants? Did they have the right to refuse
to participate or to withdraw without penalty?
• Were participants deceived in any way? Were
they fully aware of participating in a study and
did they understand the purpose and nature of
the research?
• Were appropriate informed consent procedures
used with all participants? If not, were the
reasons valid and justifiable?
• Were adequate steps taken to safeguard
participants’ privacy? How was confidentiality
maintained? Was a Certificate of
Confidentiality obtained—and, if not, should
one have been obtained?
• Were vulnerable groups involved in the
research? If yes, were special precautions
instituted because of their vulnerable status?

• Were groups omitted from the inquiry without

a justifiable rationale, such as women (or
men), or minorities?

• A person could come to some conclusions

based on a description of the study methods.

• There may be sufficient information to judge,

for example, whether study participants were
subjected to harm or discomfort.
• Reports do not always state whether informed consent
was secured, but you should be alert to situations in
which the data could not have been gathered as
described if participation were purely voluntary (e.g.,
if data were gathered unobtrusively).

• In thinking about the ethical aspects of a study, you

should also consider who the study participants were.

• For example, if the study involves vulnerable groups,

there should be more information about protective
procedures.
• You might also need to attend to who the study
participants were not.
• For example, there has been considerable concern
about the omission of certain groups (e.g., minorities)
from clinical research
Nieswiadomy, R. (2012).Foundations of
nursing research. Prentice Hall. New
Jersey

Polit, D & Beck, C. (2014). Essentials of nursing

research: Appraising evidence for nursing
practice. Philadelphia: Lippincott Williams
& Wilkins

Burns, N., Grove, S & J. Gray.m (2013) The

Practice of Nursing Research: Appraisal,
Synthesis, and Generation of Evidence (7th
ed.)
Rebar, C., Macnee, C & McCabe, S.
(2011). Understanding nursing
research: Using research in evidence-
based practice. Philadelphia:
Lippincott Williams & Wilkins