Topic:

Ethical Issues in Nursing Research

Audience:

Nursing Students

Date:

September

Time:

11: 30 am

Duration:

1 hour

Venue:

Lecture Room (The Annex)

Methodology: Lecture Discussion

Number of participants: 104
Learning Theories:

Ausubel: Emphasized the use of advance organizers which he said was

different from overviews and summaries. His use of an advance organizer acted to bridge the
chasm between learning material and existing related ideas. The advanced organizer used; sought
to bridge new knowledge with what was known (sometimes what is known is uncertain and not
concrete). Though he specified that his theory applied only to reception learning in schools, it
was utilized because it introduced the topic and aided the sequence of the information to be
imparted. (Ormrod & Rice, 2003).
Rogers: Dealt with the adult learner, he posited that learning is student centered and personalized
and the educators role is that of a facilitator. Affective and cognitive needs are central and the
goal is to develop self-actualized persons in a cooperative, supportive environment. This theory
was used because all the participants were adult learners, thus they were responsible for their
learning experience and the teacher sought to guide them through this experience. (Quinn &
Hughes, 2007).
Bruner: Believed that learners were not blank slates but brought past experiences to a new
situation, he also stated that new information was linked to prior knowledge, thus mental

representations are subjective. Bruners Discovery learning is an inquiry-based, constructivist

learning theory that takes place in problem solving situations where the learner draws on his or
her own past experience and existing knowledge to discover facts and relationships and new
truths to be learned. (Quinn & Hughes, 2007). Students interact with the world by exploring and
manipulating objects, wrestling with questions and controversies, or performing experiments. As
a result, students may be more likely to remember concepts and knowledge discovered on their
own (in contrast to a transmissionist model). (Quinn & Hughes, 2007). Models that are based
upon discovery learning model include: guided discovery, problem-based learning, simulationbased learning, case-based learning, incidental learning, among others. The advantages of this
theory are: it encourages active engagement, promotes motivation, a tailored learning experience,
and promotes autonomy, responsibility, independence, the development of creativity and problem
solving skills. (Quinn & Hughes, 2007) Bruners theory was used because it encouraged active
engagement, promotes motivation, a tailored learning experience, and promotes autonomy,
responsibility, independence and the development of creativity and problem solving skills for
this presentation.
Vygotsky: Posited that individuals learn from each other through social interaction and the
teacher and the learner collaborate in a reciprocal relationship where each learns from each other
through the same process of social interaction (Quinn & Hughes, 2007). This theory was chosen
since it lays the overall foundation for human behaviours that of interaction, where students learn
from the more knowledgeable other (MKO) it coincides with the topic and the overall mode of
delivery of the topic.
Aim of the activity: To educate nursing students on the ethical issues found in nursing research

Scientific Principle:
Resources:

Nurse Instructor, lap top computer, multimedia, white board, markers

hand outs

Objectives:

At the end of 1 hour interactive session students should be able to:

1. Discuss the historical background that led to the creation of various codes
of ethics according to Nieswiadomy (2012); Silva (1998); Polit & Beck,
2014; Rebar et al, (2011)
2. Recognize the potential for ethical dilemmas stemming from conflicts
between ethics and research demands according to Polit and Beck (2014)
3. Describe the three primary ethical principles articulated in the Belmont
report and the important dimensions encompassed by each as outlined by
Polit and Beck (2014)
4. Explicate procedures for adhering to ethical principles and protecting
study participants as proffered by Polit and Beck, (2014); Burns and
Grove, (2010); Rebar et al, (2011)
5. Evaluate the ethical dimensions of a research report as suggested by Polit
and Beck (2014)

Evaluation:
each

Formative and Summative. Questions will be asked before and after

objective by an evaluation at the end.

References:
Burns, N., Grove, K. G. (2010). The practice of nursing research: Appraisal, synthesis and
generation of evidence. St. Louis Missouri: Saunders Elsevier
Nieswiadomy, R. (2012). Foundations of nursing research. Upper Saddle River NJ: Pearsons
Ormrod, J. E. & Rice, F. P. (2003). Lifespan development and learning. Boston, MA: Pearson
Custom Publishing.
Polit, D & Beck, C. (2014). Essentials of nursing research: Appraising evidence for nursing
practice. Philadelphia. PA: Wolters Kluwer Health | Lippincott Williams & Wilkins.
Quinn, F & Hughes, S. (2007). Quinns principles and practice of nursing education. London:
Nelson Thornes

Rebar, C., Gersch, C., Macnee, C & McCabe, S. (2011). Understanding nursing research: Using
research in evidenced based practice. Philadelphia PA: Wolters Kluwer Health
Lippincott Williams & Wilkins.
Silva, M.C. (1998). Organizational and administrative ethics in health care: An ethics gap.
Online Journal of Issues in Nursing, Topic 8

Time

Objectives

2 min

Ice-breaker
David
Ausubel: The
advanced
organizer used;
sought to
bridge new
knowledge
with what was
known

5
mins

Discuss the
historical
background
that led to the
creation of
various codes
of ethics
according to
Nieswiadomy
(2011); Silva
(1995); Polit &
Beck, 2014;
Rebar et al,
2011

Contents

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.
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).

Teacher
Activity
Teacher will
ask students to
identify the
role of the
person in the
picture and
consequently
ascertain the
topic of the
presentation

S
a
id
r
p
p
a
to
p

Teacher will
randomly ask
students to
discuss any
codes of ethics
relating to
nursing and
nursing
research with
which they are
familiar

s
a
d
c
r
n
n
r
w
f

Teacher will
discuss the
historical
background

S
s
w
P

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 AfricanAmerican 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)

that lead to the

creation of
various codes
of ethics with
the aid of
PowerPoint
presentation

f
q
n
te
d
v
h
c

Teacher will
ask 4 students
in the front to
discuss one
historical event
each that led to
the
development a
code of ethics
according to
the content

F
w
o
e
le
d
o
e
a
th

10
mins

Recognize the
potential for
ethical
dilemmas
stemming from
conflicts
between ethics
and research
demands as
cited by Polit
and Beck
(2014)

ETHICAL DILEMMAS IN CONDUCTING RESEARCH

Research that violates ethical principles typically occurs out of a
researchers 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).

Teacher will
randomly ask
one student to
briefly say
what the term
ethical
dilemma
means to her

O
w
b
w
e
d
m

Teacher will
discuss the
potential for
ethical
dilemmas
stemming from
conflicts
between ethics
and research
demands with
the aid of
PowerPoint
presentation
according to
the content

S
a
a
th
g
te
p
e
d
s
c
b
a
d

Teacher will
ask three
students at the
back of the
class to outline
the similarities
and differences
in the roles of
the nurse as
manager and
as leader
according to
the content

T
a
th
o
d
s
th
n
m
a
a
th

7
mins

Describe the
three primary
ethical
principles
articulated in
the Belmont
report and the
important
dimensions
encompassed
by each as
cited by Polit
and Beck
(2014).

ETHICAL PRINCIPLES FOR PROTECTING PARTICIPANTS

Teacher will
ask three
The Belmont Report articulated three primary ethical principles on which students whose
standards of ethical research conduct are based: beneficence, respect for
surname
human dignity, and justice.
begins with the
letter T to
It is a code of ethics issued in 1978 In the United States, and adopted by
describe to
the National Commission for the Protection of Human Subjects of
describe three
Biomedical and Behavioral Research. It provided a model for many
ethical
guidelines adopted by disciplinary organizations worldwide (Polit &
principles (one
Beck, 2014).
each) as
articulated by
1. Beneficence
the Belmont
A fundamental ethical principle in research is that of beneficence, the
Report
duty to minimize harm and maximize benefits.
Human research should produce benefits for participants themselves or
a situation that is more commonfor other individuals or society as a
Teacher will
whole.
describe the
three primary
The Right to Freedom From Harm and Discomfort - Researchers
ethical
have an obligation to prevent or minimize harm in studies with humans.
principles as
Participants must not be subjected to unnecessary risks of harm or
articulated by
discomfort, and their participation in research must be essential to
the Belmont
achieving societally important aims. In research with humans, harm and
Report with
discomfort can be physical (e.g., injury), emotional (e.g., stress), social
the aid of

T
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le
a
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e
a
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R

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to
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(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.
(Polit & Beck, 2014).
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.
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 nursepatient (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 researchers role as nurse, not as researcher
(Polit & Beck, 2014).
2. Respect for Human Dignity
Respect for human dignity is the second ethical principle articulated in
the Belmont Report. This principle includes the right to selfdetermination 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, 2010).
It also means that people have the right to ask questions, to refuse to give
information, and to withdraw from the study.
A persons 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 & Grove (2010)
The Right to Full Disclosure - Respect for human dignity encompasses
peoples right to make informed, voluntary decisions about study
participation, which requires full disclosure.

PowerPoint
presentation
Teacher will
ask two
students who
surname begin
with the letter
B to describe
any two of the
tree primary
ethical
principles as
articulated by
the Belmont
report
according to
the content

T
w
b
le
d
a
th
e
p
a
th
R
a
th

Full disclosure means that the researcher has fully described the study,
the persons 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 if the issue being studied is sensitive to explain
(Polit & Beck, 2014; Burns & 2010)
3. Justice
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
peoples vulnerabilities. (Polit & Beck, 2014; Burns & Grove, 2010;
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 & Grove, 2010; 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

36
mins

Explicate
procedures for
adhering to
ethical
principles and
protecting

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. Further researchers should not
invade peoples personal space unless they are otherwise directed to do
so (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

Teacher will
ask students to
get themselves
into five
groups, each
group will

S
g
in
g
e
w

study
participants as
cited by Polit
& Beck,
(2014); Burns
& Grove,
(2010); Rebar
et al, (2011)

consent by having participants sign a consent form (Polit & Beck, 2014;
Burns & Grove, 2010; Rebar et al, 2011) DIAGRAM OF AN
INFORMED CONSENT TO BE SHOWN WITH ITS 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 & Grove, 2010; 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
(Polit & Beck, 2014; Burns & Grove, 2010; Rebar et al, 2011)
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 childrens parents or
guardians should be obtained.
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 (Polit & Beck, 2014; Burns & Grove,
2010; Rebar et al, 2011).
Severely ill or physically disabled people - For patients who are very ill
or undergoing certain treatments (e.g., mechanical ventilation), it might

discuss the
treatment of
one vulnerable
group drawn
from a bag
which the
teacher will
present

d
tr
o
g
f
w
te
p

Teacher will
explain the
procedures for
protecting
study
participants
with the aid of
PowerPoint
presentation

S
s
f
P
a
q
n

Teacher will
ask one student
sitting closest
to the front
door to explain
the procedures
for protecting
study
participants
according to
the contents

O
s
to
d
e
p
p
s
p
a
th

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.
Terminally ill - Terminally ill people can seldom expect to benefit
personally from research, and thus the risk/benefit ratio needs to be
carefully assessed.

Evaluate the
ethical
dimensions of
a research
report as
proffered by
Polit and Beck
(2014)

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 (Polit & Beck, 2014;
Burns & Grove, 2010; Rebar et al, 2011).
Members of an Internal Review Board (IRB) or human subjects or ethics
committees 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, here are some 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.
QUESTIONS TO ASK

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

Teacher will
randomly ask
students to
evaluate a
research report
shown by the
teacher

S
a
e
r
s
te

Teacher will
evaluate a
research report
with the aid of
PowerPoint
presentation

S
f
P
p
a
r
e

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 obtainedand, 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. There 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

EVALUATION

1.

Name four historical situations that led to the establishment of a Code of Ethics

2.

Give one example of an ethical dilemma in nursing research

3.

State the three primary ethical principles as articulated by the Belmont Report

4.

Identify four groups that should be protected when research is being conducted

5.

State four pertinent questions that should be asked when evaluating a research report

ANSWERS

1. The Nazi medical experiments of the1930s and 1940s; wartime experiments that raised
ethical concerns were conducted in Japan and Australia; 1932 and 1972, the Tuskegee
Syphilis Study, sponsored by the U.S. Public Health Service; 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.
2. 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 behaviour be normal?
3. Beneficence, respect for human dignity, and justice.
4. Mentally or emotionally disabled people; Severely ill or physically disabled people;
Terminally ill; Institutionalized people; children
5. 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?