ETHICS IN NURSING

RESEARCH

Diana Parsons McIntyre

In-service Education Officer
2024
 Objectives

• Define the term Ethics in Nursing

Research
• Explain the Development of Ethical Codes
and Guidelines for Research
• Discuss the Ethical Principles of Nursing
Research
 Objectives

• Examine Research Scenarios

• Discuss the main purposes of Research
Ethics
• Highlight the Role of the Nurse
Researcher as a Patient Advocate
Ethics in Nursing Research
• Ethics in Nursing Research can be
defined as the act of moral principles
which the researcher has to follow
while conducting nursing research to
ensure the rights and welfare of
individuals, groups or community
understudy (Fouka & Mantzorou, 2018).
Perspectives for Assessing Ethical
Acceptability
• Utilitarian Perspective - the good of a
project is defined by the
consequences of the results
• the greatest good for the greatest
number
• the end justifies the means
• each researcher may have a different
idea about what is “good”
Perspectives for Assessing Ethical
Acceptability
• Deontological Perspective
• Proposes absolute moral imperatives
(Kant) (e.g. deception in experiments is
never justified no matter what the
positive contributions of knowledge).
Perspectives for Assessing Ethical
Acceptability

• Some deontologists are more flexible,

making a distinction between harm and
wrong

• Harm can be compensated for but

wrongs cannot.
Kant’s Deontology Ethics
• If you hide an escaped Jew “Mr. A” in your house in
Nazi, Germany, and the police came to your house
and asked a straightforward question, “Is Mr. A in
your house?” Your duty is to answer truthfully.
• Your duty is to obey the moral law, not to try to
predict consequences.

• To act with a Good Will, duty for duty’s sake, is

intrinsically holy, a jewel shining in the unseen
fabric of reality. To lie would be unholy, would
darken the unseen fabric of reality.
Health Research carried out in USA
• One of the most widely known unethical
studies was started in Macon County,
Alabama, in 1932 by the U.S. Public Health
Service.
• The study was titled “Tuskegee Study of
Untreated Syphilis in the Negro Male” Of the
600 black male subjects, 399 had syphilis.

• The subjects with active disease were given

no treatment.
Health Research carried out in USA
• They were given free medical exams,
free meals, and burial expenses (Centers
for Disease Control and Prevention,
2006).

• Even after Penicillin was accepted as the

treatment of choice for Syphilis in 1945,
subjects were still given no treatment.
Health Research carried out in USA

• This unethical study became common

knowledge 40 years after it was begun on
May 16, 1997, President Bill Clinton
made a public apology on behalf of the
nation.
Health Research carried out in USA

• During 1942 and 1943, prisoners’

wounds were deliberately infected with
bacteria.

• Infection was aggravated by the forcing

of wood shavings and ground glass into
the wounds.
Health Research carried out in USA

• Sulphanilamide was then given to these

prisoners to determine the effectiveness
of this drug.

• Some subjects died and others suffered

serious injury.
Health Research carried out in USA

• Many nurses participated in these

unethical experiments; others found ways
to avoid participation, such as becoming
pregnant or asking for transfers to other
assignments (Bonifazi, 2004).
Health Research carried out in USA
• In July 1963 doctors at the Jewish
Chronic Disease Hospital in Brooklyn,
New York, injected live, cancer cells into
22 elderly patients.

• The study was designed to measure

patients’ ability to reject foreign cells.
The patients were told that they were
being given skin tests (Katz, 1972).
• Hungary’s President Pal Schmitt resigned in early
April over charges of plagiarism, the Chicago Sun-
Times reported.

• Concerning the resignation, the Sun-

Times quoted Schmitt as saying during Parliament,

• “In this situation, when my personal issue divides my

beloved nation instead of uniting it, I feel it to be my
personal duty to finish my service and resign from my
presidential mandate.”
• We wrote in January when Hungarian
magazine HVG.hu accused Schmitt of
plagiarizing “more than 80 per cent of his
doctoral thesis.”

• In late March, Semmelweis University’s

investigating committee “cleared” Schmitt
of plagiarism charges even though it
found he “copied from other sources” and
made a “long list of errors.”
Codes for Ethical Decision Making
• Nuremberg Code
• American Nurses Association Code of
Ethics
• Code of Professional Conduct for the
Nurse, Midwife and Health Visitor
(UKCC)
• International Council of Nursing Code
of Ethics
 Nuremberg Code
• The 1947 Nuremberg Code resulted from the
revelations of unethical human behaviour that
occurred during the war (Nazi experiments).
• This code is concerned with several criteria for
research including the following:

(Polit & Hungler, 1999).

 Nuremberg Code
1. Researcher must inform subjects
about the study
2. Research must be for the good of
society
3. Research must be based on animal
experiments, if possible

(Polit & Hungler, 1999).

Nuremberg Code
4. Researcher must try to avoid injury to
research subjects
5. Researcher must be qualified to
conduct research
6. Subjects or the researcher can stop
the study if problems occur

(Polit & Hungler, 1999).

The Belmont Report

• In 1978 The National Commission for the

Protection of Human Subjects of
Biomedical and Behavioural Research
was formed.

(Polit & Hungler, 1999).

The Belmont Report
• The goals of this commission were to:
❑identify basic ethical principles that
should guide the conduct of research
involving human subjects and

❑develop guidelines based on principles

that had been identified.
(Polit & Hungler, 1999).
 The Belmont Report
• The report published by this commission in
1979 was titled “The Belmont Report”
• Three basic principles related to research
subjects were identified:
1. Beneficence – research subjects should be
protected from harm
2. Respect for Persons – research subjects
should have autonomy and self determination
3. Justice – research subjects should receive
fair treatment
(Polit & Hungler, 1999).
 ETHICAL PRINCIPLES IN
NURSING RESEARCH
Principle of Beneficence
• Freedom from Harm
• Freedom from Exploitation
• Benefits from Research
• The Risk / Benefit Ratio

(Polit & Hungler, 1999).

ETHICAL PRINCIPLES IN
NURSING RESEARCH
Principle of Respect of Human Dignity
• Right to self determination
• Right to full disclosure

(Polit & Hungler, 1999).

Respect for Persons
• Forms the foundation of participant’s right to
informed consent, privacy, & confidentiality
• involves respecting autonomy or right to
choose freely
• right to be free from pressure or coercion
• confidentiality & anonymity must be protected
• must have information to make informed
choices (risks vs benefits)
ETHICAL PRINCIPLES IN
NURSING RESEARCH
Principle of Justice
• Right to Fair Treatment
• Right to Privacy
❖Anonymity
❖Confidentiality

(Polit & Hungler, 1999).

Duty to care vs
Duty to advance knowledge
• Research Imperative vs Therapeutic
Imperative.

• When in doubt the therapeutic

imperative must take precedence
over the research imperative
Justice
• People ought to be treated fairly

• Protection of participants from

incompetence and access to research
treatments are expectations of the justice
principle

• Random selection of participants avoids

potential bias and unfairness in sample
selection
Methods of Protecting Human
Subjects
• Informed Consent

• Institutional Review Boards

ETHICAL PRINCIPLES IN NURSING
RESEARCH
• The principal means for ensuring that the
rights of research subjects are protected is
through informed consent.

• Informed consent concern subjects’

participation in research in which they have
full understanding of the study before the
study begins.

Nieswiadomy, 2008
Major Elements of Informed Consent
1. Researcher is identified and credentials
presented
2. Subject selection process is described
3. Purpose of study is described
4. Study procedures are discussed
5. Potential risks are described.
6. Potential benefits are described
7. Compensation, if any, is discussed

Nieswiadomy, 2008
Major Elements of Informed Consent
8. Alternative procedures, if any, are disclosed
9. Anonymity or confidentiality is assured
10. Right to refuse to participate or to withdraw
from study without penalty is assured
11. Offer to answer all questions is made
12. Means of obtaining study results is
presented

Nieswiadomy, 2008
Process Consent

• In qualitative investigations the

researcher negotiates the consent and
then renegotiates the consent as
unforeseen circumstances arise.

• The participant is part of the decision

making as the study unfolds.
Rules to Protect Participants
• Protect confidentiality
• Do not place pressure on participants
• Make participation free from harm and
discomfort
• Identify sponsors
• Disclose the basis on which participants have
been selected
• Avoid hidden ID codes on questionnaires
• Honor promise to provide report
• Base participation on informed consent
• Debrief participants
Rules for Socially Responsible Nursing
Research
• Distinguish between science and advocacy
• Do not search data in support of your views
• Be aware of potential sources of bias
• Represent the literature fairly
• Always seek to do the best research
possible
• Acknowledge your sources
• Seek advise on ethical issues
 Documentation of Informed Consent
• The researcher must document that informed
consent was obtained. If self-report
questionnaires are used, a statement should be
included on the questionnaires in capital letters,
similar to the following: RETURN OF THIS
QUESTIONNAIRE WILL INDICATE YOUR
CONSENT TO PARTICIPATE IN THIS STUDY.

Nieswiadomy, 2008
 Documentation of Informed Consent
• In other types of studies, consent is
obtained in written form, stating that the
subject has willingly given permission and
is aware of the risks and benefits.

• Language must be understandable.

Nieswiadomy, 2008
Student Activity

Identify Ethical Issues in

the following Scenarios
Scenario 1
• Two graduate students have made some
measurements on a new material. The data
points are as shown. To prove their
hypothesis the results should lie on the
curve shown. The two students considered
omitting the two data points which were off
the theoretical curve.
• Unethical as it would amount to falsification
of data

• Should include outliers and give probable

reasons or find out statistically acceptable
ways of trimming outliers
Scenario 2
A group of medical students conducted a
research on the awareness of diabetic
diet in medical clinic participants. Their
research was recognized as the best
undergraduate research and later they
submitted the same research paper to
two different journals to see which
journal publishes it first.
• Unethical as it would result in "inadvertent
double-counting or inappropriate weighting of
the results of a single study, which distorts the
available evidence.
o it would give a false idea of the number of
publications in a given area
o wasting of resources on the review and
publication process
• Should submit to one journal and wait for
response prior to submitting to another
Scenario 3
Students are required to prepare a research
proposal during their undergraduate
programme. Nimal developed the idea for
his project and discussed with a friend.

Several months later, he found that his idea

had been submitted as a research proposal
by his friend without his knowledge.
• Unethical as failure to give credit to the
person whose idea it is (intellectual
property) amounts to plagiarism

• Should discuss and include as co-author

Scenario 4

Four friends decide to work together on a

research project during the vacation. One of
them went abroad during the vacation and
did not contribute to the research.

The friends included all 4 names in a

presentation made at a scientific congress.
• Unethical as only those who contributed
intellectually should be cited as authors

• Those who contribute in other ways may be

acknowledged
Scenario 5

A group of undergraduate students planned

a research project on the detection of fetal
abnormalities in the second trimester, by
ultrasound scanning. They collected data
from the scan room without informing the
mothers
• Unethical as informed consent was not
taken

• Should have informed mothers of their

intent even though there is no
particular advantage/disadvantage to
the mother in doing so
Scenario 6

A group of undergraduate students collected

data from a group of bank officers, with their
consent, regarding their working hours and
salary with regards to the prevalence of high
blood pressure. Subsequently the
researchers gave the same data to another
group who were in need of same data
variables.
• Unethical as violating principles of informed
consent and confidentiality
• Data can be used for a secondary purpose
which was not first considered as long as
- informed consent for sharing has been
given
- identities anonymised
- due consideration to access restrictions
• Develop ethical guidelines for data sharing
 Breach of ethics in
research would amount to
Scientific Misconduct
 Scientific Misconduct
• Fraud : invention/fabrication of data

• Plagiarism : copying data, ideas, text without

acknowledgement of source
• Piracy : infringement of a copyright

• Submitting/Publishing the same paper to

different journals

Nieswiadomy, 2008
Scientific Misconduct …
• Not informing a collaborator of intent to file a
patent in order to make sure the researcher
is the sole inventor.

• Including a colleague as an author on a

paper in return for a favor even though the
colleague did not make a serious
contribution to the paper

Nieswiadomy, 2008
Scientific Misconduct …
• Trimming outliers from a data set without
discussing the reasons in paper

• Using an inappropriate statistical technique

in order to enhance the significance of the
research

Nieswiadomy, 2008
Scientific Misconduct …
• Bypassing the peer review process and
announcing the results through a press
conference without giving peers adequate
information to review the work.

• Conducting a review of the literature that

fails to acknowledge contributions of others

Nieswiadomy, 2008
Scientific Misconduct …
• Stretching the truth on a grant
application in order to convince
reviewers that the project will make a
significant contribution to the field.
• Giving the same research project to two
graduate students in order to see who
can do it the fastest
Nieswiadomy, 2008
Scientific Misconduct …
• Overworking, neglecting, or exploiting
research students

• Making derogatory comments and personal

attacks in the review of author's submission

• Making significant deviations from the

research protocol approved by the Review
Board without informing the committee
Nieswiadomy, 2008
Scientific Misconduct …
• Not reporting an adverse event in a human
research experiment
• Wasting animals in research

• Exposing students and staff to biological

risks
• Rejecting a manuscript for publication
without even reading it
Nieswiadomy, 2008
Scientific Misconduct …
• Sabotaging someone's work

• Rigging an experiment to know how it will turn

out

• Deliberately overestimating the clinical

significance of a new drug in order to obtain
economic benefits

Nieswiadomy, 2008
 Deception
• Passive deception ( or omission) is the
withholding or omitting of information; the
researcher intentionally does not tell
participants some information about the
study.
 Deception

• Active deception ( or commission) is the

presenting of misinformation about the
study to participants. The most common
form of active deception is misleading
participants about the specific purpose of
the study.
Justified Deception
• The deception must be justified in
terms of some significant benefit that
outweighs the risk to the participants.
The researcher must consider all
alternatives to deception and must
justify the rejection of any alternative
procedures.
Debriefing
The final point is that deceived
participants must receive a debriefing
that provides a full description of the
true purpose of the study, including the
use and purpose of deception, after the
study is completed.
Purpose of Research Ethics
• To protect participants /patients / society
/resources

• Researcher?
• To ensure accuracy of scientific knowledge
• To protect intellectual and property rights
To protect participants /patients /society/
resources
• Protect from harm
• Show respect - privacy /confidentiality
- Informed consent
• Refrain from Coercion and undue inducement
When do incentives amount to coercion
/undue inducement?

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2600442
• Refrain from exploitation of vulnerable
participants. Who are the vulnerable groups?

• Refrain from indiscriminate use of resources

• Ensure Favorable Risk-Benefit Ratio: risk

should be minimized & potential benefit to
society must outweigh risks

http://www.ncbi.nlm.nih.gov/pmc/article
s/PMC2600442
To Ensure Accuracy Of Scientific Knowledge

• Should be methodically rigorous -

Scientific validity

• Fair subject selection: with inclusion /

exclusion criteria and a valid number of
subjects in order to project results to the
population

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2600442
To Ensure Accuracy Of Scientific Knowledge

• State research method clearly so that

another person can conduct advanced
study in future by using publication.

• Is it ethical to copy the methodology from

a published paper?

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2600442
To Ensure Accuracy Of Scientific Knowledge

• Do not gloss research method

• Should not falsify/modify/omit data
• Use actual data for analysis/cannot
include someone else's data
• Report errors
• Be aware of conflict of interest

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2600442
To Ensure Accuracy Of Scientific Knowledge
• Should not withhold and/or ‘vague up’
information
• Keep data and material for 5 years
• Data and material should be available to
others.
• Do not present/publish paper from
incomplete research or from anticipated
outcomes
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2600442
To Ensure Accuracy Of Scientific Knowledge

• Should not duplicate publications and

submissions
• Avoid piecemeal publication
• Should be reviewed independently by
unaffiliated individuals

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2600442
To protect intellectual and property rights
Citation and authorship - Inclusion
o Writing and significant scientific contribution
o Order of contribution
o Actual researchers
o Approval must be sought to include a name

• Whenever somebody else’s work is quoted

reference should be made to the original
author (Piracy versus plagiarism)
• Acknowledgement should include the names
of person who helped
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2600442
The Nurse Researcher as a Patient
Advocate
• The nurse researcher has the responsibility to
protect the privacy and the dignity of the people
involved in the research

• The researcher has an obligation to refrain

from conducting such research study involving
undue physical risks, psychological risks, or
both
• The nurse researcher must assume
responsibility for study conditions Nieswiadomy, 2008
 The Nurse Researcher As A
Patient Advocate
Clinical trials are research studies conducted
to evaluate new treatments, new drugs, and
new or improved medical equipment.
• Nurses should be able to answer patients’
questions about research studies, particularly
clinical trials (Habel, 2005 as cited in
Nieswiadomy, 2008)

Nieswiadomy, 2008
 The Nurse Researcher As A Patient
Advocate
Vulnerable Research Subjects
• Certain special groups of people are
considered particularly vulnerable research
subjects because they are either unable to give
informed consent or because the likelihood of
coercion to participate is strong.
• Special precautions must be taken to ensure
that the study has a low risk potential for these
vulnerable people. Nieswiadomy, 2008
Vulnerable Research Subjects

These groups include:

• Children
• Geriatric clients
• Prisoners
• People with AIDS
• Homeless
• Unconscious
• Sedated patients
Nieswiadomy, 2008
 The Nurse Researcher As A Patient
Advocate
• When children are younger than 7 years, parental
consent is sufficient. If a child is older than 7 years,
not only must the parent consent to the child’s
participation but the child must also agree to be in
the study by giving assent to participate in a study.

• Assent means that an underage child or adolescent

freely chooses to participate in a study.

Nieswiadomy, 2008
The Institutional Review Board
Each institution or agency is required to
establish a committee called an Institutional
Review Board ( IRB), which is composed of
both scientists and nonscientists.
Ethical review committee
(Institutional Review Boards)
Convened to:
• maintain ethical standards of practice in
research
• ensure protection of subjects/research
workers from harm or exploitation
• to provide reassurance to the public
• protect researchers from unjustified criticism
Procedure for Ethical Clearance
• Fill ethical clearance form and attach
proposal, questionnaires, informed consent
forms, information leaflets etc., and submit

• When ethical clearance is granted, data

collection can commence according to the
approved methodology.
 Scenario 7
• A group of undergraduate students planned a
research on family planning practices of Sri
Lankan females. As they were close to the
deadline for presenting their results, they
started collecting information from participants
before formal approval by the ethics review
committee
• What should members of ethics review
committees consider in evaluating a
proposal for ethical clearance?
• Elements of a review
 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.
 Conclusion
• 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.
References
Fouka G., & Mantzorou, M (2018) Health Science Journal
What are the major ethical issues in conducting research?
is there a conflict between the research ethics and the
nature of nursing?
http://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

Nieswiadomy, R. M. (2008) Foundations of Nursing

Research, Prentice Hall New Delhi.

Polit, D.F., & Hungler, B.P. (2006).Sampling designs. In Nursing

Research: Methods Appraisal, and Utilization (7th ed.), 171-194.
Philadelphia: Lippincott, Williams &Wilkins