Ethics in nursingresearch

1. ETHICS IN NURSING
RESEARCH

2. IMPORTANCE OF ETHICS IN
NURSING RESEARCH
• Protect the vulnerable group & other study participants
from harmful effects of the experimental interventions.
• Participants are safeguarded from exploitation
researchers.
• Establish risk – benefit ratio for the study subjects
• Ensure the fullest respect, dignity, privacy, disclose of
information & fair treatment for study subjects.
• Build the capability of subjects to accept or reject
participation in study & to have access to informed or
written consent for participation in research

3. Post World War II Research- Ethics?
• How long does it take for
body parts to freeze when
people are kept naked
outdoors in subfreezing
temperatures?
• What signs and symptoms
are seen when people are
kept in tanks of ice water
for 3 hours?
• These questions were
asked by so-called
researchers in Germany in
the early 1940s
• They were trying to determine
the most effective means of
treating German Air Force
pilots who had been exposed
to cold conditions
• The so-called subjects for
these experiments were
prisoners in the German
concentration camps

4. Post World War II Research- Ethics?
• 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
• Sulfanilamide was then given to
these prisoners to determine the
effectiveness of this drug
• Some subjects died and others
suffered serious injury
• 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)

5. Post World War II Research- Ethics?
• Between June and
September 1944,
photographs and body
measurements were taken
of 112 Jewish prisoners
• Then they were killed, and
their skeletons were
defleshed.
• One purpose of this study
was to determine if
photographs from live
human beings could be
used to predict skeletal
size
• The skeleton collection
was to be displayed at the
Reich University of
Strasbourg (Nuremberg
Military Tribunals, 1949)

6. Examples Of Research Carried Out In
US
• 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.

7. • 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.
• 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

8. Ethics?
• It is common knowledge that smallpox is no
longer a threat to the world.
• Few people remember, or even know, that
Edward Jenner deliberately exposed an 8-
years-old child to cowpox to try out his new
vaccine for smallpox (Hayter, 1979).

9. Health Research In US
• 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)

10. Development Of Ethical Codes And
Guidelines
• The present ethical standards used in nursing
research, and in research conducted by other
disciplines, are based on the guidelines developed
after World War-II
• The 1947 Nuremberg Code resulted from the
revelations of unethical human behavior that
occurred during the war

11. Nuremberg
Code
This code is concerned with several criteria for
research including the following.
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
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

12. The Belmont Report
• In 1978 The National Commission for the protection of
Human Subjects of Biomedical and Behavioral Research was
formed
• The goals of this commission were to:
(a) identify basic ethical principles that should guide the
conduct of research involving human subjects and
(b) develop guidelines based on principles that had been
identified.

13. 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. Respect for Persons – research subjects
should have autonomy and self
determination
2. Beneficence – research subjects should be
protected from harm
3. Justice – research subjects should receive
fair treatment

14. Principle of beneficence
• Establishing the positive risk benefit ratio, where
the risk of the research should never exceed
expected benefits for people from knowledge
generated by the research activity.
• A potential risk of the research study must be
carefully assessed & participants are protected
from any harmful effect of research activity

15. • In addition to physical harm, study subjects are also
protected from expected adverse psychological
consequences caused by research study.
• For example, psychological or emotional distress
caused from self-discloser, introspection, fear of
the unknown, or interacting with a stranger.

16. • Research must be conducted by a scientifically
qualified expert to avoid undue discomfort or
distress to study participants.
• Participants must be provided with maximum
physical, psychological, social & religious comfort &
undue disturbance & time utilization of the
subjects should be avoided

17. Principle of respect of human
dignity
• This principle of the ethics emphasizes on the
freedom of choice, where participants have right to
accept or reject to be a part of the research study.
• Participants have full right to question the
researcher for any additional information or
clarification of doubts.
• Participants have right to quit from the study at any
stage of the research study

18. Principle of justice
• This ethical principle directs the researchers to
abide by the participant’s right of fair treatment &
maintenance of privacy.
• The fair & non discriminatory selection of the
participants such as any risk & benefits will be
equally shared by study participants.
• Participant’s selection should be based on research
requirement & not convenience, gullibility or
compromised position of certain types of people.

19. Research Guidelines For Nurses
• In 1968 the American Nurses Association Research and
Studies Commission published a set of guidelines for
nursing research
• These guidelines were revised in 1975 and 1985 and are
titled Human Rights Guidelines for Nurses in Clinical and
Other Research
• The American Nurses Association published another set of
guidelines in 1995
• This document is titled Ethical Guidelines in the Conduct,
Dissemination, and Implementation of Nursing
Research (Silva, 1995)

20. Elements Of Informed Consent
• 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

21. Major Elements Of Informed Consent
• Researcher is identified and credentials presented
• Subject selection process is described
• Purpose of study is described
• Study procedures are discussed
• Potential risks are described.
• Potential benefits are described
• Compensation, if any, is discussed

22. • Alternative procedures, if any, are disclosed
• Anonymity or confidentiality is assured
• Right to refuse to participate or two withdraw
from study without penalty is assured
• Offer to answer all questions is made
• Means of obtaining study results is presented

23. Documentation Of Informed Consent
• The researcher must document that informed
consent was obtained.

24. 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

25. Guidelines for Critiquing the Ethical
Aspects of a Study
1. Was the study approved by an Institutional Review
Board (IRB)?
2. Was informed consent obtained from the subjects?
3. Is there information about provisions for anonymity or
confidentiality?
4. Were vulnerable subjects used?
5. Does it appear that subjects might have been coerced
into acting as subjects?

26. Guidelines for Critiquing the Ethical
Aspects of a Study
6. Is it evident that the benefits of participation
in the study outweighed the risks involved?
7. Were subjects provided the opportunity to
ask questions about the study and told how
to contact the researcher if other questions
arose?
8. Were the subjects told how they could get
the results of the study?