Nursing Research Ethics

-Mrs. Nilofar Loladiya
Mrs. Nilofar: UNIT-II Ethics in Research 1

Define Research Problem
 Identify sources of problem area
Formulate research problem statement
Describe the criteria for good statement
Define research objectives
Formulate research objectives
Discuss qualities of research objectives
UNIT-II OBJECTIVES

Define operational definition
Explain conceptual framework / Model
Define Hypothesis
Enlist types of hypothesis
Formulate statement for hypothesis
Enumerate ethical consideration
UNIT-II OBJECTIVES

Questions to answer???????
• What is the risk for the subjects?
• Should the subjects know the purpose for the
research?
• Should the subjects know the nature of study
situation?
• What is the secondary effect of research upon the
subject?
• Must the investigator respect the confidentiality of the
subjects?
• What is the nature of relationship between the subject
and investigator?

DEFINITION
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 &
welfare of individuals, groups or
community under study.

Nursing ethics is defined as the principles of
proper professional conduct concerning the rights
and duties of nurses themselves, their patients, and
their fellow practitioners, as well as their actions in
the care of patients and in relations with their
families
- U S National Library of Medicine (2014)
DEFINITION

IMPORTANCE OF ETHICS
Protect the vulnerable group & study participants from
harmful effects of the interventions.
Safeguard from exploitation of researchers.
Establish risk – benefit ratio
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
access to informed or written consent for participation

HISTORICAL EVENTS AND
DEVELOPMENT OF CODE OF ETHICS

1940s
Famous Research for unethical treatment
of human subjects
• Nazi medical experiments
• Tuskegee Syphilis study
• Willow brook study
• Jewish Chronic Disease Hospital study

NAZI MEDICAL EXPERIMENTS
(1933-1945)

• Medical experiments involved Selection of subjects
was racially based
• Prisoners forced to participate
• No opportunity to refuse the participation
• Subjects sustained permanent physical, mental and
social damage
(1933-1945)

Programs included in Nazi concentration camps
among Jews
• Sterilisation, euthanasia
• exposing to high altitudes,
• freezing temperature,
• malaria, poisons, typhus fever,
• untested drugs
• surgery without anaesthesia
(1933-1945)

͢ How long does it take for body
parts to freeze when people
are kept naked outdoors in
subfreezing temperatures?
They were trying to determine the most effective
means of treating German Air Force pilots who had
been exposed to cold conditions
(1933-1945)
͢ What signs and
symptoms are seen when
people are kept in tanks
of ice water for 3 hours?

(1933-1945)

To investigate the
causes of hepatitis.
Victims were injected
with the disease and
studied throughout
their prolonged
suffering.
1,000 prisoners were
either bitten by malaria-
infected mosquitoes or
had extracts from the
mucous glands
of malaria-infected
mosquitoes injected
directly into
their bloodstream.

• Forced to drink
seawater and
were deprived of
food.
• To make seawater
safe to drink.
• Soldiers away at
sea for long
periods of time
without having to
provide food and
water

Artificially inseminated
about 300 women at
Auschwitz. Semen from
animals - not humans - to
create monsters.
Surgery, pharmaceuticals,
and radiation to discover
an inexpensive method to
sterilize hundreds of
thousands of people.

To investigate the effects of
various poisons upon human
beings,
chemicals were added to
subjects' meals
either the subject would
perish or they would be
killed immediately in order to
perform autopsies.

͢ Prisoners wounds were
deliberately infected with
bacteria
͢ Sulfanilamide was then given
to these prisoners to
determine the effectiveness
of this drug
(1933-1945)

͢ Forcing of wood
shavings and ground
glass into the wounds
͢ Use of mustard gas to
treat the wound
͢ Later studied
management of
chemical burns caused
due to gas exposure.
(1933-1945)

• Between June and
September 1944,
photographs and body
measurements were
taken of 112 Jewish
prisoners
• Then they were killed,
and their skeletons were
defleshed.
• 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)
(1933-1945)

NUREMBERG CODE- 1949
Mistreatment of human subjects in Nazi
experiments led to the development of
Nuremberg Code (1949)

Mistreatment of human subjects in Nazi
experiments led to the development of
Nuremberg Code (1949)

1. 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
7. Voluntary consent of the human subject is
absolutely essential

DECLARATION OF HELSINKI -1964

• Risks, Burdens and Benefits
• Vulnerable Groups and Individuals
• Scientific Requirements and Research Protocols
• Research Ethics Committees
• Privacy and Confidentiality
• Informed Consent
• Use of Placebo
• Post-Trial Provisions
• Research Registration and Publication and
Dissemination of Results

• Greater care can be exercised to protect subjects
from harm
• Strong, independent justification for exposing a
healthy volunteer to substantial risk of harm
(benefits should outweigh the risks)
• Investigators must protect life, health, privacy and
dignity of research subjects

TUSKEGEE SYPHILIS STUDY

Study Title: “Tuskegee Study of Untreated
Syphilis in the Negro Male”
Research subjects were divided into two groups
• One group of 400 men who had untreated syphilis
• Control group of 200 men without syphilis
• After consent subjects were not informed about the
purpose and procedures of research
• Some were unaware that they are the subjects

• They were given free medical exams,
free meals, and burial expenses
• Even after penicillin was accepted as
the treatment of choice for syphilis in
1940, subjects were still given no
treatment.
• Information about treatment was
withheld from the subjects
On May 16, 1997,
President Bill Clinton
made a public apology
on behalf of the nation

WILLOWBROOK STUDY

• Research on hepatitis by Dr. Saul Krugman at Willow brook
, New York, among mentally retarded children
• Early subjects were fed extracts of stool from infected
individuals
• Later subjects received injections of purified virus
• Parents were forced to give permission for the child to be a
subject for getting admissions
WILLOWBROOK STUDY

JEWISH CHRONIC DISEASE
HOSPITAL STUDY (1960)

• Study conducted to determine patients’ rejection responses to
live cancer cells/ to measure patients’ ability to reject foreign
cells
• The patients were told that they were being given skin tests
(Katz, 1972)
• 22 patients were injected with a suspension containing live
cancer cells
• Study conducted without the informed consent
JEWISH CHRONIC DISEASE
HOSPITAL STUDY (1960)

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).

Code of Ethics in NURSING Research
ANA Published guidelines for nursing research
• 1968
“ Human rights guidelines for nurses in clinical
and other research”
• 1995
“ethical guidelines in the conduct,
dissemination and implementation of nursing
research”

ETHICAL PRINCIPLES IN NURSING
RESEARCH
1. Principle of beneficence
2. Principle of respect of human dignity
3. Principle of justice

1. Principle of beneficence(Doing good)
positive risk benefit ratio
carefully assessed & participants are protected from any
harmful effect
protected from expected adverse psychological consequences
conducted by a scientifically qualified expert to avoid undue
discomfort or distress
maximum physical, psychological, social & religious comfort &
undue disturbance & time utilization
ETHICAL PRINCIPLES

RISK BENEFIT RATIO
MAJOR POTENTIAL
BENEFITS
MAJOR POTENTIAL
RISKS
•Access to an intervention that
otherwise be unavailable to them
•Comfort to discuss situation with
a friendly person
•Increased knowledge of
themselves
•Satisfaction in helping others
•Monetary or material gains
•Physical harm
•Boredom ,fatigue, physical
discomfort
•Psychological or emotional
discomfort
•Social risks
•Loss of privacy/ time
•Monetary costs
ETHICAL PRINCIPLES

2. Principle of Respect of human dignity
freedom of choice: accept or reject to be a part
right to question any information or doubts.
Right to quit from the study at any stage
A fully informed consent
ETHICAL PRINCIPLES

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
ETHICAL PRINCIPLES

 Type of data/information to be obtained for respondents.
 Details of the potential discomfort or risk for participants in
the study.
 Details of the support available in case any harm occurs to
participants.
 Mechanism to protect privacy & anonymity of participants.
 Contact detail to collect information & clarification about
doubt.
 Statement about voluntary participation of subjects & right
to termination without any penalty.
 Description of the expected benefits of the research study.
ETHICAL PRINCIPLES
Elements Of Informed Consent

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
ETHICAL PRINCIPLES

These groups include:
• Children
• Geriatric clients
• Prisoners
• People with AIDS
• Homeless
• Unconscious
• Sedated patients
Vulnerable Research Subjects
ETHICAL PRINCIPLES

Assent
• 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
ETHICAL PRINCIPLES

3. Principle of Justice(Being fair)
right of fair treatment & maintenance of privacy.
The fair & nondiscriminatory selection of the participants,
Risk and benefits must be equally shared by all participants.
selection based on requirement & not convenience
convenient& accessible must be protected from overuse & undue use
information collected can’t be used for other purpose.
Anonymity of participants & confidentiality of information
Non prejudicial treatment of individual who decline to participate
ETHICAL PRINCIPLES

Other Ethical Principles:
Principle of Veracity: (Truthfulness) having frank
discussions. Maintain truthfulness and accuracy
in respect to the final outcome of the research.
ETHICAL PRINCIPLES
Principle of Fidelity: (Trust) researcher should
not exploit subjects participation in the
research, which will help in wholehearted
participation and cooperation

Principle of Confidentiality: (Safeguarding Personal
Interest)
maintaining confidentiality and anonymity of the
research participants
Other Ethical Principles:
ETHICAL PRINCIPLES

CODE OF ETHICS FOR NURSES
Indian Nursing Council (INC) : 2006.
The code of ethics for nurses in critical for
building professionalism & accountability.

1. The Nurse respects the uniqueness of an
individual in provision of care
2.The Nurse respects the rights of individuals as
partners in care & helps in making informed choices
3. The Nurse respects individuals’ rights to privacy,
maintains confidentiality & shares information
judiciously

4. The nurse maintains competence in order to
render quality nursing care
5. The nurse is obliged to practice within the
framework of ethical, professional & legal boundaries
6. The nurse is obliged to work harmoniously with
members of the health team
7. The nurse commits to reciprocate the trust
invested in nursing profession by the society

Institutional ethics committee
• Should consist of: Minimum 5-7 members
Expert clinicians , who have been carrying out
clinical researches
Expert on drugs
2 non medical persons
A lawyer or judge
Nurse (recently included)
Should meet once in every 3 months

Ethical committee should review the
proposal for
• Voluntary consent of individual
• Experiments will yield meaningful results
• Animal experiments support the need for
clinical research
• To avoid mental and physical sufferings or
injury
• Researcher is qualified

• https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-
principles-for-medical-research-involving-human-subjects/
• https://www.unmc.edu/elearning/egallery/tag/ethics-clinical-research-trials-
nuremberg-code-belmont-report-tuskegee-study/
• https://webmedia.unmc.edu/eLearning_open/RFA10/EthicalResearchClinicalTrials
/story_html5.html
• https://www.ranker.com/list/nazi-experiments/jacob-shelton
• https://encyclopedia.ushmm.org/content/en/gallery/nazi-medical-experiments-
photographs

Nursing Research Ethics

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