The document discusses ethics in nursing research. It defines ethics as moral principles researchers must follow to protect individuals, groups, and communities being studied. Key points include: - Ethics are important to protect vulnerable groups from harm, safeguard against exploitation, and establish risk-benefit ratios for subjects. Researchers must ensure informed consent, privacy, dignity, and fair treatment. - Ethical principles in nursing research are beneficence (maximizing benefits and minimizing risks), respect for human dignity (voluntary and informed consent), and justice (fair selection and treatment of subjects, maintaining confidentiality). - The Indian Nursing Council Code of Ethics outlines nurses' responsibilities to respect individuals, maintain competence, practice legally and professionally, and

1. Ethics In Nursing
Research
MS. PRIYANKA J SOLANKI
ASSISTANT PROFESSOR

2. • 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
understudy.
DEFINITION

3. IMPORTANCE
OF ETHICS IN
NURSING
RESEARCH

4. 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.

5. 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 study.

6. ETHICAL
PRINCIPLE IN
NURSING
RESEARCH

8.  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.
1. PRINCIPLE OF
BENEFICENCE

9.  A potential risk of the research
study must be carefully assessed &
participants are protected from any
harmful effect of research
activity.

10.  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.

11.  Research must be conducted by a
scientifically qualified expert to
avoid undue discomfort or distress to
study participants.

12.  Participants must be provided
with maximum physical, psychological,
social & religious comfort & undue
disturbance & time utilization of the
subjects should be avoided.

13. 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.
2. PRINCIPLE OF RESPECT
OF HUMAN DIGNITY

14.  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.

15.  A fully informed consent must
be taken from the participants. In
case of the fetus, child,
psychological, neurological or
physical inability to give informed
consent; this can be obtained from
parents or legal guardians.

16. This ethical principle directs
the researchers to abide by the
participant’s right of fair treatment
&maintenance of privacy.
3. PRINCIPLE OF
JUSTICE

17.  The fair & nondiscriminatory
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.

18.  The non prejudicial treatment of
individual who decline to participate
or who withdraw from the study after
agreeing to participate.

19.  Anonymity of participants &
confidentiality of information must
be maintained.
 No information collected from
study participants can be used for
other than research purpose.

20.  The vulnerable subjects such as
children, pregnant women, mentally
ill patients, physically disabled,
terminally ill &institutionalized
(prisoners) people, who are
conveniently &easily accessible must
be protected from overuse & undue
use for research purpose.

21. Code Of Ethics
For Nurses In
India

22. • Indian Nursing Council (INC) has
published the code of Ethics for
Nurses in India in year 2006.
• The code of ethics for nurses in
critical for building professionalism
& accountability.

23. • Ethical consideration are vital in any
area dealing with human beings
including nursing research because
they represent values, rights &
relationships.
• The code of Ethics for nurses in
India (2006) areas follows:

24. 1.The nurse respects the uniqueness
of an individual in provision of care
Nurse

25. 2. The nurse respects the rights of
individuals as partners in care &
helps in making informed choices
Nurse.

26. 3. The nurse respects individuals’
rights to privacy, maintains
confidentiality & shares information
judiciously Nurse

27. 4. The nurse maintains
competence in order to render
quality nursing care Nurse

28. 5. The nurse is obliged to practice
within the framework of ethical,
professional & legal boundaries
Nurse.

29. 6. The nurse is obliged to work
harmoniously with members of
the health team Nurse.

30. 7. The nurse commits to
reciprocate the trust invested in
nursing profession by the society
Nurse

31. ICMR ETHICAL
GUIDELINES
FOR
BIOMEDICAL
RESEARCH

32. ICMR
(Indian
Council of
Medical
Research)

33. These guidelines are meant to
safeguard the dignity, rights,
safety, and well being of human
participants involved in biomedical
and health research.

34. ICMR Code
 These statements of General and Specific
Principles may be varied, amended,
substituted and added from time to time.

35. PURPOSE: increase in knowledge
about the human condition in
relation to its social and natural
environment.
CONDUCTED: under the condition
that no person becomes mere means
for others, respect dignity and well
being, transparency, avoiding risks.
EVALUATION: at all stages of the
research. eg – design , conduct and
reporting of results there of.

36. 1. Principle of
Essentiality
• Whereby after due consideration of
all alternatives in the light of existing
knowledge, the use of human
participants is considered to be
essential for the proposed research.
This should be duly vetted by an
ethics committee (EC) independent of
the proposed research.

37. 2. Principle of
Voluntariness
• Whereby respect for the right of
the participant to agree or not to
agree to participate in research, or
to withdraw from research at any
time, is paramount. The informed
consent process ensures that
participants’ rights are safeguarded.

38. Principle of Non-
exploitation
• Whereby research participants are
equitably selected so that the
benefits and burdens of the research
are distributed fairly and without
arbitrariness or discrimination.
Sufficient safeguards to protect
vulnerable groups should be ensured.

39. Principle of social
responsibility
• Whereby the research is planned
and conducted so as to avoid
creation or deepening of social and
historic divisions or in any way
disturb social harmony in community
relationships.

40. Principle of ensuring
privacy and confidentiality
 Whereby to maintain privacy of the
potential participant, her/his identity and
records are kept confidential and access
is limited to only those authorized.
However, under certain circumstances
(suicidal ideation, homicidal tendency,
HIV positive status, when required by
court of law etc.)

41. • privacy of the information can be
breached in consultation with the EC
for valid scientific or legal reasons as
the right to life of an individual
supersedes the right to privacy of the
research participant.

42. Principle of risk
minimization
• whereby due care is taken by all
stakeholders (including but not limited
to researchers, ECs, sponsors,
regulators) at all stages of the research
to ensure that the risks are minimized
and appropriate care and compensation
is given if any harm occurs.

43. Principle of professional
competence
• whereby the research is planned,
conducted, evaluated and monitored
throughout by persons who are
competent and have the appropriate
and relevant qualification, experience
and/or training.

44. Principle of
maximization of benefit
• whereby due care is taken to design
and conduct the research in such a
way as to directly or indirectly
maximize the benefits to the
research participants and/or to the
society.

45. Principle of institutional
arrangements
• Whereby institutions where the
research is being conducted, have
policies for appropriate research
governance and take the responsibility
to facilitate research by providing
required infrastructure, manpower,
funds and training opportunities.

46. Principle of
transparency and
accountability
• Whereby the research plan and
outcomes emanating from the
research are brought into the public
domain through registries, reports
and scientific and other publications
while safeguarding the right to
privacy of the participants.

47.  Stakeholders involved in research
should disclose any existing conflict
of interest and manage it
appropriately. The research should be
conducted in a fair, honest, impartial
and transparent manner to guarantee
accountability. Related records, data
and notes should be retained for the
required period for possible external
scrutiny/ audit.

48. Principle of totality
of responsibility
• Whereby all stakeholders involved in
research are responsible for their
actions. The professional, social and
moral responsibilities compliant with
ethical guidelines and related
regulations are binding on all
stakeholders directly or indirectly.