This document discusses ethical considerations in nursing research. It outlines various codes of ethics that were developed in response to human rights violations in medical experiments, including the Nuremberg Code and Helsinki Declaration. The document also discusses principles for protecting research participants, such as beneficence, respect for human dignity, and justice. It describes guidelines from the Indian Council of Medical Research and ethical review procedures that require research proposals involving human participants to be cleared by an institutional ethics committee.

1. Ethical consideration
in
nursing research
Presented By-
Ms Sudharani Banappagoudar

2. .
Ethics
Ethics are the moral
Principles governing
or influencing
conduct.

3. ETHICS AND RESEARCH
In any discipline that involves human
beings or animals , range of ethical
issues must be addressed
When humans are used as study
participants, care must be exercised in
ensuring that the rights of those
humans are protected.
But the fact is that ethical
considerations have not always been of
adequate attention.

4. Code of Ethics
 In response to human rights
violation various code of ethics
have been developed.
 The Nazi medical experiments of
the 1930s & 1940s are the most
famous example of recent disregard
for ethical conduct.
 One of the first internationally
recognized efforts to establish
ethical standards is Nuremberg
Code

5. CoNTD….
 Based on the preliminary efforts
of the council for international
organizations of medical sciences
in 1964 at Helsinki, the world
Medical Association formulated
general principles & specific
guidelines on use of human
subjects in medical research,
known as the Helinski
Declaration.

6. CONTD…..
 ANA gave a latest revised code
of ethics for nurses in 2001 that
covers primarily ethical issues
for practicing nurses but that
also apply to nurse researchers.
 In 1975, ANA issued a statement,
entitled Human Rights Guidelines
for Nurses in clinical and other
Research.

7. CoNTD….
. In this the Human Rights are discussed in
two main aspects:
1. The Rights to freedom from intrinsic risk
of injury
2. The right to privacy and dignity.
These two rights cover all aspects of freedom
from harm and right to privacy,
confidentiality, anonymity and human
dignity

8. Ethical Dilemmas in conducting research-
Research that violates ethical principles is
rarely done.
Specifically to be cruel or immoral, but more
typically occurs out of a conviction that
knowledge in important & potentially life
saving or beneficial to others in the long
run. There are research problems in which
participants’ right & study demands are put
in direct conflict, posing ethical dilemmas
for researchers.

9. Ethical Principles for protecting study
participants
 Beneficence
 Respect for human dignity
 justice

10. Indian council of medical research
 The Indian Council of Medical research
brought out the 'Policy Statement on Ethical
Considerations involved in Research on
Human Subjects' in 1980 and revised these
guidelines in 2000 as the 'Ethical guidelines
for Biomedical Research on Human
Subjects'.

11. Statement of general principles
1) Principle of essentiality
2) Principle of voluntariness, informed
consent & community agreement
3)principle of non-exploitation
4)principle of privacy & confidentiality
5)principle of precaution and risk
minimization.
6) principle of professional competency.
7) principles of accountability and
transparency.

12. Cont……
8) principle of maximisation of the public
interest & of distributive justice
9) principle of institutional arrangements
10) principles of public domains
11) principles of totality of responsibility
12) principle of compliance

13. Principles of essentiality
After a due consideration of all alternatives in the light of
the existing knowledge in the proposed area of research
and after the proposed research has been duly vetted and
considered by an appropriate and responsible body of
persons who are external to the particular research.
Advancement of knowledge and for the benefit of all
members of the human species and for the ecological and
environmental well being of the planet.


14. Principles of voluntariness, informed consent and community
agreement
Research participants are fully apprised of the research and the
impact and risk of such research . The principles of informed
consent and voluntariness are cardinal principles. Participants are
continually kept informed of any and all developments.

15. Principles of non-exploitation
Research participants are remunerated for their
involvement in the research or experiment;
and, irrespective of the social and economic
condition or status, or literacy or educational
levels.
Such human participants should be selected so
that the burdens and benefits of the research
are distributed without arbitrariness &
discrimination .
Each research shall include an in-built
mechanism for compensation for the human
participants either through insurance cover or
any other appropriate mean.

16. Principles of privacy and confidentiality
Identity and records of the human participants of the
research or experiment are as far as possible kept
confidential; and that no details about identity of said
human participants, which would result in the
disclosure of their identity, are disclosed without
valid scientific and legal reasons.
Human participant does not suffer from any form of
hardship, discrimination or stigmatisation .

17. Principles of precaution and risk minimization
The research participants are put
to the minimum risk, suffer from
no known irreversible adverse
effects, and generally, benefit
from and by the research or
experiment; and that requisite
steps are taken to ensure that
both professional and ethical
reviews of the research.

18. Principles of professional competence
Research is conducted at all times by competent and
qualified persons who act with total integrity and
impartiality and who have been made aware of, and
are mindful of, preferably through training, the
ethical considerations to be borne in mind in respect
of such research or experiment.

19. Principles of accountability and transparency
The research will be conducted in a fair, honest, impartial
and transparent manner after full disclosure is made by
those associated with the research or experiment of
each aspect of their interest in the research, full and
complete records of the research inclusive of data and
notes are retained for such reasonable period as may
be prescribed or considered necessary for the purposes
of post-research monitoring.

20. Principles of the maximization of the public
interest and of distributive
Justice
whereby the research or experiment and its
subsequent applicative use are conducted
and used to benefit all human kind and not
just those who are socially better off but
also the least advantaged; and in particular,
the research participants themselves and or
the community from which they are drawn.

21. Principles of institutional arrangements
All the procedures required to be complied
with and all institutional arrangements
required to be made in respect of the
research and its subsequent use or
application are duly made in a bonafide and
transparent manner.

22. Principles of public domain
Whereby the research and any further
research, experimentation or evaluation in
response to, and emanating from such
research is brought into the public domain
so that its results are generally made known
through scientific and other publications
subject to such rights as are available to the
researcher and those associated with the
research under the law in force at that time.

23. Principles of totality of responsibility
Professional and moral responsibility, for the
due observance of all the principles,
guidelines or
prescriptions laid down generally or in
respect of the research or experiment in
question, devolves on all those directly or
indirectly connected with the research or
experiment.

24. Principles of compliance
There is a general and positive duty on all
persons, conducting, associated or
connected with any research entailing the
use of a human participant to ensure that
both the letter and the spirit of these
guidelines, as well as any other norms,
directions and guidelines which have been
specifically laid down or prescribed and
which are applicable for that area of
research or experimentation, are
scrupulously observed and duly complied .

25. ETHICAL REVIEW PROCEDURES
It is mandatory that all proposals on research
involving human participants should be
cleared by an appropriately constituted
Institutional Ethics Committee(IEC), also
referred to as Institutional Review
Board(IRB)

26. BASIC RESPONSIBILITIES
 Basic resposibility of an IEC is to ensure a
competent review of all ethical aspects of all
the project proposals . IEC should provide
advice to the researchers on all aspect of the
welfare and safety of the research
participants. after ensuring the scientific
soundness of the proposed research through
appropriate scientific review committee.
 In institutions where this is lacking, the
IEC may take up the dual responsibility of
review of both scientific content and ethical
aspects of the proposal.

27. COMPOSITION:-
The IEC should be multidisciplinary and
multisectorial in composition.
Independence & competence are the two
hallmarks of an IEC.
The composition may be as follows
 Chairperson
 Two persons from medical Sc. Area
 One- two clinicians from various inst.
 One legal expert
 One social Scientist
 One Philosopher
 Member secretary

28. Questions for critiquing the ethical aspect of a
study.
 Was the study approved & 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?

29. CONTINUED……
 Did the benefits to participants outweigh
any potential risks or actual discomfort they
experienced? Did the benefit to the society
outweigh the cost 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?

30. CONTINUED……
 Were participants deceived in any way?
Were they fully aware of participating in a
study, & did they understand the purpose &
nature of the research?
 Were appropriate informed consent
procedures used with all participants? If
not, were there valid & justifiable reasons?

31. CONTINUED……
 Were adequate steps taken to safeguard the
privacy of participants? How were data kept
anonymous or confidential? Were privacy
rule procedures followed (if applicable)?
Was a certificate of confidentiality obtained?

32. CONTINUED…
 Were vulnerable groups involved in the
research? If yes, were special precautions
instituted because of the vulnerable status?
 Were groups omitted from the enquiry
without a justifiable rationale( e.g. women,
minorities) ?

33. CONTINUED……
 Were vulnerable groups involved in the
research? If yes, were special precautions
instituted because of the vulnerable status?
 Were groups omitted from the enquiry
without a justifiable rationale( e.g. women,
minorities) ?

34. informed consent
Informed consent means that participants
have adequate information regarding the
research, are capable of comprehending the
information, & have the power of free
choice, enabling them to consent to or
decline, participation voluntarily.

35. Content of informed consent-
 Fully informed consent involves
communicating the following pieces of
information to participants:
 Participant status
 Study goal
 Type of data
 Procedure
 Nature of the commitment
 Sponsorship

36. Contd…
 Participant selection
 Potential risks
 Potential benefits
 Alternatives
 Compensation
 Confidentiality pledge
 Voluntary consent
 Right to withdraw & withhold information
 Contact information

37. Conclusion
Ethical issues are cardinal to carry out any
research with human subjects and we must
remember the principal of Universal Human
Rights Declaration to prevent any violation
at any time.