Nursing research for B.Sc nursing and M.Sc Nursing

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

2. .
Ethics
Ethics are the moral Principles
governing or influencing
conduct.
Dr Sudharani Banappagoudar

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.
Dr Sudharani Banappagoudar

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
Dr Sudharani Banappagoudar

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.
Dr Sudharani Banappagoudar

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.
Dr Sudharani Banappagoudar

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
Dr Sudharani Banappagoudar

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.
Dr Sudharani Banappagoudar

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

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'.
Dr Sudharani Banappagoudar

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.
Dr Sudharani Banappagoudar

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
Dr Sudharani Banappagoudar

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.

Dr Sudharani Banappagoudar

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.
Dr Sudharani Banappagoudar

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.
Dr Sudharani Banappagoudar

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 .
Dr Sudharani Banappagoudar

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.
Dr Sudharani Banappagoudar

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.
Dr Sudharani Banappagoudar

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.
Dr Sudharani Banappagoudar

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.
Dr Sudharani Banappagoudar

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.
Dr Sudharani Banappagoudar

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.
Dr Sudharani Banappagoudar

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.
Dr Sudharani Banappagoudar

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 .
Dr Sudharani Banappagoudar

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)
Dr Sudharani Banappagoudar

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.
Dr Sudharani Banappagoudar

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
Dr Sudharani Banappagoudar

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?
Dr Sudharani Banappagoudar

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?
Dr Sudharani Banappagoudar

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?
Dr Sudharani Banappagoudar

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?
Dr Sudharani Banappagoudar

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) ?
Dr Sudharani Banappagoudar

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) ?
Dr Sudharani Banappagoudar

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.
Dr Sudharani Banappagoudar

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
Dr Sudharani Banappagoudar

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

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.
Dr Sudharani Banappagoudar

38. Dr Sudharani Banappagoudar