Ethics in research, Ethical guidelines, Nuremberg code, Helinski Declaration, WMA, ICMR ethical guidelines.

1. ETHICS IN RESEARCH
Dr. Usha (PT)
Assistant Professor

2. CONTENTS
• Research and its Importance
• Research Ethics
• Need of ethics in research
• Objectives In Research Ethics
• Declaration of ethical principles
• General Guidelines
• General Ethical Principles of ICMR

3. WHY RESEARCH IS DONE?
Research is done-
• For advancement- which is already known should be evaluated continuously
• To further knowledge in a particular area
• To increase understanding
• To invent or develop new strategies, equipments etc.

4. RESEARCH ETHICS
• Ethics are the moral principles that govern a person’s behaviour.
Research ethics may be referred to as doing what is morally and
legally right in research.
• Research ethics is concerned with the responsibility of the
researchers to be honest and respectful to all individuals who
are involved in research study and research should not inflict
harm on researcher as well as research subjects.

5. Need Of Ethical Research
• Research ethics provides guidelines for the responsible conduct
of biomedical research.
• Research ethics also educates and monitors scientists/
researchers conducting research to ensure a high ethical
standard.
• Research ethics involves the application of fundamental ethical
principles to a variety of topics involving scientific research.

6. Objectives In Research Ethics
1. The first and broadest objective is to protect human participants.
2. The second objective is to ensure that research is conducted in a way that
serves interests of individuals, groups and/or society as a whole.
3. Finally, the third objective is to examine specific research activities and
projects for their ethical soundness, looking at issues such as the
management of risk, protection of confidentiality and the process of
informed consent.

7. DECLARATION OF ETHICAL PRINCIPLES
• Nuremberg code -1947
1
• WMA (World Medical Association ) Declaration
of Helsinki -1964, revised regularly (last updated
2013)– a concise summary of research ethics
2
• Belmont Report- 1979, from the National
Commission for the protection of human subjects of
biomedical & behavioral research
3
4 ICMR (Indian Council of Medical Research) code-
2006

8. GENERAL GUIDELINES
• Every proposal for medical research on human subjects must be
reviewed and approved by an independent ethics committee before it
can proceed
• Medical research involving human subjects must be justifiable on
scientific ground
• If the risk is entirely unknown, then the researcher should not proceed
with the project until some reliable data are available

9. • The voluntary consent of the human subject is absolutely essential.
• Research subjects have a right to privacy with regard to their personal
health information.

10. NUREMBERG CODE -1947
• The Nuremberg Code consisted of ten basic ethical principles:
1. Research participants must voluntarily consent to research participation
2. Research aims should contribute to the good of society
3. Research must be based on sound theory and prior animal testing
4. Research must avoid unnecessary physical and mental suffering
5. No research projects can go forward where serious injury and/or death
are potential outcomes

11. 6. The degree of risk taken with research participants cannot exceed
anticipated benefits of results
7. Proper environment and protection for participants is necessary
8. Experiments can be conducted only by scientifically qualified persons
9. Human subjects must be allowed to discontinue their participation at any
time
10. Scientists must be prepared to terminate the experiment if there is cause
to believe that continuation will be harmful or result in injury or death

12. Helsinki Declaration
• Lays out basic ethical principles for conducting biomedical
research and specifies guidelines for research conducted either
by a physician, in conjunction with medical care, or within a
clinical setting

13. Unique Principles Developed Within The Helsinki
Declaration
• The necessity of using an independent investigator to review
potential research projects
• Employing a medically qualified person to supervise the research
and assume responsibility for the health and welfare of human
subjects
• The importance of preserving the accuracy of research results
• Suggestions on how to obtain informed consent from research
participants

14. • Rules concerning research with children and mentally
incompetent persons
• Evaluating and using experimental treatments on patients
• The importance of determining which medical situations and
conditions are appropriate and safe for research

15. Belmont Report
• Beneficence- Risk to human subject be justified by the value
or requirement of knowledge the study is expected to
generate
• Respect for the person/ Participant- Person should be
treated autonomous, obtain informed consent from the
research subject
• Justice- Equal distribution of research benefits and burdens

16. ICMR (INDIAN COUNCIL OF MEDICAL
RESEARCH) CODE- 2006
• Ethical guidelines given for biomedical research on human
participants by ICMR, New Delhi

17. General Principles of ICMR: Common
to all areas of biomedical research
1. Essentiality
2. Voluntariness, informed consent and community agreement
3. Non-exploitation
4. Privacy and confidentiality
5. Precaution and risk minimisation
6. Professional competence

18. General Principles of ICMR: Common
to all areas of biomedical research
7. Accountability and transparency
8. Maximization of the public interest and of distributive justice
9. Institutional arrangements
10.Public domain
11.Totality of responsibility
12.Compliance

19. Statement of General Principles
1. Principles of essentiality
• The research entailing the use of human participants is
considered to be absolutely essential after a due consideration of
all alternatives in the light of the existing knowledge in the
proposed area of research.

20. 1. Principles of essentiality continue…
• 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 and who, after careful
consideration, come to the conclusion that the said research is
necessary for the 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.

21. 2. Principles of voluntariness, informed consent and
community agreement
• Research participants are fully explained about the research,
impact and risk of such research on the research participant
and others; and
• The research participants have the right to abstain from further
participation in the research

22. • Where the human participant is incapable of giving consent and it
is considered essential that research or experimentation be
conducted on such a person incompetent to give consent, the
principle of voluntariness and informed consent shall continue to
apply and such consent and voluntariness shall be obtained and
exercised on behalf of such research participants by someone
who is empowered and under a duty to act on their behalf.

23. 3. 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
attained by the research participants kept fully apprised of all the
dangers arising in and out of the research so that
-they can appreciate all the physical and psychological risks as
well as moral implications of the research whether to
themselves or others, including those yet to be born

24. • Such human participants should be selected so that the burdens and
benefits of the research are distributed without arbitrariness, discrimination
or caprice.
• Each research shall include an in-built mechanism for compensation for the
human participants either through insurance cover or any other appropriate
means to cover all foreseeable and unforeseeable risks, including treatment
during and after the research or experiment, in respect of any effect that the
conduct of research or experimentation may have on the human participant
and to ensure that immediate recompense and rehabilitative measures are
taken in respect of all affected, if and when necessary.

25. 4. Principles of privacy and confidentiality
• The 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 which may be essential for the purposes of therapeutics or
other interventions, without the specific consent in writing of the human
participant concerned, or someone authorised on their behalf; and after
ensuring that the said human participant does not suffer from any form of
hardship, discrimination or stigmatisation as a consequence of having
participated in the research or experiment.

26. 5. Principles of precaution and risk minimisation
• Due care and caution is taken at all stages of the research and experiment to
ensure that the research participant and those affected by it including
community 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 are undertaken at appropriate stages so that further
and specific guidelines are laid down, and necessary directions given, in
respect of the conduct of the research or experiment.

27. 6. Principles of professional competence
• The 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.

28. 7. Principles of accountability and transparency
• The research or experiment 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, and any conflict of interest that
may exist; and

29. • Whereby, subject to the principles of privacy and confidentiality and the
rights of the researcher, 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, evaluation of the research, conducting further research
(whether by the initial researcher or otherwise) and in order to make such
records available for scrutiny by the appropriate legal and administrative
authority, if necessary.

30. 8. Principles of the maximization of the public
interest and of distributive justice
• 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.

31. 9. Principles of institutional arrangements
• There shall be a duty on all persons connected with the research
to ensure that 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; and to take all
appropriate steps to ensure that research reports, materials and
data connected with the research are duly preserved and
archived.

32. 10.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.

33. 11.Principles of totality of responsibility
• The 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 including the
researchers, those responsible for funding or contributing to the funding of
the research, the institution/s where the research is conducted and the
various persons, groups or undertakings who sponsor, use or derive benefit
from the research, market the product (if any) or prescribe its use so that,
inter alia, the effect of the research or experiment is duly monitored and
constantly subject to review and remedial action at all stages of the research
and experiment and its future use.

34. 12.Principles of compliance
• whereby, 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 with.

35. MORAL PRINCIPLES OF RESEARCH ETHICS
• Non-maleficence : no harm to the researcher as well as research
participants
• Beneficence : benefit to mankind
• Autonomy: rights and dignity of individuals to be considered
• Justice : benefits and risk should be fairly distributed among
people

36. How do individuals decide what is ethical?
• “Individuals are ultimately responsible for making their own
ethical decisions and for implementing them.”

37. How do individuals decide what is ethical?
Non-rational approaches:
• Obedience
• Imitation
• Feeling or Desire
• Intuition
• Habit
Rational approaches:
• Deontology
• Consequentialism- utilitarianism,
• Principlism

38. Mechanism to ensure ethical compliance
Institutional Review/ Ethics Committee (IEC)
• Committee that reviews research to ensure that the
researcher is conducting research ethically
• Comprises of at least 5 members from different fields

39. • Institutional Ethics Committee (IEC) composition
1. Chairperson-(outside the Institution)
2. One - two persons from basic medical science area
3. One - two clinicians from various Institutes
4. One legal expert or retired judge
5. One social scientist/ representative of NGO
6. One philosopher/ ethicist/ theologian
7. One lay person from the community
8. Member Secretary- from the same Institution

40. Responsibilities of an IEC
1. To protect the dignity, rights and well being of the potential
research participants.
2. To ensure that universal ethical values and international
scientific standards are expressed in terms of local community
values and customs.
3. To assist in the development and the education of a research
community responsive to local health care requirements.

41. Function of IEC
• IEC should review every research proposal on human
participants before the research is initiated
• Should ensure that a scientific evaluation has been completed
before ethical review is taken up

42. Review Procedure
• Exemption from review: Research on educational practices
carry no risk
• Expedited Review: minimal risk
• Full review: higher perceived risk

43. INFORMED CONSENT
• Research should be based, as far as possible and practicable, on the freely
given informed consent of those under study and is the principal means by
which participant autonomy is recognised and given meaning.
• It is the responsibility of the researcher to explain as fully as is reasonable
and appropriate, and in terms meaningful to the participants: the aims and
nature of the research, who is undertaking it, who is funding it, its likely
duration, why it is being undertaken, the possible consequences of the
research, and how the results are to be disseminated.

44. • Research participants should be aware of their right to refuse participation
at any time, including withdrawal from a research project at any stage, and
should not be given the impression that they are required to participate.
• The researcher should explain how far research participants will be afforded
anonymity and confidentiality and participants should have the option of
rejecting the use of data-gathering devices such as video cameras and audio
and digital recording devices. Participants should also be made aware
during the consent process whether the data set will be made publicly
available.

45. References
• World Medical Association Medical Ethics Manual Medical Ethics Manual, France, 3rd edi., 2015, ISBN 978-92-
990079-0-7
• WMA declaration of Helsinki – ethical principles for medical research involving human subjects,
(https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-
involving-human-subjects/ accessed on 25.04.2020)
• A guide to research ethics, University of Minnesota Center for Bioethics 2003
• Ethical guidelines for biomedical research on human participants, Indian Council of Medical Research, New Delhi,
2006

46. Thank You