An overview of international and Indian ethical codes for conducting research on human subjects

1. Ethical Issues in Research
RC Gupta
Professor Emeritus
National Institute of
Medical Sciences
Jaipur

2. - Moral philosophy
- A set of moral principles
- What is right and what is
wrong in human behaviour
Ethics

3. Intellectual – Related to intellect i.e. ability
to think logically and to understand things
Honesty – Integrity/Probity/Truthfulness
Intellectual Honesty
A Basic Requirement of Research

4. • Being honest is our moral duty
• This duty is particularly important when we
communicate our ideas to others
• Communicating our ideas informs, and can
persuade other people

5. • Intellectual honesty is honesty in acquiring,
analyzing, and communicating data/ideas
• We are being intellectually honest when we,
knowing the truth, state that truth

7. Examples of Honesty in Research
• Pertinent facts and information are not
purposefully omitted when they go against
our hypothesis
• Facts are presented without bias, and are not
twisted to give misleading impressions
• References, or earlier publications, are cited
without bias where necessary

8. Research on human beings

9. • For advancement of medical science,
research on human subjects is unavoidable
• The purpose of using human subjects is:
◦ To understand the causes, development
and effects of diseases
◦ To improve preventive, diagnostic and
therapeutic methods

10. Research must have a strong
ethical foundation, specially
scientific research involving
human beings

11. Ethical principles common across scientific
disciplines
Duty to society
Professional competence and discipline
Confidentiality
Non-exploitation
Non-discrimination
Integrity
Informed consent
Conflict of interest
Beneficence

12. The ethical principles apply to:
The nature of the research project
The conduct & behaviour of researchers

13. • Historical events that raise new concerns
• Ethical lapses that require new safeguards
• Scientific advances that open new areas
of research
• Changing cultural and social norms
Ethics emerge, change, and evolve
due to:

14. • Research involving human participants
should adhere to international ethical
standards
• Indian ethical standards are no less
exacting, and are at par with international
ethical codes

15. • Nuremberg Code (1947)
• Helsinki Declaration (1964)
• Belmont report (1978)
• Council for International Organizations of
Medical Sciences (1993)
Some International Ethical Codes

16. Nuremberg War Crimes Trials

17. Nuremberg Code (1947)
Initiated discussion on:
• Rationale and justification for research
• Risk benefit analysis
• Competence of investigators
• Voluntary consent in research

18. Helsinki Declaration
(1964)
Brought out by World Medical Association
and focused on:
• Individual’s rights to make informed
decisions
• Investigators’ duties
• Research participants’ welfare
• Revised in 1983, 1989, 1996, 2000, 2008
and 2013

20. Belmont Report
• Described the principles of autonomy,
justice and beneficence
• Emphasized informed consent
• Introduced review by ethics committee

21. Council for International
Organizations of Medical
Sciences (CIOMS)
Published International Ethical Guidelines
for Biomedical Research Involving Human
Subjects in 1993 which emphasized:
• Safety of research subjects
• Analysis of benefit-risk balance
• Reporting of adverse drug reactions
• Need for pharmacovigilance

22. • ICMR guidelines (2000, 2006)
• Genome Policy and Genetic Research
(2000)
• Indian GCP (2001)
• Drugs and Cosmetics Act (2002)
• Assisted Reproductive Technology (2005)
• Stem Cell Research and Bio-banking
(2006)
Indian Ethical Codes

23. • Ethical Review
Procedures
• General Ethical Issues
• Clinical Evaluation of
Drugs, Devices etc
• Epidemiological
Studies
• Human Genetics and
Genomics Research
• Research in
Transplantation
• Assisted Reproductive
Technologies

24. Broad ethical principles for researchers
• Respect for autonomy
• Justice
• Beneficence
• Non-maleficence

25. Respect for autonomy
• Autonomy is Latin for self-rule: We have an
obligation to respect the decisions made
by people concerning their own lives
• We must not interfere with the decisions
made by competent adults, and must also
empower them to make independent
decisions

26. • Human research subjects must be given
complete autonomy
• They have a right to decide whether to
take part in research
• They have a right to decide whether to
continue as subjects

27. Justice
• All individuals should have an opportunity
to participate in research unless contra-
indicated
• We must not impose any unfair burden on
subjects
• We must treat all people equally, fairly and
impartially

28. Beneficence
• We must be fair and just in our actions
• We must take positive steps to prevent
harm
• While pursuing beneficence, we must not
come in conflict with autonomy of people

29. Non-maleficence
• We must do no harm
• If harm cannot be avoided, we must try to
minimize it

30. Informed consent
Informing potential participants about the
proposed research in a systematic manner
and empowering them to make an informed
decision to participate in the research study

31. • Understand study procedures
• Understand risks and benefits
• Get all questions and concerns answered
• Make a considered and informed decision
to participate or not to participate
Participants must be able to:

32. Informed Consent Document
• Description of research
• Risks
• Benefits
• Confidentiality
• Reimbursement and compensation
• Contacts
• Voluntary participation and withdrawal

33. Is the research procedure adequately
explained in the IC form?
• The language - simplicity and clarity
• Translations and certification of
translations
• Test of understanding
• Impartial witness
Check list

34. • Researchers and institutions: Information –
discussion & explanation – comprehension –
voluntary decision
• Participants: Must give informed, free and
independent consent without coercion or
force
• Sponsors, monitors & regulators: Assess
fairness of consenting procedure - Verify
consent documentation
Stakeholders in informed consent process

35. • Research participants should be reasonably
reimbursed for costs incurred during the
research e.g. travel costs
• They should be reimbursed reasonably for
their inconvenience and time spent
• Compensation can be monetary or non-
monetary
Reimbursement
Continued …

36. • Non-monetary reimbursement might
include free health services unrelated to
the research, medical insurance,
educational materials or other benefits
• Reimbursement must not be so large as to
induce potential participants to consent to
participate in the research against their
better judgment

37. • Participants who suffer physical, psycho-
logical or social harm as a result of taking
part in research must receive free treat-
ment and rehabilitation
• They should also be compensated for lost
wages
• If death results from participation in
research, the participant’s dependents
should be given compensation
Compensation

38. The research subjects should be given the
option of being informed about the
outcome and results of the study
Information about the outcome

39. • Researchers have an ethical obligation to
make public the results of research
• They should ensure completeness and
accuracy in reporting of research
• Negative or inconclusive results must also
be made publicly available
• Sources of funding, institutional
affiliations and conflicts of interest must
be declared in the publication
Publication of outcome

40. • Institutional ethics committee must be
formally established
• It should be given adequate powers and
support
• It should ensure timely and competent
review following clear and transparent
procedures
Ethics Committee
Continued …

41. • The ethics committee must have multi-
disciplinary membership to ensure a
complete review of proposed research
• Committee members must be duly
qualified
• They should regularly update themselves
about ethical issues related to health
research
Continued …

42. • The institution must put in place adequate
mechanisms to ensure independence of
the ethics committee
• All proposals for health-related research
involving humans must be submitted to
the ethics committee for its clearance
Continued …

43. • The committee will determine whether a
proposal needs ethical review and will
assess its ethical acceptability
• The committee can exempt a proposal
from ethical review (depending upon the
nature of the research and upon
applicable laws or regulations)
Continued …

44. • The researcher must obtain clearance
from ethics committee before beginning
the research
• The ethics committee can conduct further
reviews as necessary, for example, when
there are significant changes in the
protocol
Continued …

45. • The researcher must have a right to appeal
against the decision of ethics committee
• The ethics committee should have a clear
procedure for hearing appeals against the
decisions of ethics committee

46. • The research ethics committee must be
constituted according to a document that
specifies the manner in which members
and the chairperson will be appointed,
reappointed, and replaced
• Research ethics committees must have
members capable of providing competent
and thorough review of research
proposals
Continued …
Composition of ethics committee

47. • Membership must include physicians,
scientists and other professionals such as
social scientists, lawyers and ethicists
• The committee should have some
community members or representatives of
patients’ groups
• Ideally, one or more members should have
experience as study participants

48. Responsibility of institutional ethics
committee or review board
• Real or potential benefit to individuals/
community
• Rights of research participants
• Benefits vis-a-vis risks
• Will the participants and community have
access to benefits of research?
• Mechanism to provide safety, care and
support to research participants

49. Changing Scenario of Research Ethics
• Attention to ethical issues in research is
increasing
• Public expectations are increasing and will
increase further in future
• Policy makers and researchers should be
prepared for further strengthening of
ethical codes