This document summarizes the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants released by the Indian Council of Medical Research (ICMR) in 2017. The guidelines cover 12 sections that establish general ethical principles, review procedures, informed consent processes, and regulations for research involving vulnerable groups or children. Key points include requirements for ethics committee review and clinical trial registration, guidelines for informed consent depending on the situation, ownership of biological materials and data, and conducting research during emergencies or with vulnerable populations.

1. ETHICAL & REGULATORY ASPECTS
OF HUMAN SUBJECTS

2. LEARNING OBJECTIVES
• Become aware of the National Ethical Guidelines for
Biomedical and Health Research involving Human
participant and children (ICMR) 2017.
• Understand the essential requirements for current ethical
considerations for conducting clinical trial in India
Upon completion of this session, the trainees will:

3. WHAT WILL WE LEARN IN THIS SESSION?
• National ethical guidelines for biomedical and health
research on human participants and children 2017 by ICMR
• Some Related Regulations

4. INDIAN COUNCIL OF MEDICAL RESEARCH (ICMR)
GUIDELINES

5. NATIONAL ETHICAL GUIDELINES FOR BIOMEDICAL AND HEALTH
RESEARCH INVOLVING HUMAN PARTICIPANTS (2017)

6. SECTION 1:
STATEMENT OF GENERAL PRINCIPLES

7. SECTION 1: STATEMENT OF GENERAL PRINCIPLES

8. SECTION 2:
GENERAL ETHICAL ISSUES

9. SECTION 2: GENERAL ETHICAL ISSUES

10. BENEFIT-RISK ASSESSMENT

11. CATEGORISATION BASED ON RISK

12. INFORMED CONSENT PROCESS

13. INFORMED CONSENT PROCESS

14. DISTRIBUTIVE JUSTICE

15. DISTRIBUTIVE JUSTICE

16. PAYMENT AND COMPENSATION

17. PAYMENT AND COMPENSATION

18. PAYMENT AND COMPENSATION

19. CONFLICT OF INTEREST

20. SELECTION OF VULNERABLE AND SPECIAL GROUPS
AS RESEARCH PARTICIPANTS

21. OTHER GENERAL ETHICAL ISSUES

22. SECTION 3:
RESPONSIBLE CONDUCT OF RESEARCH

23. RESPONSIBLE CONDUCT OF RESEARCH

24. WHO REGULATES CLINICAL TRIALS FOR
NEW DRUGS IN INDIA?

25. DATA ACQUISITION, MANAGEMENT, SHARING &
OWNERSHIP

26. REVIEWING AND REPORTING RESEARCH

27. RESPONSIBLE AUTHORSHIP AND PUBLICATION

28. POLICIES FOR HANDLING RESEARCH
MISCONDUCT
Fabrication, falsification and plagiarism

29. REGISTRATION WITH CLINICAL TRIAL REGISTRY
OF INDIA (CTRI)

30. COLLABORATIVE RESEARCH

31. COLLABORATIVE RESEARCH

32. COLLABORATIVE RESEARCH

33. SECTION 4:
ETHICS REVIEW PROCEDURES

34. SECTION 4:
ETHICAL REVIEW PROCEDURES

35. ETHICS COMMITTEE (EC): ELEMENTS

36. COMPOSITION OF AN EC

37. SPECIAL SITUATIONS: ETHICS REVIEW

38. ROLE OF ETHICS COMMITTEE

39. TYPES OF REVIEW

40. DECISION MAKING

41. DIVISION OF RESPONSIBILITY FOR REVIEW

42. CONTINUING REVIEW

43. SITE MONITORING

44. RECORD KEEPING AND ARCHIVING

45. REGISTRATION OF EC

46. ACCREDITATION OF ETHICS COMMITTEE

47. SECTION 5:
INFORMED CONSENT PROCESS

48. INFORMED CONSENT PROCEDURES

49. TYPES OF CONSENT DOCUMENTED

50. AUDIO-VISUAL RECORDING OF CONSENT

51. SECTION 6:
VULNERABILITY

52. VULNERABILITY

53. VULNERABILITY – INCLUSION CRITERIA

54. SECTION 7:
CLINICAL TRIALS OF DRUGS AND OTHER INTERVENTIONS

55. CLINICAL TRIALS

56. CLINICAL TRIALS

57. CLINICAL TRIALS

58. CLINICAL TRIALS

59. SECTION 8:
PUBLIC HEALTH RESEARCH

60. SECTION 8:
PUBLIC HEALTH RESEARCH

61. SECTION 9:
SOCIAL AND BEHAVIOURAL SCIENCES RESEARCH
FOR HEALTH

62. SOCIAL AND BEHAVIOURAL SCIENCES RESEARCH
FOR HEALTH

63. SECTION 10:
HUMAN GENETICS TESTING AND RESEARCH

64. HUMAN GENETICS TESTING AND RESEARCH

65. SECTION 11:
BIOLOGICAL MATERIALS, BIO BANKING AND DATASETS

66. BIOLOGICAL MATERIALS, BIO BANKING & DATA
SETS

67. CONSENT OPTIONS

68. SECTION 12:
RESEARCH DURING HUMANITARIAN EMERGENCIES
AND DISASTERS

69. HUMANITARIAN EMERGENCIES & DISASTERS

70. RESEARCH ON CHILDREN

71. RESEARCH ON CHILDREN

72. ASSENT

73. CHILD’S REFUSAL

74. SAMPLE COLLECTION

75. RECAP
1. Which are the latest ethical guidelines for human research released by ICMR
and when?
National ethical guidelines for biomedical and health research involving human
participants and for children 2017
2. Is it mandatory to register the clinical trials in CTRI
As of now it is mandatory to register the regulatory clinical trials in CTRI.
3. Is it mandatory for ECs to register?
Yes, it is mandatory to seek CDSCO registration for ECs reviewing regulatory
clinical trials & DHR for others

76. RECAP
4. Should only written and signed informed consent form be obtained?
As the situation may require oral, audio or A/V consent may be taken.
5. Can deception be used with regard to informed consent?
Yes, occasionally in social & behavioural science research.
6. Who owns the biological material/data?
Only the donor

77. SUMMARY
In this session, we briefly learnt about:

78. DISCLAIMER
The information within this presentation is based on the presenter’s
expertise and experience and represents the views of the presenter
for the purpose of training.
THANK YOU