GENERAL ETHICAL PRINCIPLES
1. Introduction to health research ethics
2. International guidelines on ethical conduct of health research
3. National ethical guidelines for biomedical and health research involving human participants
4. National ethical guidelines for biomedical research involving children - An overview
5. Benefits and risks in health research - principles, types and categories
RESPONSIBLE CONDUCT OF RESEARCH
6. Responsibilities of a researcher
7. Rights and duties of researchers, sponsors, participants, and IEC members under the Indian Constitution
8. Collaborative research
9. Academic/investigator initiated clinical trials
10. Regulations and guidelines for conduct of clinical trials in India
11. Good clinical practices and clinical trial registry of India
FUNCTIONING OF ETHICS COMMITTEES
12. Establishment of ethics committees
13. Administration of research ethics committees
14. Roles and responsibilities of ethics committee members
15. Monitoring ongoing research by ethics committees
REVIEW OF RESEARCH PROPOSALS
16. Conduct of research ethics committee review meeting
17. Conflicts of interest
18. Rationale and science of the research proposal
19. Risk benefit assessment process
PROTECTION OF RESEARCH PARTICIPANTS
20. Protection of privacy and confidentiality of research participants
21. Critical importance of informed consent in health research
22. Informed consent process
23. Informed consent in special situations
24. Payments-Incentives, compensation and reimbursement
25. Vulnerable populations in health research
26. Research during humanitarian emergencies and disasters
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