NIeCer 102: Ethics Review of Health Research

GENERAL ETHICAL PRINCIPLES
1. Introduction to health research ethics
2. International guidelines on ethical conduct of health research3. National ethical guidelines for biomedical and health research involving human participants
4. National ethical guidelines for biomedical research involving children - An overview5. Benefits and risks in health research - principles, types and categories
RESPONSIBLE CONDUCT OF RESEARCH6. Responsibilities of a researcher
7. Rights and duties of researchers, sponsors, participants, and IEC members under the Indian Constitution8. Collaborative research9. 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 COMMITTEES12. Establishment of ethics committees13. Administration of research ethics committees14. Roles and responsibilities of ethics committee members
15. Monitoring ongoing research by ethics committees

REVIEW OF RESEARCH PROPOSALS16. Conduct of research ethics committee review meeting17. Conflicts of interest
18. Rationale and science of the research proposal19. Risk benefit assessment process

PROTECTION OF RESEARCH PARTICIPANTS20. Protection of privacy and confidentiality of research participants21. Critical importance of informed consent in health research22. Informed consent process23. Informed consent in special situations
24. Payments-Incentives, compensation and reimbursement25. Vulnerable populations in health research
26. Research during humanitarian emergencies and disasters