ICMR-National Institute of Epidemiology (NIE) offers NIE-ICMR-WHO online course : Ethics Review of Health Research. This is second in the series of NIE ICMR e-certificate courses (NIeCer 102). The course is technically supported by the World Health Organization (WHO), India. The course will provide the fundamentals of ethical issues in biomedical research involving human participants and provide updates on research ethics guidelines in India.This is a self-paced course. The participants can go through the learning materials and submit the self-assessment quiz anytime between 1 October 2021 and 31 January 2022.INTENDED AUDIENCE :This course is intended for members of India's institutional ethics committees and institutional review boards (including secretarial staff) and professionals engaged in biomedical research involving human participants [any current or potential health researchers (clinical/public health /laboratory researchers, physicians, research associates, allied health professionals, scientists, statisticians, research administrators / managers)]
NIeCer 102: Ethics Review of Health Research
AICTE and National Institute of Epidemiology via Swayam
Overview
Syllabus
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
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
Taught by
Multifaculty
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Ethical Considerations in Human Subjects Research - Lecture 1
