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NIeCer 102: Ethics Review of Health Research

By Multifaculty   |   ICMR-National Institute of Epidemiology
Learners enrolled: 25477
ICMR-National Institute of Epidemiology (NIE) offers NIE-ICMR-WHO online course  NIeCer 102: Ethics Review of Health Research. 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-aced course. The participants can go through the learning materials and submit the self-assessment quiz at any-time after the enrolment into the course.

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)]
Summary
Course Status : Upcoming
Course Type : Elective
Language for course content : English
Duration : Self Paced
Category :
  • Multidisciplinary
Level : Certificate

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Course layout

Course process

   
Note: Name as entered during enrollment will appear in the e-certificate



Certificate Issuing Dates


COURSE CONTENT 

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 

Books and references

Reading/Resource materials will be available for each topic.

Instructor bio

This course has been developed and delivered by eminent professionals and researchers from cross-cutting domains who are involved in various organizations and committees in India related to biomedical ethics.



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COURSE COORDINATOR  
Prof (Dr) S Lokesh M.D (Gen Med), FIRD, FIMSA

TEACHING ASSISTANTS 
R. Ramakrishna Rao, M.com, M.Sc, M.A

R. Vijayaprabha, MSW

TECHNICAL ASSISTANT 
M. Saravanan, M.Sc

Course certificate

e-certificate will be awarded to the successful course participants based on the score of 50% in each assignment. 


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