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NIeCer 102: Ethics Review of Health Research

An online course for the members of India’s Ethics Committees and
Indian professionals engaged in bio-medical research involving human participants
 

About the course

NIeCer 102: Ethics review of Health Research

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 April and 31 July 2021.






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Enrollment closed. Next enrollment tentatively starts from October 2021.

 
 
 




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)]



Course Faculty

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.

Course Process

Course enrollment

Enrollment start date: 01 April 2021
Enrollment end date: 31 July 2021

Time left:




Course materials

Video lectures, handouts, transcripts, reading/resource materials available in the course page





Evaluation

Complete the quiz by answering all the assignment questions







e-Certificate


On securing >=50% in quiz







Course Content




  • General ethical principles
  • Introduction to health research ethics
  • International guidelines on ethical conduct of health research
  • National ethical guidelines for biomedical and health research involving human participants
  • National ethical guidelines for biomedical research involving children - An overview
  • Benefits and risks in health research - principles, types and categories

  • Responsible conduct of reseasrch
  • Responsibilities of a researcher
  • Rights and duties of researchers, sponsors, participants, and IEC members under the Indian Constitution
  • Collaborative research
  • Academic/investigator initiated clinical trials
  • Regulations and guidelines for conduct of clinical trials in India
  • Good clinical practices and clinical trial registry of India

  • Functioning of ethics committees
  • Establishment of ethics committees
  • Administration of research ethics committees
  • Roles and responsibilities of ethics committee members
  • Monitoring ongoing research by ethics committees
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  • Review of research proposals
  • Conduct of research ethics committee review meeting
  • Conflicts of interest
  • Rationale and science of the research proposal
  • Risk benefit assessment process
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  • Protection of review participants
  • Protection of privacy and confidentiality of research participants
  • Critical importance of informed consent in health research
  • Informed consent process
  • Informed consent in special situations
  • Payments-Incentives, compensation and reimbursement
  • Vulnerable populations in health research
  • Research during humanitarian emergencies and disasters

 



Important links

Contact

ICMR - National Institute of Epidemiology

Phone: 044-26163422

Email: nieethicscourse@gmail.com