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)]
Self-paced courses can be completed by participants at their own pace. This course do not have deadlines for enrollment/assignment submission. Participants can learn in their own time and schedule as per their flexibility and convenience .
Once
you secure the cut off scores in assignments (50% in each assignment), participants will become eligible for collecting e-certificate. Certificate will be delivered to your enrolled email id at the given dates
About the course
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-paced course. The participants can go through the learning materials and submit the self-assessment quiz at any-time after the enrolment into the course.
Participants can learn on
their own pace and schedule
Once
you secure the cut off scores in assignments (50% in each assignment), participant will become eligible for receiving e-certificate.
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 COORDINATOR Dr. S Lokesh MD, FIRD, FIMSA
TEACHING ASSISTANTS R. Ramakrishna Rao, M.com, M.Sc, M.A R. Vijayaprabha, MSW
TECHNICAL ASSISTANT M. Saravanan, M.Sc
Course Layout
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
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
Responsible conduct of research
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
Responsible conduct of reseasrch
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
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
Course Process
Course Enrollment
Enrollment will open throughout the year
No deadline for enrollment
Course materials
Video lectures, handouts, transcripts, reading/resource materials available in the course page
Note: Name as entered during enrollment will appear in the e-certificate
Course Assignments
Once the participant have cleared the minimum score requirement (>=50%), the participant may not be allowed to submit the assignment again
If 50% is not reached in any of the assignment, you will be allowed to take the test again
You will get the assignment scores for each assignments immediately after submission. You shall also check the assignment scores in the progress tab of your course page
No deadline for assignment submission
Course certificate
e-certificate will be awarded to the successful course partiicpants based on the score of >=50% in each assignment.
