2. LEARNING OBJECTIVES
• Become aware of the National Ethical Guidelines for
Biomedical and Health Research involving Human
participant and children (ICMR) 2017.
• Understand the essential requirements for current ethical
considerations for conducting clinical trial in India
Upon completion of this session, the trainees will:
3. WHAT WILL WE LEARN IN THIS SESSION?
• National ethical guidelines for biomedical and health
research on human participants and children 2017 by ICMR
• Some Related Regulations
75. RECAP
1. Which are the latest ethical guidelines for human research released by ICMR
and when?
National ethical guidelines for biomedical and health research involving human
participants and for children 2017
2. Is it mandatory to register the clinical trials in CTRI
As of now it is mandatory to register the regulatory clinical trials in CTRI.
3. Is it mandatory for ECs to register?
Yes, it is mandatory to seek CDSCO registration for ECs reviewing regulatory
clinical trials & DHR for others
76. RECAP
4. Should only written and signed informed consent form be obtained?
As the situation may require oral, audio or A/V consent may be taken.
5. Can deception be used with regard to informed consent?
Yes, occasionally in social & behavioural science research.
6. Who owns the biological material/data?
Only the donor
78. DISCLAIMER
The information within this presentation is based on the presenter’s
expertise and experience and represents the views of the presenter
for the purpose of training.
THANK YOU