It is mandatory that all proposals on biomedical research involving human participants to be approved by an appropriately constituted Institutional Ethics Committee (IEC) to protect the welfare and the rights of the participants.
At present there are 17 Institutional Ethics Committees functioning of various Institutes/Units of CCRUM which were constituted as per Standard Ethical Guidelines.
The composition of the IEC is as follows:-
- One – two persons from basic medical science area
- One – two clinicians from various Institutes
- One legal expert or retired judge
- One social scientist/ representative of non-governmental voluntary agency
- One philosopher/ ethicist/ theologian
- One lay person from the community
- Member Secretary
The IEC’s are constituted for a period of one year initially and the tenure of the committee may be extended or reconstituted after one year. The Ethics Committees initially review the proposed research protocols prior to initiation of the projects and only after granting approval they are carried out at the respective centers. The approval certificate issued by the IEC is submitted to the CTRI, for registration of the trial. The Ethics Committees also monitor the compliance of the ethics during the period of the approved projects.