Table 1.
Details required in SOP of IEC
Details required in the SOP of IEC[4] | |
---|---|
1. | Membership requirements of the ethics committee |
2. | The terms of reference, roles, and responsibilities of the committee members |
3. | Conditions of appointment of the IEC members and quorum requirements |
4. | Procedure for resignation, replacement, or removal of members |
5. | The standard operating procedures to be followed by the committee in general |
6. | Standard operating procedures to be followed by the committee for vulnerable populations |
7. | Policy regarding training for new and existing committee members, along with standard operating procedures |
8. | Policy to monitor or prevent the conflict of interest along with standard operating procedures |
For designing the SOP, one may look into the National Ethical Guidelines for Biomedical and Health Research involving Human Participants, ICMR, 2017[5]