Profiles of institutional ethics committees and status of standard operating procedures in North East India.

Abstract

Limited data are available regarding institutional ethics committees (IECs) and their standard operating procedures (SOPs) in North East (NE) India. An attempt was made to study the profiles of IECs and the status of their SOPs in health research institutes of NE India. Fourteen biomedical and health research institutes of NE India were reviewed. Only 12 of these 14 institutes had constituted their IECs. The IECs were multidisciplinary and multisectoral in nature; of the 12 institutes, 8 had adequate representation by age and seven committees had adequate representation by gender. In 11 out of 12 IECs, chairpersons were non-affiliated, and chairperson qualifications in 10 of 12 IECs were found to be in keeping with the National Ethical Guidelines for Biomedical and Health Research involving Human Participants, 2017, of the Indian Council of Medical Research (ICMR). There were no lay persons in 6 out of 12 IECs. Nine out of 12 institutes had framed their SOPs. Three out of nine IECs adopted all three types of reviews namely exemption from review, expedited review and full committee review. Six out of nine SOPs had adopted the provision of quarterly review meetings. Declarations of conflict of interest (CoI) were specified in seven out of nine SOPs. Five out of nine SOPs mentioned no voting power for members who declared CoI. Seven out of nine SOPs specified the designated office space, staff, and budget of the committee. Only 2 out of the 12 IECs were registered. Our findings concluded that the characteristics and composition of IECs of health research institutes in NE India are suboptimal. Most of the SOPs were not framed as per recommendations of the ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017, and were unregistered.