Professor and Head, Department of Community Medicine, Jorhat Medical College, Jorhat 785 001, Assam, INDIA.
Woman Scientist , DHR, Department of Community Medicine, Jorhat Medical College, Jorhat 785 001, Assam, INDIA.
Indian J Med Ethics. 2021 Apr-Jun;VI(2):1-17. doi: 10.20529/IJME.2020.124.
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.
关于印度东北部（NE）机构伦理委员会（IEC）及其标准操作程序（SOP）的数据有限。本研究试图研究印度东北部卫生研究所IEC 的概况及其 SOP 的状况。对印度东北部的 14 个生物医学和健康研究机构进行了审查。这 14 个机构中只有 12 个成立了自己的 IEC。IEC 是多学科和多部门的；在这 12 个研究所中，有 8 个委员会按年龄有足够的代表性，7 个委员会按性别有足够的代表性。在 12 个 IEC 中有 11 个主席是非附属的，在 12 个 IEC 中有 10 个主席的资格符合印度医学研究理事会（ICMR）2017 年《涉及人类参与者的生物医学和健康研究国家伦理准则》。在 12 个 IEC 中有 6 个没有非专业人员。在 12 个研究所中有 9 个制定了 SOP。在这 9 个 IEC 中有 3 个采用了三种审查类型，即豁免审查、加速审查和全委员会审查。在这 9 个 SOP 中有 6 个采用了季度审查会议的规定。在这 9 个 SOP 中有 7 个规定了利益冲突（CoI）声明。在这 9 个 SOP 中有 5 个规定了宣布 CoI 的成员没有投票权。在这 9 个 SOP 中有 7 个规定了委员会的指定办公空间、工作人员和预算。在这 12 个 IEC 中只有 2 个进行了注册。我们的研究结果表明，印度东北部卫生研究所 IEC 的特征和组成并不理想。大多数 SOP 没有按照 ICMR 2017 年《涉及人类参与者的生物医学和健康研究国家伦理准则》的建议制定，也没有注册。
