OVERVIEW OF ETHICS COMMITTEE REGISTRATION AND RE-REGISTRATION WITH THE DEPARTMENT OF HEALTH RESEARCH IN INDIA

The Government of India requires all ethics committees (EC) to register themselves with the Department of Health Research (DHR) and the study aimed to analyze the same. Since post-graduation mandates research – necessitating the presence of EC in the institution – we aimed to analyze the status of registrations along with the presence of ECs in National Medical Council(NMC) and Dental Council of India(DCI)-permitted colleges and also to study zone-wise differences in the same. We also studied the impact of COVID-19 on the registration process. The status of ECs was obtained from the DHR website. ECs information was extracted [location, date & type of Approval]. The search terms “College” and “Hospital” were used to locate Institutional ECs (IEC). A list of Medical and Dental colleges was obtained from the NMC and DCI Websites with their location information. Of 931 IECs, 103(11.06%) had final, 728(78.2%) had provisional approval while 100(10.74%) ECs registration had expired. The median delay to file for provisional approval was 857 (IQR=407) days. The expired ECs functioning without registration for 90 (IQR=131) days. 440 of 931 (47.3%) ECs got registered during the COVID-19 period. The IEC to Medical Colleges ratio shows a significant zone-wise difference (Kruskal-Wallis, p=0.019) with the Northern Zone having the highest mean ratio of 0.90(SD=0.63). It is vital to improve DHR compliance and the EC/College Ratio for appropriate ethical governance and improve international acceptance of Indian Research.