1. OVERVIEW OF ETHICS COMMITTEE REGISTRATION AND RE-REGISTRATION WITH THE DEPARTMENT OF HEALTH RESEARCH IN INDIA
- Author
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Yash Kamath, Yashashri Shetty, and Ankita Kulkarni
- Abstract
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.
- Published
- 2023