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

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.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

This study did not receive any funding

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data produced in the present study are available upon reasonable request to the authors

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