Approval from the ethics committee in published studies from the Indian Journal of Psychiatry .

Sir, Ethics committees (ECs) are the watchdogs of research conducted by researchers, which ensure the minimum standards of scientific and ethical aspects. They are mandated to review research proposals and monitor them throughout in accordance with the Indian Council of Medical Research (ICMR) National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017. ECs for clinical trials need to be registered under the Central Drugs Standard Control Organization (CDSCO) (www.cdsco.gov.in/) from 2013, and all ECs overseeing clinical trials and biomedical and health research need to be registered under the National Ethics Committee Registry for Biomedical and Health Research (NECRBHR) (www.naitik.gov.in/) from 2019. A preliminary notice for registration was circulated on August 12, 2019, and a subsequent notice was sent to all health institutes to register their ECs by July 30, 2020, deadline (www.naitik.gov.in/DHR/Notification). The list on the website is updated regularly as new ECs are registered and includes details such as whether the registration is provisional or final, and the name, address, and date of registration. Although mandatory, many ECs are not registered, and the standards of these ECs are questionable. We examined the status of ECs from which approval was obtained for the research published in the Indian Journal of Psychiatry (IJP), the leading psychiatry journal from India. The NECRBHR website was accessed on May 16, 2023, for the list of all ECs registered, and we checked both the provisional and final lists. We examined the original articles (OA) and brief communications (BC) of six regular issues of IJP published in 2022. There were 69 such publications (55 OAs and 14 BCs). We excluded studies conducted outside India (n = 14), studies using secondary data (n = 7), and studies without statements regarding EC approval (n = 1). Of the 47 studies, 14 (30%) had approval from ECs not registered under the NECRBHR. Among the ECs without approval, some were affiliated with medical colleges and some with other colleges or universities, private hospitals, or society. The details of the EC (name, approval number, and date) were available for only eight (17%) studies. In multicentric studies, no details were available regarding the ECs, except for a statement that each institute had obtained such approval. In contrast, the details of the EC with approval numbers were available for all the studies from outside India. It is possible that some of these studies might have been conducted before 2019, when EC registration was not mandatory, or that some were in the process of registration, which could be the limitation of our findings. It is heartening to note that all research studies (except for one retrospective chart review) have obtained approval from EC. This is much higher than observations from other Indian journals, which have much lower rates of EC approvals in the published studies.[1,2] However, almost a third of ECs are not registered under the relevant bodies, thus raising questions about the standards. Almost 2.5 years into the implementation of the registration of ECs under the Department of Health Research (DHR), less than 40% of the medical and dental colleges had registered their ECs in the DHR portal.[3] The details of the EC including name, approval number, and date should be included in the manuscript for the editor, peer reviewer, and readers to check the quality; however, this may be masked during manuscript submission for journals having blinded peer review and mentioned in the covering letter for the information of the editor. In a multicentric study, ethics approval may be obtained from multiple institutions where studies are approved and monitored by respective ECs; in such manuscripts, the details can be added as an appendix or supplementary file. ECs have the responsibility to monitor the quality of the research, thus upholding internal validity. It is the responsibility of the ECs to obtain necessary registrations to maintain the standards and not merely act as “rubber stamps” for protocol approvals. To improve quality, additional accreditation under the National Accreditation Board for Hospitals and Healthcare Providers (NABH) (www.nabh.co/) can be obtained by ECs under the Ethics Committee Accreditation Programme for the ECs registered under CDSCO. An upcoming tool from the World Health Organization (WHO) for benchmarking ethics oversight of health-related research[4] is at a draft level and can be piloted in India. The researchers should be aware of the registration status of the ECs while submitting their protocols. In addition to the institutional ECs, there are several independent ECs, which may be registered. The editors of the journals should check whether the submitted studies have approvals from competent ECs, which are registered. This will avoid poor-quality and questionable research being published in journals of repute such as IJP. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.