Scenarios in Medical Ethics-4: Ethics Committee-Registration and Accreditation

It is mandatory for all ethics committees in India reviewing biomedical and health research studies to register with the Department of Health Research (DHR) under the Ministry of Health and Family Welfare. This information has been added to the New Drugs and Clinical Trials Rules, 2019 with details of the registration procedure.[1] About 1225 Institutional Ethics Committees (IECs) have registered with Central Drug Standard Control Organization (CDSCO) to date.[2] Institutes doing both regulatory and biomedical health research need to register with the CDSCO as well as with DHR. However, accreditation is only optional for the IECs. Accreditation recognizes the functioning of the IECs as per the latest guidelines and rules. A two-day workshop was organized to train IEC members during September 2019 at the Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, in association with ICMR bioethics unit, Bengaluru.[3,4]

The workshop consisted of six-panel discussion sessions. In a variation from the usual ethics workshops,[4] we planned each session to have a lecture followed by case discussions. Each session included a series of 3–6 scenarios followed by 1–3 questions. After presenting each scenario, the participants were invited to give their comments. After a thorough discussion, a set of panelists, who were experts in biomedical ethics, were invited to discuss the scenario and provide more informed and authoritative opinions. The discussions were quite lively and we believe that the case scenarios should be of wider interest.

In this piece, we present the panel discussion on Ethics Committee Registration and Accreditation. The answers provided by the participants are listed first followed by the expert opinion by the panelists.