Abstract

PERCEPTIONS OF SOCIAL SCIENTISTS REGARDING THEIR ROLE IN ETHICS COMMITTEES, AND CURRENT PRACTICES IN THE STATE OF MAHARASHTRA

Jadhav U., Shetty Y.C.*, Singh V.K., Katkar J.

ABSTRACT

Objective: This study aimed to assess the contribution of social scientists (SS) serving Central Drugs Standard Control Organization (CDSCO)-registered institutional ethics committees (IECs) in the State of Maharashtra, India. Methodology: We conducted a prospective, cross-sectional, online survey in which the SS of the IECs of 6 zones in Maharashtra were contacted through emails from July 2016 to July 2017. A validated questionnaire was administered, which included questions on the profile, role, perception, bioethical knowledge, and contribution of SS while serving IECs. Result: Overall, 23 SS from 12 districts across various zones [Vidarbha=1, Marathwada=4, Nagpur=1, Pune=6, Mumbai=11] responded. Of these, 69.6% (n=16) reported that they had not received any formal training before joining the IEC and as a result, while 8.7% (n=2) participants were able to follow the scientific and bioethical part of research projects, 60.9% (n=14) felt intimidated at IEC meetings. Only 13.0% (n=3) of SS were actively engaged in the discussions of the committees on serious adverse events, which oversee the infringements of participants’ rights and accord due compensation to them. Conclusion: This qualitative exploration of the views of SS on the functioning of IECs underlines that it is imperative to provide training in bioethical aspects to achieve the benchmark in reviewing biomedical protocols.

Keywords: Social scientist, non-technical member, ethics committee, .registered, quorum