1Assistant Professor, Department of Pharmacology, TNMC and BYL Nair Ch Hospital, Mumbai, Maharashtra, India
2Junior Resident, Department of Pharmacology, TNMC and BYL Nair Ch Hospital, Mumbai, Maharashtra
32nd year MBBS Student, TNMC and BYL Nair Ch Hospital, Mumbai, Maharashtra
*Corresponding author email id: kumardeep.paul01@yahoo.in
Online published on 17 December, 2016.
The present study was planned to understand the role & experiences of laypersons in Ethics Committees (ECs) of Mumbai city using a questionnaire.
This was a cross-sectional questionnaire-based study. Fifty-four ECs were randomly selected.
Our study showed that all ECs had at least one layperson and all of them were either graduates or postgraduates. More than 85% had undergone good clinical practice training. Training on standard operating procedure of their own EC was noted in 45% participants. Most of the laypersons had over 75% attendance at the meeting and more than 80% reviewed all the documents submitted to the EC for approval. Our study showed that more than half of the laypersons found difficulty in understanding the technical terms of the protocol, and more than 60% laypersons always ask questions and actively participate in the EC meetings.
Overall, our results suggest that layperson actively participates in the EC meetings and that their points of view are taken seriously and valued by other members.
Layperson, GCP training, Ethics committees, CDSCO, Schedule Y, Community members, Informed consent document
