An evaluation of knowledge, attitude, and practice of institutional ethics committee members from eastern India regarding ethics committee functioning and pharmacovigilance activities conducted during clinical trials: A pilot study

Abstract

Purpose of study:The vital responsibility of Institutional Ethics Committee (IEC) members is to ensure the safety of the subjects participating in clinical trials. Hence, it is essential for IEC members to be aware of the common pharmacovigilance strategies followed during clinical trials. However, the information about the knowledge, attitude, and practice of IEC members regarding the pharmacovigilance activities followed during clinical trials is scarce worldwide, especially in India. Hence, this cross-sectional study was designed to assess the knowledge, attitude, and practice of IEC members of 10 hospitals of Kolkata, India.Materials and Methods:A cross-sectional study using a self-administered, validated questionnaire was conducted among 10 hospitals (five government and five corporate hospitals) in Kolkata conducting active clinical research and having functional Ethics Committees (ECs) in the month of September-November, 2012. An IEC approval was taken for this study. Two reminders were given to all EC members through telephone/e-mail for completion and returning of the forms. The filled in forms were returned to their respective Member Secretaries, from whom authors' collected the forms. Data were analyzed using SPSS version 16.0 software and MS-Excel 2007. Categorical data were analyzed using Chi-square test and a P < 0.05 was considered statistically significant.Results:Out of the 100 distributed questionnaires, 40 were returned of which 10 were not filled properly. Overall awareness regarding different pharmacovigilance terminologies and activities among EC members from nonmedical background (71.43%) was found to be more than that of the medical members (68.75%), though the figure was not statistically significant. Majority of the members (75%) felt that EC should decide compensation in case of a serious adverse event.Conclusion:The present study signifies that there is a low level of awareness in IEC members of Kolkata regarding pharmacovigilance activities conducted during clinical trials; and, hence the functioning of the ECs to safeguard the safety of patients during clinical trials remains questionable. There is a definite need for immediate intervention in the form of mandatory training hours for EC members about pharmacovigilance activities and reporting timelines to ensure clinical trial subject safety in the long run.

Knowledge and Perception Regarding Clinical Trials Among Dental Students-A Questionnaire Based Study

“…This study coincided with Dhodiet et al, he stated doctors who received clinical trials training were(36.3%), the proportion of not received higher than the received (Dhodi et al, 2013). About (55.6%) students believed informed consent is mandatory, this coincided with the study provided by Bhowmick et al, he stated that majority of the doctors believed that the informed consent procedure followed in our country and it is mandatory (Sikdar et al, 2014). About (53.9%) of the students thought patients were at risk by participating in clinical trials.…”

Curricular adequacy on basics of clinical trials

“…[2425] IECs in India have been found to have limited resources and members are still not trained as there is no formal training on bioethics and there are no training requirements for being IEC members. [26] IEC members are usually senior most faculty members rather than being qualified, trained, and skilled experts.…”

Knowledge and perception regarding clinical trials among doctors of government medical colleges: A questionnaire-based study

“…where 68.75% of medical members of Ethics Committees were aware of pharmacovigilance terminology and activities. [ 16 ] In all likelihood, the higher awareness among the medical members of Ethics Committee has developed due to training and regular exposure. Yet, it is desirable that all medical personnel should know the basic terminologies of CT methodology.…”