title: 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: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Consultant Clinical Pharmacologist and Medical Superintendent (Academics, Quality and Research), Peerless Hospitex Hospital And Research Center Limited, Kolkata, West Bengal, India.
authors.forename: Subhrojyoti
authors.initials: S
authors.lastname: Bhowmick
authors.affiliation: Student of Public Service Management (Hospital & Healthcare), IISWBM (Calcutta University), Kolkata, West Bengal, India.
authors.forename: Koyel
authors.initials: K
authors.lastname: Banerjee
authors.affiliation: Executive, Department of Clinical Research, Peerless Hospitex Hospital And Research Center Limited, West Bengal, India.
authors.forename: Shreya
authors.initials: S
authors.lastname: Sikdar
authors.affiliation: Director, Clinical Research Centre, Jadavpur University, Kolkata, West Bengal, India.
authors.forename: Tapan Kumar
authors.initials: TK
authors.lastname: Chatterjee
keywords: Attitude; Eastern India; Institutional Ethics Committee; knowledge; pharmacovigilance; practice