Announcements Talk on ‘How Pharma Companies Fudge Data’ on 23rd September 2019 in Mumbai   |   ESIC Medical College and PGIMSR, Chennai present Wissendurst’19 on 20 September 2019 with networking partner Forum for Medical Ethics Society and FMES’s Institute of Health Sciences   |   Citizenship, Governance and Accountability in Health – Join the COPASAH Conclave of Global Health Accountability and Human Rights Advocates: October 15-18, 2019 New Delhi, India   |   Open Letter: Stop the war on Syria’s hospitals

Reports of site monitoring visits by institutional ethics committees in an Indian tertiary care hospital: A retrospective analysis

Yashashri C Shetty, Kritarth Naman M Singh , Padmaja A Marathe , Sharmila V Jalgaonkar , Snehalata Gajbhiye , Janhavi Katkar , Manali U Vengurlekar

DOI: 10.20529/ IJME.2019.042


The monitoring of clinical trials is an integral function of the institutional ethics committee (IEC)to ensure the ethical conduct of research. The National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017, of the Indian Council of Medical Research, underline a strong need for active monitoring of clinical trials. A previous study by the authors, of research studies initiated between 2008 and 2010, had found many lapses after site monitoring. In the present study, 12 clinical studies—both sponsored and investigator initiated—were monitored by members of the King Edward Memorial Hospital (Mumbai) IEC between 2011 and 2017. The most common violations seen were related to informed consent (8/12 sites). The other violation themes were lack of investigator understanding of protocol (6/12), deviation from the investigational plan (5/12), non-reporting of the study’s progress to the IEC (4/12), and patient recruitment prior to IEC approval (2/12). The IEC took various corrective actions, such as ordering retaking of consent and good clinical practice (GCP) re-training and requiring interim reports, explanations for deviations, upgradation of facilities, and payment of pending compensation. The IEC even froze review of protocols from a frequently defaulting Principal Investigator’s (PI) site and put study recruitment on hold for the same PI. This study demonstrates that active site monitoring by IECs is a must for ensuring the ethical conduct of studies.

Full Text





There are currently no refbacks.

Article Views

PDF Downloads

Click here to support US