Monitoring of approved studies: A difficult tightrope walk by Ethics Committees

Abstract

Continuing review of studies approved by the Ethics Committees (ECs) involves review of the progress of the study, annual reports, protocol deviations/violations, serious adverse event monitoring, and on-site monitoring. International and national regulations and guidelines for continuing review state that it is an opportunity for the EC to be assured that risks to subjects are minimized and is are reasonable in relation to anticipated benefits if any to the subjects and the knowledge it will generate. There are several barriers (e.g. lack of workforce, lack of training of members for conducting onsite review, and poor infrastructure) for ECs to do ongoing review of projects approved by them. Industry is an important stakeholder for the research enterprise in India and strongly advocates that ECs should at a minimum have pragmatic standard operating procedures for continuing review/monitoring of studies initially approved. ECs which deal with larger volume of studies with well-functioning secretariat, appropriately trained EC members and funding should definitely conduct onsite review/monitoring in addition to the ongoing review.

Keywords

• Ethics Committees
• ongoing review
• onsite review