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.

Operation of research ethics committees in Colombia, Costa Rica, Guatemala, and Mexico: Mesoamerican Project

“…20 After a protocol has been approved, there is no comprehensive system in place to monitor research and ensure that the REC's recommendations are carried out. 24 Unfortunately, the lack of a sufficient workforce, the lack of training of REC members on how to conduct monitoring, and inadequate funds are cited as major salud pública de méxico / vol. 64, no.…”

Protecting Participants in Genomic Research: Understanding the “Web of Protections” Afforded by Federal and State Law

“…19 Although the Common Rule often obligates IRBs to provide continuing review, 20 it would be unusual for an IRB to revisit a study's overall design unless a problem occurs. 21…”

Audit of principal investigator's compliance for submission of continue review application and decisions taken on lapses in validity of approval by the Institutional Ethics Committee at tertiary oncology center in Navi Mumbai

“…Continuing review is an important responsibility of the IEC, since it involves the reviewing of the progress of the study, which was previously approved; not only for the changes but to ensure continued protection of the rights and welfare of research participants. [ 2 ] The continuing review of these studies is required to occur as long as the research remains active, even when the research is closed for the enrolment of new participants, and all participants have completed all research-related intervention and remains active for long-term follow-up for a period of the study. [ 3 ]…”