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Are institutional review boards prepared for active continuing review?
Yashashri C Shetty1, Kshitij S Jadhav1, Aafreen A Saiyed1
1Department of Pharmacology and Therapeutics, Seth Gordhandas Sunderdas Medical College and King Edward Memorial Hospital, Parel, Mumbai, Maharashtra, India.
Perspectives in Clinical Research
|February 20, 2014
Summary
Continuing review by Institutional Review Boards (IRBs) is crucial but often neglected. Implementing standard operating procedures, regular training, and dedicated monitoring boards can improve participant safety.
Area of Science:
- Clinical Research Oversight
- Bioethics and Regulatory Science
Background:
- Continuing review is a key responsibility of Institutional Review Boards (IRBs) mandated by national and international guidelines.
- Routine continuing review is primarily conducted in the UK, with other regions facing significant challenges in its implementation.
Purpose of the Study:
- To identify barriers to the consistent execution of continuing reviews by IRBs.
- To propose actionable solutions to enhance IRB oversight and ensure participant protection.
Main Methods:
- Analysis of existing guidelines and common practices regarding IRB continuing review.
- Identification of systemic challenges including inadequate training, resource limitations, and member engagement.
- Proposal of a multi-faceted approach involving SOPs, training, and specialized monitoring boards.
Main Results:
- Continuing review is inconsistently performed globally due to factors like insufficient training, workload, lack of enthusiasm, and cost.
- This inconsistency leads to a failure in fulfilling the local oversight responsibilities of IRBs.
- Proposed solutions aim to address these specific barriers to improve compliance and oversight.
Conclusions:
- Establishing Standard Operating Procedures (SOPs) for continuing review is essential.
- Regular training for IRB members and the creation of internal Data and Safety Monitoring Boards (DSMBs) can bolster oversight.
- Adequate budget allocation from sponsors or institutions is critical for effective participant safeguarding.
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