There has been a recent trend in clinical research toward the use of central Institutional Review Boards (IRBs) or Ethics Committees (ECs) for multi-center trials. 21 CFR Part 56.114 outlines the following on cooperative research:
“In complying with these regulations, institutions involved in multi-institutional studies may use joint review, reliance upon the review of another qualified IRB, or similar arrangements aimed at avoidance of duplication of effort.”
The FDA’s guidance document titled “Using a Centralized IRB Review Process in Multicenter Clinical Trials” from 2006 further describes the use of a central IRB as advantageous “especially in situations where centralized review could improve efficiency of IRB review.” The guidance further goes on to discuss the following considerations for a multicenter trial: the participant roles in a centralized process, consideration of various community attitudes, documentation of agreements between the local and central IRBs, and implementation of procedures for centralized review.
In 2013, the Clinical Trials Transformation Initiative (CTTI) examined the potential barriers for use of central IRBs in the United States. This article describes the reason for examining this topic, methods used to gather information, and the resulting perceived barriers and suggested solutions to using centralized IRB review in multicenter trials. These involved issues such as liability to the institution, quality of review, and loss of local community context.
And recently, the National Institutes of Health (NIH) released a draft policy regarding promotion of the use of a single Institutional Review Board on record for domestic sites of multi-site studies funded by the NIH with the goal to “enhance and streamline the process of IRB review and reduce inefficiencies so that research can proceed efficiently without compromising ethical principles and protections.”
In clinical research, ensuring protection of study subjects is critical. While the use of centralized IRBs is one way to achieve this goal in an efficient manner, there are some significant considerations to evaluate when making decisions about which approach your study should follow. What do you think about the use of central IRBs? Should it be a requirement or study dependent? Share your thoughts below!
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