Are central institutional review boards the solution? The National Heart, Lung, and Blood Institute Working Group's...

Area of Science:

• Research Oversight
• Bioethics
• Health Economics

Background:

• Proposed regulatory changes and increasing multicenter clinical trials necessitate efficient Institutional Review Board (IRB) models.
• Current multiple IRB reviews can be inefficient for multi-site research.
• The National Heart, Lung, and Blood Institute (NHLBI) convened a working group to explore alternatives.

Purpose of the Study:

• To examine alternative institutional review board (IRB) models for government-supported research.
• To address inefficiencies in multicenter clinical trial reviews.
• To identify best practices, metrics, and IT needs for IRBs.

Main Methods:

• Convened a working group of experts in research, oversight, ethics, economics, regulations, and IT.
• Discussed alternative IRB models, ethical considerations, evaluation metrics, IT requirements, and economic factors.
• Reviewed existing models, including the National Cancer Institute's central IRB (CIRB).

Main Results:

• Identified research gaps in IRB best practices and metrics.
• Recommended process changes: defining IRB performance in funding announcements and encouraging efficient alternative IRB models.
• Proposed developing IT systems for inter-IRB information sharing and collaboration.

Conclusions:

• Did not recommend creating a new NHLBI-funded central IRB due to cost concerns and potential burden shift.
• Emphasized process improvements and IT solutions for enhancing IRB efficiency.
• Highlighted the need for better metrics and best practices in IRB operations.