Researchers' perceptions of US Defense Health Agency Institutional Review Board performance

Area of Science:

• Health Services Research
• Regulatory Science
• Human Subjects Protection

Background:

• The US Defense Health Agency (DHA) oversees research through five Institutional Review Boards (IRBs).
• The IRB Researcher Assessment Tool (IRB-RAT) was developed to gauge researcher perceptions of IRB performance and identify areas for improvement.

Purpose of the Study:

• To evaluate researcher perceptions of DHA IRB performance using the IRB-RAT.
• To identify specific areas for process improvement within the DHA's IRB system.

Main Methods:

• A cross-sectional program evaluation was conducted.
• 5,960 DHA Electronic IRB (EIRB) users were invited to complete the IRB-RAT; 473 responded.
• Performance gap scores (Actual minus Ideal) were calculated, and linear mixed-effects models analyzed responses and institutional variability.

Main Results:

• Key ideal characteristics identified by researchers included timeliness, complete explanations for changes, and IRBs not suppressing research.
• The largest performance gaps were observed in timeliness, IRBs acting as allies rather than hurdles, and accountability for errors/delays.
• Significant variability in performance was noted across the five DHA IRBs.

Conclusions:

• The IRB-RAT effectively captured researcher perceptions of DHA IRB performance, highlighting timeliness as a universal concern.
• Improvements in IRB scope of function and explanation of changes are recommended to minimize delays.
• Further investigation is needed to address the perception of IRBs as hurdles, and harmonization of best practices across IRBs is crucial.