FDA 483 - BRI-IRB - February 07, 2013

The FDA inspection identified multiple violations at an Institutional Review Board (IRB) concerning its review and approval processes for research, particularly Single Patient Protocols (SPPs).

A key observation was the IRB's use of expedited review for research not on the FDA's eligible list and not previously approved by the full IRB. Numerous pediatric and adult subjects (e.g., 023115, 023320, 023410, 020367, 022881) received expedited approval for SPPs, only to be fully approved by the IRB months later. This indicates a failure to follow established procedures, as these cases should have undergone full board review per the IRB's own SOPs.

The IRB also approved research without adequately determining if risks to subjects were reasonable in relation to anticipated benefits. For several subjects (e.g., 022056, 023356, 023520), expedited approvals were granted based solely on the Informed Consent document, lacking necessary clinical or health history information to assess risk minimization. In one instance (Subject #021237), an expedited approval noted a need for clarifying history and physical information to ensure risk-benefit balance, indicating incomplete initial assessment.

Furthermore, the IRB failed to document its determination that studies involving children complied with 21 CFR Part 50 Subpart D