FDA WARNING_LETTER - Brookhaven Memorial Hospital Medical Center - March 13, 2008

On July 8, 2008, the FDA issued a Warning Letter to Brookhaven Memorial Hospital Medical Center's Institutional Review Board (IRB) Chairman, James H. Bowers, Jr., M.D., following an inspection from March 6-13, 2008. The inspection aimed to assess compliance with 21 CFR Part 56 (Institutional Review Boards) and Part 50 (Protection of Human Subjects) for device investigations.

The FDA identified serious violations, including: 1. **Inadequate Written Procedures:** The IRB lacked written procedures for continuing review, determining review frequency, ensuring prompt reporting of research changes and unanticipated problems, and ensuring proper meeting quorums. 2. **Improper Meeting Conduct and Conflict of Interest:** The IRB failed to ensure a majority of members, including a nonscientific member, were present at convened meetings. Additionally, Dr. R. Rubenstein participated in the review and approval of studies where he was the principal investigator, without documentation of abstention. 3. **Failure to Conduct Annual Continuing Review:** Several studies, including the [redacted] and [redacted] studies, lacked documented annual continuing reviews for multiple years. 4. **Inadequate Documentation of IRB Activities:** Meeting minutes did not reflect vote counts (for, against, abstaining). Records for the [redacted] study lacked copies of the protocol and approved informed consent, and meeting minutes for the [