FDA WARNING_LETTER - Agnesian Healthcare IRB - November 13, 2012

An FDA inspection of Agnesian Healthcare's Institutional Review Board (IRB) from November 7-13, 2012, revealed substantial failures to comply with 21 CFR parts 50 and 56, governing human subject protection in clinical investigations.

Key violations include: 1. **Failure to maintain and follow written procedures:** The IRB lacked required written procedures for initial/continuing review, reporting findings, determining review frequency, ensuring prompt reporting of research changes, preventing unapproved changes, and reporting unanticipated problems, noncompliance, or IRB approval suspensions/terminations (21 CFR 56.108(a), 56.108(b), 56.115(a)(6)). 2. **Failure to provide written notification of IRB decisions:** Investigators and the institution were only verbally informed of IRB decisions, lacking required written communication for approvals, disapprovals, or modifications (21 CFR 56.109(e)). 3. **Inadequate documentation of IRB activities:** Meeting minutes failed to record the number of members abstaining from votes (21 CFR 56.115(a)(2)). 4. **Failure to ensure basic elements of informed consent:** An IRB-approved consent form for Study (b)(4) omitted four serious risks (heart failure, decreased heart pumping ability, heart attack, pulmonary hypertension) despite prior notification