FDA WARNING_LETTER - Monmouth Medical Center IRB - April 20, 2015

The FDA issued a Warning Letter to Monmouth Medical Center following an inspection of its Institutional Review Board (IRB) from April 1-20, 2015, to assess compliance with 21 CFR parts 50 and 56 for human subject protection. The inspection revealed the IRB did not adhere to FDA regulations. Key violations include: 1) Failure to determine at initial review that studies involving children complied with 21 CFR part 50, subpart D (Additional Safeguards for Children), lacking proper documentation [21 CFR 56.109(h)]. 2) Failure to review proposed research at convened meetings with a required quorum, including a nonscientific member, and improperly counting members with conflicts of interest towards quorum [21 CFR 56.108(c)]. 3) Failure to prepare and maintain adequate documentation of IRB activities, specifically meeting minutes, showing discrepancies in voting records for conflicted members [21 CFR 56.115(a)(2)]. The FDA acknowledged the IRB's proposed corrective actions but found the submitted documentation insufficient for evaluation, requesting finalized forms, revised SOPs, and training details within 15 working days. These deficiencies raise concerns about the protection of human subjects, particularly children, and the adequacy of the IRB's review process, with potential for further regulatory action if not promptly addressed.