FDA WARNING_LETTER - Center for the Improvement of Human Functioning International, Inc. IRB - July 08, 2011

This Warning Letter details objectionable conditions observed during an FDA inspection of the Center for the Improvement of Human Functioning International, Inc. IRB, conducted from July 6-8, 2011, and subsequent interviews with clinical investigators (January 23 - February 1, 2012). The inspection aimed to assess compliance with 21 CFR parts 50 and 56 regarding human subject protection in FDA-regulated clinical investigations.

The IRB failed to adhere to statutory requirements and FDA regulations, specifically: 1. **Lack of Written Procedures:** The IRB had no written procedures for its functions and operations, including initial/continuing review, determining review frequency, reporting changes, ensuring changes are IRB-approved, and promptly reporting unanticipated problems, noncompliance, or suspension/termination of approval [21 CFR 56.108(a), 21 CFR 56.108(b), 21 CFR 56.115(a)(6)]. 2. **Inadequate Documentation of Activities:** The IRB failed to maintain complete documentation, including full research protocols, approved consent documents, and progress reports for studies like "(b)(4)" [21 CFR 56.115(a)(1)]. 3. **Inadequate Meeting Minutes:** Only one set of meeting minutes (June 25, 1997) was found, despite the IRB operating