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

Source: https://www.keypedia.com/records/warning_letter/center-for-the-improvement-of-human-functioning-international-inc-irb/36c8923c-99d8-4e37-864c-c6b8616655d5

> FDA WARNING_LETTER for Center for the Improvement of Human Functioning International, Inc. IRB on July 08, 2011. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Center for the Improvement of Human Functioning International, Inc. IRB
- Inspection Date: 2011-07-08
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

## Related Officers

- [Leslie K. Ball](https://www.keypedia.com/people/leslie-k-ball/8306ea83-6a4c-4f2f-9527-9d22e58b5378)
- [Charles T. Hinshaw](https://www.keypedia.com/people/charles-t-hinshaw/ddc745f5-5def-4369-b9f1-4c3bf999da29)

Company: https://www.keypedia.com/companies/center-for-the-improvement-of-human-functioning-international-inc-irb/7e43576c-5f87-416f-8303-e2e3849bdb9e

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c