FDA EIR - Center for the Improvement of Human Functioning Intl IRB - July 08, 2011

An FDA inspection conducted between July 6-8, 2011, at the Ctr. for the Improvement of Human Functioning International, Inc., identified significant deficiencies in its Institutional Review Board (IRB) operations. The inspection, carried out under regulatory guidelines for IRBs, revealed eleven observations detailed in a Form FDA 483. Key issues included a lack of essential information in informed consent documents regarding foreseeable risks. The IRB failed to maintain updated registration details, including changes in leadership and information on the senior officer. Critical administrative records, such as a complete list of IRB members with their qualifications and roles, were not properly maintained. Furthermore, the IRB's composition did not meet the minimum five-member requirement, and its members' diversity and expertise were not adequately documented. A significant conflict of interest was noted, where an IRB member participated in the review of a project they were involved with. Procedural non-compliance was widespread, with the absence of written operating procedures for the IRB. The organization also failed to retain comprehensive documentation, including research proposals, scientific evaluations, progress reports, injury reports, and correspondence with investigators. Minutes from IRB meetings lacked necessary detail regarding attendance, actions taken, voting records, and rationale for decisions. Crucially, records were not maintained for the required three years post-research, and subjects were not consistently provided with a complete copy of their signed informed consent forms. Management acknowledged these findings, was cautioned about the implications of non-compliance, and committed to prioritizing corrective actions and submitting a written response to address these serious deficiencies.