FDA EIR - Institutional Review Board of Franciscan Health Lafayette - February 13, 2013

The FDA conducted a routine surveillance inspection of Franciscan St. Elizabeth Health IRB in Lafayette, IN, from January 28 to February 13, 2013. This inspection, carried out under FDA regulations for Institutional Review Boards (CP 7348.809), identified significant non-compliance, with many issues echoing those from a previous inspection in 2003. A 6-point FDA-483 Inspectional Observations report was issued, along with several verbal findings, highlighting systemic deficiencies in the board's operations and documentation.

Primary violations included the failure to ensure a nonscientific member was present at specific board meetings and the improper use of expedited review for research not eligible for such procedures. Lapses in conducting annual continuing review for studies were also noted. The inspection found that meeting minutes lacked sufficient detail regarding voting records, and there were no adequate written procedures for various critical functions, such as determining studies requiring more frequent review or handling humanitarian use devices. Furthermore, the IRB failed to maintain a comprehensive list of members with required professional and institutional details and lacked a system to inform members about research approved under expedited review. Verbal observations pointed to further procedural gaps, including insufficient detail in meeting minutes regarding risk-benefit analysis, no clear process for assessing investigator qualifications, and undefined methods for reporting problems. The company is required to provide a written response to the FDA outlining corrective actions to address these deficiencies and ensure full compliance with federal regulations governing institutional review boards.