Sierra Providence Health Network IRB – FDA Warning Letter, Mar 14, 2008

The FDA issued a Warning Letter to Sierra Providence Health Network IRB, Providence Memorial Hospital, following an inspection from March 10-14, 2008. The inspection aimed to determine compliance with 21 CFR Part 56 (IRBs), Part 50 (Protection of Human Subjects), and Part 812 (Investigational Device Exemptions). The review identified several serious violations, which were discussed in an FDA 483 form and the IRB's March 28, 2008, written response. Key violations include: 1) Failure to follow required written procedures [21 CFR 56.108(a)], exemplified by a lack of documented informed consent approval, conducting meetings without a physician quorum, and allowing investigators to be present during votes on their own studies. 2) Failure to prepare and maintain adequate documentation of IRB activities [21 CFR 56.115(a)], including inaccurate or incomplete meeting minutes and missing or inadequate written procedures for critical functions such as reporting unanticipated problems, determining risk status for device studies, and establishing review frequency. 3) Failure to conduct continuing review of research at appropriate intervals, not less than annually [21 CFR 56.109(f) and 812.64], with 12 of 34 active studies not reviewed for 17 months or more. The FDA found the IRB's responses inadequate, lacking comprehensive corrective and preventive action plans. The IRB must provide written documentation of corrective actions, prevention plans, and staff training procedures within fifteen working days to avoid further regulatory action.