Covenant Healthcare – FDA Warning Letter, Apr 20, 2011

The FDA issued a Warning Letter to Covenant HealthCare following an inspection of its Institutional Review Board (IRB) from April 4-20, 2011. The inspection revealed the IRB failed to comply with FDA regulations for human subject protection (21 CFR parts 50 and 56).

Key violations include: 1. **Inadequate Documentation of IRB Activities:** The IRB failed to document discussions and resolutions of controverted issues, specifically regarding a study where a placebo group might receive less than the standard of care for preventing preterm birth. This suggests the IRB approved research without ensuring minimized and reasonable risks to subjects [21 CFR 56.115(a)(2), 56.111(a)(1) and (2)]. The IRB's response was deemed inadequate as it did not address the lack of documentation for the controverted issue. 2. **Improper Expedited Review Procedures:** The IRB used expedited review for studies involving more than minimal risk and for continuing review when studies were still open for accrual, violating 21 CFR 56.110(b). This included approving the use of an investigational drug in pregnant women, a vulnerable population explicitly excluded from expedited review by the IRB's own policy. The IRB's response indicated a misunderstanding of expedited review regulations. 3. **Deficient Informed Consent Documents (ICDs):** ICDs for two subjects