Pikeville IRB Did Not Follow Regs: FDA

An 8/17-8/21/15 FDA inspection at the Pikeville Medical Center Institutional Review Board (IRB) Pikeville, KY, found that the IRB did not adhere to applicable FDA regulations governing the protection of human subjects. A just-released 3/1 Warning Letter says that violations shown on an FDA-483 included:
         failing to prepare, maintain, and follow written procedures governing the functions and operations of the IRB;         failing to prepare and maintain adequate documentation of IRB activities, including minutes of IRB meetings;         failing to review proposed research at convened meetings at which a majority of the IRB members are present, including at least one member whose primary concerns are in non-scientific areas; and         failing to conduct continuing review of research at intervals of not less than once per year.

The IRB was told to take specific steps to prevent similar violations in the future.