FDA IRB Warning Letter: Pikeville Medical Center

FDA posted a warning letter to the Pikeville Medical Center last week for the following items:

  • Failing to maintain written procedures as required by 21 CFR 56
  • Failing to adequately document activities, including maintaining meeting minutes. FDA specifically notes that vote counts were not always recorded.
  • Failure to achieve a quorum for review of research
  • Failure to review studies at least once per year

Throughout the warning letter, FDA discusses that the initial response from the IRB was to transfer governance of the IRB to the hospital board of directors. FDA notes that this response is inadequate, because it is unclear what the board of director's role will be and no procedures were submitted as part of the warning letter response.