coin toss

FDA IRB Warning Letter: Oeyama-Moto Cancer Research Foundation IRB

FDA posted a warning letter to an IRB this week. Oeyama-Moto Cancer Research Foundation IRB was warned for:

  • Failure to develop, maintain and follow written procedures for the operation of the IRB as required by 21 CFR 56. FDA notes that the IRB's response to the original Form 483 contained a discussion of the procedures for conducting clinical investigations.
  • Failure to prepare and maintain adequate documentation of IRB activities, including meeting minutes. FDA notes that vote counts were not always recorded, and attendance was not always recorded which brings into question if IRB members with a conflict of interest recused themselves from voting on studies they participated in. FDA notes that the IRB appears to have approved one study by a coin toss, and transferred a low dose patient group to a higher dose for "humanitarian reasons." 
  • Failure to notify an investigator in writing of approval or disapproval of research or modifications to research. FDA notes that the response to the original 483 referenced items that were not provided to the FDA.