FDAnews Drug Daily Bulletin


Aug. 7, 2006

The FDA has sent the Oklahoma Blood Institute Institutional Review Board (IRB) a warning letter over its failure to follow meeting and documentation procedures. This is the latest in an unusual string of warning letters the agency has recently sent to IRBs, the panels that review the protocols of clinical trials and ensure that they are performed effectively and ethically.

The Oklahoma Blood Institute IRB warning letter cites four specific violations. The IRB failed to:

Review a proposed clinical trial and an addendum to a trial protocol at convened meetings at which a majority of the members were present;

Notify a clinical investigator (CI) in writing of its approval of a proposed trial protocol, the associated consent forms and the information sheets for the same study for which it failed to hold a convened meeting. The IRB also did not notify the CI of its approval of several revisions to the informed consent forms;

Prepare and maintain adequate documentation of its activities. Specifically, the minutes of several meetings were deficient; and

Maintain and follow adequate written procedures for conducting its initial and continuing review of research.

"The warning letter makes it look like we did not review research. We did, but not in a convened meeting -- [instead, it was] in expedited format," Charles Mooney, vice president of ancillary systems for Oklahoma Blood Institute, said. "Any time we have any communication with the FDA we consider it very seriously. We are investigating extensively everything in the [Form] 483 and the warning letter," Mooney said. He added, however, that the violations cited in the warning letter "are more clerical in nature."