FDA SENDS WARNING LETTER TO IRB FOR CONFLICT OF INTEREST

The FDA has issued a warning letter to the Vail Valley Medical Center Institutional Review Board (IRB), saying that it was a conflict of interest for its vice chairman to vote to approve the protocol of a clinical trial that he himself had authored.

Kevin Lawlor, compliance officer for Vail Valley Medical Center, said the IRB prohibited that individual from voting on any more protocols as soon as it got the Form 483 that preceded the warning letter. He added that the IRB would review other protocols that the vice chairman had voted on, but said that at this point the board is more focused on correcting several documentation failures that the warning letter also cited.

"Our files were a mess. They hadn't gotten the attention that they deserve," Lawlor said. "Since late June, we have gone through all our files." The IRB has also hired an outside consultant from a major academic research center and outside legal counsel to help it fix the problems, he said.

The warning letter, which was sent June 22 and recently posted on the agency's website, said that the agency's review of study documents and related meeting minutes indicated that the IRB failed to ensure that it had reviewed, at least once a year, all research for which it was responsible. Lawlor said that as part of the corrective action plan the IRB implemented after receiving the warning letter, it sent letters to investigators inquiring as to the status of their protocols, some going back as far as 1992.

The warning letter also cited the IRB for inappropriately using the expedited review procedure, which is only supposed to be used for certain kinds of research involving no more than minimal risk or for minor changes in approved research. On Jan. 6, 2005, according to the letter, the IRB granted initial approval of an expedited review for a new study on the grounds that "it was a multicenter study and had already been reviewed and approved by one or more other institutional review boards." Lawlor acknowledged that the IRB should have been doing a full review in cases like this and said the outside consultant and lawyer will advise the IRB on this matter.