FDA Warns Idaho IRB Over Lack of Documentation

An Idaho institutional review board recently was warned by the FDA for documentation shortcomings.

An FDA inspector found a half dozen problems related to the way the Kootenai Medical Center’s IRB handled certain studies involving several mental health drugs, according to the Nov. 15, 2013 warning letter posted recently online. Among the concerns was a lack of proper documentation of IRB practices and meetings. The IRB’s minutes lacked required details such as the approval of one study and an adequate review of how minors were to be treated in a separate study, the letter says.

Ron Lahner, Kootenai’s general counsel and the IRB chairman at the time of the inspection, said the shortcomings were related to documentation and have since been resolved. Moreover, the IRB has since been closed — a process that began before the FDA audit commenced.

“We went through all of the appropriate processes and decisionmaking for this study and we have the additional safeguards for minors in the IRB policies and procedures, but it wasn’t documented in the minutes appropriately,” Lahner said. “We explained that to the FDA, and the FDA also identified that we were transferring all our studies to central IRBs.”

Lahner said the agency has closed out its audit without any further findings, adding that he decided to shut down the IRB when he became chairman in March 2013.

“There just wasn’t much activity and I didn’t see a reason for us to be in the IRB business,” Lahner said. He noted that Kootenai had recently acquired a cardiology practice that had a relationship with a central IRB and was doing the bulk of the hospital’s research.

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