Stay one step ahead even after the audit
Here’s what came out of previous FDA audits
Two IRB coordinators say they were surprised by some of the findings and requests made by the U.S. Food and Drug Administration (FDA) auditors who visited their facilities. While each auditor and audit will be different, these findings may offer some clues as to what the FDA might find wrong with an IRB’s practices:
• From the minutes: When Our Lady of the Lake Regional Medical Center in Baton Rouge, LA, was audited several years ago, the FDA auditor was concerned that the IRB’s meeting minutes did not show that principal investigators (PIs) were asked to leave the room before the IRB began its protocol review, says Cynthia A. Harper, IRB coordinator. Typically, the IRB had asked PIs questions during the meetings and then held a vote afterward, Harper says. "The PI had been staying there during the voting, but that’s been changed."
For example, the IRB’s chairman was the PI for certain studies, and while the IRB was not counting his vote, he remained in the room. The new practice, which is being reflected in the meeting minutes, is for the PI to leave after the presentation. The members will then vote, and the IRB will let the PI know the vote’s outcome by a letter or phone call, Harper adds.
• IRB composition: At the recent FDA audit of M.D. Anderson Cancer Center Orlando (FL), the auditor said the IRB would not permit physicians and other PIs to vote on a proposal for which they might sign up patients, says Barbara Ward, IRB coordinator. "We’d been having the main PI abstain from voting, but the auditor suggested that all people who can sign up a patient on a project should abstain from voting," Ward explains.
It’s also an issue because the IRB handles a lot of cooperative group projects, such as National Cancer Institute studies in which board members may be involved. "Regulations say they should abstain if there’s a conflict, and our board didn’t think there was a conflict because they don’t benefit monetarily and they don’t change study design," Ward says. "But the FDA said that if they could enroll a patient they should not vote on that protocol."
Wanted: A few good members
The IRB is left with the challenge of changing its board composition while maintaining expertise. "We’re going to have to change our membership to reach quorum, since there are five PIs on the board," Ward adds. "We’re looking for board members now."
• Continuous reviews: The FDA auditor who reviewed files from Our Lady of the Lake IRB said the IRB needed to begin submitting summaries of ongoing study protocols, Harper says. After a year or more, an IRB coordinator might not remember details of each protocol, so the auditor said the coordinator must file an abstract of the protocol, documenting past informed consent, current informed consent, and other details. "We came up with a form that showed how many people had been enrolled since inception and how many adverse events had occurred since inception, and whether there are any deaths and whether they are related," Harper says.
This continuous review form is sent to PIs to complete and return for the file. Harper has a computer database that automatically pulls up the projects that must be reviewed in the next month. This gives her the contact person’s name and address, and so she mails that person a letter and the form. (To see the IRB continuous review report and PI letter, click here.)
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