Optimization committee helps with consistency
IRB chairs, others, work out issues for themselves
Every other week, those most directly involved in protecting human subjects in Vanderbilt University’s research programs meet in an effort to ensure that the university’s policies and procedures are implemented consistently across its four institutional review boards.
The IRB Optimization Committee (OC) brings together university research officials with IRB chairs, the committees’ protocol analyst team leaders and others to discuss problems, brainstorm solutions and head off potential inconsistencies in the ways that policies are carried out from board to board.
Formed in 2000 as part of a broader overhaul of IRB operations at Nashville-based Vanderbilt, the OC has helped the IRBs stay on top of an increased workload, says Vanderbilt’s IRB director Denise Roe, BA, CCRP, CIP.
Key to the OC’s success, says Roe, is that its structure ensures the autonomy of individual committees, while helping IRB chairs arrive at solutions on their own.
"Our committee members are very sensitive, and they don’t want anyone telling them what to do. They’ll say, We are independent.’ We don’t vote, we don’t approve or disapprove protocols. We actually discuss issues," Roe says. "There are some institutions that have developed what they call oversight committees, but they make specific recommendations back to the committees. We try to really steer clear of that. That’s not our goal. It’s really a place for the chairs to come and talk amongst each other."
She says an issue can be referred back and forth between the OC and individual IRBs several times so that the committees can work out a problem themselves.
Part of larger IRB overhaul
Roe says that the OC got its start after Gordon Bernard, MD, was named medical director of the IRB in 1999. In light of problems at other institutions that were being publicized nationally at the time, Bernard sought a number of changes in the way the IRB operated, Roe says.
One was the Optimization Committee, whose initial charge was to "ensure careful integration of new procedures that were necessary to optimize the operation of the IRB and for the protection of human subjects, and looking at compliance with OPRR (now the Office for Human Research Protections, or OHRP) and the FDA regulations," she says.
The committee first spent a lot of time looking at the mistakes of other institutions, combing through OHRP determination letters to find areas that might be vulnerabilities at Vanderbilt as well.
As the university developed new policies and procedures for protecting human subjects, the OC focused on making sure those policies were implemented consistently on all boards for all protocols.
When the OC began, Roe says, the university had three IRBs — two health science and one behavioral/social science — and had about 1,000 active protocols. Now, there is an additional health science IRB, and the workload has nearly tripled.
As the human subjects protection program has grown, it has become more of a challenge for policies to be administered evenly across the boards.
"We can’t eliminate all variation, it’s impossible," Roe says. "We have 46 voting committee members. It’s unreasonable to think that any of them are going to be exactly alike all the time.
"I try to explain to our investigators that if everything was templated and it was always the same answer, than you wouldn’t need an IRB. So you will have a little variance, but if you optimize how we will do our processes, perhaps we can get a little more consistency."
At Vanderbilt, nearly all new health science protocols are assigned to IRBs in the order they’re submitted.
"We don’t separate them out by field, or area of expertise, or even by principal investigator. It’s very much 1, 2, 3, 1, 2, 3, to balance workload," Roe says. She says the only exception is protocols involving radiation, which always go to a particular board.
When variations are identified and referred for discussion to the OC at its biweekly meeting, members of the committee attempt to discern the reason behind them. Does one committee have information that the others don’t? Has a shift in membership on a board caused a change in the way it views an issue?
"It could be something small, like a process that’s different," Roe says. "It’s a very small process that’s different, but it’s impacting our research community and how they are able to relate to the IRB."
Letting IRB chairs work it out
While Roe and Bernard attend OC meetings, they refrain from making recommendations themselves, or steering the committee to make a formal recommendation.
"A lot of times what we’ll do is let the chairs themselves talk it out, and if we have something we can’t seem to come to agreement with, we table it and we’ll bring it back in a few weeks to the next OC meeting," she says. "Typically, we end up seeing things from a different light then."
What Bernard will do, occasionally, is to help reorient a discussion that seems to be veering off the track of protecting the subjects, Roe says.
"Sometimes members will get into a discussion and feed off each other a little bit," she says. "And soon, they’ve lost focus of, what I should expect as a participant. They’ll say, As a physician, you should do this.’
"Recently, Dr. Bernard kind of brought the committee back by representing himself as a patient, as a participant in the trial," Roe says. "The committee said, Oh, yes, that’s right, that is why we’re here.’"
Whether an issue has been resolved or not, OC members leave the meeting with an understanding of what each will do about the subject, Roe says — whether it’s revising a procedure, reeducating members about a particular policy, or taking the matter back for more discussion.
As an example, Roe points to a recent problem that came up over a large research project being shared between Vanderbilt and a collaborating institution. Although the usual procedure was for Vanderbilt’s IRB to review amendments to the plan first, for some reason both institutions reviewed one at the same time, and came to different conclusions. The chair of the Vanderbilt IRB that reviewed the project believed its decision should stand, regardless of what the other institution did. But he was convinced to bring the matter to the next OC meeting, Roe says.
"Instead of focusing on the details of the [disagreement], we took the approach of how are we protecting participants?" Roe says.
"Fundamentally, our IRB made a decision based on what they believed to be the principle of what the project was going to be. Of course the other IRB made a determination on what they believed to be the principles behind the study."
She says the other committee chairs were instrumental in helping the IRB chair see that it might be worth another discussion in his committee — and that the chair of the collaborating institution’s committee should be given a chance to explain his committee’s decision. The chair took it back to his committee and invited the collaborating institution’s IRB chair to contribute by speakerphone. Ultimately, the matter came before the OC three times, but in the end, the Vanderbilt IRB agreed with the collaborating institution’s decision, with a few revisions.
"I’m not even sure that the chair was on board, but when the chair presented the OC discussion back to the [original reviewing IRB], the committee got it, and said, we need to think about this — we know we’re independent, but we’ve got to talk about it. We can’t just put it in a drawer and say we’ve made our decision and we’re done."
Without the work of the OC, Roe says the two institutions could have been stalemated much longer.
Roe says that the approach of the optimization committee — striving for consensus even while respecting the IRBs’ individual autonomy — is a good model for other collaborative IRB efforts, such as maintaining consistency across multisite studies.
"Essentially, the protocol is the same at every institution. What most people get hung up about is all the local context," she says. "What I think the standard of care is at Vanderbilt may not be the standard of care somewhere else. And sometimes, state laws are different. How do we find closure more quickly?"
She sees the possibility of a similar body to an OC, bringing together IRB decision makers from different institutions to discuss problems and try to reach consensus. "I could see optimization committees being used in a lot of different settings, not just at the local IRB level," Roe says.
Every other week, those most directly involved in protecting human subjects in Vanderbilt Universitys research programs meet in an effort to ensure that the universitys policies and procedures are implemented consistently across its four institutional review boards.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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