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Some suggestions to make your IRB fiscally fit
Require departmental pre-reviews
As IRBs face budget cuts, they can make some improvements in their processes that will make them more cost efficient.
Some of these changes might require institutional and departmental buy-in, but their long-term benefits could be worth the effort, an expert suggests.
For instance, IRBs at large academic institutions often are bogged down with protocols that have questionable scientific merit and are poorly prepared.
This consumes IRB time and resources and could be reduced by requiring a departmental review of protocols before they're submitted to the IRB, suggests Roberto A. Dominguez, MD, CIP, a professor at the University of Miami, Miller School of Medicine in Miami, FL.
"Before an investigator sends a proposal to the IRB office there should be some peer review," Dominguez says.
Here are his suggestions for improving an IRB's efficiency and outcomes:
1. Require two-pronged departmental review.
The University of Miami has mandated a departmental review with two spheres: "The first is scientific merit because we used to get bogged down all the time with some proposals [lacking scientific merit]," Dominguez says. "And the second is an administrative review where the administrator will look at the resources and study-related fees and expenses of the proposal."
Once an investigator satisfies requirements of the scientific merit review and the administrative review, then the study can be submitted to the IRB, he adds.
"Looking at it from that perspective, the burden has shifted from what the IRB office does to the department being held more accountable for what is sent for review," Dominguez says.
2. Assign a regulatory analyst to preview protocols.
Another way to make the IRB more efficient is to assign an IRB employee to the role of regulatory analyst, he suggests.
"A regulatory analyst looks at the study only from the perspective of completeness," Dominguez says. "If the study suggests a particular questionnaire, is the questionnaire there? Is the informed consent there?"
The analyst will identify possible pitfalls in the study based on his or her own knowledge and experience regarding the IRB's particular interests.
"The analyst will alert the investigator and say, 'I perceive some weakness and believe this should be modified,'" Dominguez says.
3. Impose IRB review fees for all studies.
"I believe that we have to impose IRB review fees for studies that lack funding," Dominguez says. This is a highly controversial move because it shifts the resource burden for unfunded study review to the departments, he notes.
A good reason for making this move is that it will help cut down on poorly-executed protocols being submitted to the IRB.
"What comes to the floor for IRB review sometimes is at best an idea," Dominguez says. "The researcher puts this idea together and then the perception — at least in some departments and for a minority of investigators and faculty — was that it's the IRB's job to fix it."
The IRB would meet, see the glaring problems with the protocol and attempt to fix it, resulting in six-hour long meetings at times, he adds.
"Then people would get up and leave, and we'd lose quorum," Dominguez says. "And those studies later on the agenda, which were more important, had to be deferred until the next meeting."
Although the IRB chair could cut off discussion on a particular study and move the agenda forward, this proved difficult to do, he says.
From the chair's perspective, the concerns were how he or she was supposed to say this wasn't the IRB's mission, he explains. "We're supposed to just point out the deficiencies and let the investigators fix them, but it was very difficult to do," Dominguez says.
4. Convince leading faculty to serve on IRB.
The IRB sometimes can become the extracurricular activity that no one wants to do — like freshman cheerleading coaching, Dominguez says.
"It would attract the lowest person on the totem pole," he says. "We saw that the most junior members of faculty and staff were appointed to the IRB."
This created two problems, he says. "As far as interaction with the investigator submitting a proposal, medical schools are like pyramids, and if you're an assistant professor you don't call a professor and say, 'I was reviewing your proposal, and I see some deficiencies,'" Dominguez says.
"The second problem was they were reading the IRB's role, process, and function and had to be educated on the fly," he adds.
"Now we have experienced members on the IRB," Dominguez says. "We put up our most experienced people, and the IRB has evolved because of stronger leadership."
The new leaders on the IRB are able to exert adequate influence to the chairs of different clinical departments, and they better understand their human subjects protection roles and have greater influence when interacting with investigators, he adds.