IRBs combine to better use resources, expertise
IRBs combine to better use resources, expertise
Ensure social-behavioral researchers aren't in the cold
As many IRBs rethink their organizational structure to provide for more efficient review, some decide the time is right to create a second IRB and divide their studies into different areas of expertise.
At Washington University in St. Louis, MO, they did just the opposite. They took separate IRBs from two campuses and combined them under one organization. In the process, biomedical and social-behavioral studies, which had been for the most part separate, now were under the same umbrella.
It's proved to be a successful strategy — so successful that the institution recently was honored by the Health Improvement Institute with its Award for Excellence in Human Research Protection, best practice division.
Prior to the consolidation, Washington University maintained separate IRBs at its main campus and at its medical school three miles away. The main campus IRB handled social-behavioral research, while the medical school IRB handled both biomedical studies and a small number of social-behavioral studies, mostly in psychiatry, occupational therapy, and physical therapy.
Rose Walker, executive director of the university's Human Research Protection Office (HRPO), says a major impetus for the consolidation came during the university's accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) in 2004.
"When AAHRPP did their site visit, they were confused by our organizational structure," Walker says. "As part of their review, they recommended that communication between the two IRB offices improve. They commented that it was apparent that there were applicable resources available such as guidance, education, and checklists that were not utilized due to the lack of awareness."
Marjorie Speers, PhD, executive director of AAHRPP in Washington, DC, says that while she's seen some institutions separate their IRBs and others join them together, recently the trend has been toward consolidation.
"What they're finding is there are really more similarities than differences," she says. "A university is one unit. Even if it has multiple campuses, it is one university, and so there is a tendency to want to have one set of policies and procedures so there is a consistent message."
She notes that with the advent of greater communications technology, even far-flung campuses can operate as one unit without difficulty.
Faculty committee formed
Washington University officials considered the AAHRPP recommendations and saw a number of advantages to consolidating the two IRBs. The merger was viewed as a step toward further improving Washington University's already nationally recognized IRB system and to achieving higher levels of responsiveness and effectiveness in protecting research participants.
In addition, it would make the resources of the medical school IRB, which had a substantially larger staff, more readily available to the main campus. An unanticipated benefit was the sharing of the social-behavioral expertise of investigators at both campuses to review research studies within their specialty.
Walker says a 2005 reorganization at the medical school IRB further pointed the way toward an eventual consolidation with the main campus board.
"The sense was that with the changes that were made, the reorganization would support the consolidation," she says. "So in July 2005, the chancellor sent a letter to all the research faculty and staff and announced an initiative would be started to consolidate both IRBs."
To begin the process, the university eliminated its separate federal-wide assurance from the U.S. Department of Health and Human Services for the main campus, says Geralyn Fisher, manager of behavioral expedited review.
"Now, we have one FWA, so we operate under one set of policies and procedures," she says.
Philip Ludbrook, MD, previously the chairman of the medical school IRB and now executive chairman of the HRPO, next brought together a faculty committee with behavioral researchers from both campuses to begin developing the best model for review of that research.
Many of the researchers came to that meeting with concerns about what consolidation would mean for them, Walker says.
"Behavioral scientists had major concerns that all of the rules that we applied to the more risky biomedical research would be applied to them," she says. "That they did not want to complete an application that had a lot of questions that didn't pertain to their research."
Walker says the researchers also were concerned that they could get lost in the crowd, because the medical school investigators are responsible for initiating the largest percentage of research studies at Washington University.
"We took a lot of time and expended considerable effort to make sure that we understood the differences between biomedical and social-behavioral research," she says.
She also credits Sandra Hale, PhD, formerly chairwoman of the main campus IRB and now chairwoman of the university's behavioral minimal risk subcommittee, with helping gain the trust of the main campus researchers in moving forward with a consolidation.
"She has a tremendous amount of respect and a good track record with the faculty at the [main] campus," Walker says.
A dramatic realignment
Hale says that despite the initial worries of the social-behavioral researchers, they're now pleased with the final product.
As a measure of their comfort level, they ended up endorsing a model of IRB review that called for a dramatic realignment in the way the IRBs were constituted and run.
- The new HRPO oversees 10 full board IRB committees (the same number the medical school had before the consolidation).
- All boards have behavioral members, and all can review behavioral research, although one committee has been created to have extra expertise in different types of behavioral research, and researchers can request that their proposals be reviewed by that board.
- There are now two minimal-risk subcommittees — one for biomedical research and one for social-behavioral research — that review exempt and expedited studies. Previously, behavioral studies did not have their own minimal risk subcommittee, Fisher says.
"We presented four models, each with pros and cons, and the faculty group unanimously agreed that the best solution was number four — to our surprise," Walker says. "We actually didn't think that they would choose model four because it is the most dramatic change. We thought they would want to maintain some of the things that were already in existence at [the main campus].
"We were happy because we thought it was probably the best model, but we were willing to work with the faculty committee to develop an implementation strategy for the preferred model."
Hale says the inclusion of a special "extra-strength, extra-breadth" board on behavioral research helped reassure researchers at the main campus that they would have an option that was somewhat familiar in an otherwise unfamiliar process.
"This was especially true for the main campus folks who thought, 'I'm not so sure I want my full review going to a bunch of people who don't even know who I am,'" she says. "So by designating this committee, you can ask that your behavioral research go to that committee, with the recognition that if it has to go back, it could take another month."
Ironically, she says, no one has yet requested the committee's full review, in part because most studies from the main campus (97 percent during the 2005-2006 fiscal year) are exempt or expedited.
"But I expect that when someone in my psychology department wants to do a study with deception, involving confederates, or with other things that make people worry about risk, when one of those comes along, the committee will be requested," Hale says. "We just haven't had that yet."
Ludbrook notes that the increased caseload from the consolidation hasn't caused problems for the 10 full-board committees, despite the fact that most members have little social-behavioral research experience, since most of the social-behavioral studies have gone to the minimal risk review subcommittee.
eIRB helps smooth the way
Hale and Walker say another factor in the success of the consolidation was the simultaneous roll-out of a new electronic IRB submission process, which the social-behavioral researchers have embraced wholeheartedly.
"I think it helped to assure the behavioral scientists that we value their research and take the differences into consideration," Walker says. "I think that eIRB development really helped pave the way and made the transition easier."
Hale notes that members of the behavioral minimal risk subcommittee can also review studies online, which minimizes the amount of travel between the two campuses.
She says that only she and Fisher must ferry back and forth frequently.
"Gerri already was at both campuses, so I'm the one person who has to be at both campuses more than I used to be," Hale says. "And as it turns out, I live just a couple of blocks from the medical school campus, so it really has worked out.
"If only two people have had to do a lot more back and forth, that's not a terrible burden," she says.
Hale says that members of the former main campus IRB have expressed excitement about the new arrangement, although she admits to having encountered a little culture shock herself when serving on a board that reviews both behavioral and biomedical studies.
"I came to meetings, and instead of there being three items on the agenda — and I had been warned about this — there were 15 items," she says. "And 12 of them were studies where people could die! I was certainly not used to that."
"And the speed with which they were gone through was very different. When you only have three items on an agenda, and you're only meeting three or four times a year, you can take your time."
The Washington University officials say that the key to the success of this consolidation was securing buy-in from those who would have to use the IRBs — particularly the social-behavioral researchers from the main campus, who easily could have been swallowed up by the larger biomedical IRB structure.
"If you're going to take a medical institution that's primarily biomedical research and you bring in this smaller group, you have to make certain that they are treated well, that they're respected and that their point of view is respected," Hale says. "If you have an administration who recognizes that, it will make all the difference."
Fisher says that administrative support was demonstrated from the top, by Ludbrook's creation of the faculty advisory committee, and by the eIRB development process, which ensured that the needs of social-behavioral researchers were taken into account.
In fact, Hale says, for the period that she helped work on the eIRB project, she was given a complete course reduction to give her the necessary time to concentrate on it.
"So for a year, while we built this system, I was available for the innumerable meetings that were required," she says. "It takes a long time to go through — you need to ask the questions that need to be asked of all researchers, and then branch off appropriately depending on the kinds of research.
"If I hadn't had that kind of course release, I would have had to make it a lower priority," Hale says. "They made it possible for me to do that."
Speers agrees that when two differing IRBs consolidate, they need to be treated as equals within the new structure accommodating both. She supports the idea of a committee representing both campuses that can have a say in policies and procedures.
Speers says that Washington University's experience is a good example of how accreditation can help an institution take a critical look at its program and use that process to improve.
"They had an excellent human research protection program, and as a result of going through the accreditation process and continuing to work on accreditation, they've made changes that will make it even more effective," she says.
As many IRBs rethink their organizational structure to provide for more efficient review, some decide the time is right to create a second IRB and divide their studies into different areas of expertise.Subscribe Now for Access
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