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IRB splits to improve quality and efficiency
Research advisory council reviews study design
The IRB at Oakwood Healthcare System in Dearborn, MI, reviews protocols for four hospitals, including protocols written by master’s level, doctoral level, nursing students, and the 150-plus residents.
The caseload is challenging. The institution recently decided that the IRB cannot do all of this alone in as effective a manner as desired, so officials came up with an innovative solution: "We created another body called the research advisory council [RAC] that basically derives authority through the IRB, although its function is different," says Mary Barnhart, CIM, CIP, manager of IRB programs.
"We’re finding that because of the amount of paperwork and protocols, it’s too easy to rubber-stamp protocols, and people don’t have time to go through 900 pages of paper," she explains. "We’re hoping the process will alleviate the amount of time both boards have to meet and work."
The idea for splitting the IRB into two groups that worked jointly came from the Institute of Medicine’s suggestion for institutions to form ethics boards, Barnhart notes.
"We took our cue from this to divide the workload of the IRB, and we took it a step further and said, We don’t need an ethics review so much as study validity and study design,’" she reports. "So that’s how we split it, which makes sense to us because we have ethics people on the IRB, and that to us is part of human protections."
The RAC will look at the scientific review, while the IRB focuses on human subjects protection, Barnhart says.
The new program will work this way: When investigators, students, and residents submit protocols, the application process begins with the RAC, whose members study the protocol’s validity, design, study analysis, budget, financial issues, and conflict of interest, she explains.
"The RAC’s make-up is more technical than the IRB’s," Barnhart says. "Their function is to look at those areas of the protocol and report to the IRB so the IRB can then be free to focus on human subjects protection."
The IRB’s 18 members are divided between the IRB and the RAC. The RAC will have more physician members, and the IRB will have all of the community members.
Also there will be some membership changes, she adds. For example, the RAC with its 10 members will have a grants expert to address budget, grants, and financial issues, Barnhart says.
"We never had a grants person on the IRB before, so we revised who we have admitted to each board," she says. "We haven’t added members so much as adjusted memberships, letting some board members go and putting others in."
When the RAC needs additional expertise, it can call on additional experts.
"We have an ad hoc committee we can pull from that would be suggested by chairs of departments when we have a protocol in a particular area where we may have a little expertise," Barnhart says.
For example, for a dermatological study, the RAC might ask for consultation with a dermatologist. Once satisfied with the science and study design of a protocol, the RAC will sign off on it and hand it to the IRB, which will look more closely at the informed consent process, study population, level of risk, and subject recruitment, Barnhart notes. "This is our innovative way to deal with not having enough time and too much to review," she says. "We hope this will streamline the process."
The institution has plans to begin educating staff and board members about the new program this month, Barnhart reports.
After the education process is complete, the IRB will be divided, and the new process will begin, she notes.
"Then we’ll do our own study and review the process to see if it is indeed helpful," Barnhart says. "Our biggest challenge has been duplication and getting this program rolling without duplicating processes."
With one submission process and close interaction between the RAC and IRB, it hopefully will roll out smoothly without adding to the time it takes for a protocol to receive full IRB approval, she adds.
"We’re still trying to do this within a four- to six-week approval time, but we won’t know if we can do this until it’s up and running," Barnhart explains.
Since the IRB will be a much smaller board that can focus on the human subjects aspect of research, it likely will have shorter meetings than it has, she says. "Our meetings now are two to 3½ hours, and it’s too much of a burden on our IRB."
Another benefit is that with a smaller board it will be easier to obtain quorum, Barnhart adds.