Thursday, December 8, 2011

Strategies to Address IRB Bashing

Complaints about IRBs have existed as long as IRBs themselves. But according to directors of human research protection programs (HRPPs) at three accredited institutions, that doesn’t mean complaints are inevitable, and it certainly doesn’t mean they should be ignored.
“IRBs are a fairly easy target because, to some researchers, the requirements for comprehensive review seem more like an impediment than a necessity,” says Moira Keane, M.A., C.I.P., Executive Director, HRPP, University of Minnesota (U of M), and Chair, AAHRPP Council on Accreditation.
Although much of the criticism is unwarranted, “some complaints have a lot of merit,” she says. “IRBs need to listen, to understand when they’re over-interpreting and overstepping and, if necessary, to make changes.”
Ms. Keane and two of her colleagues and fellow AAHRPP site visitors—Sharon Friend, M.S., C.I.P., Director, Office of the HRPP (OHRPP), University of California, Los Angeles (UCLA), and Karen Hale, R.Ph., M.P.H., C.I.P., Interim Director, Office of Responsible Research Practices (ORRP), the Ohio State University―have maintained strong, ethical research programs while winning over IRB critics. Below they share some strategies for addressing and preventing IRB bashing.

Educate your customers and IRB staff. When faculty and researchers understand the role of the IRB, they are less likely to criticize. U of M has made a concerted effort to educate investigators about the regulations governing research with human participants, the need for often-rigorous review, and the benefits of that review to the research enterprise. Ohio State views quality improvement visits as opportunities to educate researchers and IRB staff. “We talk to them about the process and answer their questions, and they give us a better sense of what’s going on in the field,” Ms. Hale says.
Both Ohio State and UCLA emphasize staff education as a way to enhance professionalism and improve customer service. As a result, at Ohio State, all eligible ORRP staff members have earned their Certified IRB Professional credentials. “They are well-educated and able to respond creatively when necessary,” Ms. Hale says.
Streamline the process whenever possible. The three institutions use expedited review procedures for studies that pose minimal risk to research participants. All three have simplified the system for making minor changes to research proposals. Ohio State has added staff to improve the turnaround time both for amendments and for expedited review of research.
Perhaps the most dramatic changes have been at UCLA, which has seen a marked improvement in the relationship between researchers and the IRB. When Ms. Friend joined the OHRPP three years ago, one of the biggest complaints was that too few protocols were reviewed using an expedited process. Now, of the approximately 4,000 studies submitted for review each year, roughly 2,800 qualify for the expedited procedure. About 1,000 are reviewed by the convened IRB, and the rest are exempt.
Involve faculty and researchers in decision making. When researchers and IRB staff work together, they gain a better understanding of each other’s perspectives—and of the reasoning behind policies and procedures. Equally important, if faculty and researchers are involved in shaping the review process, their colleagues are more likely to accept it. At UCLA, for example, when people question the application process, “I can tell them it reflects faculty input, and they’re less likely to object,” Ms. Friend says.
Forge and strengthen connections with researchers. At all three institutions, involvement works both ways. IRB staff don’t just extend invitations; they also are quick to accept them. Ms. Friend set the tone for her staff at UCLA when, on her second day there, she accepted an invitation to attend a meeting to field complaints with faculty. At Ohio State, ORRP members often agree to serve on institutional committees to help build bridges and raise the department’s profile with faculty. Recently, an ORRP member took part in a committee’s work to implement the medical center’s new electronic medical records system. The motivation was twofold: to determine appropriate ways to access medical records for research, and to connect with other committee members.
Keep pace with the changing research landscape. Part of the IRB’s role is to facilitate research in a changing environment. “Instead of standing in the way, we try to figure out how to say yes,” Ms. Hale says. In keeping with that philosophy, Ohio State is developing policies and procedures for research conducted via the Internet. The university also is helping to draw up protocols for creating a data and specimen bank that about 100 institutions engaged in collaborative research projects will share.
Make yourselves available to those who need help. Many problems between IRBs and investigators can be prevented by giving assistance upfront. UCLA and Ohio State offer to help new researchers complete their IRB applications. All three institutions provide online resources to guide researchers through the review process. All three also encourage researchers to contact staff, via phone or email, with any questions.
Above all, listen. It’s standard practice at all three institutions to solicit feedback and respond either with an explanation or with appropriate action. One of the most striking examples comes from Ohio State, where researchers want to be able to submit applications online. The university is developing an electronic submission system, but it will take time. As an interim solution, the ORRP set up “IRB Submit” to allow researchers to upload files in any format to a Web-based document management system. “In a perfect world, we wouldn’t introduce something we weren’t going to stay with, especially since this will be more work for our office,” Ms. Hale says. “We’re really doing this just for our customers, until we can offer the ability for them to complete forms online.”

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