2011-12-08T06:25:00.001-08:00

AAHRPP/Advance

IRBbashing

revised, 12/1/2011

Strategies to Address IRB Bashing

Complaints about IRBs have existedas long as IRBs themselves. But according to directors of human researchprotection programs (HRPPs) at three accredited institutions, that doesn’t meancomplaints are inevitable, and it certainly doesn’t mean they should beignored.

“IRBs are a fairly easy targetbecause, to some researchers, the requirements for comprehensive review seemmore 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 isunwarranted, “some complaints have a lot of merit,” she says. “IRBs need tolisten, to understand when they’re over-interpreting and overstepping and, ifnecessary, to make changes.”

Ms. Keane and two of her colleaguesand fellow AAHRPP site visitors—Sharon Friend, M.S., C.I.P., Director, Officeof the HRPP (OHRPP), University of California, LosAngeles (UCLA),and Karen Hale, R.Ph., M.P.H., C.I.P., Interim Director, Office of Responsible ResearchPractices (ORRP), the Ohio State University―have maintained strong, ethical research programs whilewinning over IRB critics. Below they share some strategies for addressing andpreventing IRB bashing.

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· Educate your customers and IRB staff.

· Streamlinethe process whenever possible.

· Involvefaculty and researchers in decision making.

Forge and strengthen connections with researchers.
Keep pace with the changing research landscape.
Make yourselves available to those who need help.

· Aboveall, listen.

Educate your customers and IRB staff. When faculty and researchers understand the role of theIRB, they are less likely to criticize. U of M has made a concerted effort toeducate investigators about the regulations governing research with humanparticipants, the need for often-rigorous review, and the benefits of thatreview to the research enterprise. Ohio State views quality improvement visits asopportunities to educate researchers and IRB staff. “We talk to them about theprocess and answer their questions, and they give us a better sense of what’sgoing on in the field,” Ms. Hale says.

Both Ohio State and UCLA emphasizestaff education as a way to enhance professionalism and improve customerservice. As a result, at Ohio State, all eligible ORRP staff members haveearned their Certified IRB Professional credentials. “They are well-educatedand able to respond creatively when necessary,” Ms. Hale says.

Streamline the process whenever possible.Thethree institutions use expedited review procedures for studies that poseminimal risk to research participants. All three have simplified the system formaking minor changes to research proposals. Ohio State has added staff toimprove the turnaround time both for amendments and for expedited review ofresearch.

Perhapsthe most dramatic changes have been at UCLA, which has seen a markedimprovement in the relationship between researchers and the IRB. When Ms.Friend joined the OHRPP three years ago, one of the biggest complaints was thattoo few protocols were reviewed using an expedited process. Now, of the approximately4,000 studies submitted for review each year, roughly 2,800 qualify for the expeditedprocedure. About 1,000 are reviewed by the convened IRB, and the rest areexempt.

Involve faculty and researchers indecision making. Whenresearchers and IRB staff work together, they gain a better understanding ofeach other’s perspectives—and of the reasoning behind policies and procedures. Equallyimportant, if faculty and researchers are involved in shaping the reviewprocess, their colleagues are more likely to accept it. At UCLA, for example,when people question the application process, “I can tell them it reflectsfaculty input, and they’re less likely to object,” Ms. Friend says.

Forge and strengthen connections with researchers. At all three institutions, involvement worksboth ways. IRB staff don’t just extend invitations; they also are quick toaccept them. Ms. Friend set the tone for her staff at UCLA when, on her secondday there, she accepted an invitation to attend a meeting to field complaintswith faculty. At Ohio State, ORRP members often agree to serve on institutionalcommittees to help build bridges and raise the department’s profile withfaculty. Recently, an ORRP member took part in a committee’s work to implement themedical center’s new electronic medical records system. The motivation wastwofold: 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 researchin a changing environment. “Instead of standing in the way, we try to figureout how to say yes,” Ms. Hale says. In keeping with that philosophy, Ohio Stateis developing policies and procedures for research conducted via the Internet.The university also is helping to draw up protocols for creating a data andspecimen bank that about 100 institutions engaged in collaborative researchprojects will share.

Make yourselves available to those who need help. Many problems between IRBs and investigators canbe prevented by giving assistance upfront. UCLA and Ohio State offer to helpnew researchers complete their IRB applications. All three institutions provideonline resources to guide researchers through the review process. All threealso encourage researchers to contact staff, via phone or email, with anyquestions.

Above all,listen. It’sstandard practice at all threeinstitutions to solicit feedback and respond either with an explanation or withappropriate action. One of the most striking examples comes from Ohio State,where researchers want to be able to submit applications online. The universityis developing an electronic submission system, but it will take time. As aninterim solution, the ORRP set up “IRB Submit” to allow researchers to uploadfiles in any format to a Web-based document management system. “In a perfectworld, 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’rereally doing this just for our customers, until we can offer the ability forthem to complete forms online.”

AAHRPP Advance 2