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Combating 'mission creep' in IRB review
Gauging the effects five years after white paper made recommendations to OHRP, IRBs
Five years ago, a panel of researchers and others involved in social and behavioral sciences convened to explore concerns about the scope and effectiveness of IRB review.
The goal of the project, participants said, was to help IRBs refocus their energies on important biomedical research by freeing them up from unnecessary bureaucratic procedures, as well as from fields of study where their oversight was unnecessary and unsuited to the research at hand.
They produced a document called the Illinois White Paper, which outlined several recommendations: gathering more empirical data about IRB activities; seeking more specific guidance from the Office for Human Research Protections about oversight of social-behavioral research; collecting best practices in this area; and removing some activities, such as journalism and oral history, from IRB oversight entirely.
C.K. Gunsalus, JD, director of the National Center for Professional and Research Ethics at the University of Illinois at Urbana-Champaign, chaired the committee that produced the Illinois White Paper. Five years later, she says dialogue about IRB "mission creep" has moved forward, but solutions remain elusive.
"I think there are some pretty interesting national conversations going on about how do we clear the underbrush, particularly for minimal-risk research, so that we can really focus on the areas of serious risk," she says. "So the foundations are laid, and there's an opportunity for more progress."
One area in which Gunsalus has seen significant progress is in the collection of empirical data about IRB activities. She pointed to the Journal of Empirical Research on Human Research Ethics (JERHRE), which began publication around the same time that the white paper was released.
"I think the field is being jumpstarted by having reputable journals that are seen as a prestigious place to publish," Gunsalus says. "That makes an enormous difference in terms of validating and encouraging research."
Joan Sieber, PhD, JERHRE's editor-in-chief since its founding, says the field of empirical research into human research ethics has been expanding rapidly, encompassing not only IRB activities but the ethical questions posed by new research techniques and technology. However, she says a fundamental question remains unanswered.
"We really don't have a way of figuring out whether IRBs protect human subjects," Sieber says. "We know they generate an enormous amount of paperwork and an enormous amount of anxiety and aggravation, but do they protect subjects?"
And she says that even as more lessons are learned about how to improve the functioning of IRBs, institutions are wary of implementing them, for fear that a study gone wrong could come back to haunt them.
"The first person who would get fired if an institution got into trouble would be the untenured IRB administrator, because they're not a faculty member," Sieber says. "So there is a kind of fear of doing something wrong that I think impedes genuine ethical problem-solving and produces a bureaucratic mindset that distorts priorities."
The Illinois White Paper called for more clarity in guidance from OHRP, as well as gathering best practices in this area that IRBs can use to help guide their policies.
OHRP has made an effort to provide relevant guidance in the area of social-behavioral studies, says spokeswoman Ann Bradley. She notes that in recent guidance documents on continuing review and approval of research with conditions, OHRP included illustrations of policy changes that would apply to social-behavioral research.
While Gunsalus says there have been small steps in the direction of more clear-cut guidance for IRBs about social and behavioral studies, those efforts are still somewhat fragmented. Her own National Center for Professional and Research Ethics is partnering with Public Responsibility in Medicine and Research (PRIM&R) to provide IRB-related items in its new national online ethics resource center. IRB items will cover best practices, including sample consent forms for various kinds of research projects.
"The ideas are out there," she says. "But how do you share them effectively, how do you overcome the local standards? I continue to believe that leveraging and empowering researchers by saying 'Here's our gold-standard form that's been approved at 43 IRBs' is bound to be helpful."
Gunsalus would like to see a more organized effort at gaining consensus on addressing many of these issues. The problem, she says, is that institutions are waiting for some kind of direction from the federal government before attempting to proceed.
"It's a chicken-and-egg problem," she says.
Jeffrey Cooper, MD, MMM, of Huron Consulting Group in Arlington, VA, advises IRBs about ways to streamline their procedures and eliminate unnecessary activities (see accompanying story). A former vice president for education and regulatory affairs at the Association for the Accreditation of Human Research Protection Programs, Cooper says AAHRPP has been trying to help institutions understand and apply the regulations appropriately.
"But we're not in an environment where a majority of institutions are accredited," he says. "It's having an effect, but I see it as something that's going to take time."
Fields of conflict
The authors of the Illinois White Paper recommended removing some fields of studyincluding oral history and journalismfrom IRB oversight. The authors argued that these fields have their own established ethical guidelines and that risks to participants were extremely low.
In the five years since, those who work in those fields say that federal regulations remain essentially unchanged, and in the case of oral history, that promised guidance from OHRP has not been produced.
Zachary Schrag, PhD, an associate professor of history at George Mason University in Fairfax, VA, writes about the intersection of social-behavioral research and IRB review.
While he is pessimistic about guidance from ORHP settling questions regarding oral history, he says several universities have made their own decisions to remove or limit IRB oversight of oral history activities.
"We're talking about less than a dozen institutions total, but those include some very prestigious universitiesColumbia, Princeton, the University of Michigan, the University of Texas," Schrag says. "It includes the University of Nebraska-Lincoln, which is an AAHRPP-accredited institution. It includes a couple of federal agencies, the U.S. Army and the Smithsonian Institution. That is certainly a big difference from five years ago."
In the field of journalism, there continue to be problems at individual institutions, says Esther Thorson, PhD, associate dean for graduate studies and research at the University of Missouri School of Journalism in Columbia.
While Thorson has worked out a solution with her own IRB, she says she continues to hear from journalism educators at other universities who struggle with their IRBs over what activities require oversight.
"Nationally, I think it's a fairly horrendous problem," she says. "There continues to be a lot of discussion about it."
"The Illinois White Paper: Improving the System for Protecting Human Subjects, Counteracting IRB Mission Creep" http://www.primr.org/uploadedFiles/PRIMR_Site_Home