The most award winning
healthcare information source.
TRUSTED FOR FOUR DECADES.
Mission Creep: Is it leading IRBs astray?
White paper makes case that IRBs have gone too far afield
Social behavioral scientists says IRB overreach is stifling research
Editor’s Note: This month’s issue of IRB Advisor contains a special report on the phenomenon known as "mission creep"— the charge that IRBs are inappropriately delving into fields of research that don’t require their review. This story focuses on the Illinois White Paper, a project of social behavioral researchers at the University of Illinois. They recommend that IRBs withdraw from reviewing work in some disciplines in order to focus more fully on biomedical studies that more urgently need their oversight. Also, inside this issue are articles about how institutions should handle quality improvement projects that may or may not involve research and about how some IRBs have become overzealous in their pursuit of human subjects protection. To view the Illinois White Paper, visit http://www.law.uiuc.edu/conferences/whitepaper/.
The latest round in the ongoing debate between IRBs and social and behavioral researchers about the scope and effectiveness of IRB review has come in the form of a white paper, "Improving the System for Protecting Human Subjects: Counteracting IRB "Mission Creep," released late last year by the Center for Advanced Study at the University of Illinois at Urbana-Champaign.
The paper’s authors, who represent a range of the social and behavioral sciences and many of whom have previously served on the university’s institutional review board, say their effort isn’t intended as an attack on IRBs. Instead, they say, they want to see IRBs freed up from activities that don’t require their review so that they can focus on more pressing concerns of human subject protection.
"It was not a bunch of angry academics screaming, Academic freedom,’" says Gregory A. Miller, PhD, a clinical psychologist and professor at the university. "It was not a confrontational situation.
"We saw the pressures on IRBs — not only ours — growing. We saw universities running scared because the feds were shutting down places. We see the range of scholarly activity that might fall under an IRB, and we see IRBs expanding their reach, what we call mission creep, but applying rules that didn’t seem to be that applicable."
The white paper explores those issues and makes a series of recommendations to IRBs and universities including one that could potentially be the most controversial: Removing IRBs entirely from some fields of study to which the authors believe IRB review is unsuited.
"In summary, expansive notions of university research and institutional commitments to the IRB reviewing all human research are untenable," the paper states. "The scope and purpose of IRB review must be clarified."
More hassled than the baseline’
C.K. Gunsalus, JD, former executive secretary of the IRB at the university and currently an adjunct professor of law and special counsel to the institution, chaired the committee that wrote the Illinois White Paper. She was prompted to take up the issue after hearing more and more stories from researchers about examples of what she saw as overzealousness by IRBs.
"There’s always going to be someone who says, Oh, I have to fill out this form, I have my important research to do; you’re in my way.’ There’s a baseline," Gunsalus says. "But I was beginning to hear something different than what I have seen for more than 20 years. I began to perceive a theme of people feeling more hassled than the baseline."
Those concerns led to pulling together a group of academics to discuss the issue, and to convene a conference, inviting experts from both sides of the IRB board table. The resulting report identifies two separate but connected issues arising in IRB review:
• Overemphasis on documentation issues, even to the detriment of real ethical review. The authors note that the most frequently cited lapses in IRB audits by OHRP and the FDA are "poor or missing standard operating procedures" and "poor minute keeping."
"It’s very easy to end up saying, Let’s count some more beans,’" Gunsalus says. "You can count signatures on consent forms, but consent is a continuing process, not a signature. Somebody needs to say, Yes, we have pristine files, do we have ethical research?’"
• Mission creep, or the gradual insertion of IRB oversight into new areas of study, which the authors suggest they may be ill-equipped to regulate.
The paper suggests that this is the result of a number of factors, including poor definition by federal authorities as to what constitutes "research," "harm," or "risk." That leaves the definition to IRBs, which may lack the expertise to know how to apply those terms to minimal-risk social and behavioral research. The IRBs also may over-regulate out of a knee-jerk fear of allowing research that may result in a government shut-down or a lawsuit, the authors say.
The resulting climate leads to incidents in which, for example, an IRB required an anthropologist to administer written consent forms to an illiterate tribe he is studying. Or journalism students were required to consider the potential risk to sources they interviewed for articles. Or an IRB wanted to review a proposal to analyze taped speeches by the late President Ronald Reagan that were stored at his presidential library because at the time of the proposal, he was still living.
The authors argue that beyond stifling some research, this system overloads the IRB, shortchanging important work in protecting subjects of biomedical research. And they say it leads to a deterioration of confidence in the IRB by researchers, who may then seek to bypass it.
"I believe very, very strongly, that compliance systems require respect and buy-in from the regulated to function," Gunsalus says.
Not all agree
Those who work with IRBs, not surprisingly, disagree with some of the white paper’s assertions, particularly its recommendation that areas such as oral history and journalism be removed from the purview of IRBs.
Jeffrey Cohen, PhD, president of HRP Associates Inc., located in New York City, is a consultant for IRBs. He discounts the argument that because many social-behavioral science activities are low risk, an IRB shouldn’t have to review them.
"That’s not all that IRBs look at or are responsible for," he says. "Risk is only one component. They also should be looking for respect for persons, which has nothing to do with risk. And they should look at justice, the exploitation of subject groups."
Cohen also believes that researchers can’t be objective about the true risks of their work, and need someone to review it who can look at it more detachment.
"Now, that doesn’t necessarily need to be a full board IRB review," he says. "It could be expedited review, it could be review for exemption. There’s a lot of flexibility in the regulations about how that review can take place, and a lot of it applies to minimal risk research."
But those involved with the white paper group say such a review can be accomplished without involving the IRB. Edward M. Bruner, PhD, a professor of anthropology at the University of Illinois who has done extensive ethnographic research, says his work could be more effectively addressed by a review panel within his own department, which would understand the complexities of informed consent in ethnography, and could apply his own professional association’s code of ethics to his proposed study.
At the very least, he says, such departmental panels could serve as expert boards to advise the IRB in fields where it lacks the necessary expertise.
Marjorie Speers, PhD, executive director of the Association for the Accreditation of Human Research Protection Programs (AAHRPP), agrees with Cohen that all research involving human subjects needs to be under the IRB’s authority.
"I don’t agree with a blanket statement that there are no activities in the discipline of history or oral history or journalism that are human subjects research," she says. "It depends. Depending on the discipline, the vast majority of the activities might not be human subjects research, but there might be some that are."
But both Speers and Cohen agree with some of the other recommendations of the white paper including:
• Conducting more empirical research into IRB functions themselves, into the IRB decision-making process, about their workloads and their effectiveness in protecting human subjects.
The authors say it’s ironic that this is an area of research that is under-explored. Miller says that’s because the issues fall outside the realm of most researchers’ areas of study. He and Cohen say another major factor is that there’s little grant money available to pursue studies of the research process.
"I think the [National Science Foundation] and the [National Institutes of Health] should be funding this type of research," Cohen says. "I think professional organizations should probably be funding this type of research."
Cohen also would like to see more research into how participation in social and behavioral research affects subjects, particularly in the long term. "A lot of the possible harms that could come to subjects in social and behavioral research are not obvious," he says. "It’s not like taking a drug and getting sick or having surgery and dying. The effects of being in social and behavioral research are subtle and they could be delayed."
• Seeking OHRP guidance that more specifically addresses social-behavioral research.
"There are some inherent difficulties in the federal regulations, and so I think it’s important for institutions to continue to have a dialogue with OHRP about what the concerns are and try to get OHRP to issue guidance," Speers says.
However, officials from OHRP declined comment on the white paper for this article, saying the response to the report was better left to IRBs.
Speers notes that the research community should communicate with the Secretary’s Advisory Committee on Human Research Protections, whose Subcommittee on Federal Policy for the Protection of Human Subjects (Subpart A) is examining issues having a bearing on IRB review of social-behavioral research.
"Subpart A is where most of the challenges are for investigators and IRBs in reviewing behavioral and social science research," Speers says. "It’s important to follow what that subcommittee is doing and to interact with that subcommittee so they hear loud and clear what the concerns are from the behavioral and social science community."
• Providing methodologically appropriate examples for IRBs to use when reviewing social and behavioral research. The authors suggest that those examples could help clarify issues of "risk" and "harm" in non-biomedical settings.
• Fostering development of "best practices" in IRB operations, which could include such issues as potential appeal procedures, IRB membership, policy seminars and use of exemptions and waivers of consent.
Where do we go from here?
Miller and Gunsalus say they hope the white paper furthers the debate on the problems between IRBs and researchers, regardless of whether it results in all of the changes they have recommended.
Gunsalus says it’s particularly important considering the continuing efforts to bring even more research under the IRB’s responsibilities. "The next time there’s a scandal, and the next time there’s congressional interest, it will be all too easy to say we should make all human subjects research of whatever funding covered by federal regulations," she says. "There’s going to come a time when these regulations are reopened. Let us be prepared so we can have a nuanced and informed discussion and really focus our energies on the places that have ethical implications rather than counting signatures."
In the meantime, the paper does suggest that even without federal action on the issue, institutions can begin addressing it on their own, by looking at the degree of intensity they give research of different levels of risk and by using more flexible guidelines for research that is not federally funded.
Speers says AAHRPP tries to use the accreditation process to help educate IRBs not just about where they’re falling short of federal requirements, but also where they may be exceeding them and causing problems for researchers in the process. She says some IRBs may not be using mechanisms such as exemptions and expedited review as they should be.
"If we feel that they’re doing more than is required by the federal regulations — particularly if they have limited resources and they’re overburdened — and they’re not using all of these mechanisms that they have available, then we point that out," Speers says.
All say that IRBs and faculty should work together to try to sort out their differences, and make the process work better.
Miller, who himself served on the University of Illinois’ IRB for several years, says researchers who are willing to delve into human subjects protection and even serve on a board themselves will have more knowledge and authority when they think an IRB is wrong. "If you served on an IRB, you might be an effective person to argue with them," he says
Cohen believes that cooperation, rather than confrontation, is the key to getting IRBs to listen to researchers’ complaints.
"The approach should be, How do we make the IRB work better? How do we make it more efficient, more flexible, more appropriate to the kind of research that we’re doing?’" he says. "If those were the arguments that faculty were making to those institutions, then they’d be more likely to get a positive response."