Social scientists take issue with IRB aversion to risk
Researchers also concerned about IRB workloads
As IRBs grapple with the issues raised by social-behavioral research, they may also want to consider the concerns of researchers who in a recent study charged that delays in processing proposals and overly intense risk aversion have impeded valuable research. T. Gregory Barrett, MBA, MA, PhD, assistant professor of educational leadership at the University of Arkansas-Little Rock, says he and colleague Jim Vander Putten, MS, PhD, assistant professor of higher education and IRB chair at UALR, did a series of studies of social science researchers and IRB officials.
Their goal, Barrett says, was to understand the attitudes of researchers regarding climate of human subjects research at their institutions. Barrett presented early results from his work last year to a conference sponsored by the Department of Health and Human Service’s Office of Research Integrity.
Barrett says he and Vander Putten felt it was important to look specifically at the attitudes of researchers he terms "outliers" "folks who are frustrated with IRB rules, regulations, policies, practices and so forth," to get a better overall picture of the research climate.
They identified 12 individuals, who conducted a range of different types of social and behavioral research at different institutions, both public and private.
"The interesting thing about this study is that all 12 participants are active researchers and all 12 of them believe strongly in the role of the IRB in protecting human subjects," Barrett says. "Their issues revolved around policies and practices they felt had become onerous, or had caused difficulties in getting prompt IRB approvals, or situations in which they felt the IRB had been overly cautious with their assessment of risk, that sort of thing."
Regulation-bound, overloaded?
Barrett says many of the researchers felt overly regulation-bound, particularly at institutions that were heavily dominated by biomedical research. Researchers speculated that the IRB was worried a mistakenly approved study might get an entire research operation shut down.
Barrett says those concerns were expressed even at institutions with separate social-behavioral IRBs.
"The whole concern revolves around protection of institutional reputation," he says. "The federal government doesn’t differentiate between social science IRBs and biomedical IRBs. If something’s done in a psychological study, through the social science IRB, it can still shut down the entire research operation, potentially."
Another concern raised by the researchers was that the IRBs reviewing their studies were overloaded with work, which led to critical delays in approval.
"As research expectations and research productivity have increased exponentially, the number of people employed by IRBs and the number of people engaging in volunteer work for IRBs has not kept pace, so they get bogged down in research overload," Barrett says.
Researchers in the outliers study complained that IRBs have become overly risk-averse, applying reasonable federal regulations in ways they were not intended to be used. Some researchers also believed that IRBs had crossed the line in reviewing the methodology of studies.
Barrett says participants gave some specific examples of cases in which these disagreements hampered their work:
• One organizational behaviorist reported that he had been given permission to conduct a study in a corporation and was given a period of time in which he could conduct his research. Because of IRB concerns about his study, its review was put on hold repeatedly, for more than six months. In the end, Barrett says, the researcher lost his opportunity to do the work at the corporation.
• A community psychologist, who was doing research related to HIV at a prison, saw her proposal approved by the prison’s IRB with no problem. However, when she attempted to gather other information at a local community hospital, a different IRB wanted to make changes to the consent form indicating that some data for the study had been collected in a prison.
"They felt like that would give a stigma, and that perhaps prevent women from participating in the study at the community hospital," Barrett says.
• The same psychologist gave another example, that of a student of hers who wanted to interview victims of sexual assault. The IRB insisted that she interview the women in a clinic setting so that there could be a psychological intervention if the subject became distraught. The psychologist noted that the student wasn’t a clinical student, and that they felt doing the interviews in a clinical setting gave subjects the impression that they were too fragile to confront the facts of their assault.
"As we thought further about recovery from trauma," the psychologist said in her interview, "we began to theorize more about how the requirement of the IRB worked against what is necessary to be a successful survivor of sexual assault. That is, not to convey the message that someone is damaged goods or someone who the minute you ask them about sexual assault is going to fall apart or go to pieces."
Vander Putten says that as he looked at the outliers’ comments through his eyes as an IRB chair, he sees an atmosphere in which researchers often don’t understand the role of the IRB or their own responsibility to submit to the board’s judgment.
"Part of it may be faculty viewing themselves as independent contractors," he says. "Faculty love their autonomy, and I think that’s important, but it’s also important to note that there are limits to that autonomy and faculty cannot always act as free agents."
He says that many researchers harbor the opinion that IRB restraints are a violation of academic freedom, a stance that’s been rejected by the American Association of University Professors. And he notes that the time pressure researchers report is often of their own making, and could be avoided with planning. For example, he says many researchers at his college are working within the preschool-high school academic calendar, and wait until late in the year to seek necessary approvals of their work.
"I always kind of cringe about April or so because I know IRB proposals are going to come screaming in because people are going to want to collect data before the kids get out of school for the year," he says. "The researchers place much more emphasis on getting the data than they do on protecting the rights of prospective participants."
Bridging the gap
The researchers Barrett interviewed did have ideas about ways in which IRBs could bridge the gap with social scientists while still preserving a commitment to protecting research subjects:
• Find ways to manage workload and turn proposals around more efficiently.
• Create IRBs that are specific to individual academic units, which would have more understanding of their methodological approaches.
• Create an atmosphere in which IRBs see it as part of their mission to encourage good research, while still abiding by the regulations.
One participant suggested more active presentations by the IRB to inform the research community of how to conduct research properly.
Both Barrett and Vander Putten say that their experiences on the other side of the IRB review table have helped broaden their understanding of the tensions between social-behavioral researchers and IRBs.
As part of their study into attitudes regarding research, Vander Putten says he wrote IRB proposals for the different institutions at which they wanted to survey faculty and staff.
Several of those proposals were rejected by IRBs at the other institutions, despite the fact that his own IRB had approved it. It’s a problem Vander Putten calls "double jeopardy," and he sees it as an emerging point of conflict in social-behavioral research review.
"I was surprised at the reasons given for the IRB proposal rejections," he says. "These other institutions were using much higher levels of scrutiny than the IRB does here for the lowest risk social science research."
Vander Putten says one proposal was rejected because the consent document wasn’t written in the past tense; another was turned back because the pages lacked consecutive pagination (Page 1 of 3, Page 2 of 3, etc.).
By comparison, he says, his own IRB focused attention on what he considers to be more substantive issues, such as readability levels of consent documents or conflicts between consent forms and data collection documents.
For his part, Barrett recently began serving on a behavioral IRB at the University of Arkansas for Medical Sciences in Little Rock. He says his experiences there have helped him see the situation from the IRB’s point of view.
For example, he says, he now sees some of the problems with turnaround can be caused by investigators not submitting all the necessary materials. Barrett says he also has more concerns about issues of identifiability of subjects and the readability of consent forms after seeing those issues from the IRB’s side of the table.
"I think it’s a two-way street," he says. "I’ve become more sensitized to the issues that the IRBs face as well as the issues that researchers face. I think I have more of a balance now."
Vander Putten says studies such as this one don’t address instances in which the relationship between IRB and researcher does work. He worries that horror stories about "heavy-handed" IRBs have become the prevailing impression.
He’d like to see more research done on a national level to see how social-behavioral IRBs function in areas such as staffing, workload and turnaround time. While there have been some studies looking at biomedical IRBs, Vander Putten says there’s a dearth of information about social science IRBs.
"What I’ve seen indicates to me that there are such wildly varying practices in IRB work that it’s time for national data to be collected to begin to empirically look at what’s going on and where there need to be some standards set so there can be some semblance of consistency across institutions."
As IRBs grapple with the issues raised by social-behavioral research, they may also want to consider the concerns of researchers who in a recent study charged that delays in processing proposals and overly intense risk aversion have impeded valuable research.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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