9 No. 1
Who's Afraid of the IRB?
How the Institutional Review Board stepped into the research culture gap
Bolstering the Infrastructure
"If you look at the exponential growth in the amount of research dollars at Emory in 1990 as compared to 2005–06, it’s clear that we hadn’t invested in the overall infrastructure to keep pace with the volume of research and research dollars flowing through the institution."
"The granting organizations aren’t stupid. They’re going to go where they think can get a trial done fastest. If we’re slow, they’ll know about it and go somewhere else. When people approach me about doing clinical trials, they ask me how fast our IRB is. It’s one of their first questions."
New interest in an old standard
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The Italian Virtual Class Chiavi di lettura method
Ten years after the Emory Commission on Teaching
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Reading to help you write
With a word, the federal Office for Human Research Protection could shut down most of Emory’s research that involves humans. A few years ago they did it to Duke and Johns Hopkins, and they did to the University of Pennsylvania, the University of Illinois, and the University of Alabama, because researchers had allegedly endangered the rights and welfare of study subjects. If it happened here, the cost––in prestige, dollars, and lost opportunities––would be incalculable.
To ensure that researchers protect subjects’ health, safety, and confidentiality (thereby averting such drastic measures), organizations that accept federal money to conduct human research seat an institutional review board (IRB). Emory’s IRB currently consists of four committees, populated mostly by faculty volunteers. An administrative staff monitors the committees’ work and manages the flow of submissions, the vast majority of which involve medical research.
The prospect of federal action may have prompted Michael Johns, executive vice president for health affairs, who is ultimately responsible for irb decisions, to initiate a reorganization in September 2005. In a memo to Emory deans and directors, Johns and Provost Earl Lewis wrote that they had “encountered some serious problems at the university, specifically with reviews of protocols that involved social/behavioral and other types of non-invasive research.” The missteps said to have taken place in the social/humanist/behavioral (SHB) committee referred to obliquely in the memo are known to a handful of people, as are similar concerns raised about the committees that review biomedical protocols. (Emory administrators directly involved with irb operations, as well as senior staff at the IRB office, did not respond to multiple requests for interviews.)
In short order, the SHB was rolled into Committee I, which, along with the three other committees, is set up to review biomedical protocols. The
plan was to “cross-train” SHB members so that they would be “better able to achieve consistency in the application of regulatory review standards across all of its committees,” and then restore the SHB as a separate committee.
“There is definitely a culture of fear regarding IRBs,” says Claire Sterk, senior vice provost for faculty development and academic planning. “Schools dread being investigated by the federal government, because there’s a chance of being shut down. In reality, the [Office for Human Research Protection] is a small office, and they can’t really cover much.”
A week before the memo circulated, Karen Hegtvedt, professor of sociology and chair of the SHB, got wind of the change in a letter from Johns. She was informed that her term had ended and was thanked for years of service. It was the first she’d heard about any of it. Some in the college were incensed by what they considered unfounded accusations against the SHB and an unwarranted dismissal of Hegtvedt.
Critics also charged that dissolving the SHB—even temporarily—
amounted to a maneuver by the health sciences to consolidate control over all funded research at Emory, and yet another sinister sign that the massive medical establishment had encroached into a domain where they were neither welcomed nor belonged.
That just wasn’t the case, insists Lewis. “I was told that there were reasons that a change made sense, that there were things we needed to do and things we needed to be more attentive to, given the new compliance environment,” he says, adding that federal regulators are more aggressive than ever in compliance oversight. He assured college faculty that any appearance of secrecy was completely unintentional—the result of an unfortunate but innocent bureaucratic oversight.
But hard-edged perceptions congealed quickly. One professor called the restructuring a “colonization of college prerogatives by the health sciences.” Social scientists and humanists worried that the flexibility they knew and appreciated would evaporate along with the committee—that they’d face an IRB ill equipped to respond to the diverse character
of their research.
“In the humanities and social sciences, the research context varies enormously from study to study and discipline to discipline, unlike clinical research, where you can take a more systematic approach,” notes Mark Risjord, associate professor of philosophy, who served as vice chair of the shb until it was disbanded. “My greatest concern is that [the SHB’s] flexibility and sensitivity to differences among research projects is preserved. . . . Most of this research is extremely low-risk and involves mostly talking. I think the auditors at the federal government understand very well that regulations should be applied differently to low-risk social/behavioral research than it is to high-risk medical research.”
The IRB administrative office—already underfunded and understaffed—now stumbled under new pressures. Research proposals that had been funneled to the shb lingered, sometimes for months, according to several faculty. Emails and phone calls often went unreturned; questions about the status of submissions went unanswered. Even undergraduates were affected when IRB submissions were held up, threatening the timely completion of senior theses in the spring.
While social science and humanist researchers were unaccustomed to such delays, their counterparts in medicine were not. “Some protocols have taken more than a year to get approved, and responses to the irb office have been misplaced,” says J. Douglas Bremner, professor of psychiatry and radiology and director of Emory’s Positron Emission Tomography Center. “There’s a lot of turnover on the [IRB office] staff, and it’s often hard to trace things. I’ll get emails saying that someone on my staff hasn’t completed his research training, when that’s not accurate. Sometimes you can delay, but there are some situations where you have to get something started, and it impairs your ability to do research.” Bremner adds that, on occasion, he has gotten up and walked to the irb office to track down information.
One of the stated rationales for merging the shb with a biomedical committee—cross-training—also came under fire. “Those on the biomedical committees need the cross-training,” says John Boli, professor of sociology and chair of the sociology department, “because they do not understand social science research, do not understand issues we’re dealing with, and want to apply their standard ideas of research, which are often inappropriate.” Boli also believes that the shb cannot function optimally as long as the chain of command links it to health
sciences. “It should be completely separate from health sciences, with no administrative link to the medical school,” he says. “Creating a truly independent SHB is crucial to the legitimacy of the process in future and the only way to really get the college faculty back on board for participating and making the process work again.”
Aided by a graduate assistant, Boli surveyed twenty-six major universities: thirteen supported SHBs with independent administrative structures. “The message is plain,” he says. “Half the places have highly independent SHBs, and there’s no comparison argument to say that this is a model that doesn’t work.”
Hegtvedt has also campaigned for shb independence. In 2002, when the arts and sciences IRB was re-christened the SHB and its oversight was first shifted to health sciences, she wrote in a 2002 article for the newsletter of the American Sociological Association that “we must vigorously enforce our autonomy from the medical committees.” Hegtvedt now says, “I’ve been arguing that one of the important things is to make structural changes to restore faculty members’ confidence. What would go the farthest is to have a separate shb committee for the college, potentially administered separately from the biomedical committees.”
In the shadow of the health sciences?
How realistic are fears that the sprawling medical complex is overwhelming the college? The tension is nothing new, says Bobby Paul, dean of Emory College.
“The culture gap between the two is very real. It’s apples and oranges, and there are bound to be misunderstandings.” Some in the college are just having their eyes opened, he adds. “It’s easy for faculty in the college to remain unaware from day to day of what a huge operation the health sciences constitute. That research enterprise certainly accounts for the great majority of IRB cases.”
Paul, a practicing psychoanalyst who holds an appointment in the Department of Psychiatry and Behavioral Sciences, recounts a minor example illustrating that brawn. A proposed multidisciplinary initiative that emerged from the university-wide strategic planning process last year, first dubbed “Mind and Brain,” was changed to “Mind, Brain, and Neuroscience.” Finally, all reference to the mind was dropped, and the project became, as Paul puts it, “defined by just the keyword ‘neuroscience,’ with no explicit mention of the study of the ‘mental’ side of the equation. The psychology department, anthropology department, philosophy department, and all of these areas that study the mind were written out. I do not think this was deliberate, and in fact that situation has now been addressed and rectified. But this episode illustrates that there can sometimes be a tendency for things to drift in the direction of health science concerns—or at least to appear that way.”
That type of influence, even in a very limited context, is worrisome, Paul continues. “It’s possible for many in the college, including myself, to see [the health sciences] as rivals and as a threat, and that is to some extent true insofar as there’s a limited pie. We’re always scrambling for as much as we can get, and we don’t want the liberal arts mission of the university overshadowed.” The health sciences, he points out, consumes and processes an enormous amount of money: 56 percent of Emory’s $2.5 billion fiscal 2005 budget is allocated to Emory Healthcare. It also attracts staggering amounts of research dollars. “And it needs more money,” Paul concedes. “It’s by no means an unjustified division. For example, they run vast hospitals and clinics that require resources beyond the scope of anything the typical liberal arts faculty member requires or even imagines.”
Nor does the imbalance preclude partnerships, and Paul sees many opportunities. “They’re a tremendous resource and offer many avenues of constructive collaboration,” such as global health initiatives that involve social sciences and humanities, and the history and philosophy of medicine. “I think there will be much more educational interchange between the two sides of Clifton Road. . . . The areas of interest already greatly overlap, and there will be synergies.”
Lewis observes that the affair has exposed the fact that faculty are insulated from one another.
“I think the greatest challenge and perhaps the greatest threat to the implementation of our overall strategic plan may be the fact that our faculty tend to live in their own local cultures and don’t understand how operations work across the institution. This may have enlightened them and may have reinforced certain perceptions and prejudices.”
In the end, Lewis adds, this is less a story of conflict between the health sciences and the college, but one about strengthening Emory’s research infrastructure. “If you look at the exponential growth in the amount of research dollars at Emory in 1990 as compared to 2005–06, it’s clear that we hadn’t invested in the overall infrastructure to keep pace with the volume of research and research dollars flowing through the institution.”
Risjord takes a pragmatic view of the health sciences’ looming presence. “I have some worries—not as strong as some colleagues’—that the professional schools, including medicine, law, and business, are starting to dominate Emory to the disadvantage of the college and graduate school, which are being turned into just service organizations,” he says. “They dominate also in terms of the research culture and intellectual atmosphere. We want to say over here in the college, ‘Hey, we’re doing something important.’ No, we’re not inventing drugs that are going to make Emory millions of dollars, and we’re not on the front pages of newspapers. Yet there’s a sense that we carry a very important intellectual burden of the community.” —S.F.