Aset of new federal rules aims to simplify a process that has long frustrated scholars: getting approval for research that involves human subjects. But the changes could result in universities’ doing inadvertent harm to the careers of young scientists, and could reduce the amount of research that is conducted in the first place.
That’s because the rules could lead universities to charge fees for the use of their institutional review boards, or IRBs, the administrative panels that act as checks on human research. Some scientists worry that any additional expenses will threaten work that does not receive significant financial backing.
The concern isn’t just theoretical. In March, Washington University in St. Louis posted a fee schedule that, for the first time, would have charged some researchers supported by funds from nonprofit sources. The fee was set at $2,500 to have their proposals reviewed, plus more for annual continuing reviews or reviews of proposed revisions.
In May a graduate student there posted the new schedule on Twitter, along with a series of questions and concerns about the impact of the fees and their timing. Colleagues and other researchers chimed in, decrying the university’s move as “harmful,” “awful,” and “absurd.” A day later, the university put the fees “on hold, pending review.”
Why all the concern? Institutional review boards are typically funded through indirect-cost payments, which often come in the form of overhead paid by the government agencies or other entities that award grants. Other research services funded through indirect costs include facility maintenance, library services, and administration.
Still, universities have charged institutional-review-board fees to researchers whose work is funded by for-profit companies since the early 2000s, said Karen Allen, executive director of research protections at the University of California at Irvine.
But assessing fees for the review of research funded by nonprofits may have been a first.
Jennifer Lodge, vice chancellor for research at Washington University, said the fees had been introduced partly as a response to federal rules set to change in the next 18 months. Those regulations, known as the Common Rule, are being updated to streamline the oversight of human research, said Carrie Wolinetz, associate director for science policy at the National Institutes of Health.
Lodge cited one of those changes as the reason Washington University briefly planned to introduce the new fees. It’s in a rule known as the “single IRB (sIRB) review requirement,” which mandates that nearly all federally funded research involving researchers at multiple institutions be reviewed by a single IRB.
Unintended Consequence
The new rule, which is set to go into effect in January 2020, will replace a system under which every institution’s IRB has to approve the research. The NIH already put into effect, in January, a similar provision relating to research it funds.
The change is intended to reduce burdens on researchers and universities, saving them time and money. Not only does it allow research to get off the ground more quickly, Wolinetz said, but it helps “the consistency of review, because you’re not getting five different answers from five different IRBs, which is a really common phenomenon.”
But the change may also bring an unintended consequence in terms of how IRBs are funded in the first place. One reason: In studies that are spread across multiple universities, only the one operating the IRB of record receives any of the overhead funding for project review.
Another reason: The single-IRB rule permits direct costs for IRB review to be charged to the grantor if the costs are not already included in the university’s facilities and administrative budgets.
As a result, Washington University decided to stop funding IRBs indirectly from facilities and administrative budgets, and instead to do so only from fees. “I think many other universities will follow this as well,” Lodge said. “It makes it cleaner.”
The rescinded fee schedule at Washington University went beyond charging fees for federally funded studies across multiple institutions. It would also have assessed fees for any single-site study funded by private, nonprofit sources, although studies funded by departments or the university would have been exempted.
Such a change worried Christopher Lynn, an associate professor of anthropology and director of evolutionary studies at the University of Alabama at Tuscaloosa. “We’d all love to have big grants with indirect costs associated,” he said, “but they’re increasingly difficult to get. So what this seems to do is chop the legs out from under the people who are already struggling to get grant funding.”
Some areas of research — biomedical, for example — are unlikely to be much affected by new fees, Lynn said, because large grants support that work. But other areas could be severely hampered.
“It’s going to be particularly hard on the social sciences,” Lynn said. “Grant funding is lower there.”
‘Little or No Budget’
Michelle Rodrigues, a postdoctoral fellow at the University of Illinois at Urbana-Champaign’s interdisciplinary Beckman Institute, said virtually any IRB fee would shutter her research. “I’m an anthropologist,” she said, “and anthropology is not the best-funded discipline.”
As an example, she described a small research project, requiring IRB approval, in which she led focus groups with female scientists of color. The budget allowed for three $20 Amazon gift cards and $1,000 for transcription services.
“If a big chunk of the funding they’re able to get ends up going to IRB review,” Rodrigues said, “that takes away from a lot of the ability to essentially do the research itself.”
Even survey-based research “still has to go through IRB processes,” said Cara Ocobock, an assistant professor of anthropology at the University at Albany, in the State University of New York system. Fees could make such projects untenable. “We’re working on either very little or no budget to start with,” she said of her own research, “and if we’re suddenly being charged $1,000 to $2,500, a lot of us just don’t have that money.”
Researchers early in their careers would suffer if they had to pay IRB fees. “I have managed countless research assistants over the years, and I would be concerned about their ability to produce research,” said Samuel Taylor, who worked as a research-program manager at Washington University’s Envolve Center for Health Behavior Change.
That hindrance could have further consequences. “I see that negatively impacting graduate students, who then, of course, would negatively impact how many Ph.D.s are put out into this world,” Ocobock said. “And then, of course, negatively impact, eventually, faculty down the line.”
Joshua Eyler, director of the Center for Teaching Excellence at Rice University, takes it one step further: “It seems like it could eventually have a detrimental effect on the number of research studies that are submitted to the IRB, which in turn has a detrimental effect on our spheres of knowledge.”
Other changes in the Common Rule could allay some of these concerns by making some human-subject research exempt from IRB review. Among the new exemptions are oral histories, surveys, observations of public behavior, and the use of data that can’t be traced back to specific people. Those changes will go into effect in January 2019.
As for Washington University, Lodge, the vice chancellor for research, said it had not handled the development of the new fees appropriately. “It wasn’t done in terms of really engaging with the faculty to understand what their issues would be,” she said. As a result, she is meeting with faculty members to better understand their concerns and how to craft a policy that meets their needs.
That’s good news to Tess Thompson, a research assistant professor at Washington University’s school of social work, who was concerned about the review fees. “I just hope that everyone’s being mindful of the effect that these can have on small projects,” she said. “It’s important not to disincentivize doing good science.”
