New federal rules that have just been passed are aiming to simplify the process of getting approval for research that involves human subjects. But according to The Chronicle of Higher Education, the changes could also cause universities to charge fees for the use of their institutional review boards. Researchers are worried that this additional expense will threaten work that does not receive significant financial backing, and that this will harm the careers of young investigators in particular.
The concern is already being played out, The Chronicle reports. In March, Washington University in St. Louis posted a fee schedule that 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. Researchers protested the new fees, and the university put them on hold, pending a review.
IRBs 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, The Chronicle says. Universities have charged IRB fees to researchers whose work is funded by for-profit companies since the early 2000s, but assessing fees for the review of research funded by nonprofits may have been a first.
The new rule is set to go into effect in January 2020. It is intended to reduce burdens on researchers and universities and save them time and money, according to the article. But 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. Therefore, The Chronicle adds, Washington University decided to stop funding IRBs indirectly from facilities and administrative budgets, and instead to do so only from fees.
But it gets worse -- the rescinded fee schedule at Washington University would also have assessed fees for any single-site study funded by private, nonprofit sources, although studies funded by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.
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," Samuel Taylor, who worked as a research-program manager at Washington University's Envolve Center for Health Behavior Change, tells The Chronicle.
Joshua Eyler, director of the Center for Teaching Excellence at Rice University, adds, "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."