Basic researchers who study the brain and human behavior thought lawmakers had come to their rescue in March by blocking the National Institutes of Health (NIH) in Bethesda, Maryland, from redefining their studies as clinical trials. But NIH officials are still pushing ahead with new requirements that scientists say make no sense and will cripple their research.
What some see as NIH’s narrow interpretation of a directive from lawmakers has researchers up in arms as they navigate confusing new rules and paperwork. The clinical trial policies “are not appropriate for fundamental research,” a group of societies wrote in an email to NIH this week.
The issue goes back almost a year, when researchers became aware that a new NIH definition of clinical trials would encompass many basic studies involving human subjects. Since January 2018, these projects must now go through a new submission and review process and will need to be registered and have results reported on clinicaltrials.gov, a public database, among other requirements aimed at improving rigor and transparency in clinical research.
Last summer, several scientific and university groups, individual scientists, and more than 3500 petition signers protested that filing studies that aren’t testing drugs or other treatments on clinicaltrials.gov would confuse the public. They were also worried that redefining their studies as clinical trials would make it harder to get funding. In response, NIH spent months tweaking a set of “case studies” that exempt some basic work, such as certain brain imaging studies, but still sweep up much fundamental research, says Sarah Brookhart, executive director for the Association for Psychological Science (APS) in Washington, D.C.
A 2018 spending bill passed last month offered relief: In an accompanying report, lawmakers expressed “concern” that redefining basic studies as trials “could have long-term, unintended consequences,” and they asked NIH to delay clinicaltrials.gov registration and gather input on alternatives. Although NIH is delaying the clinicaltrials.gov requirement, the agency is moving ahead with other clinical trials policies for basic studies because the directive appears to focus only on registration and reporting, agency officials say.
Brown University vision scientist William Warren, whose work involves having healthy adults navigate a virtual reality landscape, faced the new rules earlier this year. He wasn’t sure his project would be considered a clinical trial: It depended on whether the study “prospectively” assigned participants to different “interventions.” It also depended on whether he expected the intervention—in his case, a change in the virtual landscape—to modify the volunteer’s behavior, or whether he was just measuring normal behavior.
Warren’s university and NIH program officers advised him to err on the side of caution. He then had to fill out an “unbelievably laborious” set of questions for clinical trials that he says took a week, eating into time for the research portion of his proposal. Then, he learned that his study would not be considered a trial.
Megan Gunnar, a developmental psychologist at the University of Minnesota in Minneapolis, wasn’t so lucky. She’s studying why young children but not teens do better under stress when they’re with a parent rather than a stranger. Partly because she’s comparing these two situations, NIH now says the work is a clinical trial. She says required paperwork came with nearly 200 pages of instructions and added about 30 pages to her 12-page application. The forms “are hugely burdensome,” she says.
Warren worries that an application process designed for rigid clinical protocols doesn’t make sense for basic research, where the result of one experiment informs the design of the next one. “The issue is whether basic research can be shoehorned into the clinical trial model and still survive,” he says.
Scientific groups say congressional staff are sympathetic to their concerns. And some feel encouraged after a meeting this week with NIH officials, representatives from universities, APS, and four other scientific societies to discuss the matter. In an email sent to NIH officials yesterday, the groups call for NIH to exclude basic research from “any of the clinical trial policies.”
As for NIH, it “is committed to honoring the congressional direction,” the agency said in a statement. “NIH is working with congressional members and professional societies for the behavioral sciences to address specific concerns as we move forward.”
CLARIFICATION: The description of a meeting with NIH officials has been revised to better reflect the views of attending organizations.