The National Institutes of Health (NIH) in Bethesda, Maryland, has confirmed that the agency’s definition of clinical trials now includes imaging studies of normal brain function that do not test new treatments. The change will impose new requirements that many researchers say don’t make sense and could stifle cognitive neuroscience.
Although NIH revised its definition of clinical trials in 2014, the agency is only now implementing it as part of a new clinical trials policy. Concerns arose this summer when an NIH official said the definition could apply to many basic behavioral research projects, including brain studies—for example, having healthy volunteers perform a computer task while wearing an electrode cap or lying in an MRI machine. Scientists say the new requirements—such as training and registration on clinicaltrials.gov—are unnecessary, will impose a huge paperwork burden, and will confuse patients seeking to enroll in trials.
NIH told ScienceInsider in July that the agency was still deciding exactly which behavioral studies would be covered by the new definition. On 11 August, the agency released a set of case studies that has confirmed many researchers’ fears. Case No. 18 states that a study in which a healthy volunteer undergoes MRI brain imaging while performing a working memory test is now a clinical trial because the effect being evaluated—brain function—is a health-related outcome.
This example suggests “that almost all basic science behavioral research and experimental psychopathology research would be viewed misleadingly as a clinical trial,” wrote neuroscientist William Iacono of the University of Minnesota in Minneapolis in one of more than 30 comments expressing concern on the Open Mike blog of NIH extramural chief Michael Lauer.
Critics also find NIH’s reasoning inconsistent. Case No. 22 states that a study of learning in children will not be considered a trial because an evaluation of learning “has no clear link to health.” It is not clear why a study of memory in adults would be health-related and yet learning in children would not, several researchers argued in comments.
Cognitive psychologist Nora Newcombe of Temple University in Philadelphia, Pennsylvania, who studies childhood learning, writes that although “it’s nice to be exempted from the regulatory burden,” she worries that if her research isn’t considered health-related, “will there later be criticism of funding from NIH?”
The Association of American Medical Colleges (AAMC) in Washington, D.C., shares concerns about the case studies. They “don’t provide as much clarity as the research community would need” to know which projects must follow the new clinical trial policies, says Heather Pierce, AAMC’s senior director for science policy.
NIH’s Lauer says the agency is trying to address the concerns. “We are continuing to receive feedback on the case studies and anticipate updating them, including Case 18, in the next 2 weeks and as needed on an ongoing basis to eliminate confusion,” Lauer said in a statement.