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The basic research study that produced this brain scan of a child looking in a mirror could now be considered a clinical trial by the National Institutes of Health. 

Thierry Berrod, Mona Lisa Production/Science Source

NIH’s new clinical trial policy kicks in despite concerns from basic behavioral researchers

Scientists who conduct basic behavioral research are bracing for a policy kicking in this week that will impose new rules on their federally funded studies, many of which the National Institutes of Health (NIH) in Bethesda, Maryland, will now consider clinical trials. Although many researchers maintain that the policy makes no sense and will hinder their work, recent revisions by NIH officials have eased some fears.

“There’s still a problem, but the problem is less dire than the original set of concerns that we had,” says cognitive psychologist Jeremy Wolfe of the Harvard University–affiliated Brigham and Women’s Hospital in Boston, who is also the immediate past president of the Federation of Associations in Behavioral & Brain Sciences (FABBS) in Washington, D.C.

The changes, which take effect for proposals with due dates of 25 January or later, are part of a new clinical trials definition that NIH released in 2014 but only began implementing last year. That was when scientists who use tools such as MRI scans to explore how the normal brain works realized that their studies, which they never thought of as clinical trials because they don’t test drugs or other treatments, fell under the new definition. The change imposed several new requirements on researchers, such as submitting proposals in response to a formal funding opportunity for clinical trials and registering the studies in, the federal trials database.

Researchers and university groups have since flooded NIH with emails and comments, especially after NIH published a set of case studies confirming that basic studies would be included. More than 3500 scientists signed an open letter last September asking NIH to delay the policy.

Michael Lauer, NIH deputy director for extramural research, has since made several revisions to the case studies. For example, pilot studies with a few healthy volunteers that are used to design a more formal study may not be considered clinical trials (see case #18f here).

In an interview with Wolfe published yesterday in Nature Human Behavior, Lauer says basic science grants will likely go to the same peer-review panels as before, not clinical trial panels. And a 1-hour online course may be sufficient to meet new training requirements. These and other answers “address many of the problems in perfectly sensible ways,” Wolfe says. The same journal issue contains several letters from other researchers for and against the policy.

The controversy is not over, however. “The definition is still murky in areas … and relies primarily on one person at NIH, Mike Lauer, to make the call” on which studies are included, says Paula Skedsvold, executive director of FABBS. Wolfe says the coalition hopes NIH will work out a separate registration and reporting option for “mechanistic studies.” It would allow basic researchers to be more transparent without confusing the public by filling with studies that aren’t testing treatments, he says.

Meanwhile, FABBS is talking to staff on key committees in Congress about their complaints. “Our communities of scientists continue to call for a return to the historically clear distinction between basic science and clinical trials,” Skedsvold says. One possibility is that lawmakers will insert a provision in a spending bill that would stop NIH from moving forward with the policy.