Scientists who conduct basic behavioural research are bracing for a policy kicking 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 Behavioural & Brain Sciences (FABBS) in Washington, D.C.
The changes, which take effect for proposals with due dates of 25 January 2018, or later, are part of a new clinical trials definition that NIH released in 2014 but only began implementing in 2017. 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 clinicaltrials.gov, 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.