NIH delays controversial clinical trials policy for some studies

Basic brain and behavioral researchers will get more than a year to comply with a new U.S. policy that will treat many of their studies as clinical trials. The announcement from the National Institutes of Health (NIH) appears to defuse, for now, a yearlong controversy over whether basic research on humans should follow the same rules as studies testing drugs.

Although research groups had hoped NIH would drop its plans to tag basic studies with humans as trials, they say they’re relieved they get more time to prepare and give the agency input. “It’s a positive step forward,” says Paula Skedsvold, executive director of the Federation of Associations in Behavioral & Brain Sciences in Washington, D.C.

At issue is a recently revised definition of a clinical trial along with a set of rules in effect since January that are meant to increase the rigor and transparency of NIH-funded clinical trials. About a year ago, basic scientists who study human cognition—for example, using brain imaging with healthy volunteers—were alarmed to realize many of these studies fit the new clinical trial definition.

Researchers protested that many requirements, such as registering and reporting results in the ClinicalTrials.gov federal database, made no sense for studies that weren’t testing a treatment and would confuse the public. NIH then issued a set of case studies explaining that only some basic studies would fall under the trials definition. But concerns remained about confusing criteria and burdensome new paperwork.

Now, after receiving a request from Congress to hold off on the ClinicalTrials.gov requirement, NIH is delaying it until 24 September 2019, the agency announced on 20 July. In the meantime, officials will seek feedback on using reporting platforms designed for basic studies. If researchers aren’t sure whether their study is a clinical trial and send their proposal to the wrong funding opportunity announcement (FOA), they will be given “leniency” and it will still be reviewed. NIH eventually plans to issue FOAs tailored to basic studies that qualify as clinical trials.

Behavioral researchers conducting studies that meet the clinical trials definition will also have to take a training course on clinical practices, but it can be a brief online seminar tailored to the field.

“This delay is progress because it gives them more time to get it right, and in the interim people aren’t going to be in trouble if they get it wrong,” says cognitive psychologist Jeremy Wolfe of Harvard Medical School in Boston. One problem he and others hope NIH will work on is a requirement that all basic researchers studying humans submit a separate form for each experiment, which they say doesn’t make sense for exploratory research.

However, academic and scientific groups are disappointed that NIH hasn’t dropped basic science from the clinical trials definition altogether. “Basic research should not be construed as a clinical trial,” says Sarah Brookhart, executive director of the Association for Psychological Science in Washington, D.C., a point on which “the community stands firm.”