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NIH Delays Basic Brain Research Rules

August 20, 2018

NIH has delayed a controversial new policy that would have required basic brain and behavioral researchers to treat their work as clinical trials.

The measure, originally set to take effect next month, called for scientists who study human cognition or behavior — for example using brain scans with healthy volunteers — to follow the same rules as studies testing drugs or diagnostics, including registering their studies and publishing results in the ClinicalTrials.gov federal database.

NIH made the move in response to a 2016 Government Accountability Office (GAO) report that slammed the agency for failing to keep track of nearly $3 billion in taxpayer dollars it had allocated to support scientific research.

Psychologists and neurologists had pushed back against the policy, insisting it would subject them to extraneous government oversight of experiments that, in their view, didn’t involve any real risk to human subjects and made no sense for studies that weren’t testing a treatment.

They also balked about massive unnecessary paperwork and administrative nightmares they predicted the new requirements would create — and complained that some of NIH’s language about “priority” research could be misinterpreted and block funding for exploratory research and training.

NIH postponed the move a year — until Sept. 24, 2019 — after Congress asked it to delay action.

In the interim, behavioral researchers will still have to register their proposed studies “with the expectation that data will eventually be transported to ClinicalTrials.gov,” the NIH says. They’ll also have to take special training on clinical practices, regardless of the focus of their research.

NIH is the nation’s largest funder of clinical trials. After the GAO released its report, the agency acknowledged that it “had difficulty reporting how many clinical trials it has funded” and that “results from many NIH-funded clinical trials are never published or reported in a public database.”

The new policy was among steps it took designed to remedy the lapses and increase transparency of NIH-funded clinical trials.

Last year more than 3,500 scientists signed an online petition urging NIH Director Francis Collins to scrap the plan —and opponents had hoped NIH would scuttle it. But they said they’re pleased to have extra time to adjust and provide more input.

“APA supports policies that encourage open science approaches such as preregistration of studies and data sharing,” Howard Kurtzman, executive director of the American Psychological Association, which opposes the policy, told CenterWatch. “Such policies should be developed with the input of the research community and be sensitive to the purposes and nature of the research being conducted.”

The NIH said it plans to work with scientists to iron out wrinkles and ease compliance over the next year.

 

-By Bill Myers