NIH redefines clinical trials, attracting critics

21 July 2017 Vol 357, Issue 6348

In Depth U.S. Biomedical Research
NIH redefines clinical trials, attracting critics
Jocelyn Kaiser
A new National Institutes of Health (NIH) policy aimed at boosting the rigor and transparency of clinical trials is triggering concerns among many behavioral scientists. They are worried that the agency’s widening definition of clinical trials could sweep up a broad array of basic science projects studying the human brain and behavior that do not test treatments. The clinical trials designation would impose a raft of new requirements on work that has already passed ethics review, such as different standards for applications submitted for funding, and a mandate to report results on, a public database. Critics say that would result in wasted resources and public confusion. NIH officials say they are still determining which behavioral studies will be defined as clinical trials.