July 27, 2017
In an effort to “enhance stewardship and transparency” of clinical trials, NIH issued a new policy in September 2016 that defines clinical trials so broadly that it sweeps in basic science research. The new policy complements a federal regulation on clinical trials (see link to Final Rule) that was issued a few days later. Basic scientists have been caught off guard by the breadth of the NIH policy on clinical trials and its implications for basic science research.
According to the policy, a clinical trial is “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”
Although the new NIH policy became effective in January 2017, few basic scientists were aware of its reach. The Final Rule, the NIH policy, and early versions of both that invited public comment were focused on clinical trials – in title and substance. Only recently have basic scientists learned that they will need to comply with the new policy.
The policy requires registration of the research and results in the ClinicalTrials.gov database as well as good clinical practice training for investigators. It also affects funding opportunities (see link below) and review of grant applications for research that fits the broad definition of a clinical trial. There are criminal and civil penalties for noncompliance.
In mid-July, FABBS sent a letter to the NIH Director to express the concerns of basic scientists in our community, and to ask that the agency pause implementation of the policy and seek feedback from the entire scientific community affected by the policy. According to a news article in Science, NIH is working to “clarify the scope of the definition” and will offer guidance within a few months. Our sense, at this point, is that NIH will not seek revisions to the policy or definition of a clinical trial, but will tweak its implementation. FABBS will update the community as we learn more.
FABBS Letter: NIH Letter to Dr. Collins
NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information: NOT-OD-16-149
NIH Policy on Good Clinical Practice Training: NOT-OD-16-148