In September 2016, the National Institutes of Health (NIH) issued a new NIH policy that requires the submission of grant applications requesting support for clinical trials in response to clinical trial-specific funding opportunity announcements (FOAs). According to the NIH, the purpose of the new is policy is to improve the NIH’s “ability to identify proposed clinical trials, ensure that key pieces of trial-specific information are submitted with each application, and uniformly apply trial-specific review criteria.” The new policy goes into effect September 27, 2017. Subsequently, all applications must be submitted in response to a clinical trial-specific FOA. Any applications not directed to a non-clinical trial FOA will be returned without review.
In an October 16 blog post, NIH Office of Behavioral and Social Sciences Research (OBSSR) Director Bill Riley noted that “although these policies and efforts were developed primarily with the traditional biomedical clinical trial in mind, they are applicable to social and behavioral trials as well.” Riley’s blog post is designed to assist the social and behavioral community in adhering to the policies and “highlight OBSSR’s efforts to make these policies and efforts fit better with the typical social or behavioral intervention trial.” In addition, NIH Director Francis Collins et al. authored a Viewpoint Essay describing the new policy in the Journal of the American Medical Association (JAMA).