Beginning for January 25, 2018 due dates, all applications for National Institutes of Health (NIH) funding proposing clinical trials must be submitted through a funding opportunity announcement (FOA) designated specifically for clinical trials. This past Friday, November 3, 2017, NIH has released two Parent Funding Opportunity Announcements (R01 and R21) for research involving clinical trials.
Scientists interested in applying to one of these funding opportunities should note that not all of NIH’s institutes and centers participate in these announcements, and of those that do, some only accept applications in specific thematic areas. For example, the National Institute of Mental Health (NIMH) will only accept mechanistic studies, meaning studies designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention, via the parent clinical trial FOA. All other clinical trials must be submitted to one of NIMH’s Clinical Trial FOAs. Other institutes have also stated similar policies, and therefore researchers need to carefully review not only the FOA itself, but also the institute- or center-specific policies as related to that FOA.
APS recommends that psychological scientists wishing to apply for NIH grants read the funding opportunity announcements and application instructions very closely to ensure that they are eligible to apply for the funding opportunities of interest and to understand the changed application process/requirements instigated by these policy changes. Specifically, for applications proposing a clinical trial, the structure and content of both the research design and human subjects sections of NIH applications has changed.
The scientific community has expressed concerns over NIH’s updated definition of clinical trials and related policies. APS has been in the vanguard of efforts to bring the scientific community’s concerns to the attention of NIH officials as well as congressional liaisons. APS and other organizations are working with Congress, which in turn has been talking to NIH, on a means to address the expressed concerns. Watch this space for more information as APS continues to monitor NIH’s clinical trials policies.
Last, to read more about NIH’s updated definition of a clinical trial, read a July 19, 2017 piece in Science featuring APS titled, “Some scientists hate NIH’s new definition of a clinical trial. Here’s why.”