As previously reported, the National Institutes of Health (NIH) has been working for the last few years to enhance its stewardship of and increase transparency over the clinical trials it funds. In a recent blog post, Mike Lauer, Deputy Director for Extramural Research, explained that while no changes have been made to the definition of a clinical trial, which is the primary area of concern for the social science community, the case studies developed by NIH to help investigators determine whether their research would now fall under the new definition have been updated and clarified.
COSSA described the planned changes and their impacts on the social science research community in a Hot Topic piece last year. All social and behavioral science researchers who have received NIH funding in the past, or who are looking to apply in the very near future, are strongly encouraged to review this information as your research may now fall under NIH’s revised definition of a “clinical trial” and require new steps to be taken. This policy impacts funding opportunity announcements with due dates of January 25, 2018 and beyond.