January 9, 2018
For at least six months now, NIH and segments of the basic science community have been engaged in a dialogue around the agency’s operationalization of the clinical trials definition to include much basic science involving humans. Through petitions, open letters (see NIH Director Awardee letter and Study Section Chairs letter), emails, responses to NIH blog posts, Advisory Council discussions, and more, the back-and-forth has led to some improvements in the process (e.g., assurances that there will be no change in the review of basic science applications) and a narrowing of what research is included as a clinical trial. A Frequently-Asked-Questions interview between immediate Past-President, Jeremy Wolfe, representing FABBS, and NIH will appear in Nature Human Behavior in two weeks, which highlights problematic areas and NIH’s plans for addressing them. However, ther remains widespread concern about the basic science research that is still included in NIH’s definition of a clinical trial as well as confusion about the rationale for the changes.
The full implementation of the policies takes effect with the January 2018 round of applications. Meanwhile, NIH released a new set of case studies last week, which will help investigators determine whether their particular research project is considered a clinical trial by the agency and therefore subject to clinical trial policies. Despite efforts by NIH to clarify the boundaries of what is and is not a clinical trial, a clear definition as defined through the case studies remains elusive. Two scientists shared with FABBS their recent letters to the NIH Director regarding the latest revision to the case studies. With their approval, we share them with our readers (Pekar and Saxe). Similar concerns have been raised about cases 24 and 26 (see responses to the NIH blog).
NIH and Scientist Communications: http://www.fabbs.org/nih-clinical-trial/