Although I typically do not submit grants to NIH, I recently was perusing their Funding Opportunity Announcements (FOAs) to find out if any would align with my educationally relevant research. The great news is that I found some promising announcements, but the “Clinical Trial Not Allowed” warning made me flash back to NIH’s recent decision to begin implementing a definition of clinical trials that was established in 2014.
Several concerns and questions immediately came to mind: Would my particular question and methodological approach count as a clinical trial? If so, how could I change my approach so that it was not a clinical trial? And, if my research were considered a clinical trial and I could submit, would it be sent to a review panel that understood my science or instead would it go to a special committee that reviews proposals with clinical trials? No doubt if you have been thinking about applying to NIH, you too may need answers to these and other questions.
Fortunately, Jeremy Wolfe (past chair of the Psychonomic Society and current editor of CRPI) has done our field a great service by interviewing Dr. Mike Lauer (Deputy Director for Extramural Research at NIH) in search of answers to pressing concerns about NIH clinical trial policies.
I encourage you to read the interview for important details, but I’d also like to point out a few highlights. First, the policies have been in place since 2014, so what has changed since then is that NIH is now attempting to implement them; in the simplest terms, they want to make sure that applicable clinical trials are subjected to the oversight and penalties in the FDA system, which presumably will increase the chances that more funded clinical trials will be conducted and reported in a timely fashion. Such transparency is what Psychonomics members desire, so we should all be on board with those goals.
Second, given that NIH is now implementing the policies, many have taken a closer look, and it is not obvious what exactly counts as a clinical trial, especially given that the detailed case studies appear to have broadened the scope of what counts. Jeremy’s focused questions did help Lauer clear up some confusion, such as “that most of basic behavioral and brain science clinical trials funded by NIH are likely to be mechanistic trials,” and hence they are not subject to oversight by the FDA. As chair of the governing board for the Psychonomic Society, I’m somewhat embarrassed to admit that I’m still a bit confused about whether my research would be considered a clinical trial. Such confusion can be costly, because grants that include clinical trials must be submitted to a different FOA. So, what should you do if there is any doubt? Dr. Lauer suggests several avenues, such as consulting case studies they have compiled or their list of FAQs (for links to these please refer to the complete interview).
When in doubt, however, I think a key take-home message from the interview (and one that often holds about any questions concerning a grant) is to contact a program officer for guidance.
It is too early to tell how much NIH’s implementation of the clinical trial policies will impact our research and funding. The Wolfe-Lauer interview did assuage some of my own concerns by clarifying NIH’s agenda for implementing the policies. No doubt we will seek further clarification, and we will continue to share what we have learned. Finally, many thanks to Jeremy Wolfe for his continued efforts to clarify and inform Psychonomics members on these issues: His posts here, here, and here are essential reading for anyone concerned about this issue.
I certainly feel more confident about how to proceed, but I also plan on contacting my program officer before moving forward with the next NIH grant.