If you are planning to submit a grant application that includes human subjects to NCCIH this fall, we want to help you select the best funding opportunity announcement (FOA) to use.
In a March 2017 NIH Guide Notice (NOT-AT-17-006) and through blog posts, webinars, and direct letters, NCCIH announced changes regarding the types of applications NCCIH will accept via the NIH Parent FOAs.
As of May 2017, NCCIH no longer accepts applications that include a study that meets the NIH definition of a clinical trial with aims focused on clinical outcomes if they are submitted through the generic NIH Parent FOAs (R01, R21, R15). Instead, applications that include clinical outcome focused trials need to be submitted to NCCIH via our new clinical trial specific FOAs (https://nccih.nih.gov/grants/funding/clinicaltrials). This policy is valid for new, resubmission, and renewal applications. Only clinical trials with a focus on mechanistic outcomes may still be submitted through the generic NIH Parent FOAs.
If you use the Parent FOAs and include a clinical-outcome-focused-trial in your Fall 2017 application, NCCIH will not accept assignment of the application. The Division of Receipt and Referral at NIH will try to find another Institute or Center (IC) to accept your application, but it must fit with the IC’s mission and the ICs must accept clinical trials via these Parent FOAs. If NIH cannot find an IC willing to accept your application, it will be withdrawn and returned to your institution without being reviewed. Let’s prevent this from happening!
Guidelines for selecting the best FOA:
If you’re working on an application that includes human participants for the Fall 2017 receipt dates and you want your application to be assigned to NCCIH, here’s some general guidance for selecting the best FOA:
- Observational or epidemiologic human studies can and should still be submitted via the Parent R01, R21, or R15 FOAs.
- Natural product clinical trials:
- Early phase pilot studies can use the NCCIH R61/R33 (PAR-17-319)
- Mid-stage studies can use the NCCIH R33 (PAR-17-318) or U01 (PAR-17-216)
- Full-scale multi-site efficacy trials can use the companion FOAs for the UG3/UH3 Clinical Coordinating Center and the required U24 independent Data Coordinating Center (PAR-17-174 and PAR-17-172)
- Mind and body intervention clinical trials focused on clinical outcomes:
- Early phase pilot studies to refine interventions and assess feasibility can use the NCCIH R34 (PAR-14-182)
- Mid-stage studies can use the NCCIH U01 (PAR-17-215)
- Full-scale multi-site efficacy trials can use the companion FOAs for the UG3/UH3 Clinical Coordinating Center and the required U24 independent Data Coordinating Center (PAR-17-175 and PAR-17-173)
- Mind and body intervention with mechanistic outcomes:
- If none of the aims will assess a clinical outcome (symptoms, physical functioning, disease outcomes), you can still use the Parent FOAs. NCCIH strongly encourages you to contact a Program Director in the Basic and Mechanistic Branch to make sure your aims could not be interpreted as clinical outcomes.
- You can use the NCCIH R61/R33 (PAR-17-149) if you plan to evaluate the impact of the intervention on a biological mechanism or psychological process and then optimize the impact on the mechanism or process and assess the association with relevant clinical outcomes.
- You can use the NCCIH R33 (PAR 17-162) if you plan to optimize the impact on the mechanism or process by modifying delivery of the intervention, combining it with other known interventions, or selecting for a more mechanism-relevant population, and assess the association with relevant clinical outcomes.
We always recommend talking to a program officer to make sure that the research you are planning to submit in your application is a good fit with the NCCIH mission and priorities. Because of the changes in how we are funding clinical trials, we encourage you to also check if you’ve selected the best FOA to support the human subjects research you want to do.
NIH is implementing policy changes and new forms for applications received after January 25, 2018. Subscribe to the NCCIH Blog (link) to receive updates on how to apply for grant funding.
For More Information:
- NCCIH Clinical Trial Funding Opportunity Announcements
- Show Me the Money! Finding Funding to Study the Clinical Effects of Mind and Body Interventions (Blog)
- Finding Funding for the Building Blocks of Natural Product Clinical Trials (Blog)
- Tips from NCCIH’s Office of Scientific Review for Responding to the New Clinical Trial Funding Announcements (Blog)