1. Will all applications be assigned to NCCIH?
All applications will initially be assigned to the National Centery for Complementary and Integrative Health (NCCIH) because they will go to the same review panel. However, after review, applications that are considered for funding or co-funding by multiple Institutes, Centers, and/or Offices will be transferred to the lead Institute or Center that will administer the award and that has the most relevant scientific expertise.
2. Should applicants identify which NIH Institute or Center they would want their application to go to if the proposal passes the first review and scores well?
You may do this, and it would be helpful for the National Institutes of Health (NIH) to have this information.
3. If the application has multiple principal investigators, does each principal investigator have to contribute 20 percent effort?
All the principal investigators together need to commit to at least 20 percent. The requirement is for the combination, not each individual. Note that 20 percent is the minimum. Applicants should budget for the amount of time that each of the principal investigators will actually devote to the project. Investigators in the Collaboratory are usually very actively engaged in their projects.
4. If staff will be hired, must they be in place at the beginning, or can they be hired for the UH3 phase? Can research funds be used to hire the person who will deliver the intervention, or will the health care system deliver it?
Because pragmatic and implementation trials are embedded within routine health care in the health care system, the intervention would be delivered by clinicians already working within that system. Therefore, it’s not anticipated that clinicians would need to be hired for these implementation trials. These are not traditional randomized controlled trials in which independent research delivery of care is developed. The purpose of these pragmatic trials is to determine whether the intervention works as part of the routine care provided by the health care systems. The purpose of the implementation trial is to determine how to achieve adoption, implementation, and sustainability of evidence-based health interventions.
During the planning year or at the start of the UH3 phase, investigators can work in the field to train the clinicians who will ultimately deliver the intervention, rather than hiring clinicians.
Study staff, such as research assistants, can be hired after a project is funded. It is not necessary to have staff available at the time of application.
5. Must the application include a detailed UH3 trial conduct phase budget?
Yes, the application must include budgets for both the UG3 phase and UH3 phase. It is possible that the UH3 budget may change due to activities in the planning phase; however, the budget for the UH3 phase must be within the budget cap described in the request for applications (RFA). Investigators will be able to finalize their UH3 budget during the UG3 planning phase.
6. Does each co-investigator listed in the application need to submit a letter of support?
Individuals who will contribute in a meaningful way to the project can provide a letter of support, including their level of effort and what they expect to contribute. Letters of support from collaborators/co-investigators are encouraged but are not required. Advice on letters of support can be found at niaid.nih.gov/grants-contracts/letters-support, grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general/g.400-phs-398-research-plan-form.htm#9, or nexus.od.nih.gov/all/2019/09/11/reference-letters-vs-letters-of-support-whats-the-difference.
7. Health care systems are sometimes reluctant to obtain signatures from all institutional officials on detailed budgets for all years of a study prior to engaging with us during the planning year. Is it acceptable to submit a proposed detailed budget that has been discussed with each health care system and obtain signatures from all institutional officials as part of the just-in-time documents instead of at the time of application?
The funding opportunity announcement (FOA) requires letters of support from the health care system partners in your application. Letters from the health care systems should describe their commitment to the proposed research and outline how the project fits with organizational priorities, the quality of the proposed electronic health record and data systems, and the commitment of their IT staff to the project. Applications that do not have letters of support from the health care systems will be incomplete and will not be reviewed. The application should include a detailed budget for both the UG3 and UH3 phases, although this may need to be modified slightly before the start of the UH3 phase. This information cannot wait until the just-in-time stage. Subcontracts need to be signed off and submitted with the application.
8. When do I need to apply?
Application due dates are December 15, 2021, and June 17, 2022. Letters of intent are due 30 days prior to the application due date.
9. Who should I contact with general questions about the RFA?
Wendy Weber, N.D., Ph.D., M.P.H.
National Center for Complementary and Integrative Health (NCCIH)