Programmatic Questions

1. Will all applications be assigned to the National Center for Complementary and Integrative Health (NCCIH)?

All applications will be assigned to NCCIH initially because they will go to the same review panel. However, after review, applications that are considered for NIH HEAL Initiative funding will be transferred to the NIH Institute or Center with a mission that aligns with the research proposed.

2. Should I contact NIH program staff before I apply?

Applicants are strongly encouraged to contact a program director at the Institute or Center that has a mission that aligns best with your proposal. It is always a good idea to speak with a program director to inquire about the level of interest at the Institute or Center where your application seems a best fit. See the scientific/research contact list in the FOA.

3. Should applicants identify which NIH Institute or Center they want to receive their application if the proposal passes the first review and scores well?

You may do this, and it would be helpful for NIH to have this information.

4. Is a letter of intent required?

A letter of intent is desired but not required. Letters of intent are helpful for NIH staff, as they allow for better management of the workload involved in reviewing applications. They also help program staff ensure your application will be responsive to the FOA. Letters of intent should be sent to Martina Schmidt at SchmidMa@mail.nih.gov.

5. If the application has multiple principal investigators, does each principal investigator have to contribute a 20 percent level of effort?

The project director/principal investigator must devote a minimum level of effort of 20 percent (2.4 person months) to the project annually. The requirement is for the combination, not each individual. Note that 20 percent is the minimum. Applicants should budget for the amount of time each principal investigator will actually devote to the project. Usually, investigators in the PRISM Program are very actively engaged in their projects.

6. If staff will be hired, must they be in place at the start of the UG3 phase, 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 is not anticipated that clinicians need to be hired for these pragmatic or implementation trials. 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. Additional research staff can be hired at the beginning of the UH3 phase to assist with the conduct of the trial.

7. Must the application include a detailed budget for both the UG3 planning phase and the UH3 trial conduct phase?

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 FOA. Investigators will be able to finalize their UH3 budget during the UG3 planning phase.

8. For the budget, is the dollar amount listed on the FOA direct only, or direct plus indirect?

The budget listed on the FOA refers to direct costs. Please note that the planning year will have a lower budget than the other years. If the milestones from the planning year are met and the project is approved to move forward, the award will transition to the second stage of funding to conduct the trial.

9. 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

10. Health care systems are sometimes reluctant to obtain signatures from all institutional officials on detailed budgets for all years of a study. 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 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 information technology 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. Signed subcontracts need to be submitted with the application.

11. Can foreign institutions submit proposals?

No, all applicant institutions and study sites must be domestic.

12. Are foreign components as defined in the NIH Grants Policy Statement allowed?

No, foreign components as defined in the NIH Grants Policy Statement are not allowed.

13. Can I be a principal investigator on an application for one FOA and also be a principal investigator or multi–principal investigator on an application submitted for another FOA?

Yes, however, participation as a principal investigator is limited by your available percentage of level of effort.

14. What are the plans for data and resource sharing for this program?

Through the NIH HEAL Initiative Public Access and Data Sharing Policy, NIH seeks to create an infrastructure that addresses the need for researchers, clinicians, and patients to collaborate on sharing their collective data and knowledge about opioid misuse and pain to provide scientific solutions to the opioid crisis. See the NIH HEAL Initiative Public Access and Data Sharing webpage (heal.nih.gov/data/public-access-data) for more information.

15. Do you have some idea how many awards will be made through this FOA?

Funds are available for approximately three awards through this FOA and the companion FOA, RFA-AT-22-005, in fiscal year 2022.

16. When do I need to apply?

Applications are due on December 15, 2021. Letters of intent are due 30 days before the application due date.

17. Whom should I contact with general questions about the FOA?

Wendy Weber, N.D., Ph.D., M.P.H.

National Center for Complementary and Integrative Health (NCCIH)

Telephone: 301-402-1272

Email: weberwj@mail.nih.gov