1. I wish to propose a clinical trial. Which PAR should I submit to?
It depends on whether or not your target IC is participating in both NOFOs or not. If the IC is only participating in
PAR-25-213 (R01 Clinical Trial Optional), you would apply under this NOFO for research proposing clinical trial or non-clinical trial research. If the target IC is participating in both PAR-25-213 (R01 Clinical Trial Optional) and
PAR-25-223 (R61/R33 Clinical Trial Required), utilize PAR-25-223 (R61/R33 Clinical Trial Required) for all proposed clinical trial research; PAR-25-213 (R01 Clinical Trial Optional) is only utilized for proposed non-clinical trial research in this case. When in doubt, we recommend that you reach out to the IC-specific contact listed in the NOFO.
2. What is the life course approach within this call? Is it preventative or management focused?
This call focuses on multimorbidity management in people groups already experiencing multimorbid conditions, as opposed to preventative measures or approaches. While the study population in question should have existing multimorbidity and focus on management of multimorbid conditions within the context of your study setting, it is still allowed to study ancillary preventative measures as long as management is still the primary research focus. For additional context, please check out this article
here.
3. Can I add a Clinical Trial (CT) in the middle of my grant?
Please refer to the
NIH Clinical Trial Policy for the relevant information regarding requirements and timelines of clinical trials. While it is generally not allowed to reclassify your award following funding from a non-clinical trial to a clinical trial, you may utilize the delayed onset mechanism outlined in the NIH Clinical Trial Policy for clinical trial research that would require further intervention contextualization and design prior to final development of clinical trial protocols, etc., and approval for beginning the proposed clinical trial.
4. How does an applicant reach out to a respective IC?
IC Program Officer contact information is listed
Section VII. Agency Contacts.
5. Would a project focused on multimorbidity management within a Native Hawaiian and Pacific Islander population be responsive?
Proposals focused on NHPI groups may be responsive if based in an LMIC or if focused on Native Hawaiian or Pacific Islander populations in the US. It is important to also ensure responsiveness to other NOFO requirements, such as those related to community engagement, equitable partnership, and research capacity building. If you have questions about the eligibility of your proposed research population, please reach out to one of the contacts listed in the NOFO.
6. What happens if my yearly budget is greater than the $500,000 cap?
You will need to specify in your application if you plan to exceed the yearly $500,000 direct cost cap. Additionally, you will need to reach out to your proposed funding IC at least six weeks prior to the application deadline to receive written approval. Please refer to
Section IV – Application and Submission Information in the NOFO for more information.
7. Would a multi-country application be feasible for this type of NOFO? For example, a Tribal Nation (USA) and Indigenous groups in another country in Latin America?
Multi-country applications are certainly allowable, though not required. In the example above, an application could also focus solely on an American Indian/Alaskan Native population in the US.
8. If my study includes those living with and without HIV, is my deadline still the same?
If any population in your study includes people living with HIV/AIDS (PLHIV), you may submit your application according to the AIDS-related deadline listed in
Part 1 – Overview Information: Key Dates of the NOFO. Be mindful, though, that HIV/AIDS receipt dates are for applications that propose to study the implications of HIV/AIDS in the population in question, not simply that PLHIV are included. For instance, if you proposed to study comorbid cardiovascular disease in people living with chronic kidney disease, your application must also propose to study comorbid implications of HIV/AIDS within this study population to utilize the HIV/AIDS receipt date, not simply include persons that may or may not have HIV/AIDS within the study population.
9. Can we include tribal populations in LMICs?
Yes, research proposed in an LMIC may include LMIC-based tribal populations.
10. I am uncertain whether the health question I'm interested in would be considered a long-term (chronic) condition or just a risk factor. How shall I proceed?
As described in the NOFO, only one of the multi-morbid conditions under study is required to be an NCD. The NOFO has been left intentionally broad regarding what constitutes other long-term/chronic conditions. However, this funding opportunity is specifically focused on management of existing multi-morbidities, not prevention of multimorbidity or management of a single disease with risk factors for additional complications. If you are uncertain whether your targeted health condition(s) are responsive, reach out to the IC-specific contact to discuss your specific aims.
11. Does having one LMIC or multiple LMICs affect the way the application is reviewed and scored?
No. Only the review criteria described in Section V. Application Review Information will be considered in the review process.
12. What is the capacity building expectation?
A key element of this program is to provide opportunities within each funded project to build implementation research capacity especially, but not exclusively, in lower resourced environments, such as LMICs or AI/AN communities, and among early-career researchers from these communities. Exact requirements or expectations for capacity building are left open-ended, to enable research teams to propose capacity building strategies that meet priority needs in their area. That said, proposed capacity building efforts are expected to build research capacity, not simply service capacity. Questions about capacity building plans should be directed to the PO.
13. Can we include vaccine administration as part of the project? What about developing a diagnostic and implementing it?
A proposed study of vaccine treatment and administration would be considered relevant if integrated within the context of multimorbidity management. Likewise, use of a diagnostic may be appropriate, depending on its incorporation into the broader research. It will be important to define where, when, and how these approaches fit within your overall study, which should necessarily be focused on implementation of evidence-based interventions in the context of NCD multimorbidity management. As always, please reach out to listed program officer contacts in cases where there is lacking clarity around the fit of your proposed research with the goals of the program.
14. What is the review process like for this NOFO?
Please refer to
Section V – Application Review Information of the NOFO for detailed information on how applications are reviewed. All applications will be reviewed together in a Center for Scientific Review (CSR)-led Special Emphasis Review Panel instead of utilizing standing CSR study sections for review.
15. Are there specific NCDs and co-morbidities of priority you are interested to fund?
While this NOFO is purposefully broad to capture a wide range of NCDs and co-morbidities, it will also be important to review the IC-specific priorities described in
Section I – Notice of Funding Description of the NOFO. Remember that the Fogarty International Center (FIC) manages this overall program but does not fund awards. As such, your application must be aligned with the priorities of a participating NIH IC to be considered for funding.
16. The NOFO seems to be focused on "care" for multimorbidity. What about projects seeking to prevention multimorbidity or reducing severity of multimorbid conditions by addressing risk factors like physical activity or diet?
It is expected that projects will focus on management of patients with existing multimorbidity and will not focus on prevention of multimorbidity (though projects focusing on the secondary prevention of increased severity of existing NCDs through risk factor management are appropriate).
17. Can an institution submit more than one application?
Yes, as long as the applications are scientifically distinct. See
Section IV – Application and Submission Information in the NOFO for more information.
18. Will hybrid type 2 studies that have both primary implementation AND effectiveness outcomes be responsive to the NOFO?
The NOFO specifies that the proposed primary outcome measures should be
implementation research outcomes but does not preclude additional focus on effectiveness outcomes; hybrid studies that address both implementation and effectiveness outcomes are generally appropriate.
19. What is the LMIC requirement for this NOFO? What about high-income country involvement?
Applications will be accepted from US and LMIC institutions only. Eligible LMIC institutions are defined by the World Bank at the following link:
datahelpdesk.worldbank.org/knowledgebase/articles/906519-world-bank-country-and-lending-groups. While it is not required (although encouraged) for applications submitted to this NOFO by
LMIC institutions to have US partners, all applications submitted to this NOFO by
US institutions are required to involve LMIC researchers as key personnel. Please refer to
Section III – Eligibility Information for more information.
20. What is the difference between patient-centered intervention and evidence-based intervention?
Evidence-based interventions are those that have been proven to be effective in improving outcomes, while patient-centered care refers to care that is responsive to patient preferences, needs, and values . Addressing multimorbidity from a patient-centered approach demands a shift from fragmented models of care, that treat individual health issues separately as they occur, to a more holistic, integrated care model that provides a whole person focus on health management. This NOFO emphasizes implementation research of patient-centered approaches with evidence for their effectiveness. For additional context, please refer to this article
here.