Late-Stage Implementation Research Addressing Hypertension in Low- and Middle-Income Countries: Scaling Up Proven-Effective Interventions (UG3/UH3 Clinical Trial Optional)

Q1. Can you confirm that this FOA is not subject to the requirement for prior approval on any annual budget greater than $500,000 or more in direct costs?

A1. Prior approval is not required for applicants responding to this FOA.

Q2. Am I required to submit a letter of intent?

A2. A letter of intent is not required and it does not enter into the review of a subsequent application. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

Q3. When are applications due?

A3. The receipt date for this FOA is July 8, 2019. Applications must be submitted by 5:00 PM local time of applicant organization.

Q4. Does the application have a page limit?

A4. Yes. All page limitations are described in the SF424 Application Guide and the Table of Page Limits must be followed.

Q5. How should I submit my application?

A5. All applications must be submitted electronically. Applicants should follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise [in this FOA ( Section IV. Application and Submission Information) or in a Notice from NIH Guide for Grants and Contracts.

Q6. Can I be a named researcher on more than one application?

A6. Applicants may be named investigators on more than one proposal.

Q7. Are U.S.-based institutions eligible for this funding opportunity announcement?

A7. Applicant institutions from High Income Countries, including the U.S., are not eligible applicant organizations for this FOA.

Q8. Can Co-Principal Investigators (PIs) from institutions in two different LMICs apply for the grant— with the same activities conducted in both countries?

A8. Yes, multiple PIs are welcomed in the application as well as multiple performance sites within the same country and/or within multiple LMICs.

Q9. Are there countries that are not permitted to apply to this Funding Opportunity Announcement (FOA)? If so, can research be proposed to occur in restricted countries?

A9. Given that the GACD expects applicants to apply to research calls from the funding agencies within their own countries, applications from the following GACD member countries are not eligible for this FOA: Canada, United Kingdom, Argentina, Japan, India, Brazil, Australia, Mexico, China, New Zealand, South Africa, Thailand. The applicant may not be located in these countries.

Q10. Collaboration between institutions in LMICs and HICs is highly encouraged. Who must be the lead?

A10. The award goes to the LMIC institution. While Multi-PI (MPI) leadership is allowed and encouraged, including MPIs from HICs, the LMIC institution must be the administrative lead, and the LMIC investigator should be the contact PI for an award.

Q11. Can I apply if I am from a high-income country?

A11. Partnerships between LMIC and HIC institutions are highly encouraged. You may form a partnership with researchers from any of the LMIC countries in the regions listed in the FOA (except GACD partner countries stated in the FOA as exempt). Please bear in mind that in order to be eligible, research projects must be based in LMICs, with the foreign institution as the administrative lead.

Q12. The RFA states that “Application budgets are limited to $460,000 direct costs in Fiscal Year 2020, and $460,000 direct costs per year in FY2021, $1,150,000 direct costs through FY2022-FY2024, and $552,000 in FY2025. Budgets should reflect the actual needs of the proposed project.” Is it $1,150,000 in direct costs per year in FY2022, FY2023 and FY2024? Or is the budget limit 1.15 million direct costs per year in years 3-5; or 1.15 million direct costs spread across years 3-5?

A12. Applicants may request direct costs of us to $460,000 in FY2020; $460,000 in FY2021; $1,150,000 in FY2022; $1,150,000 in FY2023; $1,150,000 in FY2024; and $552,000 in FY 2025.

Q13. Is it possible to have multiple PIs, with one of the PIs located in a U.S.-based institution?

A13. Yes, applications with multiple PIs are not restricted, but the award would be awarded to the LMIC institution. Please note that while it is highly encouraged that LMIC researchers partner with a researcher or institution in a high-income country (HIC), the HIC institution does not have to be U.S.-based. The institution can be located in any other HIC.

Q14. Can I apply to both the NHLBI or NINDS for this FOA?

A14. Applicants may not apply to both ICs with the same project. We strongly recommend that you contact us before submitting your application for further guidance.

Q15. Is there is a limit on the number of collaborating countries?

A15. No. It is up to the LMIC PI. The important factor is to establish partnerships with institutions with demonstrated experience and expertise in relevant areas including late-stage translation phase 4 research (T4TR), global health, heart, lung, blood, and sleep (HLBS) diseases and disorders in low-resources settings, as well as the ability to provide appropriate technical assistance, enhanced resources, and expertise to build local capacity in the LMIC award country.

Q16. Is the UG3 exploratory/developmental phase conceived as a planning phase, where partner communities are engaged to identify the programs and health areas of most importance for implementation strategies, and identification of strategies most appropriate and effective in the community of interest?

A16. The UG3 phase will support planning activities focused on sustainable uptake of proven-effective interventions throughout the community of interest. The UG3 phase will provide 2 years of planning activity support vital to properly planning, contextualizing, and informing the UH3 phase of the award, along with necessary time for partnership building and capacity building efforts.

Q17. What is required to convert the award from the UG3 developmental phase into the UH3 implementation phase?

A17. Funding for the UH3 phase of the award, which will provide up to 4 years of funding for implementation of interventions throughout the community of interest, is contingent on appropriate progress made during the UG3 planning phase of the award. Milestone Accrual Plans (MAPs) will be utilized for both the UG3 and UH3 phases of the award and effective milestone completion during the UG3 phase of the award will determine conversion of the award to the UH3 phase. If progress toward meeting award milestones during the UG3 phase is deemed insufficient, the award will not be converted to the UH3 phase and the award will end.

Q18. What is the role of the GACD?

A18. The GACD is a unique collaboration of major research funding agencies in twelve countries and the European Commission that seek to address the prevention, control and treatment of chronic non-communicable diseases in low- and middle-income countries as well as indigenous and vulnerable populations in high-income countries. The GACD Secretariat is independent and impartial and facilitates joint international calls for proposal and supports funded research projects’ collaboration with other international teams in GACD Research Network.

Research under GACD involves regular exchange of research findings and information across participating projects by means of cross-project working groups and annual joint meetings that will be organized by the GACD, which all awardees are expected to attend. The NHLBI, NINDS, GACD, will work together wherever feasible to harmonize and standardize data collection and exchange data across awards. Applicants are encouraged to use data dictionaries developed by GACD programs.

Q19. I’m proposing a clinical trial. Is a Data and Safety Monitoring Board (DSMB) required?

A19. Yes. A DSMB will be required for all clinical trials.

Q20. Who do I contact if I have any further queries?

A20. Please direct all general questions to the Scientific/Research Contacts listed in the FOA.