Disparities Elimination through Coordinated Interventions to Prevent and Control Heart and Lung Disease Risk (DECIPHeR) (UG3/UH3 Clinical Trial Optional)

Released Date
Expiration Date
Activity Code
Full Announcement

Frequently Asked Questions for DECIPHeR UG3/UH3 (RFA-HL-20-003)

Q1. When are applications due?

A1. A change in the application receipt dates for the two DECIPHeR FOAs was announced in two separate NIH Notices (see NOT-HL-19-703 and NOT-HL-19-710). The two receipt dates were updated to May 17, 2019 and December 2, 2019, pending availability of funds. Applications must be submitted by 5:00 PM local time of the applicant organization.

Q2. Where can I find the webinar slides from Monday, April 15, 2019?

A2. Here you will find the webinar slides for the DECIPHeR UG3/UH3 FOA RFA-HL-20-003. Likewise, the link to the webinar slides for DECIPHeR U24 FOA RFA-HL-20-004 is found here.

Q3. Per the SF424, it states "if you are requesting a budget with $500,000 or more in direct costs for any budget period, contact the awarding component to determine whether you must obtain prior approval before submitting the application." Do I need prior approval?

A3. No. Applicants to this RFA do not need prior approval as budget thresholds are spelled out in the RFA. Prior approval is needed for regular R01s that come in over the $500K cap.

Q4. We would like our grant to start in April 2020, which is between 2 federal fiscal years. How do I interpret the budgetary limits for the award?

A4. Grants funded in April of 2020 will receive FY 2020 federal funds. The budget for Year 01 may not exceed $635,000 in direct costs. If funded, you will receive 1 year (12 months) of funding, as the funding is based on the fiscal year at the time of award. This funding does not split across budget periods.

Q5. From a budgetary perspective, what should the application budget look like if we are only planning to use a single year (April 2020 to March 2021) for the UG3 phase.

A5. If you’re proposing to have a one year UG3 phase begin on April 2020, then the UH3 phase will begin in April of 2021. Your budget will need to specify that you anticipate only doing 1 year at the UG3 phase so that NHLBI knows when you intend to move into the UH3 phase.

Q6. Do the two interventions need to focus on risk factors for same disease (e.g. 2 CVD risk factors)? Or can one focus on CVD and one asthma or other pulmonary diseases?

A6. The proven-effective interventions do not need to focus on risk factors for the same cardiovascular or pulmonary disease.

Q7. Please provide an example of a project that would be deemed responsive to this FOA.

A7. A few examples of projects that would be deemed responsive are included below:

  • Community-engaged, community-participatory research on tobacco cessation, and obesity and hypertension prevention and control in the Appalachian Region that engages national organizations (e.g., FQHCs), regional organizations (e.g., Appalachian Regional Commission), state health agencies, and local health systems and providers to study optimal and sustainable strategies for evidence-based prevention guideline delivery using the REACH implementation research approach
  • Implementation research studies for hypertension prevention and control within inner-city and/or low-income populations with large CVD burdens that engage local, city, and state NGOs, health providers, health systems, local health organizations, local businesses, and local civic leadership to lower dietary salt intake and improve delivery of hypertension guideline-based care using the CFIR implementation research framework
  • Implementation research focused on cardiovascular disease risk factors with racial/ethnic groups with a high burden of cardiovascular disparities that engages national organizations, regional, and local health organizations to study optimal and sustainable delivery strategies for delivering evidence-based care for hypertension, dyslipidemia, and smoking cessation

Q8. Will I lose my early stage investigator (ESI) status for a future R01 submission for myself if I am awarded a grant under the DECIPHeR funding opportunity?

A8. An ESI is defined as a Program Director / Principal Investigator (PD/PI) who has completed their terminal research degree or end of post-graduate clinical training, whichever date is later, within the past 10 years and who has not previously competed successfully as PD/PI for a substantial NIH independent research award. Applicants are encouraged to review the information found at this link to learn more about NIH’s ESI policies. A list of NIH grants that a PD/PI can hold and still be considered an ESI can be found here.

Q9. When will notification be given to prospective applicants as to whether or not there will be a second application receipt date.

A9. A formal NIH notice was issued on June 24, 2019 (NOT-HL-19-703) which announced a change in the second application receipt date. There are currently two receipt dates for this FOA, May 17th and December 2nd. It is anticipated that applications will be accepted for both dates. 

Q10. How should I submit my application?

A10. 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 ]

Q11. Am I required to submit a letter of intent?

A11. 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.

Q12. Does the application have a page limit?

A12. Yes. All page limitations are described in the SF424 Application Guide and the Table of Page Limits must be followed.

Q13. What populations are of high interest for this FOA?

A13. The NHLBI anticipates research will focus on reduction or elimination disparities in populations in at least one of the following communities with a high burden of cardiovascular and/or pulmonary health disparities:

  • Geographic regions (e.g., Mississippi Delta, Appalachia, Stroke Belt, Stroke Buckle, etc.)
  • Rural locales
  • Inner-city neighborhoods
  • Racial/Ethnic Groups (e.g., Blacks or African Americans, American Indians or Alaska Natives, Hispanics or Latinos, Native Hawaiians and/or other Pacific Islanders, etc.)
  • Low socioeconomic status
  • Disability status
  • Sex and gender minority populations.

Q14. Can an applicant submit an applicant for both the DECIPHeR Research Coordinating Center (RCC) and a UG3/UH3?

A14. Yes.

Q15. Who qualifies as an implementation research expert?

A15. Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

Q16. How many awards does NHLBI intend to Fund?

A16. While NHLBI intends to fund up to 8 awards, the actual number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Q17. On what basis are applications selected for funding?

A17. Applications will be selected for funding based on scientific merit, current NIH program research priorities, and availability of funds. Applicants are highly encouraged to discuss potential research aims with program officials to determine fit with programmatic research priorities.

Q18. Where will my application be reviewed?

A18. Applications will be evaluated for scientific and technical merit via a special emphasis panel convened by NHLBI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

Q19. Are foreign institutions eligible to apply?

A19. Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Q20. This FOA states that clinical trials are optional. How is this determined?

A20. Applicants proposing to conduct a clinical trial under this FOA should review NHLBI’s requirements for clinical trials research (See https://www.nhlbi.nih.gov/health-topics/about-clinical-trials). The NIH Definition of a Clinical Trial must be used to determine whether or not you are conducting a clinical trial. It states a clinical trial is “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavior outcomes.” A decision tool is available to assist with the determination. Applicants are also encouraged to review NIH policy on clinical trials and case studies for reference.

Q21. What type of research designs might you expect to see in a responsive grant application to RFA-HL-20-003?

A21. This FOA is intended to support applications that propose to : (1) employ validated theoretical or conceptual implementation research frameworks (e.g., Consolidated Framework for Implementation Research (CFIR); Promoting Action on Research Implementation in Health Services (PARiHS); Pragmatic-explanatory continuum indicator summary (PRECIS); Reach Effectiveness Adoption Implementation Maintenance (RE-AIM); PRECEDE-PROCEED, K2A, etc.); (2) include implementation research study designs (e.g., experimental, quasi-experimental, observational, modeling, cluster randomization, stepped-wedge, Type III hybrid effectiveness, etc.); (3) include implementation measures as primary research outcomes (e.g., acceptability, adoption, appropriateness, affordability, costs, feasibility, fidelity, penetrance, and sustainability etc.; and (4) inform understanding of key mediators and mechanisms of action of the implementation.

Q22. Should applications focus on treatment/secondary prevention interventions versus primary, or even tertiary, prevention? For example, COPD and sleep apnea seem more treatment-focused. Healthy eating and physical activity seem to be more primary prevention focused.

A22. Examples of projects that are of interest to NHLBI and responsive to this FOA include, but are not limited, to those that clearly identify a high burden community or population; assemble a broad-based research team that is inclusive of all key community members; tests optimal and sustainable interventions delivery strategies suitable for the local context; and are of high priority for the community being studied. As such, applicants should propose to test late-stage (T4) implementation research strategies for optimally and sustainably delivering two or more proven-effective, evidence-based, multi-level interventions to reduce or eliminate cardiovascular and/or pulmonary health disparities AND improve population health in high-burden communities. 

Q23. Must applications address implementation research delivery strategies aimed at a target population within a specific age range?

A23. No. When the proposed project involves human subjects and/or NIH-defined clinical research, the review committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed.

Q24. Are applications with multiple PIs permitted?

A24. Yes. For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

Q25. Can an organization submit more than one application?

A25. Yes. Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time.

Q26. Is the 12 pages for the Research Plan primarily to provide details about the work to be completed in the UG3 phase of the project?

A26. Applications submitted in response to this FOA must address both the UG3 and UH3 phases and are expected to include plans for project management and performance milestones for each phase within the research plan as outlined in the FOA (Section IV. Application and Submission Information).

Q27. Is the UG3 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?

A27. The UG3 phase will support planning activities focused on sustainable uptake of proven-effective interventions throughout the community of interest.

Q28. For the UH3 phase, is a second independent review conducted and an additional proposal submitted, or does the transition to the UH3 phase take place after program staff review milestones from the UG3 phase?

A28. The application is expected to propose a well-defined set of milestones for the UG3 phase as well as the UH3 phase. An administrative review of the extent to which peer-reviewed milestones are met in the UG3 phase will determine whether the UH3 phase award will be issued, subject to NHLBI funding availability.

Q29. As the DECIPHeR research alliance is developed, will individual awardees of the different grants be required to work together?

A29. The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined in this FOA under Section VI. Award Administration Information.

Q30. Who needs to be included in the multi-disciplinary teams mentioned in the announcement?

A30. Project team composition will be determined in large part by the research question and proposed approach. It is anticipated that each multi-disciplinary research team will, at minimum, include members with the appropriate level of expertise in behavioral and social science, implementation science, cardiovascular and/or pulmonary science, health disparities, economics, epidemiology, and/or policy.

Q31. How often with the DECIPHeR network (DECIPHeR UG3/UH3 awardees and the RCC awardee) meet over the course of the proposed 7 year period of performance?

A31. It is anticipated that representatives from the DECIPHeR UG3/UH3 and RCC awardees will meet at least one time per year. In YEAR 1, there will be a two-day, start-up meeting that will take place in the Washington, DC area, and representatives from each UG3/UH3 grant and the 1 RCC awardee are expected to attend. In the Year 2 and beyond (until the end of the award), DECIPHeR network meetings will continue to take place annually and each of the DECIPHeR activity sites will co-host an annual meeting on a rotating basis.

Q32. What additional guidance can you share with the applicants as it pertains to budgeting for the required meetings?

A32. The specific budget guidance is included in each FOA under Section IV. Application and Submission Information. In order to provide cost clarifications for the FOA required meetings, it should be noted that application budgets for UG3/UH3 and RCC applicants must include funds for the PD/PI and two additional key personnel to participate in a two-day, start-up meeting in the Washington, DC area (e.g. Bethesda, Maryland at the NIH) during the first year of the award. For YEAR 2 and beyond until the end of the award, budgets from RCC applicants should include costs to both participate and host each annual meeting at one of the UG3/UH3 sites on a rotating basis. Moreover, budgets from UG3/UH3 applicants should include costs to 1) participate in every annual meeting held in Years 2-7, and 2) host one annual meeting at their location. UG3/UH3 applicants should add the costs for hosting the annual meeting to their YEAR 3 budget request.

Q33. Is the RCC awardee expected to participate in the Community Engagement meetings?

A33. In the RCC FOA (RFA-HL-20-004: Section IV. Application and Submission Information), it states that applications should budget for local community meetings or other appropriate activities. It is anticipated that applicants will describe their proposed level of participation in these meetings and/or related activities, as well as provide the appropriate justification and rationale.