Community-Based Participatory Research to Advance Data and Practice Transformation

Community-Based Participatory Research to Advance Data and Practice Transformation is sponsored by National Institute of Dental and Craniofacial Research (NIDCR) at NIH. This funding opportunity supports community-based participatory research that can improve health outcomes and reduce disparities, aligning with 'Health and Wellbeing' and 'Community Development and Infrastructure'.

PAR-27-015 Community-Based Participatory Research to Advance DAta and Practice Transformation (ADAPT) for Optimizing Oral Health for All (UG3/UH3 Clinical Trial Optional) RFA-DE-27-001 Community Engagement Evaluation and Data Coordination (CEED) Hub to Advance DAta and Practice Transformation (ADAPT) for Optimizing Oral Health for All (U01, Clinical Trial Not Allowed) How will applications be assigned to NIH Institutes, Centers, and Offices (ICOs) and reviewed?

A: All applications will be assigned to NIDCR and will be evaluated for scientific and technical merit by the NIH Center for Scientific Review (CSR) and brought to the National Advisory Dental and Craniofacial Research Council for second level review. Other ICOs may consider co-funding at NIDCR’s request. Who makes funding decisions for UG3/UH3 CBPR project applications and U01 CEED Hub applications?

A: After the two-tier peer review processes, NIDCR will make funding decisions for both the CBPR project and the CEED Hub applications. How are applications evaluated? A: Application review criteria are described in Section V of the NOFOs.

Please also review Section IV, Application and Submission Information, for key research strategies to be included in your applications. How many awards will be given under PAR-27-015 and RFA-DE-27-001? Will there be a set payline for these NOFOs?

A: The number of UG3 awards (PAR-27-015) will be determined by the number of qualifying applications and availability of funding during the fiscal years 2027, 2028, and 2029. Transition to the UH3 award is determined by availability of funds and success in meeting UG3 phase milestones. There will be a single U01 award from RFA-DE-27-001.

NIH has moved away from the use of paylines for funding decisions , and there will be no payline set for these two NOFOs. How many letters of support can be included in an ADAPT initiative application? A: There is no limit to the number of letters of support that may be included in an application.

Please see Section IV, Application and Submission Information, in PAR-27-015 for more detailed instructions on letters of support. Can institutions submit more than one ADAPT initiative application at a time? A: Yes.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct. NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement, Section 2. 3.

7. 4 Resubmission of an Unfunded Application . This means that NIH will not accept: A new (A0) application submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

A resubmission (A1) application submitted before issuance of the summary statement from the review of the previous new (A0) application. An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement, Section 2. 3.

9. 4 Similar, Essentially Identical, or Identical Applications ). Can I be an investigator on more than one ADAPT initiative application at a time?

A: Yes. If there is no effort and/or scientific overlap, investigators can be listed on multiple ADAPT initiative applications. Applicants should remain aware of the recent NIH policy change regarding large numbers of submitted applications ( NOT-OD-25-132 ).

NIH will only accept up to six new, renewal, resubmission, or revision applications from an individual Principal Investigator (PI)/Program Director (PD) or Multiple Principal Investigator for all council rounds in a calendar year. Are applications with multiple PIs permitted? A: 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 . How is a cooperative agreement different from a grant? A: Both CBPR projects (UG3/UH3) and the CEED Hub (U01) will be cooperative agreement awards.

Unlike a grant, a cooperative agreement involves substantial involvement of NIH staff. For this CBPR Consortium, NIDCR staff will serve as project scientists and science advisors on UG3/UH3 research projects and the CEED Hub. Like a grant, every cooperative agreement award has a program official and grants management specialist assigned who will engage in the usual stewardship of NIH awards.

Do we need to request prior approval to submit a budget for a UG3/UH3 application responding to PAR-27-015 or a U01 CEED application responding to RFA-DE-27-001 if the yearly budget equals or exceeds $500,000 in direct costs? A: No. According to NOT-OD-26-019 , and because the budget limits are specified in the NOFOs, permission to submit a large budget is not required.

Can an individual at a community-based organization or non-academic institution be a principal investigator or project director? A: Yes, as long as the PI/PD has appropriate skills and experience to carry out the planned CBPR project and the administration of NIH funds and reporting responsibilities. Please see Section III, Eligibility Information, of the NOFOs for a listing of eligible organization types.

Individuals at a community-based organization who would serve as a cross-sector partner are encouraged to be a PD/PI in a multiple PD/PIs model. Please find additional details and guidance on multiple PD/PIs models on the NIH Grants & Funding website . Do key personnel from non-academic organizations need to submit an NIH biosketch?

A: Yes, per the SF424 (R&R) Application Guide , biosketches are required for all key personnel. All key personnel will need to demonstrate the ability to fill the roles that they are assigned for the project based on their relevant experience and expertise. Are New Investigators (NIs) or Early-Stage Investigators (ESIs) eligible to serve as PIs?

Will NI/ESI status be considered in peer review? A: Yes, NIs and ESIs can serve as PIs or multiple PIs. However, NI/ESI status will not be formally considered during peer review.

Are preliminary data required for UG3/UH3 project applications? A: No, preliminary data are not required, and you can use the UG3 phase to pilot test the feasibility/acceptability of study procedures and finalize the project materials, community engagement, and recruitment planning.

However, describing preliminary studies in the application may help justify the proposed study/target population and/or demonstrate the research team’s previous research with the community of interest. What are the population-based interventions?

A: Instead of interventions targeted at addressing individuals’ risk factors and behaviors to improve an individual’s health, population-based interventions address contextual risk and/or resilience factors driving an entire population’s or specific subgroups’ health outcomes.

These interventions may address place-based policies, programs, and/or practices that impact individuals’ oral health, health decisions and behaviors, and/or access to evidence-based disease prevention and health care in the community. Are there specific research designs that should be used for CBPR projects?

A: Each CBPR project should use research designs that are appropriate for the level(s) of intervention and as rigorous as possible to answer the proposed research questions and enhance generalizability. Research designs should also maximize the generation of evidence related to effective implementation strategies and mechanisms of success in real-world settings.

Furthermore, CBPR projects must be collaborative research between community members and researchers to foster mutual benefit and sustainability. The NIH Research Methods Resources website has useful resources for selecting research methods and sample size. My project will test a system-level intervention in the community.

Do I need to assess oral health outcomes at an individual level? A: Yes, each CBPR project should collect relevant oral health and health-related data from individuals in the community. While common data elements (CDEs) for the CBPR Consortium are not yet finalized, core CDEs from the Science Collaborative for Health and Artificial intelligence Reduction of Errors ( SCHARE ) will be considered.

Is a partnership between a safety net health center and the local health department or a professional health organization/society considered a cross-sector partnership? A: No, these are all examples of health-related organizations or agencies in this NOFO. Please reach out to the scientific point of contact of PAR-27-015 via email at NIDCR-ADAPT@nih.

gov for specific inquiries related to whether your proposed cross-sector partnership meets the NOFO’s requirements. Do cross-sector partnerships refer to organizations or individuals? A: In this NOFO, cross-sector partnerships refer to organizations or agencies, not individuals.

The leadership/decision maker(s) in the partnering organizations/agencies should be involved in the project as appropriate. Individuals not affiliated with a collaborating organization or agency, or without the authority to act on behalf of the organization, would not constitute a cross-sector community partner. Where is the best section in the application to demonstrate existing/previous cross-sector partnerships for research?

A: The Letter of Support, Biographical Sketch, and Approach sections are a few examples of sections appropriate to describe existing/previous cross-sector partnerships for the proposed research. In addition, the planned community partnerships must be demonstrated in the budget and budget justification to ensure equitable effort is allocated to community partners.

In my CBPR application, some cross-sector collaborators will contribute their in-kind efforts; thus, no NIH funds will be allocated. Is this acceptable when the NOFO emphasizes “equitable” community-researcher partnerships? A: Yes.

It is important, however, that sufficient details (e.g., personnel effort, salary support, source of funding/support for each project year) are described in the budget justification page, even for those partners who will contribute in-kind effort. In addition, the scope of work/effort should be clearly described in the letters of support so that reviewers can accurately assess community-researcher partnerships.

It is unlikely that a letter of support from community partners will be obtained in time for the application submission deadline. Is there flexibility in submitting a letter of support as part of the application package? A: Letters of support from community collaborators may be submitted as post-submission material, up to 30 days before the study section meeting.

Note that this flexibility is not extended to letters of support from Key Personnel and consultants with academic or research organization affiliations. Can the project include international subcontracts or project sites? A: No. International consultants may be permitted, but it must be justified why equivalent experts are not available in the United States.

If my new UG3/UH3 application is not funded, can I submit the revision before the expiration of PAR-27-015? A: Yes, you can submit the revision as a resubmission. I am interested in seeking two Community Engagement Alliance Consultative Resource (CEACR) consultations during the study period.

Can we plan to have one CEACR consult during the UG3 phase to finalize the community engagement plan for the UH3 phase and one consult during the late UH3 phase to discuss the dissemination plan? A: Yes, as long as the application includes a budget for two CEACR consultations ($6000 each x2). I and/or my co-investigator have done community engagement and community-engaged research.

Do I need to receive a consultation from CEACR? A: Yes, it is a requirement to receive at least one expert consultation on a community engagement plan and finalize strategies and milestones for outreach and cross-sector partnerships during the UG3 phase. However, you can choose to receive a consultation from locally available expert(s) in community engagement instead of budgeting a CEACR consultation.

Will a data and safety monitoring board be provided through the Consortium, or should I propose one for my UG3/UH3 research project? A: NIDCR will arrange oversight resources according to the Clinical Terms of Award policy for individual projects determined to require additional oversight due to elevated risk to human subjects.

In general, a project PI and the PI's institute will be responsible for an individual project’s safety and data quality oversight. A community advisory board (CAB) for an individual UG3/UH3 project may include subject matter expertise related to data and human subject research safety to better reflect the local community’s perspectives.

At the Consortium level, the CEED Hub will coordinate data harmonization, data quality, and integrity in the SCHARE platform. How can cloud data storage and computing costs for my project be estimated? A: There are various formulas and tools available to estimate your project’s cloud costs.

It may be best to consult with your institutional data information technology expert and/or biostatistician. My project data will not be publicly shareable because of the sensitivity of human subject data and/or policies that control data access, transfer, and reuse. Is it acceptable to submit a Data Management and Sharing (DMS) Plan that does not use the SCHARE Repository?

A: Even if your raw project data would require a data use agreement and thus not be deposited in the SCHARE Repository, you should plan to make metadata, such as a data/variable code book, interview guides, etc., accessible via the SCHARE Repository, and the metadata should be described in the DMS Plan. Although it is not a requirement, it is highly recommended that awardees of PAR-27-015 use the SCHARE Repository.

Will the CEED Hub be responsible for performing data analysis for UG3/UH3 research projects in the Consortium? A: No, the CEED Hub will not centrally analyze individual UG3/UH3 project data, but the CEED Hub will coordinate data harmonization, quality management, and data-related consultations and technical assistance for data analyses as needed.

Each UG3/UH3 team therefore should have a project biostatistician/data coordinator who collaborates with the CEED Hub. Do I need to include proposed activities and their approaches for participation in the CBPR Consortium and/or Steering Committee in my UG3/UH3 application?

A: Applicants are expected to indicate an understanding of and willingness to participate in the Consortium activities, including collaborations with other CBPR project awardees and the CEED Hub for the steering committee and community engagement evaluation study conducted by the CEED Hub.

The application budget should include personnel efforts and travel to one in-person meeting in the Bethesda, MD area during Year 1 for selected project team members. There is no need to propose the plan for Consortium activities in detail. Are the 12 pages of the Research Strategy primarily to provide details about the work to be completed in the UG3 (Planning) phase of the project?

A: No, both the UG3 (planning) and the UH3 (implementation) phases should be addressed in the Research Strategy, which must be no longer than 12 pages. A: Milestones are objective measures of progress toward research goals and should represent the completion of specific activities projected to have a significant impact on the completion of the project.

Milestones must provide objective and quantitative outcomes to justify continued funding of the project. They must be measurable, have appropriate endpoints, and have specific due dates. Milestones are required for both the UG3 and UH3 phases.

The CEED U01 award is for five years. What happens to the CEED Hub and CBPR Consortium after five years? A: NIDCR intends to maintain continuity of the CEED Hub resources to support ongoing research within the CBPR Consortium.

One of the CEED Hub objectives/scope of work is a Community Engagement Evaluation. Is the CEED Hub anticipated to have expertise on Community Engagement and Community Engaged Research? A: It would be helpful to have community engagement expertise in the CEED Hub, however it is not a requirement because the Consortium will collaborate with CEACR.

CEED U01 applications should include theory-based program evaluation strategies and how communication and consultations will be coordinated with CEACR based on the CEACR’s scope of work outlined in the Consortium Structure description in the NOFO. The CEED Hub application does not need to budget for CEACR consultation costs. How many UG3/UH3 projects should CEED Hub anticipate working with each year?

A: The numbers may fluctuate due to the addition of new UG3 projects during the first three years and non-transition of some UG3 projects into the UH3 phase. It is anticipated, however, that the number of CBPR projects in the Consortium should not exceed 10–15 in any year during the award period. Is a Data Management and Sharing Plan required for CEED U01 applications?

A: Yes. The CEED Hub will conduct community engagement evaluations by collecting data from CBPR project teams and their cross-sector partners and community members. Thus, the CEED Hub applications must describe human subject studies and include a DMS Plan.