It depends. It would count as a multi-sectoral collaboration if the community partners represented two or more service sectors (e.g., health, public health, education, housing, labor, social services, child welfare, transportation, parks and recreation, commerce, justice, environmental protection, etc.). The academic institution itself would not count as a service sector unless university students were the focus of the preventive intervention. 

Yes, applicants are welcome to provide letters of support from collaborators. However, this is not sufficient to demonstrate multi-sectoral collaborations. To be responsive to the UG3/UH3 PAR (PAR-24-053), collaborations must be indicated by the inclusion of organizational representatives as key personnel and/or proposed subcontracts to the organizations.

“Multi-sectoral partners” refer to organizations or agencies, not individuals. Representatives from these organizations should be included as key personnel as appropriate, and subcontracts to the organization can be used to support organization staff or other expenses associated with the project. Individuals not affiliated with a collaborating organization or agency, or without authority to act on behalf of the organization, would not constitute a multi-sectoral partner.

No, to maintain impartiality during the grant submission, peer review, and selection process, NIH cannot recommend specific individuals or organizations to potential applicants. However, NIH provides NIH RePORTER as a resource, where potential applicants can search for relevant active awards and reach out to the PIs of those awards.

The UG3/UH3 PAR (PAR-24-053) defines a multi-sectoral intervention as “involving two or more service sectors (e.g., health, public health, education, housing, labor, social services, child welfare, transportation, parks and recreation, commerce, justice, environmental protection, etc.).” The nature of this involvement in intervention development, implementation, delivery, and/or evaluation is left up to applicants to specify and justify. Applicants can see the Areas of Research Interest of the participating NIH Institutes and Centers for multi-sectoral preventive interventions of interest in PAR-24-053.

No, NIH does not have a definitive list of service sectors for the UG3/UH3. Investigators are strongly encouraged to reach out to the relevant scientific contacts in PAR-24-053 to discuss their proposed multi-sectoral interventions, as the participating Institutes and Centers have different priorities regarding service sectors and types of interventions.

For the UG3/UH3 PAR, “sector” refers to the type of services an organization provides (e.g., healthcare, housing assistance) rather than the characteristics of the organization (e.g., public vs. private). Based on this definition, a governmental agency and a community-based organization could be classified within the same sector if they offered the same types of services (e.g., employment assistance). Investigators are encouraged to reach out to the relevant scientific contacts in PAR-24-053 to ensure that their proposed intervention meets the PAR definition of multi-sectoral.

No, projects that only intervene at the individual level or use an individual-level randomized trial design are not responsive. The objective of the MSPI Research Network is to evaluate interventions that move beyond addressing knowledge, attitudes, and behaviors of individuals to intervene upon SDOH that drive inequities. Interventions that modify SDOH beyond the individual level require corresponding study designs that examine units of analysis beyond the individual (e.g., health clinics, schools, neighborhoods, etc.).
 

No, NIH does not have a preferred study design, with the exception that individual-level clinical trials are non-responsive. Methods consistent with plans for assignment of participants and delivery of interventions in groups or clusters (e.g., families, clinics, schools, worksites, communities, counties, states) should be documented in the application. Information about appropriate study designs is available at the NIH Research Methods Resources website. Sample size calculators for cluster randomized trial designs (both parallel group-randomized trials and stepped wedge group-randomized trials) are available at researchmethodsresources.nih.gov/Tools.

No, projects that propose to evaluate natural experiments in the absence of conducting a prospective intervention implemented as part of the UG3/UH3 award would be non-responsive to PAR-24-053.

No, other populations may be included, as long as the study is adequately powered to identify intervention effects for the HD population(s) of focus and/or the impact of the intervention on reducing or eliminating disparities in health outcomes.

No, preliminary data are not required. However, describing preliminary studies in the application may help provide justification for the proposed multi-sectoral intervention and/or demonstrate that the research team has experience working in areas relevant to the proposed project. The proposed intervention is not required to be pilot tested prior to the start of the award; this may be proposed as one of the activities in the UH3 (implementation) phase.

No, interventions are required to have a focus on U.S. populations that experience health disparities, so international intervention sites are not responsive to PAR-24-053. However, personnel from foreign institutions may be involved as collaborators on UG3/UH3 projects.

No, the MSPI Research Network does not require a common protocol for all projects, and it is likely that projects will be quite different in their focus. However, the expectation is that, with the support of the Coordinating Center, the network will identify common data elements as appropriate for the range of projects in the network.

No, each awarded UG3/UH3 is expected to be a stand-alone project with enough sites or participants to achieve the study aims without needing data from the other projects.

UG3/UH3 recipients will be expected to participate in the network steering committee and other committees or workgroups as appropriate.  

Applicants are expected to budget for one in-person meeting in the Bethesda, MD, area annually, but the final schedule for in-person and virtual meetings will be established by the Coordinating Center and network steering committee.

No, the network will be established after the UG3/UH3 and U24 awards are made. There is no requirement to connect with other applicants beforehand.

The application should indicate an understanding that the proposed project will be part of a collaborative network and a willingness to work with the Coordinating Center. This plan can be brief.

UG3/UH3 research projects are expected to establish and manage their own governance and oversight processes, including any advisory committees or boards, that are necessary to conduct the projects.

No, each UG3/UH3 research project will be responsible for analyzing data associated with its study aims and should budget accordingly. The Coordinating Center may be involved in data analysis for collaborative activities across multiple UG3/UH3 research projects.

No, because the UG3/UH3 projects will all have their own independent protocols, each UG3/UH3 project is responsible for obtaining IRB approval rather than the MSPI Research Network using a single IRB. However, individual UG3/UH3 projects conducting the same protocol at multiple sites would still be expected to adhere to the NIH Policy on the Use of a Single IRB for Multi-Site Research.

No, LOIs are not required, are not binding, and are not part of the review of the submitted application. However, the information in the LOI enables scientific review officers to initiate the planning process for the scientific review meeting, which includes identifying expert reviewers. 

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.

No. The decision of how many PIs to include on a multi-PI application is the responsibility of the investigators and the applicant organization. Those decisions should be consistent with and justified by the scientific goals of the project. Additional information on the NIH multi-PI option is available at grants.nih.gov/grants/multi_pi/index.htm.

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.

Yes, all applications, regardless of the amount of direct costs requested for any one year, must include a Data Management and Sharing Plan. 

NIH encourages researchers to select the repository that is most appropriate for their data type and discipline.

Applications submitted to the National Institute on Alcohol Abuse and Alcoholism (NIAAA) are expected to adhere to NIAAA’s expectations about scientific data from studies with human subjects as described in NOT-AA-23-002.

It depends. NIH restricts the use of appendices to limited types of materials. Do not include appendices unless you have carefully reviewed NIH requirements (see NOT-OD-18-126).

There is no limit to the number of letters of support that may be included in an application.  Submitted letters should describe specific roles and responsibilities of collaborators and/or resources they will provide. Letters of support that solely provide endorsement of the application in the absence of a specified collaborating role are discouraged.

No, both the UG3 (planning) and UH3 (implementation) phases should be addressed in the Research Strategy, which must be no longer than 12 pages.

No, the UH3 phase cannot be longer than five years, so proposing a shorter UG3 phase would not lengthen the UH3 phase.

Milestones are objective measures of progress toward research goals and should represent the completion of specific tasks that are projected to have a significant impact on the completion of the project. Milestones must provide objective and quantitative outcomes by which to justify continued funding of the project. They must be measurable, have appropriate endpoints, and have specific due dates. For PAR-23-053, milestones are required for the UG3 and UH3 phases.

The milestones should be mentioned in the Research Strategy. Milestones can be fully specified in the Research Strategy or referenced in the Research Strategy and then fully specified in the Study Timeline attachment in the PHS Human Subjects and Clinical Trials Information section. 

No, activities planned for the UH3 (implementation) phase cannot start until NIH has approved the transition from the UG3 (planning) phase to the UH3 phase.

Yes, because the application addresses both the UG3 and UH3 phases, the entire project must be classified as involving a clinical trial.

No, the request to transition from the UG3 to UH3 phase will be administratively reviewed and awarded by the administering NIH Institute or Center. The administrative review will determine the extent to which the peer reviewed milestones for the UG3 phase have been met.

The Coordinating Center will provide consultation and technical assistance to the UG3/UH3 projects, which will be responsible for collecting, managing, storing, and analyzing their own local data. The Coordinating Center may conduct data analysis for collaborative activities across multiple UG3/UH3 projects.

The team for the Coordinating Center is expected to have demonstrated expertise in the three areas of responsibility outlined in RFA-OD-006: (1) administration, coordination, and communication; (2) methodology, data, and analytic support and consultation; and (3) community and other collaborator engagement and dissemination support. Expertise in the specific topic areas of multi-sectoral preventive interventions and health disparities will likely help the Coordinating Center provide effective technical assistance and support in these areas of responsibility.

The NIH Grants and Funding webpage includes tutorials, videos, and other information regarding grant application preparation, writing, and submission. You can also watch videos about the NIH grants process from NIH experts with this YouTube playlist: https://www.youtube.com/playlist?list=PLOEUwSnjvqBKWjASuPFjwWPYKXGjsC4wj.

For help with the Grants.gov registration process, visit grants.gov/register or contact Grants.gov customer support at 1-800-518-4726 (toll free) or via email at support@grants.gov.

For more information regarding the eRA Commons registration process, visit era.nih.gov/register-accounts/register-in-era-commons.htm.

For further information or assistance, contact the eRA Service Desk at 1-866-504-9552 (toll free) or 301-402-7469 from Monday–Friday, 7:00 a.m. to 8:00 p.m. (Eastern Time), or submit a web ticket at era.nih.gov/need-help.

No, contacting NIH program staff is not a requirement for submission, but it is strongly encouraged. This will help you determine if your proposed project is aligned with the priorities of one or more participating Institutes and Centers and that your application is responsive to the NOFO.

As always, applicants are strongly encouraged to reach out to the relevant scientific contacts listed in PAR-24-053 for more information about Institute or Center research priorities. It’s fine for applicants to reach out to multiple Institute or Centers before deciding which Institute or Center to request as the primary assignment.

If you need help determining the potential fit for several Institute or Centers, please contact Jennifer Alvidrez in the NIH Office of Disease Prevention, Jennifer.alvidrez@nih.gov.

Applicants responding to PAR-24-053 are not required to choose an Institute or Center when the application is submitted. Applicants may indicate their preferred Institute by submitting the PHS Assignment Request Form in the SF424 (R&R) application package, but the final decision regarding Institute or Center assignment will be made by NIH. Applications are assigned based on the relevance to an Institute’s or Center’s mission and scientific interests.

No, because the budget limits are specified in the NOFOs, permission to submit a large budget is not required.

It is important that you check with your sponsored research office in advance of application preparation to determine whether your institution is registered with Grants.gov. The institution’s Authorized Organizational Representative (AOR) is responsible for completing the registration process. If your institution is not already registered, it must first register with the System for Award Management and then with Grants.gov.

Both the institution and the investigator must also complete a one-time registration in the NIH eRA Commons to submit applications to NIH. Institutional officials are responsible for registering investigators in the eRA Commons. You should work with your AOR (also known as the Signing Official in the eRA Commons) to determine your own institution’s process for registration.

All key personnel now require an individual eRA Commons username/ID. If any key personnel are from organizations not currently registered with eRA Commons, see Special Registration Instructions for Unaffiliated/Independent Applicants (PDF) for available options.