The NIH Common Fund is piloting a program to establish a coordinated infrastructure that integrates innovative research into routine clinical care in primary care settings. This initiative embraces individual and community engagement, innovative clinical research designs, and is responsive to the shared priorities of HHS agency partners, NIH Institutes, Centers, and the Office of the NIH Director.

In recent years, the U.S. has experienced trending declines in health that are disproportionately occurring in medically underserved and disadvantaged populations. Many of these sectors are also often underrepresented in clinical research. When study demographics don’t match the demographics of those impacted by the illness or condition under investigation, the results may have limited generalizability, leading to evidence gaps and further compounding health disparities. A major barrier to participating in clinical research is lack of access to or availability of clinical studies. In addition, the majority of Americans have never talked to their doctor about participating in research. There is a critical need to extend research participation opportunities to communities often underrepresented in clinical research, and to integrate those opportunities into settings where people seek care.

There is a critical need to extend research participation opportunities to broader communities. Therefore, NIH is proposing to establish a network to conduct research in primary care settings. This network will address barriers to access to clinical research participation by implementing a sustained infrastructure that integrates innovative research with routine clinical care in real world settings, with a focus on sustained engagement with communities that are traditionally underrepresented in clinical research. NIH envisions this network will facilitate and accelerate research advances for adoption and implementation into everyday clinical care, improving health outcomes and advancing health equity for all Americans.

The network infrastructure NIH will pilot and implement is anticipated to include the following components:

• Clinical Science Center
  • Providing oversight of the studies/protocols and site and study selection.
  • Providing statistical and data management support
  • Developing innovative clinical study designs and implementation strategies to minimize burden on participants and providers in primary care settings.
• Operations Center – conducting site feasibility assessments, site agreements/contracting, and coordination of study operations (protocol development; compliance with Food and Drug Administration (FDA) and Office of Human Research Protections (OHRP) regulatory and participant protection requirements; communications; training; auditing; quality assurance; and data monitoring)
• Independent Review and Monitoring Boards - including Data and Safety Monitoring Board (DSMB), Observational Study Monitoring Board (OSMB), and the Central Institutional Review Board (IRB)
• Network Research Hubs – leveraging existing research networks and partnerships with Clinical Sites to conduct clinical research in primary care settings.
• Community Engagement – providing support, advice, and resources, in part through partnerships with existing entities, to facilitate sustained participant and community engagement, community-driven research, and integration of studies in primary and community care settings.
• Industry Partnerships – engaging for-profit partners for collaborative knowledge sharing and potential participation in/use of the infrastructure.

Integrating Clinical Research into Primary Care Settings through Network Research Hubs – A Pilot (OT2)

OTA-24-016

The announcement is posted on the NIH Common Fund website here:

The purpose of this limited competition research opportunity announcement (ROA) is to invite applications by organizations currently affiliated with and participating in specific existing clinical research networks to serve as “Network Research Hubs” and establish the infrastructure to conduct clinical research in primary care settings.

This opportunity is limited to organizations that focus on serving rural communities and are part of or funded by: NIH Institutional Development Award Clinical and Translational Research (IDeA-CTR) awards, the NIH Clinical and Translational Science Award (CTSA) Program, and/or the Patient-Centered Outcomes Research Institute’s (PCORI) Patient-Centered Clinical Research Network (PCORnet). In addition, applicant organizations must be located in a state/jurisdiction where at least 25% of its census tracts are defined as rural using the Revised 2010 RUCA Codes. See Eligibility criteria for more information.

A Network Research Hub is an institution/organization with an established organizational structure and scientific and statistical leadership for developing, implementing, and analyzing multi-institutional clinical studies/trials.

All questions are welcome. Please reach out to ResearchInPrimaryCare@od.nih.gov with questions about this initiative.

Eligible applicants are limited to organizations that are lead, or funded partner organizations of, one or more of the following clinical research networks: the NIH IDeA-CTRs, NIH CTSA, and/or PCORI PCORnet. For the purposes of this ROA, organizations with IDeA-CTR and CTSA awards or sub-awards in no-cost-extensions are eligible to apply. In addition, applicant organizations must be located in a state/jurisdiction where at least 25% of its census tracts are defined as rural using the Revised 2010 RUCA Codes.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education
• Hispanic-Serving Institutions (HSIs)
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• American Indian/Native American Tribal Governments (Federally Recognized)
• American Indian/Native American Tribal Governments (Other than Federally Recognized)

Other

• Independent School Districts
• Public Housing Authorities/American Indian Housing Authorities
• Native American Tribal Organizations (Other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

MPIs are allowed. 

For-profit organizations are allowed per the eligibility requirements: https://commonfund.nih.gov/clinical-research-primary-care/Primary-care-research-network-Research-Opportunity-Announcement-FY24#eligibility 

This can be found on the program FAQs: https://commonfund.nih.gov/clinical-research-primary-care/faq 

Eligibility is limited to where at least 25% of its census tracts are defined as rural using the Revised 2010 RUCA Codes. Details on the RUCA Codes can be found here: https://www.ers.usda.gov/data-products/rural-urban-commuting-area-codes/

Please note, per the eligibility requirements, applicant organizations must be located in a state/jurisdiction where at least 25% of its census tracts are defined as rural. If needed, applications may be triaged for review with those with  catchment areas characterized by >50% of the population being from rural areas being prioritized. The catchment area is not limited to the state where the organization is located.

We are focusing on organizations from states that have 25% or more census tracts as rural based on RUCA codes, though we understand many states have rural communities even if the state does not meet this threshold. We're starting small as a pilot, prioritizing rural-serving organizations, but this limitation will not likely persist in potential future opportunities.

The eligibility criteria does require that the prime organization to be from a state that meets the eligibility criteria. The prime may include other partners in the application.

1. Non-domestic (non-U.S.) Entities (Foreign applicants) are not eligible to apply.
2. Non-domestic components of domestic organizations are not eligible.
3. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. 

LOIs are not requested or required for this Research Opportunity Announcement.

NIH anticipates 2-5 awards will be issued through this ROA in FY24. NIH intends to allocate a total of approximately $5M in FY24 and approximately $20M in FY25 to fund components during the two-year pilot phase, contingent on programmatic objectives, performance and availability of funds. After the two-year pilot phase, individual awards may be terminated, extended, or curtailed based on programmatic objectives, performance, and availability of funds.

Institutions with an established Facilities and Administrative (F&A) rate should use their federally approved rate to calculate indirect costs.

Program staff will negotiate indirect costs with applicant organizations without an established F&A rate during negotiations of a potential award.

The costs in the ROA are total costs. And we expect awards to be issued in September of this fiscal year and that would be the start date September 2024.

Applicants shall assume a budget period of 12 months initially, and an additional 12-month option period during the 2-year pilot of this infrastructure for research in primary care settings. Study budgets should include funds for the community partners to be fully engaged and successfully participate in research prioritization, design and implementation.

Provide the overall expected cost per year for expanding research enrollment in primary care settings including but not limited to each of the following categories:

• Personnel
• Equipment
• Travel
• Subawards/subcontracts/consultants
• Other direct costs
• Total cost (with indirect costs included)
• Proposed Cost Share contribution (if applicable)

Applicants must provide a budget justification for all budget items. Subrecipients/subaward budgets must include a breakdown of costs and a budget justification. Applicants should provide one budget and budget justification per institution or organization in the application.

A Letter of Intent is not required.

A letter from the applicant's current affiliated clinical research network(s) (e.g., the director of the network coordinating center, administrative core, other authorized representative) should provide assurance that the proposed Network Research Hub is active and in good standing with the affiliated clinical research network. In addition, letters of interest and support should be provided from an authorized official from each of the proposed Clinical Sites and should include references to or direct evidence of prior research partnership or relationship with the Network Research Hub.

Applications must be submitted via Application Submission System & Interface for Submission Tracking (ASSIST).

1. To submit an application via ASSIST, the applicant organization must be registered in eRA Commons. Applicant organizations must be registered in eRA Commons, which may take weeks to complete, applicants should therefore begin the registration process as soon as possible.
2. On the eRA Commons home page, select the “Register Organization” link for more details.

No, as stated in the Research Opportunity Announcement, late applications will not be accepted.

Yes, there is flexibility in the specific sections of the project plan.  The application must keep the project plan within 16 pages, and we will accept applications with subsection page limits that are slightly (but not majorly) adjusted from what is in the ROA.

The application must be submitted by the Business Official/Signing Official of the organization that meets eligibility requirements.

Applicant organizations may submit more than one application, provided that each application is distinct and non-overlapping.

Organizations can submit more than one application as long as they're distinct and separate.

No, there is not a maximum number of MPIs.

Citations may be included in a reference list in an appendix.

Clinical sites do not have to be a part of the CTSA, the IDeA CTR or from an IDeA state.

They do not have to be NIH funded.

Applicants should include information that characterizes the population that they would serve through the hub, such as geographic boundaries and demographics of the catchment area and specifying the urban vs rural breakdown. Additionally,  share any unique features to facilitate accrual of populations underrepresented in research. This is described in the Application Requirements section of the ROA.

In the first year, the program wants to jump start activities. Applicants should include partners with whom they have an established relationship. Reviewers will consider evidence of partnership and how quickly applicants can begin accruals, as described in the objective review criteria. For the second year, applicants should demonstrate how they will broaden their reach, including the approaches and methods to engage the community.

Yes, as provided in pages 337-347 within the Application Submission System & Interface for Submission Tracking (ASSIST) User Guide (nih.gov).

To complete registration, if you have not done so already, you may need to register for the following:

1. Register with eRA Commons , which requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/P I ) account in order to submit an application.
2. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance.

For the first year, NIH will select a list of clinical trials that will be negotiated with applicants for selection;  new studies may be supported in the second year

The NIH is working with partners across the NIH to solicit for potential studies that could be offered in the first  year, and is narrowing this list down that would be feasible for primary care settings. The NIH plans to offer 10-20 studies to applicants during the negotiation phase before an award is issued. We expect that Network Research Hubs will be able to choose from the list of 10-20 studies based on the needs and priorities of the communities served by the Clinical Sites.

At this time we cannot provide more detailed information about the funded studies. We recognize the budget will depend on what studies are  selected in this first year. The review process will proceed with an understanding of the level of ambiguity applicants face. 

The NIH list of studies that will be offered in the first year may include pediatric and adult studies, but the specifics will be worked out during the negotiation phase. 

Not necessarily. We expect to choose from both interventional or observational studies. 

We anticipate one study per hub for the first year.

No. The applicant organization must be affiliated with the CTSA or the PCORNet awards, as we will be assessing the affiliation of the applicant organization with research network sites to enhance site readiness and the ability to rapidly launch.

Biosketches may be trimmed in areas that may include redundant information with other components of the application. For example, the application requirements asks in subsection B of the project plan to “Share the team’s expertise and experience with operationalizing…solutions” that address challenges with integrating research into primary care settings. Subsection C of the project plan asks applicants to “Illustrate the team’s expertise in implementing related [comprehensive engagement] plans through recent examples and experiences”.  Such information doesn’t need to be duplicated in the biosketches.

That is in the non-responsive criteria and is referring to patient care. The NIH is not able to fund patient care that is unrelated to research studies in our extramural awards.

Organizations funded by this ROA will serve as Network Research Hubs. The additional infrastructure components will be formed and implemented by NIH.

For this ROA, funding for the Clinical Sites is expected to go through the Network Research Hubs. As we further develop the program and learn which approaches are more or less successful, NIH may establish a direct relationship with the Clinical Sites.

Clinical Sites are expected to be primary care settings, without explicit location requirements for Clinical Sites. This ROA is prioritizing rural-serving sites, and the program is focused on enhancing representation of underrepresented populations.

Expansion and ongoing infrastructure building, will happen in 2025 and beyond. Additional network research hubs may be funded in 2025 with the $20M budget.

Yes, the catchment area is defined as the geographic area defining potential research participants.

For this ROA, we are using the HRSA definition of "primary care settings": a setting with integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community. The following don't meet the criteria: emergency departments, inpatient hospital settings, ambulatory surgical centers, independent diagnostic testing facilities, skilled nursing facilities, inpatient rehab facilities, and hospices."

Expansion and ongoing infrastructure building, including network hubs, will happen in 2025 and beyond. New funding opportunities will be posted on the program website: https://commonfund.nih.gov/clinical-research-primary-care.

NIH is planning to launch this effort as a two-year pilot. The first year of the pilot will involve selecting and funding Network Research Hubs through this ROA to support participation in select existing NIH-funded studies that are agreed upon between the applicant and NIH (in coordination with NIH-funded investigators as needed) during negotiations of a potential award. These initial studies may be interventional or observational and are expected to be reasonably suitable for primary care settings. It is expected that the select existing NIH-funded studies will have infrastructure to support operational aspects (e.g., central IRB, data management) for new sites, but resources available and needed will be negotiated prior to award.

If the Network Research Hub is successful in enhancing participant accrual into an existing study, they may potentially expand in year two with new research in coordination with the other components of the infrastructure. In order to leverage the coordinated research infrastructure described above, these new research concepts will require approval by the Scientific and Medical Director, and Operations Director and funding from external sources for all study aspects not covered by the coordinated infrastructure described above (e.g., specific interventions, additional clinical research staff). Before ramping up to an implementation phase in year three, NIH will conduct an evaluation of the program to assess which approaches and efforts are working. NIH may expand, pivot, and/or sunset awards and/or components based on the results.