Opportunity Information: Apply for RFA RM 12 002
Apply for RFA RM 12 002
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIH Health Care Systems Research Collaboratory Pragmatic Clinical Trials Demonstration Projects (UH2/UH3)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.310 Trans NIH Research Support.
- This funding opportunity was created on Jan 24, 2012 and posted on Jan 24, 2012.
- Applicants must submit their applications by May 2, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $500,000.00 in funding.
- Eligible applicants include: City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments Private institutions of higher education Native American tribal governments (Federally recognized) Small businesses County governments Others (see text field entitled Additional Information on Eligibility for clarification) Independent school districts For profit organizations other than small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
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Opportunity Summary:
The NIH Health Care Systems Research Collaboratory Pragmatic Clinical Trials Demonstration Projects opportunity (Funding Opportunity Number RFA-RM-12-002) is a National Institutes of Health cooperative agreement solicitation designed to jump-start efficient, large-scale pragmatic clinical trials embedded in real-world health care delivery settings. The central idea is to support “demonstration projects†that can be carried out within the NIH Health Care Systems (HCS) Research Collaboratory, an NIH Common Fund effort focused on improving the methods, infrastructure, and practical know-how needed to run pragmatic trials inside functioning health systems. In contrast to tightly controlled explanatory trials, these projects are meant to test interventions under typical clinical conditions, using routine care workflows and data sources where possible, so results are more directly relevant to everyday health care decisions.
This FOA uses a two-phase UH2/UH3 structure within a single combined application. The first phase (UH2) is a milestone-driven planning period lasting one year. During UH2, awardees are expected to complete concrete feasibility and readiness activities required to responsibly launch a pragmatic trial at scale, such as finalizing trial protocols, demonstrating that recruitment and implementation strategies will work in participating health systems, confirming data availability and quality (often including electronic health record and administrative data), addressing regulatory and human subjects protections in a pragmatic setting, and establishing operational coordination across sites. The second phase (UH3) is the implementation phase, where the pragmatic clinical trial is actually conducted. Transition from UH2 to UH3 is not automatic; NIH makes UH3 awards only after an administrative review confirms that the UH2 milestones have been met and the project is scientifically and operationally prepared to proceed. This milestone-based gate is intended to reduce the risk of launching large pragmatic trials before the necessary infrastructure and agreements are in place.
As a cooperative agreement, the funding mechanism signals substantial NIH involvement beyond what is typical for a standard research grant. While applicants still lead the science and execution, NIH staff and the Collaboratory framework are expected to play an active partnership role, which commonly includes involvement in refining milestones, aligning projects with Collaboratory standards and resources, and supporting cross-project learning around pragmatic trial methods. The activity category is health, and the listing is associated with CFDA 93.310 (Trans-NIH Research Support). The FOA states there is no cost sharing or matching requirement.
Key administrative details include a posted date of January 24, 2012, with an original and current closing date of May 2, 2012, and an archive date of June 2, 2012. The opportunity includes an award ceiling of $500,000 (as listed in the source data). Applicants are directed to the full announcement for specific instructions applicable to each phase and to ensure the single application clearly distinguishes UH2 planning activities and milestones from UH3 implementation plans, since the two phases have different expectations and review considerations.
Eligibility is broad across many U.S.-based organization types, reflecting the practical, health-system-embedded nature of these trials. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; small businesses; for-profit organizations (other than small businesses); and nonprofit organizations both with and without 501(c)(3) status (other than institutions of higher education). The FOA also recognizes a range of mission-focused and community-serving institutions and entities, including historically Black colleges and universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, tribally controlled colleges and universities (TCCUs), faith-based or community-based organizations, and regional organizations, as well as eligible federal government agencies and U.S. territories or possessions. Foreign institutions are not eligible to apply, and foreign components are not allowed; likewise, non-U.S. components of U.S. organizations are not eligible, consistent with NIH policy restrictions stated in the source.
Overall, this opportunity is best understood as NIH’s effort to fund a small set of real-world pragmatic trial “demonstration†studies that both answer important clinical or delivery questions and serve as learning platforms for how to plan and execute large pragmatic clinical trials inside health care systems. The two-stage UH2/UH3 design is meant to ensure that only projects that can demonstrate feasibility and readiness after a focused planning year move forward into the more resource-intensive implementation phase. For full requirements, details on milestones, and application formatting expectations, applicants are directed to the official announcement link provided by NIH (http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-12-002.html).
FAQs: NIH Health Care Systems Research Collaboratory Pragmatic Clinical Trials Demonstration Projects (RFA-RM-12-002)
What is this funding opportunity?
This is an NIH cooperative agreement solicitation titled "Health Care Systems Research Collaboratory Pragmatic Clinical Trials Demonstration Projects" (Funding Opportunity Number RFA-RM-12-002). It is intended to jump-start efficient, large-scale pragmatic clinical trials that are embedded in real-world health care delivery settings.
What is the main purpose of the program?
The purpose is to support "demonstration projects" that can be conducted within the NIH Health Care Systems (HCS) Research Collaboratory. These projects are designed to improve methods, infrastructure, and practical know-how for running pragmatic clinical trials inside functioning health systems, while also producing results that inform everyday health care decisions.
What is meant by a "pragmatic clinical trial" in this context?
In this opportunity, pragmatic trials are studies that test interventions under typical clinical conditions rather than tightly controlled research environments. The intent is to use routine care workflows and data sources where possible (for example, electronic health records and administrative data) so findings are directly relevant to real-world practice.
How is this opportunity structured (UH2/UH3)?
The FOA uses a two-phase UH2/UH3 structure submitted as a single combined application. UH2 is a milestone-driven planning phase lasting one year. UH3 is the implementation phase in which the pragmatic clinical trial is carried out.
How long is the UH2 planning phase?
UH2 lasts one year and is focused on completing specific, concrete milestones that demonstrate feasibility and readiness to launch the trial at scale.
What kinds of activities are expected during the UH2 planning year?
During UH2, awardees are expected to complete feasibility and readiness work needed to responsibly begin a large pragmatic trial, such as finalizing trial protocols, demonstrating workable recruitment and implementation strategies across participating health systems, confirming availability and quality of needed data (often including EHR and administrative data), addressing regulatory and human subjects protections in pragmatic settings, and establishing operational coordination across sites.
What happens during the UH3 phase?
UH3 is the implementation phase where the pragmatic clinical trial is conducted in the participating health care delivery settings.
Is the transition from UH2 to UH3 automatic?
No. Transition is not automatic. NIH will make UH3 awards only after an administrative review confirms that UH2 milestones have been met and that the project is scientifically and operationally prepared to proceed.
Why does NIH use a milestone-based gate between UH2 and UH3?
The milestone-based transition is intended to reduce the risk of launching large pragmatic trials before critical infrastructure, data readiness, and operational agreements are in place.
What does it mean that this is a cooperative agreement?
A cooperative agreement indicates substantial NIH involvement beyond what is typical for a standard research grant. While the applicant leads the science and execution, NIH staff and the Collaboratory framework are expected to be active partners, which may include refining milestones, aligning projects with Collaboratory standards and resources, and supporting cross-project learning about pragmatic trial methods.
What is the NIH Health Care Systems (HCS) Research Collaboratory?
It is an NIH Common Fund effort focused on improving the methods, infrastructure, and practical know-how needed to run pragmatic trials within functioning health systems. The demonstration projects supported by this FOA are intended to be carried out within this Collaboratory environment.
What is the activity category and CFDA listing associated with this opportunity?
The activity category is health. The listing is associated with CFDA 93.310 (Trans-NIH Research Support).
Is cost sharing or matching required?
No. The FOA states there is no cost sharing or matching requirement.
What is the award ceiling listed for this opportunity?
The source information lists an award ceiling of $500,000.
When was the opportunity posted and when did it close?
The posted date is January 24, 2012. The original and current closing date is May 2, 2012. The archive date is June 2, 2012.
Who is eligible to apply?
Eligibility is broad across many U.S.-based organization types. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; small businesses; for-profit organizations (other than small businesses); and nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education).
Are community-serving and mission-focused institutions included in eligibility?
Yes. The FOA recognizes entities including historically Black colleges and universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, tribally controlled colleges and universities (TCCUs), faith-based or community-based organizations, and regional organizations.
Are federal agencies eligible to apply?
Yes. Eligible applicants include eligible federal government agencies, as stated in the source information.
Are U.S. territories or possessions eligible to apply?
Yes. The FOA includes U.S. territories or possessions among eligible applicants.
Are foreign institutions eligible to apply?
No. Foreign institutions are not eligible to apply.
Are foreign components allowed as part of an application?
No. Foreign components are not allowed, and non-U.S. components of U.S. organizations are not eligible, consistent with NIH policy restrictions stated in the source.
What should applicants pay attention to when preparing the single combined UH2/UH3 application?
Applicants are directed to the full announcement for phase-specific instructions and are expected to clearly distinguish UH2 planning activities and milestones from UH3 implementation plans within the single application, because the two phases have different expectations and review considerations.
Where can applicants find the official full announcement?
The official NIH announcement is available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-12-002.html
What kinds of trials is NIH trying to fund through these demonstration projects?
NIH is aiming to fund a small set of real-world pragmatic trial demonstration studies that both answer important clinical or health care delivery questions and also serve as learning platforms for how to plan and execute large pragmatic clinical trials inside health care systems.
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