Opportunity Information: Apply for RFA RM 11 003

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIH HMO Collaboratory Coordinating Center Limited Competition (U54)" 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 Feb 17, 2011 and posted on Feb 17, 2011.
  • Applicants must submit their applications by May 27, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal governments (Federally recognized) For profit organizations other than small businesses City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Public and State controlled institutions of higher education Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Public housing authorities/Indian housing authorities Independent school districts.
  • Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions 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.
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Opportunity Summary:

The NIH HMO Collaboratory Coordinating Center Limited Competition (U54) funding opportunity (RFA-RM-11-003) is a NIH Common Fund initiative designed to build a central Coordinating Center that helps multiple health care organizations work together as a distributed research network. The award mechanism is a cooperative agreement (U54), which generally means NIH expects substantial involvement in the project through collaboration, coordination, and ongoing stewardship rather than a purely hands-off grant. At its core, the opportunity is about making it easier, faster, and more cost-effective to run large, longitudinal, multi-site studies that rely on real-world clinical data and, where available, biospecimens collected through routine care across participating organizations.

The long-term objective of the overall HMO Collaboratory program is to strengthen national capacity and capability for conducting high-quality, large-scale research using primary clinical data and samples that already exist in health system environments. Instead of building one centralized mega-database, the vision emphasizes a distributed network of health care organizations, meaning data can remain within each organization while still being used for coordinated, multi-site research. This approach is intended to support studies that follow people over time, span multiple sites, and reflect the messy complexity of everyday clinical practice, which is often hard to capture in traditional clinical trials.

In this specific FOA, the Collaboratory Coordinating Center (CCC) is expected to play a backbone role. The CCC is responsible for developing and expanding the infrastructure needed to meet the collaboratory’s long-term goals, putting appropriate governance structures in place, and evaluating whether the resulting infrastructure is valuable and scalable for broader implementation. Practically, that points to work like creating common operating procedures, establishing policies for data access and use, coordinating cross-site collaboration, supporting study start-up and management, and ensuring that the network can function efficiently as a research platform rather than as a loose affiliation of independent projects.

A major component of the work described involves developing and improving research methodology through pilot projects. These pilots are a way to test and refine how the network will collect, standardize, and analyze information from electronic databases that include demographic, administrative, and clinical data, as well as information tied to biospecimens. The FOA emphasizes the use of electronic clinical databases as a core asset, which implies attention to data quality, harmonization across different systems, and methods for extracting comparable variables across organizations that may use different EHRs, coding practices, or workflows. The pilots are not just demonstrations; they are meant to surface real operational and scientific challenges and then drive practical solutions that can be reused across future studies.

The broader research payoff NIH is aiming for is the ability to generate stronger evidence for evaluating health care interventions using real-world populations and settings. The CCC-supported infrastructure is positioned to enable research that advances personalized medicine, prevention strategies, and population-based studies that include community participation. In other words, the network should help researchers learn what works, for whom, and under what circumstances, using routine-care data at scale rather than relying only on narrowly controlled trial environments.

A particularly important goal highlighted in the FOA is improving the nation’s ability to collect and curate both prospective and retrospective data that can inform research in groups that are often underrepresented in randomized controlled trials. The announcement explicitly mentions patients with multiple comorbidities, people at the extremes of age, rural populations, and minorities. This reflects a real limitation of many traditional trials, which frequently exclude complex patients or fail to recruit representative samples. By leveraging clinical data from health systems, the collaboratory model aims to capture more inclusive and clinically relevant populations, improving the generalizability of findings and supporting equity-oriented research.

Administratively, this opportunity was posted February 17, 2011, with an original and current closing date of May 27, 2011, and an archive date of June 27, 2011. The activity category is Health, and the CFDA number listed is 93.310 (Trans-NIH Research Support). Cost sharing or matching is not required. The eligible applicant list is broad and includes federal recognized tribal governments, other tribal organizations, for-profit entities (other than small businesses), small businesses, nonprofits (including both 501(c)(3) and non-501(c)(3)), public and private institutions of higher education, and a range of government entities (state, county, city/township, special districts), among others. The eligibility section also explicitly includes Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, Hispanic-serving institutions, HBCUs, TCCUs, regional organizations, and U.S. territories or possessions, reinforcing that NIH intended the applicant pool to be inclusive across organizational types and geographies.

Overall, the FOA is less about funding a single hypothesis-driven research study and more about funding the shared engine that makes many future studies feasible. The CCC is expected to build the operational, technical, and governance foundation for a distributed research network that can responsibly use electronic clinical data and biospecimen-related information to answer important real-world questions, test methods through pilot work, and demonstrate that the infrastructure is robust enough to scale beyond the initial effort.

FAQs: NIH HMO Collaboratory Coordinating Center Limited Competition (U54) (RFA-RM-11-003)

What is this funding opportunity?

This is the NIH HMO Collaboratory Coordinating Center Limited Competition (U54) funding opportunity (RFA-RM-11-003), a NIH Common Fund initiative to build a central Coordinating Center that supports multiple health care organizations working together as a distributed research network.

What is the main purpose of the Coordinating Center (CCC)?

The CCC is intended to serve as the backbone for the collaboratory by developing and expanding shared infrastructure, establishing governance, coordinating cross-site collaboration, supporting study start-up and management, and evaluating whether the resulting infrastructure is valuable and scalable for broader implementation.

Is this grant meant to fund one specific research study?

No. The focus is less on funding a single hypothesis-driven study and more on funding the shared engine (infrastructure, governance, and operations) that makes many future multi-site studies feasible.

What is the award mechanism and what does it imply?

The award mechanism is a cooperative agreement (U54). This generally implies NIH expects substantial involvement through collaboration, coordination, and ongoing stewardship rather than a fully hands-off grant relationship.

What is meant by a "distributed research network" in this FOA?

The FOA emphasizes a model where participating health care organizations work together without necessarily building a single centralized mega-database. Data can remain within each organization while still being used for coordinated, multi-site research.

What kinds of studies is the collaboratory meant to enable?

The infrastructure is aimed at making it easier, faster, and more cost-effective to run large, longitudinal, multi-site studies that rely on real-world clinical data and, where available, biospecimens collected through routine care across participating organizations.

What types of data does the FOA emphasize?

The FOA highlights electronic clinical databases that include demographic, administrative, and clinical data, along with information tied to biospecimens when available. The intent is to leverage data generated through routine clinical practice.

Why does the FOA focus on real-world clinical data rather than traditional trial data?

The overall goal is to strengthen national capacity for research that reflects the complexity of everyday clinical practice and can generate stronger evidence about interventions in real-world populations and settings.

What role do pilot projects play in this opportunity?

Pilot projects are a major component used to test and refine research methods and operations across the network, including how data are collected, standardized, and analyzed across different organizations and systems.

Are the pilot projects only demonstrations?

No. The pilots are intended to surface real operational and scientific challenges (for example, differences in systems and workflows) and drive practical, reusable solutions for future studies.

What methodology challenges is the CCC expected to address?

Based on the FOA description, the CCC is expected to help tackle issues such as data quality, data harmonization across sites, and methods for extracting comparable variables across organizations that may use different EHRs, coding practices, or workflows.

What kinds of governance and policies are expected?

The CCC is expected to put governance structures in place and develop policies and procedures that help the network function efficiently, including policies for data access and data use, and common operating procedures across participating organizations.

How does this initiative relate to biospecimens?

Where biospecimens are available through routine care, the collaboratory is expected to incorporate biospecimen-related information into the research platform and to address associated data collection, standardization, and analysis needs.

What is the long-term objective of the overall HMO Collaboratory program?

The long-term objective is to strengthen national capacity and capability for conducting high-quality, large-scale research using primary clinical data and samples that already exist in health system environments.

What is the intended research payoff for NIH?

NIH is aiming for an improved ability to generate stronger evidence for evaluating health care interventions using real-world populations and settings, including support for personalized medicine, prevention strategies, and population-based studies with community participation.

Does the FOA address inclusion of underrepresented populations?

Yes. A stated goal is improving the ability to collect and curate prospective and retrospective data that can inform research in groups often underrepresented in randomized controlled trials, including patients with multiple comorbidities, people at the extremes of age, rural populations, and minorities.

Why is inclusion of these populations emphasized?

The FOA notes that many traditional randomized controlled trials exclude complex patients or fail to recruit representative samples. Using clinical data from health systems is meant to capture more inclusive and clinically relevant populations and improve generalizability of findings.

What is the activity category for this opportunity?

The activity category listed is Health.

What is the CFDA number for this opportunity?

The CFDA number listed is 93.310 (Trans-NIH Research Support).

When was the opportunity posted and what were the key dates?

The opportunity was posted on February 17, 2011. The original and current closing date was May 27, 2011. The archive date was June 27, 2011.

Is cost sharing or matching required?

No. Cost sharing or matching is not required.

Who is eligible to apply?

The eligible applicant list is broad and includes federal recognized tribal governments, other tribal organizations, for-profit entities (other than small businesses), small businesses, nonprofits (including 501(c)(3) and non-501(c)(3)), public and private institutions of higher education, and a range of government entities (state, county, city/township, special districts), among others.

Are minority-serving institutions and community-based organizations included in eligibility?

Yes. The eligibility language explicitly includes Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, Hispanic-serving institutions, HBCUs, TCCUs, regional organizations, and U.S. territories or possessions.

What does "limited competition" mean here?

The FOA title indicates "Limited Competition," but the provided information does not specify additional constraints beyond the broad eligibility categories listed.

How is success for the CCC expected to be evaluated?

The FOA indicates the CCC should evaluate whether the infrastructure it develops is valuable and scalable for broader implementation, meaning success is tied to usefulness as a platform and the ability to scale beyond the initial effort.

Does this initiative require a centralized database?

No. The vision described explicitly emphasizes a distributed network rather than building one centralized mega-database.

What operational functions is the CCC expected to support?

Practical functions described include creating common operating procedures, establishing data access and use policies, coordinating cross-site collaboration, supporting study start-up and management, and ensuring the network operates efficiently as a research platform.

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