Opportunity Information: Apply for RFA HL 14 019
Apply for RFA HL 14 019
- The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Low Cost, Pragmatic, Patient Centered Randomized Controlled Intervention Trials (UH2/UH3)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.173 Research Related to Deafness and Communication Disorders 93.213 Research and Training in Complementary and Integrative Health 93.233 National Center on Sleep Disorders Research 93.279 Drug Abuse and Addiction Research Programs 93.361 Nursing Research 93.837 Cardiovascular Diseases Research 93.839 Blood Diseases and Resources Research 93.866 Aging Research.
- This funding opportunity was created on Nov 7, 2013 and posted on Nov 7, 2013.
- Applicants must submit their applications by Jan 23, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: County governments State governments Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Public and State controlled institutions of higher education For profit organizations other than small businesses City or township governments Special district governments Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Public housing authorities/Indian housing authorities.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) 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 funding opportunity titled "Low Cost, Pragmatic, Patient Centered Randomized Controlled Intervention Trials (UH2/UH3)" (Funding Opportunity Number RFA-HL-14-019) was designed to support the planning and execution of pragmatic randomized controlled trials that can be run efficiently and at relatively low cost. The core idea is to fund trials that test how well an intervention works in everyday, real-world health care settings rather than under tightly controlled research conditions. Projects are expected to focus on questions that matter directly to patients and to health care providers, meaning the outcomes should be meaningful for decision-making in routine clinical practice.
A defining feature of the FOA is its emphasis on leveraging what already exists in health care systems to reduce cost and increase practicality. Rather than building expensive, standalone research infrastructure, applicants are expected to use established clinical practice environments and existing electronic resources, such as electronic health records, registries, or comparable data systems, to support trial operations. The announcement specifically calls for trials where randomization happens at or near the point of patient care, and where data collection is integrated into routine clinical documentation or drawn from existing electronic sources. This structure is meant to minimize extra study visits, reduce the burden on clinicians and participants, and make the results more generalizable to typical care conditions.
The trials supported under this program are expected to be pragmatic in several operational ways. Eligibility criteria should be minimal so that participants resemble the broad populations seen in everyday practice. Interventions should be delivered as part of routine clinical care, not as specialized research-only procedures that are difficult to replicate outside a study. Overall, the FOA is looking for trials that can be embedded into normal workflows, producing evidence that is both credible (because of randomization) and directly usable by health systems, clinicians, and patients.
This opportunity used a cooperative agreement mechanism, reflecting that NIH anticipated substantial scientific or programmatic involvement during the project. The award structure was UH2/UH3, which typically indicates a phased approach: an initial planning and start-up phase followed by an implementation phase once milestones are met. While the provided excerpt does not spell out milestones, the intent of the mechanism is to support careful planning and feasibility work before full-scale trial rollout, helping ensure the eventual trial remains low cost, pragmatic, and executable in real clinical environments.
Eligible applicants were broad and included many types of U.S.-based organizations. Public and private institutions of higher education could apply, as could nonprofits (both 501(c)(3) and certain non-501(c)(3) entities), small businesses, and for-profit organizations (including those other than small businesses). Various levels of government were eligible as well, including state, county, city or township governments, special district governments, independent school districts, and public housing authorities/Indian housing authorities. Tribal governments and tribal organizations were included, along with a wide range of mission-focused institutions such as Historically Black Colleges and Universities, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and Asian American and Native American Pacific Islander serving institutions. Faith-based and community-based organizations and eligible federal agencies were also listed as eligible. Foreign institutions and non-U.S. components of U.S. organizations were not eligible, and foreign components were not allowed under NIH policy for this FOA.
Administratively, the opportunity was posted on November 7, 2013, with an original and current closing date of January 23, 2014, and it was archived on February 23, 2014. The FOA was issued by the National Institutes of Health and was associated with multiple CFDA program areas spanning health and research domains, including cardiovascular diseases, blood diseases, aging research, nursing research, sleep disorders research, drug abuse and addiction research, complementary and integrative health, and research related to deafness and communication disorders. There was no cost sharing or matching requirement stated. For full details, NIH directed applicants to the official FOA webpage, and provided contact points through the NIH Office of Extramural Research webmaster for access or linking issues.
Frequently Asked Questions (FAQs)
What is the title and funding opportunity number for this NIH grant?
The funding opportunity is titled "Low Cost, Pragmatic, Patient Centered Randomized Controlled Intervention Trials (UH2/UH3)" and the Funding Opportunity Number is RFA-HL-14-019.
What is the main purpose of this funding opportunity?
The purpose is to support the planning and execution of pragmatic randomized controlled intervention trials that can be run efficiently and at relatively low cost, with a focus on interventions tested in real-world health care settings.
What kind of trials does this FOA support?
This FOA supports pragmatic randomized controlled trials (RCTs) that are embedded in everyday clinical practice, with randomization occurring at or near the point of patient care and outcomes that are meaningful for routine decision-making.
What does "pragmatic" mean in the context of this FOA?
"Pragmatic" refers to trials designed to operate in typical, real-world clinical environments rather than highly controlled research settings. This includes minimal eligibility restrictions, delivering interventions through routine care workflows, and relying on existing clinical data sources whenever possible.
How does this FOA aim to keep trials low cost?
The FOA emphasizes leveraging existing health care system infrastructure rather than building expensive, standalone research systems. Applicants are expected to use established clinical practice environments and existing electronic resources such as electronic health records (EHRs), registries, or similar data systems to support trial operations and data collection.
Are applicants expected to build new research infrastructure for these trials?
No. A defining feature of the FOA is the expectation that applicants will leverage what already exists within health care systems (clinical settings and electronic data resources) to reduce costs and increase practicality.
How should randomization be handled under this program?
The FOA specifically calls for trials in which randomization happens at or near the point of patient care, supporting integration into routine clinical workflows.
How should data be collected in these trials?
Data collection is expected to be integrated into routine clinical documentation or drawn from existing electronic sources such as EHRs, registries, or comparable data systems. The intent is to minimize extra study visits and reduce burden on clinicians and participants.
What does "patient-centered" mean for projects submitted under this FOA?
Projects are expected to focus on questions that matter directly to patients and health care providers, and to select outcomes that are meaningful for decision-making in routine clinical practice.
What kind of participant eligibility criteria are expected?
The FOA indicates that eligibility criteria should be minimal so that participants resemble broad populations typically seen in everyday clinical practice.
How should interventions be delivered in trials funded by this opportunity?
Interventions should be delivered as part of routine clinical care, rather than as specialized, research-only procedures that are difficult to replicate outside of the study setting.
What is the funding mechanism used for this opportunity?
This opportunity used a cooperative agreement mechanism, meaning NIH anticipated substantial scientific or programmatic involvement during the project.
What does the UH2/UH3 structure imply?
The UH2/UH3 structure typically reflects a phased approach: an initial planning and start-up phase (UH2) followed by an implementation phase (UH3) after milestones are met. The excerpt does not specify milestones, but the intent is to support planning and feasibility work before full-scale rollout.
Is cost sharing or matching required?
No cost sharing or matching requirement was stated in the provided information.
Who was eligible to apply?
Eligibility was broad and included many U.S.-based organizations, such as public and private institutions of higher education; nonprofits (including 501(c)(3) and certain non-501(c)(3) organizations); small businesses; for-profit organizations (including those other than small businesses); and various government entities.
What types of government entities were eligible?
Eligible government entities included state governments, county governments, city or township governments, special district governments, independent school districts, and public housing authorities/Indian housing authorities.
Were Tribal governments and Tribal organizations eligible?
Yes. Tribal governments and Tribal organizations were included among eligible applicants.
Were minority-serving institutions included in the eligible applicant list?
Yes. The eligible applicant list included institutions such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and Asian American and Native American Pacific Islander serving institutions.
Could faith-based and community-based organizations apply?
Yes. Faith-based and community-based organizations were listed as eligible.
Were eligible federal agencies allowed to apply?
Yes. Eligible federal agencies were listed as eligible applicants.
Are foreign institutions eligible?
No. Foreign institutions and non-U.S. components of U.S. organizations were not eligible for this FOA.
Are foreign components allowed under this FOA?
No. Foreign components were not allowed under NIH policy for this FOA.
When was this funding opportunity posted?
The opportunity was posted on November 7, 2013.
What was the closing date for applications?
The original and current closing date was January 23, 2014.
Is this funding opportunity still open?
No. It was archived on February 23, 2014.
Which agency issued this FOA?
The FOA was issued by the National Institutes of Health (NIH).
What program areas or health domains were associated with this FOA?
The FOA was associated with multiple CFDA program areas spanning health and research domains, including cardiovascular diseases, blood diseases, aging research, nursing research, sleep disorders research, drug abuse and addiction research, complementary and integrative health, and research related to deafness and communication disorders.
Where does NIH direct applicants for full details and official information?
NIH directed applicants to the official FOA webpage for full details.
Who should be contacted for access or linking issues related to the FOA?
For access or linking issues, NIH provided contact points through the NIH Office of Extramural Research webmaster.
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