Opportunity Information: Apply for RFA HL 14 004
Apply for RFA HL 14 004
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Ancillary Studies in Clinical Trials (R01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233 National Center on Sleep Disorders Research 93.837 Cardiovascular Diseases Research 93.838 Lung Diseases Research 93.839 Blood Diseases and Resources Research.
- This funding opportunity was created on Sep 13, 2013 and posted on Sep 28, 2012.
- Applicants must submit their applications by May 23, 2014. (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 $250,000.00 in funding.
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) Small businesses Native American tribal governments (Federally recognized) For profit organizations other than small businesses Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments City or township governments County governments Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education Private institutions of higher education.
- 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 eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The Ancillary Studies in Clinical Trials (R01) opportunity (Funding Opportunity Number RFA-HL-14-004) is a National Institutes of Health grant program designed to fund add-on, time-sensitive research projects that can be carried out alongside an existing "parent" clinical trial or other large, ongoing clinical study. The scientific focus is aligned with the mission areas of the National Heart, Lung, and Blood Institute (NHLBI), meaning proposed ancillary studies must relate to heart, lung, and blood diseases or sleep disorders. The core idea is to take advantage of participants, infrastructure, and data already available in an active parent study and use that platform to answer additional, NHLBI-relevant research questions that would be difficult or inefficient to address through a standalone project.
A defining feature of this FOA is its emphasis on timing and feasibility. It specifically targets ancillary studies that cannot wait for standard grant timelines because they need to start collecting data early in the parent study or in parallel with the parent study's key activities. These are typically projects requiring active, longitudinal data collection, where researchers must begin recruiting and collecting measurements as close as possible to the parent study's start, or within a narrow window when participants are being enrolled, followed, or assessed. Because of that narrow window, the program offers an accelerated review and award process to help applicants secure funding quickly enough for the ancillary study to actually happen when it needs to. Applications are expected to make a clear, explicit case that the project is genuinely time sensitive and to explain why expedited review is essential, not just convenient.
The "parent" study that anchors the ancillary study is most often a clinical trial, but the FOA also allows other large clinical studies such as observational cohorts or registries, as long as they can provide a sufficiently sized, well-characterized participant group and the operational infrastructure needed to support the ancillary work. The ancillary study is expected to leverage the parent study's established systems such as recruitment pipelines, study visits, specimen collection processes, data management, and participant follow-up, while adding measurements, sub-studies, or analyses that expand the scientific value of the parent project. In practical terms, this mechanism is meant to encourage efficient science by building on existing investments rather than duplicating expensive trial infrastructure.
From an administrative standpoint, this is a discretionary grant opportunity using the R01 research project grant mechanism, categorized under health-related research funding activity. The FOA lists an award ceiling of $250,000 and indicates there is no cost sharing or matching requirement. It is associated with CFDA numbers covering sleep disorders research and cardiovascular, lung, and blood research portfolios (93.233, 93.837, 93.838, 93.839). The opportunity was posted September 28, 2012, with an original closing date of January 24, 2014, later extended to a current closing date of May 23, 2014, and an archive date of June 23, 2014.
Eligibility is broad and includes many types of U.S. organizations and governments, such as public and private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations (including small businesses), and a wide range of governmental entities (state, county, city/township, special district, independent school districts, and public housing authorities/Indian housing authorities). The FOA also explicitly includes eligibility for numerous mission-driven and community-based institution types, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribal colleges and universities, Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), among others. Importantly, non-U.S. entities (foreign institutions) are eligible to apply, and foreign components of U.S. organizations are allowed as defined under NIH policy.
Overall, this funding opportunity is best understood as a way to rapidly support scientifically compelling, operationally feasible add-on studies that must be launched quickly to align with an active parent trial or large clinical study. Successful applications would typically be those that clearly demonstrate dependence on the parent study's participants and timeline, show that delaying funding would undermine the ability to collect key data, and propose research questions squarely within NHLBI's heart, lung, blood, and sleep disorder mission areas.
FAQs: Ancillary Studies in Clinical Trials (R01) - RFA-HL-14-004
What is the Ancillary Studies in Clinical Trials (R01) opportunity?
This NIH funding opportunity (RFA-HL-14-004) supports add-on, time-sensitive research projects (ancillary studies) that are carried out alongside an existing "parent" clinical trial or other large, ongoing clinical study. The intent is to use the parent study's participants, infrastructure, and data to answer additional research questions aligned with the National Heart, Lung, and Blood Institute (NHLBI) mission areas.
What makes a study "ancillary" under this opportunity?
An ancillary study is an add-on project that depends on an active parent study for access to participants, study operations, and/or data. It leverages existing elements such as recruitment pipelines, study visits, specimen collection processes, data management systems, and participant follow-up, while adding new measurements, sub-studies, or analyses that extend the scientific value of the parent project.
What scientific areas does this FOA focus on?
The scientific focus must align with NHLBI mission areas. Proposed ancillary studies must relate to heart, lung, and blood diseases or sleep disorders.
Why does this FOA emphasize time sensitivity?
This FOA is designed for ancillary studies that cannot wait for standard grant timelines because they need to start data collection early in the parent study or in parallel with key parent-study activities. The program is meant for situations where there is a narrow window to begin recruiting and collecting measurements while participants are being enrolled, followed, or assessed in the parent study.
Does this opportunity offer an accelerated review and award process?
Yes. A defining feature is an accelerated review and award process intended to help applicants secure funding quickly enough for the ancillary study to start when it needs to.
What do applicants need to show about time sensitivity?
Applications are expected to make a clear, explicit case that the project is genuinely time sensitive and explain why expedited review is essential (not merely convenient). The rationale should connect the ancillary study's required start time to the parent study's timeline and activities.
What kinds of parent studies can support an ancillary study?
The parent study is most often a clinical trial, but other large clinical studies are also allowed, including observational cohorts or registries, as long as they provide a sufficiently sized, well-characterized participant group and the operational infrastructure needed to support the ancillary work.
What does it mean to "leverage" the parent study?
It means using existing parent-study investments and operations (for example, participant recruitment, scheduled visits, specimen collection, established data systems, and follow-up procedures) as the platform for the ancillary study, rather than building a standalone structure that duplicates major trial infrastructure.
What types of activities are these ancillary studies typically expected to include?
They are typically projects requiring active, longitudinal data collection where researchers must begin recruiting and collecting measurements as close as possible to the parent study's start or within the narrow window when the parent study is enrolling and following participants.
What grant mechanism is used for this opportunity?
This is a discretionary NIH grant opportunity using the R01 research project grant mechanism and is categorized as health-related research funding activity.
What is the award ceiling for this FOA?
The FOA lists an award ceiling of $250,000.
Is cost sharing or matching required?
No. The FOA indicates there is no cost sharing or matching requirement.
Which CFDA numbers are associated with this opportunity?
The FOA is associated with CFDA numbers 93.233, 93.837, 93.838, and 93.839, covering sleep disorders research and cardiovascular, lung, and blood research portfolios.
When was this funding opportunity posted and when did it close?
The opportunity was posted on September 28, 2012. The original closing date was January 24, 2014, later extended to May 23, 2014. The archive date was June 23, 2014.
Who is eligible to apply?
Eligibility is broad and includes many types of U.S. organizations and governments, such as public and private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations (including small businesses), and governmental entities (state, county, city/township, special district, independent school districts, and public housing authorities/Indian housing authorities).
Are community-based and mission-driven institution types included?
Yes. The FOA explicitly includes eligibility for a wide range of institution types, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribal colleges and universities, Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), among others.
Are non-U.S. (foreign) institutions eligible to apply?
Yes. Non-U.S. entities (foreign institutions) are eligible to apply, and foreign components of U.S. organizations are allowed, as defined under NIH policy.
What is the main advantage of doing an ancillary study instead of a standalone project?
The main advantage is efficiency: the ancillary study builds on an existing investment by using already-established participants, infrastructure, and data, which can make it difficult or inefficient to address the same questions through a separate standalone project.
What is the core purpose of this FOA in practical terms?
Its purpose is to rapidly support scientifically compelling, operationally feasible add-on studies that must be launched quickly to align with an active parent trial or large clinical study, especially when delayed funding would undermine the ability to collect key data during the required window.
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