Opportunity Information: Apply for RFA HL 13 003
Apply for RFA HL 13 003
- 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 Dec 7, 2011 and posted on Dec 7, 2011.
- Applicants must submit their applications by Jan 24, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $4,800,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $250,000.00 in funding.
- Eligible applicants include: Special district governments Public and State controlled institutions of higher education 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 City or township governments County governments Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses Others (see text field entitled Additional Information on Eligibility for clarification) State governments Native American tribal governments (Federally recognized) Small businesses Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education.
- 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 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-13-003) is a National Institutes of Health grant program designed to fund time-sensitive ancillary research that can be carried out alongside an existing, ongoing clinical trial or other large clinical study. The focus areas align with the mission of the National Heart, Lung, and Blood Institute (NHLBI), meaning projects must relate to heart, lung, and blood diseases or sleep disorders. The core idea is to take advantage of an established "parent" study that already has participants, a working research infrastructure, and ongoing data collection, and then add a well-justified ancillary component that addresses additional NHLBI-relevant scientific questions without needing to build a brand-new cohort from scratch.
A central feature of this FOA is its accelerated review and award process. The program is meant for situations where timing is everything: the proposed ancillary study must be truly time sensitive, typically because it requires active, longitudinal data collection that has to begin as close as possible to the start of the parent study or during a narrow, critical window in the parent study timeline. For example, an ancillary project might need baseline specimens, imaging, physiologic measures, or early follow-up assessments that would be impossible or scientifically compromised if collected later. Because of that urgency, applicants are expected to make a clear, explicit case for why an expedited review is essential to feasibility, not just convenient. In practical terms, the application needs to show that if the ancillary work is delayed, key data would be lost, recruitment opportunities would pass, or the scientific aims could no longer be achieved.
The parent study that the ancillary research "hooks into" will most often be a clinical trial, but the FOA also allows other large clinical studies such as observational studies or registries, as long as they can provide a sufficiently sized and well-characterized cohort. The ancillary study can be built around any NHLBI-relevant research question as long as it is a good fit for the parent study’s participant population, operational setup, and data stream. That means the proposed work should be designed to leverage what the parent study already does well (recruitment mechanisms, visit schedules, clinical assessments, biorepositories, endpoints, and data management systems) rather than duplicating efforts or creating major disruptions. The expectation is that the parent study provides the platform, while the ancillary study adds a focused set of additional measurements, analyses, or follow-up that produce meaningful new knowledge.
This is a discretionary grant program using the NIH R01 research project grant mechanism, categorized under health-related funding activities. It does not require cost sharing or matching. The estimated total funding listed for the opportunity is $4,800,000, and the award ceiling is $250,000. The CFDA program areas connected to this FOA include sleep disorders research (93.233), cardiovascular diseases research (93.837), lung diseases research (93.838), and blood diseases and resources research (93.839), reflecting the broad NHLBI scope.
Eligibility is broad and includes many types of domestic U.S. organizations such as state and local governments, public and private institutions of higher education, nonprofits (including but not limited to 501(c)(3) organizations), small businesses, and certain for-profit organizations (other than small businesses). The eligibility list also extends to a wide range of mission-driven and community-centered entities, including historically Black colleges and universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian serving institutions, faith-based and community-based organizations, regional organizations, U.S. territories or possessions, and eligible federal agencies. Importantly, non-U.S. entities (foreign institutions) are eligible to apply, and non-U.S. components of U.S. organizations may also apply; foreign components are allowed as defined by NIH policy. This breadth supports the program’s practical aim: enabling rapid, strategically timed ancillary science wherever a suitable parent trial or large study is already underway.
Key dates in the listing show that the FOA was posted and created on December 7, 2011, with an original and current closing date of January 24, 2013, and an archive date of February 24, 2013. While those dates indicate the specific announcement is now archived, the description clearly illustrates the NHLBI model for funding ancillary studies when a narrow operational window makes standard review timelines too slow.
For reference and official details, the FOA’s additional information link is provided as http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-13-003.html, and technical access issues were directed to the NIH Office of Extramural Research (OER) webmaster contact listed in the announcement.
Frequently Asked Questions (FAQs)
What is the Ancillary Studies in Clinical Trials (R01) opportunity (RFA-HL-13-003)?
RFA-HL-13-003 is a National Institutes of Health (NIH) funding opportunity that uses the R01 research project grant mechanism to support time-sensitive ancillary research that can be conducted alongside an existing, ongoing clinical trial or other large clinical study. The program is designed to add a well-justified ancillary component to a "parent" study that already has participants, infrastructure, and ongoing data collection.
Which NIH institute is associated with this program?
The opportunity aligns with the mission of the National Heart, Lung, and Blood Institute (NHLBI). Proposed ancillary studies must be relevant to NHLBI mission areas.
What scientific areas are considered relevant to this opportunity?
Projects must relate to heart, lung, and blood diseases or sleep disorders, consistent with NHLBI priorities.
What is an "ancillary study" in the context of this FOA?
An ancillary study is a research project that is carried out in connection with an established parent clinical trial or large clinical study. It leverages the parent study's existing cohort, operational infrastructure, and data collection activities, and adds additional measurements, analyses, or follow-up to answer additional NHLBI-relevant scientific questions.
What is a "parent" study?
A parent study is the existing, ongoing clinical trial or other large clinical study that provides the platform for the ancillary research. It already has participants and a functioning research infrastructure (for example, visit schedules, assessments, endpoints, specimen collection, or data systems) that the ancillary study can use.
Does the parent study have to be a clinical trial?
No. The parent study will most often be a clinical trial, but the FOA also allows other large clinical studies such as observational studies or registries, as long as they can provide a sufficiently sized and well-characterized cohort.
Why does this FOA emphasize "time-sensitive" research?
A central feature of this FOA is an accelerated review and award process intended for cases where timing is critical. The ancillary study must be truly time sensitive, typically because it requires active, longitudinal data collection that must begin close to the start of the parent study or within a narrow window during the parent study timeline.
What kinds of timing constraints might make an ancillary study "time sensitive"?
Examples described include needing baseline specimens, imaging, physiologic measures, or early follow-up assessments that would be impossible or scientifically compromised if collected later. The application is expected to show that delays would cause loss of key data, missed recruitment opportunities, or inability to achieve the scientific aims.
Is expedited review optional, or must applicants justify it?
Applicants are expected to make a clear and explicit case for why an expedited review is essential to feasibility, not merely convenient. The urgency must be tied to the parent study's timeline and the proposed ancillary study's data collection needs.
What is the main advantage of using an existing parent study rather than creating a new cohort?
The core idea is to take advantage of a parent study that already has participants, an operating research infrastructure, and ongoing data collection, allowing the ancillary research to be added without building a brand-new cohort from scratch.
How should an ancillary study relate to the parent study operations?
The proposed work should be designed to leverage what the parent study already does well (such as recruitment mechanisms, visit schedules, clinical assessments, biorepositories, endpoints, and data management systems) rather than duplicating efforts or creating major disruptions. The parent study provides the platform, and the ancillary study adds focused additional measurements, analyses, or follow-up.
What grant mechanism is used for this opportunity?
This is a discretionary grant program that uses the NIH R01 research project grant mechanism.
What type of funding activity is this?
It is categorized under health-related funding activities.
Is cost sharing or matching required?
No. The opportunity does not require cost sharing or matching.
What is the estimated total funding amount listed for this opportunity?
The estimated total funding listed is $4,800,000.
What is the award ceiling?
The award ceiling listed for this opportunity is $250,000.
Which CFDA program areas are connected to this FOA?
The CFDA program areas connected to this FOA include sleep disorders research (93.233), cardiovascular diseases research (93.837), lung diseases research (93.838), and blood diseases and resources research (93.839).
Who is eligible to apply?
Eligibility is broad and includes many types of domestic U.S. organizations, such as state and local governments, public and private institutions of higher education, nonprofits (including but not limited to 501(c)(3) organizations), small businesses, and certain for-profit organizations (other than small businesses). The eligibility list also includes HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian serving institutions, faith-based and community-based organizations, regional organizations, U.S. territories or possessions, and eligible federal agencies.
Are non-U.S. (foreign) organizations eligible to apply?
Yes. Non-U.S. entities (foreign institutions) are eligible to apply. In addition, non-U.S. components of U.S. organizations may also apply, and foreign components are allowed as defined by NIH policy.
What does it mean that "foreign components are allowed"?
The listing states that foreign components are allowed as defined by NIH policy, meaning the FOA permits non-U.S. components within the scope of NIH's definition and rules for foreign components.
When was this FOA posted, and what are the key dates?
The listing shows the FOA was posted and created on December 7, 2011. The original and current closing date shown is January 24, 2013, and the archive date is February 24, 2013.
Is this FOA still open?
Based on the closing date (January 24, 2013) and archive date (February 24, 2013) listed, this specific announcement is archived.
Where can applicants find the official FOA text and details?
The FOA provides an additional information link: http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-13-003.html
Where were technical access issues directed?
Technical access issues were directed to the NIH Office of Extramural Research (OER) webmaster contact listed in the announcement.
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