Opportunity Information: Apply for RFA HL 12 012
Apply for RFA HL 12 012
- 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 Jan 19, 2011 and posted on Jan 19, 2011.
- Applicants must submit their applications by Jan 27, 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 $250,000.00 in funding.
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) Private institutions of higher education City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Public housing authorities/Indian housing authorities Small businesses Independent school districts For profit organizations other than small businesses Public and State controlled institutions of higher education County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized).
- 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) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:
The Ancillary Studies in Clinical Trials (R01) opportunity (Funding Opportunity Number RFA-HL-12-012) is a National Institutes of Health grant announcement led by the National Heart, Lung, and Blood Institute (NHLBI) that supports "time sensitive" ancillary studies that must be carried out alongside an already ongoing or soon-to-begin parent clinical trial or other large clinical study. The central idea is to fund add-on research projects that take advantage of an existing study's enrolled participants, study infrastructure, and data systems, so investigators can ask additional questions relevant to NHLBI's mission without having to build an entirely new cohort from scratch. The scientific scope is broad as long as the ancillary study is clearly connected to heart, lung, and blood diseases or sleep disorders, and the parent study can realistically support the ancillary project through access to participants and operational capacity.
A defining feature of this FOA is its emphasis on urgency and feasibility tied to timing. These applications are meant for ancillary projects that cannot wait for a standard funding timeline because they require active, longitudinal data collection that needs to start as close as possible to the beginning of the parent study. In practical terms, that usually means collecting baseline measures, biospecimens, imaging, physiologic recordings, patient-reported outcomes, or other data at early study timepoints that would be missed or compromised if the ancillary study begins too late. Because of this narrow window, NHLBI established an accelerated review and award process for these applications, but applicants must make a clear, explicit case that the proposed work is truly time sensitive and that expedited review is essential for the study to be workable.
The parent study is most often a clinical trial, but the announcement also allows an observational cohort study or a registry, as long as it provides a sufficiently large and well-characterized group of participants and the necessary infrastructure to execute the ancillary protocol. The ancillary study itself can address a wide range of questions aligned with NHLBI priorities, including mechanistic, biomarker, genetic, physiologic, behavioral, or outcomes-focused aims, provided the proposal explains how the parent study setting makes the research possible or more efficient. A strong application under this FOA would typically show that the ancillary study integrates cleanly with the parent study workflow, avoids interfering with the parent study's primary objectives, and uses the existing recruitment, follow-up schedule, and data collection systems to minimize burden and maximize scientific yield.
This is a discretionary grant mechanism using the NIH R01 funding instrument within the Health activity category. The opportunity lists an award ceiling of $250,000, indicates no cost sharing or matching requirement, and is associated with CFDA numbers tied to sleep disorders research and cardiovascular, lung, and blood disease research (93.233, 93.837, 93.838, 93.839). The announcement was posted January 19, 2011, with an original and current closing date of January 27, 2012, and an archive date of February 27, 2012, meaning it is no longer open but remains useful as a reference for how NHLBI structures and evaluates these time-critical ancillary study proposals.
Eligibility is intentionally broad and includes many organization types that commonly apply for NIH funding. Examples listed include public and private institutions of higher education, nonprofits (both 501(c)(3) and non-501(c)(3)), state and local governments, tribal governments and tribal organizations, U.S. territories or possessions, small businesses and other for-profit entities, public housing authorities, independent school districts, and special district governments. The FOA also explicitly mentions additional eligible applicants such as 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, eligible federal agencies, regional organizations, and non-U.S. (foreign) organizations. This wide eligibility reflects the expectation that ancillary studies may be proposed by investigators embedded in many different kinds of clinical research ecosystems, including multi-center trial networks and large observational platforms.
Applicants were directed to the full FOA text hosted on the NIH grants website (link provided in the source), and the contact information points to the NIH Office of Extramural Research (OER) webmaster for access or linking problems. The most important takeaway is that this program was designed specifically to prevent missed scientific opportunities that occur when ancillary measurements need to be collected at the earliest stages of a parent trial or large study, and it requires applicants to justify both the scientific value of the add-on work and the operational need for an expedited funding decision.
FAQs: Ancillary Studies in Clinical Trials (R01) (RFA-HL-12-012)
What is the Ancillary Studies in Clinical Trials (R01) opportunity?
It is an NIH grant announcement led by the National Heart, Lung, and Blood Institute (NHLBI) that supports time sensitive ancillary (add-on) studies that must be conducted alongside an already ongoing or soon-to-begin parent clinical trial or other large clinical study.
What does "ancillary study" mean in this announcement?
An ancillary study is an additional research project that leverages an existing parent study's enrolled participants, study infrastructure, and data systems to answer new questions relevant to NHLBI's mission without creating a new cohort from scratch.
What is the main purpose of this funding opportunity?
The purpose is to prevent missed scientific opportunities by funding add-on research that needs to begin very early in the parent study timeline (often near baseline) and would be compromised if it started later under a standard funding schedule.
Why does the FOA emphasize "time sensitive" research?
Because the ancillary work often requires early or longitudinal data collection that must start as close as possible to the beginning of the parent study. If funding decisions take too long, key early timepoints (such as baseline measures) may be missed.
What kinds of data collection does the FOA describe as time sensitive?
Examples mentioned include baseline measures and early study timepoint collection of biospecimens, imaging, physiologic recordings, patient-reported outcomes, and other data that would be missed or reduced in value if started too late.
Does the program use an accelerated process?
Yes. NHLBI established an accelerated review and award process for these applications. Applicants must clearly justify that expedited review is essential because the project is truly time sensitive.
What types of parent studies can support an ancillary study under this FOA?
The parent study is most often a clinical trial, but an observational cohort study or a registry may also qualify if it provides a sufficiently large and well-characterized participant group and has the necessary infrastructure to carry out the ancillary protocol.
How closely must the ancillary study be connected to the parent study?
The ancillary study must be clearly connected operationally and scientifically: it should realistically be supported by the parent study through access to participants and operational capacity, and it should take advantage of the parent study setting to make the research possible or more efficient.
What scientific areas are within scope?
The scope is broad as long as it aligns with NHLBI's mission. The announcement references heart, lung, and blood diseases, as well as sleep disorders, as relevant areas for ancillary research.
What types of research aims are described as appropriate?
The FOA describes a wide range of potential aims aligned with NHLBI priorities, including mechanistic, biomarker, genetic, physiologic, behavioral, and outcomes-focused questions, provided the proposal explains why the parent study context is critical.
What makes an application strong under this FOA?
Based on the description, a strong application would typically show that the ancillary study integrates cleanly into the parent study workflow, avoids interfering with the parent study's primary objectives, uses existing recruitment and follow-up schedules, and relies on current data collection systems to reduce burden and increase scientific yield.
Does the ancillary study need to avoid disrupting the parent trial?
Yes. The FOA highlights the expectation that the ancillary study should integrate with the parent workflow and avoid interfering with the parent study's primary objectives.
What funding mechanism is used?
This opportunity uses the NIH R01 funding instrument and is described as a discretionary grant mechanism in the Health activity category.
What is the award ceiling listed for this opportunity?
The opportunity lists an award ceiling of $250,000.
Is cost sharing or matching required?
No. The opportunity indicates there is no cost sharing or matching requirement.
What CFDA numbers are associated with this FOA?
The announcement is associated with CFDA numbers 93.233, 93.837, 93.838, and 93.839, tied to sleep disorders research and cardiovascular, lung, and blood disease research.
Is this funding opportunity still open?
No. The announcement was posted January 19, 2011, had an original and current closing date of January 27, 2012, and an archive date of February 27, 2012. It is no longer open, but it can still be used as a reference for how NHLBI structured and evaluated these time-critical ancillary study proposals.
Who is eligible to apply?
Eligibility is broad and includes many organization types commonly eligible for NIH funding, including public and private institutions of higher education, nonprofits (501(c)(3) and non-501(c)(3)), state and local governments, tribal governments and tribal organizations, U.S. territories or possessions, small businesses, other for-profit entities, public housing authorities, independent school districts, and special district governments.
Are specific institution types explicitly mentioned as eligible?
Yes. The FOA explicitly mentions eligibility for 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, eligible federal agencies, regional organizations, and non-U.S. (foreign) organizations.
Are non-U.S. (foreign) organizations eligible?
Yes. Non-U.S. (foreign) organizations are explicitly listed among eligible applicants.
Where was applicants' official guidance hosted?
Applicants were directed to the full FOA text hosted on the NIH grants website (a link was provided in the source material).
Who is listed as the contact for access or linking problems?
The contact information points to the NIH Office of Extramural Research (OER) webmaster for access or linking problems.
What is the central idea investigators need to justify in these applications?
Applicants need to justify both the scientific value of the ancillary (add-on) work and the operational need for an expedited funding decision, making a clear case that the study is truly time sensitive and depends on early parent-study timepoints.
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