Opportunity Information: Apply for RFA HL 10 024

  • 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 Mar 17, 2010 and posted on Mar 17, 2010.
  • Applicants must submit their applications by Jan 28, 2011. (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: Public and State controlled institutions of higher education For profit organizations other than small businesses Small businesses City or township governments Special district governments County governments Public housing authorities/Indian housing authorities Private institutions of higher education State governments Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) 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.
Apply for RFA HL 10 024

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Opportunity Summary:

The NIH, through the National Heart, Lung, and Blood Institute (NHLBI), offered this R01 grant opportunity to fund time-sensitive ancillary studies that can be carried out alongside an existing, ongoing clinical trial or other large clinical study. The main idea is to support add-on research questions related to heart, lung, and blood diseases, as well as sleep disorders, by taking advantage of a parent study that already has participants, research infrastructure, and established data collection. These ancillary projects are meant to be tightly connected to the parent study and should use that parent study as the platform for recruitment, follow-up, or access to well-characterized cohorts and outcomes.

A defining requirement of this announcement is urgency. Applications must show that the proposed ancillary work is genuinely time sensitive, meaning the study needs to begin quickly in order to collect key data during the same time window as the parent study. This commonly involves active longitudinal data collection (for example, collecting repeated measures, biospecimens, imaging, or physiologic data over time) where delaying the start would reduce feasibility, compromise scientific value, or prevent alignment with baseline or early follow-up assessments in the parent study. Because timing is critical, the program is designed to use an accelerated review and award process, and applicants are expected to clearly explain why expedited review is essential and how delays would harm the project.

The parent study is most often a clinical trial, but the FOA also allows ancillary studies that piggyback on other large clinical research efforts such as observational studies or patient registries, as long as they can provide a sufficiently large and well-characterized cohort. The ancillary study itself can pursue any research question within the NHLBI mission areas, provided the parent study can realistically supply the participants, operational framework, and relevant context needed to execute the ancillary aims. In practice, this means the proposal should make a strong case that the parent study setting is not just convenient, but necessary for answering the ancillary questions efficiently and rigorously.

Funding is provided under the NIH Research Project Grant (R01) mechanism. For the fiscal year noted in the announcement (FY 2011), NHLBI planned to commit about $4.8 million total to support up to 12 new awards, with actual awards dependent on available funds and the quality and number of applications received. Applicants could request up to a 4-year project period, with direct costs capped at $250,000 per year (10 modules). The cap excludes subcontractor or consortium indirect costs, which is a standard NIH budgeting detail that can matter for multi-institution collaborations.

The opportunity was listed as a discretionary grant program under NIH, with activity focused on health, and it referenced CFDA program areas covering cardiovascular diseases research, lung diseases research, blood diseases and resources research, and the National Center on Sleep Disorders Research. There was no cost sharing or matching requirement. The announcement (Funding Opportunity Number RFA-HL-10-024) was posted March 17, 2010, with an original and current closing date of January 28, 2011, and it was archived February 28, 2011.

Eligibility was broad and included many types of organizations and governments. Eligible applicants encompassed public and private institutions of higher education, nonprofits (including both 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations (including small businesses), and a range of government entities (state, county, city/township, special district, independent school districts, public housing authorities). The eligibility language also explicitly included groups such as historically Black colleges and universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, tribal governments (including federally recognized tribes), faith-based and community-based organizations, U.S. territories or possessions, and foreign (non-U.S.) organizations and regional organizations, among others. The practical takeaway is that NHLBI was open to a wide range of applicants as long as they could credibly execute an ancillary study that must start quickly and is anchored to a suitable parent clinical study.

For additional details, the full announcement was made available through the NIH Grants Guide webpage for RFA-HL-10-024, and NIH Office of Extramural Research provided support contacts for access or linking issues.

Frequently Asked Questions (FAQs)

What is this NIH/NHLBI funding opportunity for?

This is an NIH (NHLBI) R01 funding opportunity intended to support time-sensitive ancillary studies that can be conducted alongside an existing, ongoing clinical trial or other large clinical study. The goal is to fund add-on research questions aligned with NHLBI mission areas (heart, lung, blood diseases, and sleep disorders) by leveraging an active parent study that already has participants, infrastructure, and established data collection.

What is an "ancillary study" in the context of this announcement?

An ancillary study is an add-on project that is tightly linked to a parent study and uses that parent study as the platform for recruitment, follow-up, and/or access to a well-characterized cohort and outcomes. The ancillary project is meant to take advantage of the parent study's existing operations rather than building an entirely new standalone study.

What qualifies as the required "time-sensitive" or "urgent" aspect?

A defining requirement is urgency. Applications must demonstrate the ancillary work needs to begin quickly to collect key data during the same time window as the parent study. This often involves active longitudinal data collection (such as repeated measures, biospecimens, imaging, or physiologic data over time) where a delayed start would reduce feasibility, compromise scientific value, or prevent alignment with baseline or early follow-up assessments in the parent study.

Why does the FOA emphasize expedited review and award?

Because the proposed ancillary study must start quickly to remain feasible and scientifically valuable, the program is designed to use an accelerated review and award process. Applicants are expected to clearly explain why expedited review is essential and how delays would harm the project.

What kinds of parent studies can an ancillary project attach to?

The parent study is most often a clinical trial, but the announcement also allows ancillary studies that piggyback on other large clinical research efforts such as observational studies or patient registries, as long as they provide a sufficiently large and well-characterized cohort.

Do the ancillary research questions need to be related to specific diseases or topics?

The ancillary study can pursue any research question within NHLBI mission areas, specifically heart, lung, and blood diseases, as well as sleep disorders, as long as the parent study can realistically supply the participants, operational framework, and relevant context needed to carry out the ancillary aims.

How closely does the ancillary study need to be connected to the parent study?

The ancillary project is expected to be tightly connected to the parent study and to use it as the platform for recruitment, follow-up, or access to well-characterized cohorts and outcomes. The proposal should make the case that the parent study setting is not merely convenient, but necessary to answer the ancillary questions efficiently and rigorously.

What grant mechanism is used for this opportunity?

Funding is provided under the NIH Research Project Grant (R01) mechanism.

How much funding was planned under this announcement?

For the fiscal year referenced in the announcement (FY 2011), NHLBI planned to commit about $4.8 million in total funding to support up to 12 new awards. Actual awards were dependent on available funds and the quality and number of applications received.

What is the maximum project period allowed?

Applicants could request up to a 4-year project period.

What is the annual direct cost cap for this R01?

Direct costs were capped at $250,000 per year (10 modules).

Are subcontractor or consortium indirect costs included in the $250,000 direct cost cap?

No. The cap excludes subcontractor or consortium indirect costs, which is a standard NIH budgeting detail that may be important for multi-institution collaborations.

Is cost sharing or matching required?

No cost sharing or matching requirement was indicated.

Who was eligible to apply?

Eligibility was broad and included many types of organizations and governments. Eligible applicants included 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 government entities such as state, county, city/township, special district, independent school districts, and public housing authorities.

Are specific institution types explicitly included (for example, minority-serving institutions or tribal entities)?

Yes. The eligibility language explicitly included groups such as historically Black colleges and universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, tribal governments (including federally recognized tribes), faith-based and community-based organizations, U.S. territories or possessions, and foreign (non-U.S.) organizations and regional organizations, among others.

Does this opportunity allow foreign (non-U.S.) organizations to apply?

Yes. Foreign (non-U.S.) organizations and regional organizations were explicitly included in the eligibility language.

What is the Funding Opportunity Number for this announcement?

The Funding Opportunity Number is RFA-HL-10-024.

When was this funding opportunity posted and when did it close?

The announcement was posted on March 17, 2010. The original and current closing date listed was January 28, 2011. It was archived on February 28, 2011.

What general program areas were referenced?

The opportunity referenced CFDA program areas covering cardiovascular diseases research, lung diseases research, blood diseases and resources research, and the National Center on Sleep Disorders Research.

Where can applicants find the full announcement details?

The full announcement was made available through the NIH Grants Guide webpage for RFA-HL-10-024.

Who provides help if there are access or linking issues with the announcement?

NIH Office of Extramural Research support contacts were referenced for assistance with access or linking issues.

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