Opportunity Information: Apply for RFA AR 10 011
Apply for RFA AR 10 011
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Ancillary Studies to Large Ongoing Clinical Projects (R21)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.846 Arthritis, Musculoskeletal and Skin Diseases Research.
- This funding opportunity was created on Apr 29, 2009 and posted on Apr 29, 2009.
- Applicants must submit their applications by Apr 1, 2010. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $1,500,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $200,000.00 in funding.
- Eligible applicants include: For profit organizations other than small businesses 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) Small businesses Public housing authorities/Indian housing authorities City or township governments Independent school districts Special district governments 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) State governments County governments Native American tribal governments (Federally recognized) 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 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.
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Opportunity Summary:
The Ancillary Studies to Large Ongoing Clinical Projects (R21) opportunity (Funding Opportunity Number RFA-AR-10-011) is a National Institutes of Health grant announcement from NIAMS, the NIH institute focused on arthritis, musculoskeletal, and skin diseases (CFDA 93.846). It is designed to fund exploratory and developmental ancillary studies that are highly innovative and explicitly time sensitive. The central idea is to let investigators take advantage of large, already-running clinical efforts and quickly add a well-justified sub-study that can produce new insights without having to build a full cohort, infrastructure, or specimen pipeline from scratch.
This FOA targets ancillary work that can be conducted alongside a substantial ongoing "parent" clinical project. The parent project can be a large clinical trial, a large observational study, or a disease registry, as long as it offers what the ancillary study needs: a sufficiently sized and well-characterized patient cohort, established research infrastructure, existing data streams, and potentially access to biological samples. The ancillary study is expected to complement and enrich the parent project rather than duplicate its aims, using the parent project's resources to answer additional, tightly scoped questions that are best addressed while the parent project is still active.
A defining feature of this announcement is the accelerated review and award process. NIAMS is signaling that these projects should move quickly because the window of opportunity is limited, for example because the parent study is nearing the end of recruitment, biospecimen collection is happening now, specific follow-up timepoints are imminent, or because key measurements must be collected prospectively during the parent study's remaining active period. Because of that, every application must include a clear timeline showing that the parent project has enough time left to complete the proposed ancillary activities. Applicants also need to make a convincing case for why the study is time sensitive and why an expedited review and award decision is necessary to make the science feasible.
The FOA also places practical and administrative requirements on applicants that reflect the fact they are working with an existing clinical enterprise. A key requirement is documentation of permission from the parent project to use the relevant patient cohort, data, and any biological materials. In other words, applicants must show they have access and approval to plug into the ongoing project, not just a conceptual plan. This typically implies coordination with the parent study leadership, alignment with the parent study's governance and consent limitations, and a realistic plan for integrating new measures or analyses into current operations.
Programmatically, NIAMS frames the goal as maximizing the return on investment from major clinical projects that already required significant resources to launch and maintain. By funding add-on studies through a flexible mechanism, NIAMS aims to leverage established cohorts and datasets to generate additional high-value findings that enhance the overall scientific contribution of the parent project. The expected payoff is stronger scientific content and broader utility of the original clinical effort, along with improved understanding of diseases or organ systems within the NIAMS portfolio. Ultimately, the ancillary studies supported under this FOA are meant to help identify novel targets or approaches relevant to diagnosis, treatment, and prevention.
From a funding and administrative standpoint, this is an R21 mechanism (exploratory/developmental grant) with an award ceiling of $200,000 and an estimated total program funding level of $1,500,000 for the announcement. Cost sharing or matching is not required. The opportunity was posted on April 29, 2009, with an original and current closing date listed as April 1, 2010, and an archive date of May 2, 2010, indicating it was a time-limited solicitation.
Eligibility is broad and includes a wide range of U.S.-based organizations and governmental entities. Eligible applicants include public and private institutions of higher education, nonprofit organizations (including both 501(c)(3) and non-501(c)(3) entities), for-profit organizations other than small businesses, and small businesses. Governmental eligibility spans state, county, city or township governments, special district governments, independent school districts, and public housing authorities/Indian housing authorities. The FOA also explicitly includes tribal governments (federally recognized and other than federally recognized), tribally controlled colleges and universities, Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving institutions, Historically Black Colleges and Universities, U.S. territories or possessions, regional organizations, and faith-based or community-based organizations. This wide eligibility is consistent with the nature of ancillary studies, which may be led by academic, nonprofit, industry, or community partners, as long as they can coordinate effectively with an eligible parent clinical project and meet NIAMS scientific and administrative expectations.
For applicants who want the official details, the announcement points to the NIH Grants Guide web page for RFA-AR-10-011. For technical access issues, NIH Office of Extramural Research webmaster contacts are provided.
FAQs: Ancillary Studies to Large Ongoing Clinical Projects (R21) - RFA-AR-10-011
What is this funding opportunity?
This is an NIH grant announcement from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) titled "Ancillary Studies to Large Ongoing Clinical Projects (R21)" (Funding Opportunity Number RFA-AR-10-011; CFDA 93.846). It supports exploratory and developmental ancillary studies that are designed to be added onto an already-running clinical project.
What is the main goal of the FOA?
The goal is to maximize the return on investment from major clinical projects that already required significant resources to establish. NIAMS intends to fund add-on studies that leverage existing cohorts, infrastructure, and data (and potentially biospecimens) to produce additional high-value findings that enrich the parent project and advance NIAMS-relevant science.
What types of studies does it fund?
The FOA is designed for highly innovative, exploratory, and developmental ancillary studies. These studies should be tightly scoped and able to take advantage of a large ongoing clinical effort without needing to build a new cohort, infrastructure, or specimen pipeline from scratch.
What counts as a "parent" clinical project?
A parent project can be a large clinical trial, a large observational study, or a disease registry, as long as it provides what the ancillary study needs, such as a sufficiently sized and well-characterized patient cohort, established research infrastructure, and existing data streams, with potential access to biological samples.
Does the ancillary study have to be conducted while the parent project is still active?
Yes. A defining feature of this FOA is that the ancillary work is expected to be conducted alongside an active, ongoing parent project. The ancillary study should use the remaining active period of the parent project to collect key measurements prospectively or take advantage of imminent recruitment, biospecimen collection, or follow-up timepoints.
What does NIAMS mean by "time sensitive" in this announcement?
Is there an accelerated review and award process?
Yes. The FOA emphasizes an accelerated review and award process due to the time-sensitive nature of the proposed ancillary studies. Applicants are expected to justify why expedited review and award timing is necessary to make the science feasible.
What timeline information is required in the application?
Every application must include a clear timeline showing that the parent project has enough time left to complete the proposed ancillary activities. The timeline should support the argument that the work must be initiated promptly to fit within the parent study's remaining active period.
How should the ancillary study relate to the parent project?
The ancillary study should complement and enrich the parent project, not duplicate its aims. It should use the parent project's resources to answer additional, well-justified questions that are best addressed while the parent project is still underway.
Can applicants rely on the parent project's cohort and infrastructure rather than creating new resources?
Yes. The central idea is to leverage an existing, well-characterized patient cohort, established infrastructure, and existing data streams (and potentially biological samples) from an ongoing parent project, avoiding the need to build these resources from the ground up.
Is permission from the parent project required?
Yes. A key administrative requirement is documentation showing permission from the parent project to use the relevant patient cohort, data, and any biological materials. Applicants must show they have access and approval to integrate with the ongoing project, not just a conceptual plan.
What does "documentation of permission" imply for project planning?
Based on the FOA description, it implies coordination with the parent study leadership, alignment with the parent study's governance and any consent limitations, and a realistic plan for integrating new measures or analyses into current operations.
What outcomes or benefits does NIAMS expect from funded ancillary studies?
NIAMS expects ancillary studies to generate additional high-value findings that enhance the scientific contribution and broader utility of the parent clinical effort. The FOA also notes that these studies are meant to help identify novel targets or approaches relevant to diagnosis, treatment, and prevention in areas within the NIAMS portfolio.
What grant mechanism is used?
This opportunity uses the NIH R21 mechanism, which is an exploratory/developmental grant.
What is the award ceiling for this R21?
The award ceiling stated in the announcement is $200,000.
How much total funding is NIAMS estimating for this program?
The FOA lists an estimated total program funding level of $1,500,000 for the announcement.
Is cost sharing or matching required?
No. The FOA states that cost sharing or matching is not required.
Who is the sponsoring NIH institute?
The sponsoring institute is NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases), which focuses on arthritis, musculoskeletal, and skin diseases.
What is the CFDA number associated with this opportunity?
The CFDA number listed is 93.846.
Who is eligible to apply?
Eligibility is broad and includes U.S.-based public and private institutions of higher education; nonprofit organizations (both 501(c)(3) and non-501(c)(3)); for-profit organizations other than small businesses; small businesses; and a wide range of governmental entities.
Which governmental entities are included as eligible applicants?
The FOA includes state, county, and city or township governments; special district governments; independent school districts; and public housing authorities/Indian housing authorities.
Are tribal entities and certain designated institutions included?
Yes. The FOA explicitly includes tribal governments (federally recognized and other than federally recognized), tribally controlled colleges and universities, Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving institutions, Historically Black Colleges and Universities, U.S. territories or possessions, and regional organizations.
Are faith-based or community-based organizations eligible?
Yes. The FOA explicitly includes faith-based or community-based organizations among eligible applicants.
When was this FOA posted and when did it close?
The opportunity was posted on April 29, 2009. The original and current closing date listed is April 1, 2010, and the archive date is May 2, 2010, indicating the solicitation was time-limited.
Where can applicants find the official FOA details?
The announcement points applicants to the NIH Grants Guide web page for RFA-AR-10-011 for official details.
Who should be contacted for technical access issues?
For technical access issues, the FOA indicates that NIH Office of Extramural Research webmaster contacts are provided.
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