Opportunity Information: Apply for RFA AR 11 013
Apply for RFA AR 11 013
- 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 Sep 1, 2010 and posted on Sep 1, 2010.
- Applicants must submit their applications by Apr 1, 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 $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: County governments Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts State governments Native American tribal governments (Federally recognized) Others (see text field entitled Additional Information on Eligibility for clarification) Public and State controlled institutions of higher education For profit organizations other than small businesses City or township governments Public housing authorities/Indian housing authorities Nonprofits having 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) 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:
Ancillary Studies to Large Ongoing Clinical Projects (R21) (Funding Opportunity Number RFA-AR-11-013) is a National Institutes of Health opportunity from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). It is designed to fund time-sensitive, exploratory, and highly innovative ancillary studies that can be added onto large clinical efforts that are already underway. The core idea is to take advantage of an existing, well-built clinical platform such as a large clinical trial, a major observational cohort, or a disease registry that already has a sufficiently sized and well characterized patient population, established study infrastructure, existing datasets, and access to biological samples. Rather than creating a brand-new cohort from scratch, applicants are expected to leverage these ongoing resources to answer new questions quickly and efficiently in areas aligned with the NIAMS mission (arthritis, musculoskeletal diseases, and skin diseases).
The studies supported under this announcement are meant to be genuinely time sensitive. Applications are expected to explain clearly why the ancillary work has to happen while the parent project is still active (for example, because participant visits are happening now, samples are being collected now, or specific follow-up windows will soon close). A key requirement is that each application includes a concrete timeline showing that the parent project has enough time remaining to realistically carry out the proposed ancillary aims. Just as important, the application must document that the investigators running the parent clinical project have granted permission for the ancillary study team to access and use the relevant patient cohort, data, and biological materials. In other words, the ancillary project cannot be speculative about access; it must show it is feasible and approved within the context of the ongoing parent study.
This FOA uses the NIH Exploratory/Developmental Grant (R21) mechanism. That typically signals shorter, early-stage projects that emphasize innovation, proof-of-concept, or development of new approaches, rather than large multi-year programs with extensive preliminary data requirements. NIAMS also ran a parallel announcement of the same scientific scope under an R01 mechanism (for more mature or larger-scope projects), with the intent that applicants choose the mechanism that best fits the maturity and scale of their ancillary work. A notable feature of this R21 FOA is that NIAMS planned an accelerated review and award process, reflecting the time-sensitive nature of add-on studies that need to start quickly to align with the parent project schedule.
In terms of funding scale and expectations, NIAMS anticipated committing about $1.5 million in total costs in fiscal year 2011 to support a combined total of roughly four to six awards across the paired R01 and R21 announcements. For this R21 opportunity, the listed award ceiling is $200,000. As with most NIH opportunities, actual awards were contingent on the availability of funds and the receipt of enough high-quality, meritorious applications. The opportunity was posted on September 1, 2010, with an original (and current) closing date of April 1, 2011, and it was archived on May 2, 2011.
Eligibility was broad and included many common applicant types across academia, government, nonprofit, and industry. Eligible applicants included public and private institutions of higher education, nonprofit organizations (including those with and without 501(c)(3) status), for-profit organizations (including small businesses and other for-profits), and various levels of government (state, county, city/township, special districts, independent school districts, public housing authorities, and tribal governments). The eligibility list also explicitly included a range of specialized institution types and communities such as Historically Black Colleges and Universities, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, faith-based and community-based organizations, U.S. territories or possessions, regional organizations, and even non-U.S. (foreign) entities, reflecting NIH’s typical openness to a wide pool of research performers when appropriate.
Overall, the practical purpose of the program is to maximize the return on investment from major clinical studies that already cost substantial time and money to build. By funding carefully targeted ancillary projects that can ride on the existing cohort, operations, and specimen pipelines, NIAMS aimed to strengthen the scientific yield of the parent studies, deepen understanding of diseases and organ systems within its portfolio, and speed the identification of new leads for diagnosis, treatment, and prevention.
Frequently Asked Questions (FAQs)
What is the funding opportunity called, and what is the FOA number?
The opportunity is titled Ancillary Studies to Large Ongoing Clinical Projects (R21). The Funding Opportunity Number is RFA-AR-11-013.
Which agency and NIH institute are sponsoring this opportunity?
This is a National Institutes of Health (NIH) funding opportunity sponsored by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
What is the purpose of this R21 program?
The program is intended to fund time-sensitive, exploratory, and highly innovative ancillary studies that can be added onto large clinical efforts already underway. The goal is to take advantage of established clinical platforms (such as trials, cohorts, or registries) rather than building a new cohort from scratch.
What does "ancillary study" mean in the context of this FOA?
In this FOA, an ancillary study is an add-on project that leverages an existing, ongoing "parent" clinical project to answer new scientific questions. The ancillary work is expected to use the parent study's established infrastructure, patient population, datasets, and/or biological samples.
What kinds of parent clinical projects can an ancillary study attach to?
The FOA emphasizes large, well-built clinical platforms such as a large clinical trial, a major observational cohort, or a disease registry that already has a sufficiently sized and well-characterized patient population and established study infrastructure.
Why does NIAMS emphasize using an existing clinical platform instead of creating a new cohort?
The intent is to maximize the return on investment from major clinical studies that have already required substantial time and resources. By leveraging an existing cohort, operations, and specimen pipelines, ancillary studies can address new questions more quickly and efficiently than starting from scratch.
What scientific areas should the proposed ancillary studies align with?
Projects should align with the NIAMS mission, including areas related to arthritis, musculoskeletal diseases, and skin diseases.
What does the FOA mean by "time-sensitive"?
The ancillary study must be genuinely time sensitive, meaning it needs to be conducted while the parent study is still active. Examples given include situations where participant visits are occurring now, biological samples are being collected now, or certain follow-up windows will soon close.
How should an application justify that the work is time sensitive?
Applications are expected to clearly explain why the ancillary work must occur during the active period of the parent project. The justification should be tied to the parent project's schedule and opportunities (such as ongoing visits, active sample collection, or time-limited follow-up).
Is a timeline required, and what should it show?
Yes. A key requirement is a concrete timeline demonstrating that the parent project has enough time remaining to realistically carry out the proposed ancillary aims while the parent project is still active.
Do applicants need permission from the parent study investigators?
Yes. The application must document that the investigators running the parent clinical project have granted permission for the ancillary study team to access and use the relevant cohort, data, and biological materials.
Can an ancillary study propose access to samples or data without confirmed approval?
No. The FOA makes clear that access cannot be speculative. The application must show that access to the cohort, data, and/or biological materials is feasible and approved within the context of the ongoing parent study.
What grant mechanism does this FOA use?
This FOA uses the NIH Exploratory/Developmental Grant (R21) mechanism.
What does the R21 mechanism imply about the type of research NIAMS expects?
The R21 mechanism typically supports shorter, early-stage projects that emphasize innovation, proof-of-concept, or the development of new approaches, rather than large, multi-year programs.
Was there an R01 version of this opportunity?
Yes. NIAMS ran a parallel announcement with the same scientific scope under an R01 mechanism, intended for more mature or larger-scope ancillary projects. Applicants were expected to choose the mechanism that best fits their project’s maturity and scale.
Does this R21 FOA mention anything about review or award speed?
Yes. A notable feature is that NIAMS planned an accelerated review and award process, reflecting the time-sensitive nature of these add-on studies that need to start quickly to align with the parent project schedule.
How much funding did NIAMS anticipate committing for these ancillary study programs?
NIAMS anticipated committing about $1.5 million in total costs in fiscal year 2011 to support roughly four to six awards across the paired R01 and R21 announcements.
What is the award ceiling for this R21 opportunity?
For this R21 FOA, the listed award ceiling is $200,000.
Were awards guaranteed?
No. As with most NIH opportunities, awards were contingent on availability of funds and the receipt of a sufficient number of high-quality, meritorious applications.
When was this opportunity posted, and what was the closing date?
The opportunity was posted on September 1, 2010. The original (and current) closing date was April 1, 2011.
Is this funding opportunity still active?
No. The opportunity was archived on May 2, 2011.
Who was eligible to apply?
Eligibility was broad and included many applicant types across academia, government, nonprofit, and industry. Eligible applicants included public and private institutions of higher education, nonprofit organizations (with and without 501(c)(3) status), for-profit organizations (including small businesses), and multiple levels of government entities.
Which types of government entities were listed as eligible?
The FOA explicitly included state, county, city/township, special district, independent school district, public housing authority, and tribal governments as eligible applicant types.
Are specialized institution types (such as HBCUs or Hispanic-serving institutions) eligible?
Yes. The eligibility list explicitly includes specialized institution types and communities such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, and tribally controlled colleges and universities.
Are Alaska Native and Native Hawaiian serving institutions eligible?
Yes. The FOA explicitly lists Alaska Native and Native Hawaiian serving institutions among eligible applicants.
Are faith-based and community-based organizations eligible?
Yes. The eligibility list explicitly includes faith-based and community-based organizations.
Are U.S. territories and regional organizations included in eligibility?
Yes. The eligibility list includes U.S. territories or possessions and regional organizations.
Are non-U.S. (foreign) entities eligible to apply?
Yes. The eligibility list explicitly includes non-U.S. (foreign) entities, reflecting NIH openness to a wide pool of research performers when appropriate.
What practical outcomes was NIAMS trying to achieve with this program?
The program aims to strengthen the scientific yield of major ongoing clinical studies by funding carefully targeted ancillary projects that use existing cohorts, operations, and specimen pipelines. NIAMS intended this approach to deepen understanding within its disease portfolio and speed the identification of new leads for diagnosis, treatment, and prevention.
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