Opportunity Information: Apply for RFA AR 13 010
Apply for RFA AR 13 010
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Ancillary Studies to Large Ongoing Clinical Projects (R01)" 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 Jul 20, 2012 and posted on Jul 20, 2012.
- Applicants must submit their applications by Apr 16, 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 $1,500,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $250,000.00 in funding.
- The number of recipients for this funding is limited to 6 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) Public housing authorities/Indian housing authorities County governments State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Public and State controlled institutions of higher education Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) Independent school districts For profit organizations other than small businesses.
- 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 to Large Ongoing Clinical Projects (R01) funding opportunity (RFA-AR-13-010) is an NIH grant program from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) designed to support time-sensitive add-on studies that can be carried out alongside an already funded, large, ongoing clinical effort. The central idea is to take advantage of major clinical projects that are already up and running, such as large clinical trials, observational cohort studies, or disease registries, and to use their established participant cohorts, infrastructure, data systems, and stored or prospectively collected biological samples to answer new NIAMS-relevant research questions. By building on existing investments rather than starting from scratch, the program aims to increase scientific yield and generate additional insights into diseases and organ systems within the NIAMS mission area, including arthritis, musculoskeletal conditions, and skin diseases, with downstream potential to inform better diagnosis, treatment, and prevention strategies.
A defining feature of this announcement is its emphasis on urgency and feasibility within the remaining lifespan of the parent project. Applicants are expected to propose an ancillary study that is genuinely time sensitive, meaning it needs to be conducted while the parent clinical project is still active and able to support it, whether because participants are currently being followed, key outcomes are about to be measured, specimens are being collected now, or the opportunity to capture certain data will disappear when the parent project ends. To support that claim, each application must include a clear timeline demonstrating that the parent study has enough time left to accommodate the proposed ancillary activities, and it must explicitly justify why an expedited process is needed. In return, NIAMS indicates that applications under this FOA will go through an accelerated review and award process, reflecting the practical reality that waiting through standard cycles could cause the opportunity window to close.
The program is also structured around responsible coordination with the parent study leadership and governance. A required component is documentation that the applicant has permission to access and use the parent project’s patient cohorts, associated clinical data, and any relevant biological materials. This permission requirement is crucial because ancillary studies can affect workload, participant burden, specimen utilization, and data sharing policies. In practice, a competitive application would need to demonstrate not only scientific merit, but also a credible operational plan that fits smoothly into the parent project’s procedures, minimizes disruption, and addresses how data and samples will be handled in alignment with the parent study’s rules and participant consents.
From a funding and program scale perspective, NIAMS expected to make about six awards under this announcement, with an estimated total funding level of about $1.5 million. The award ceiling is listed as $250,000, indicating that projects are intended to be relatively focused and efficient, consistent with the ancillary concept rather than a full standalone clinical study. The funding instrument is an R01 research project grant, and the activity category is health. There is no cost sharing or matching requirement, which simplifies budgeting for applicants and aligns with typical NIH research grant practices.
Eligibility is broad and includes many types of domestic organizations, such as public and private institutions of higher education, nonprofit organizations (both 501(c)(3) and other nonprofit structures), small businesses, for-profit entities (other than small businesses), and various government entities (state, county, city/township, special districts, and independent school districts), along with tribal governments and tribal organizations. The announcement also states that non-U.S. entities (foreign institutions) may apply, that non-U.S. components of U.S. organizations are eligible, and that foreign components are allowed as defined by NIH policy. Additional categories explicitly noted as eligible include entities such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, faith-based and community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. The broad eligibility reflects the fact that large clinical projects and registries can be hosted by many different kinds of organizations and that ancillary scientific expertise may come from a wide range of settings.
Administratively, the FOA was posted on July 20, 2012, with an original and current closing date of April 16, 2013, and an archive date of May 17, 2013. It is associated with CFDA number 93.846 (Arthritis, Musculoskeletal and Skin Diseases Research). While the opportunity itself is archived and therefore not currently open, the structure of the announcement is still useful as a model for how NIAMS and NIH think about ancillary studies: they prioritize high-value questions that can be answered efficiently by leveraging existing cohorts and infrastructure, require proof that the work must happen now (not later), and insist on clear coordination and authorization from the parent project to protect participants and maintain the integrity of the ongoing clinical effort.
Frequently Asked Questions (FAQs)
What is the Ancillary Studies to Large Ongoing Clinical Projects (R01) opportunity?
This is an NIH funding opportunity from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) intended to support ancillary (add-on) studies that can be conducted alongside an already funded, large, ongoing clinical project. The specific opportunity described is RFA-AR-13-010.
What is the main purpose of this funding opportunity?
The purpose is to increase scientific yield from major clinical efforts that are already underway by using their established participant cohorts, infrastructure, data systems, and biological samples to answer new NIAMS-relevant research questions.
What types of parent clinical projects can an ancillary study build on?
The announcement highlights large clinical trials, observational cohort studies, and disease registries as examples of eligible parent efforts that an ancillary study can leverage.
What does NIAMS mean by an "ancillary" (add-on) study?
An ancillary study is a focused research project that does not replace or restart the parent clinical effort. Instead, it layers additional research questions and measurements onto an existing, active clinical project by using resources that are already in place (participants, data collection workflows, and samples).
What research areas are considered NIAMS-relevant under this opportunity?
The opportunity is aimed at questions within the NIAMS mission area, including arthritis, musculoskeletal conditions, and skin diseases, with the broader goal of generating insights that could inform improved diagnosis, treatment, and prevention strategies.
Why does the FOA emphasize that the ancillary study must be time-sensitive?
A defining feature is urgency: the ancillary work must need to happen while the parent project is still active. The FOA frames time sensitivity in practical terms, such as participants currently being followed, key outcomes about to be measured, specimens being collected now, or data capture opportunities that will disappear when the parent project ends.
What must applicants include to demonstrate time sensitivity and feasibility?
Each application is expected to include a clear timeline showing that the parent clinical project has enough time remaining to accommodate the ancillary work. The application must also explicitly justify why an expedited process is needed (i.e., why waiting through standard cycles could cause the opportunity window to close).
Does NIAMS offer an accelerated review and award process for this program?
Yes. The FOA indicates that applications will undergo an accelerated review and award process, reflecting that time-sensitive ancillary opportunities may be lost if reviewed on a standard timeline.
What permissions or documentation are required regarding the parent study?
A required component is documentation that the applicant has permission to access and use the parent project’s patient cohorts, associated clinical data, and any relevant biological materials.
Why is permission from the parent study leadership important?
Ancillary studies can affect workload, participant burden, specimen utilization, and data sharing policies. The FOA stresses responsible coordination to protect participants and maintain the integrity of the ongoing clinical effort.
What operational considerations should an ancillary study address?
Based on the FOA description, a strong application should show a credible plan that fits into the parent project’s procedures, minimizes disruption, and explains how data and samples will be handled in alignment with the parent study’s rules and participant consents.
What is the funding mechanism and activity category for this opportunity?
The funding instrument is an NIH R01 research project grant, and the activity category is health.
How many awards did NIAMS expect to make, and what was the total estimated funding?
NIAMS expected to make about six awards, with an estimated total funding level of about $1.5 million.
What is the maximum award amount mentioned in the FOA?
The award ceiling is listed as $250,000, signaling that proposed projects should be focused and efficient and consistent with the ancillary-study concept rather than a full standalone clinical study.
Is there a cost sharing or matching requirement?
No. The FOA states there is no cost sharing or matching requirement.
Who is eligible to apply?
Eligibility is broad and includes many types of domestic organizations, including public and private institutions of higher education, nonprofits (including 501(c)(3) and other nonprofit structures), small businesses, for-profit entities (other than small businesses), and government entities (state, county, city/township, special districts, and independent school districts), as well as tribal governments and tribal organizations.
Are foreign (non-U.S.) institutions eligible to apply?
Yes. The announcement states that non-U.S. entities (foreign institutions) may apply. It also notes that non-U.S. components of U.S. organizations are eligible and that foreign components are allowed as defined by NIH policy.
Are specific institution types explicitly called out as eligible?
Yes. The FOA explicitly notes eligibility for categories such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, faith-based and community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.
What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA number 93.846, titled Arthritis, Musculoskeletal and Skin Diseases Research.
When was this FOA posted, and what were the closing and archive dates?
The FOA was posted on July 20, 2012. The original and current closing date listed is April 16, 2013. The archive date is May 17, 2013.
Is this funding opportunity currently open?
No. It is archived, and the closing date has passed, so it is not currently open for applications.
What is the core strategy NIAMS is promoting through this announcement?
The core strategy is to leverage existing investments in large clinical projects by building add-on studies that can answer high-value NIAMS-relevant questions efficiently, rather than starting a new standalone project from the ground up.
What are the key features NIAMS appears to prioritize for ancillary studies based on this FOA?
Based on the description provided, NIAMS prioritizes (1) high-value research questions aligned with its mission, (2) clear time sensitivity that requires action while the parent project is active, (3) feasibility within the remaining lifespan of the parent study, and (4) documented authorization and coordination with the parent project to protect participants and preserve study integrity.
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