Opportunity Information: Apply for RFA AR 11 012
Apply for RFA AR 11 012
- 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 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 $250,000.00 in funding.
- Eligible applicants include: State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Nonprofits that do not have 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 Native American tribal organizations (other than Federally recognized tribal governments) County governments Public housing authorities/Indian housing authorities City or township governments Others (see text field entitled Additional Information on Eligibility for clarification) Small businesses Private institutions of higher education 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) 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 to Large Ongoing Clinical Projects (R01) funding opportunity (RFA-AR-11-012) is a National Institutes of Health (NIH) grant program from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Its central goal is to pay for time-sensitive ancillary research that can be layered onto an existing large clinical effort that is already underway. Instead of building a new cohort or launching a standalone trial from scratch, applicants are expected to "plug in" a well-justified additional study to a parent project that already has the patients, systems, data flow, and often stored biospecimens needed to answer an important NIAMS-relevant scientific question quickly and efficiently. The intent is to leverage substantial prior investments in major clinical studies and registries and increase the scientific yield of those efforts.
To fit the FOA, the proposed ancillary study must be connected to a large, ongoing clinical project that is privately or publicly funded. NIAMS describes acceptable parent projects as large clinical trials, observational studies, or disease registries, as long as they provide a sufficiently sized and well-characterized cohort, plus the practical infrastructure needed to execute additional work (for example, recruitment and follow-up mechanisms, clinical sites, standardized data collection, and access to biological samples). The ancillary project is expected to enhance the value of the parent study, not derail it. In practice, this means the ancillary work should be designed to take advantage of the parent study's population and operations, adding measurements, analyses, or sub-studies that deepen understanding of diseases and organ systems within the NIAMS mission and help move the field toward improved diagnosis, treatment, or prevention.
A defining feature of this announcement is its emphasis on urgency and feasibility within the remaining lifespan of the parent project. Each application has to include a clear timeline showing that the parent study has enough time left to accommodate the additional research activities (such as extra visits, extra specimen collection, add-on imaging, new assays performed on banked samples, or additional data linkages). Applicants also must explain why the proposed work is time sensitive and why it requires an expedited review and award pathway. This is not a generic "ancillary study" mechanism; it is targeted at situations where waiting for a standard grant cycle would likely cause the opportunity to be missed (for example, because follow-up is ending soon, samples are only available during a narrow window, or a key data collection time point is imminent).
Because the ancillary study depends on access to the parent project's participants, data, and/or biospecimens, the FOA requires documentation that the parent project gives permission for that use. In other words, it is not enough to propose a scientifically attractive add-on; the application must show that the parent project leadership has agreed to allow access to the cohort and relevant resources and that the logistics of doing so are realistic. This expectation underscores NIAMS's focus on practical execution and rapid start-up.
The support mechanism is the NIH Research Project Grant (R01). The FOA also notes that it runs in parallel with a companion announcement of the same scientific scope that uses the R21 exploratory/developmental mechanism (RFA-AR-11-013). Together, these two announcements were intended to fund a small set of high-value add-on studies that can quickly capitalize on ongoing clinical investments.
For funding, NIAMS anticipated committing about $1.5 million in total costs in fiscal year 2011 to support a combined total of about four to six awards across both the R01 and R21 versions of the program. Awards were contingent on the availability of funds and the quality and number of meritorious applications received. The listing includes an award ceiling of $250,000 (as provided in the source data for this opportunity).
The opportunity fell under the health funding activity category and is associated with CFDA number 93.846 (Arthritis, Musculoskeletal and Skin Diseases Research). It did not require cost sharing or matching. Key dates in the posting show it 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 types of domestic and non-domestic organizations. Eligible applicants listed include state and local governments (including counties, cities/townships, and special district governments), federally recognized tribal governments and other tribal organizations, public and state-controlled institutions of higher education, private institutions of higher education, nonprofit organizations (both with and without 501(c)(3) status), small businesses and other for-profit organizations (other than small businesses), independent school districts, public housing authorities/Indian housing authorities, and additional categories such as U.S. territories or possessions, regional organizations, and foreign organizations. The opportunity also explicitly referenced categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and faith-based or community-based organizations, reflecting NIH's generally inclusive eligibility framework for research institutions and partners capable of conducting the proposed work.
In plain terms, this FOA was designed for research teams who could identify an important NIAMS-relevant question that can be answered by adding a focused, well-integrated set of measurements or analyses to a large clinical study that is already in motion. The program prioritizes high scientific payoff, strong justification for urgency, clear evidence that the parent study can accommodate the add-on within its remaining timeline, and documented access to the cohort and materials needed to execute the ancillary research quickly.
Frequently Asked Questions (FAQs)
What is the name and number of this funding opportunity?
The opportunity is titled Ancillary Studies to Large Ongoing Clinical Projects (R01) and is identified as RFA-AR-11-012.
Which agency and institute sponsor 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 main purpose of this FOA?
The central goal is to fund time-sensitive ancillary research that can be added onto a large, ongoing clinical project that is already underway. The intent is to leverage existing cohorts, operational infrastructure, and often existing biospecimens to answer an important NIAMS-relevant scientific question quickly and efficiently, without creating a new cohort or launching a standalone trial from scratch.
What is meant by an "ancillary study" in this FOA?
An ancillary study here is a well-justified add-on to a parent clinical effort. It is designed to "plug in" to an existing project by adding measurements, analyses, or sub-studies that enhance scientific yield while relying on the parent project’s participants, systems, data flow, and possibly stored biospecimens.
What types of "parent projects" are acceptable?
NIAMS describes acceptable parent projects as large clinical trials, observational studies, or disease registries, as long as they provide:
- A sufficiently sized and well-characterized cohort
- Practical infrastructure to support additional work (for example, recruitment and follow-up mechanisms, clinical sites, standardized data collection)
- Access to biological samples (when needed), including possibly stored biospecimens
Does the parent project have to be NIH-funded?
No. The parent project may be privately or publicly funded, as long as it is a large, ongoing clinical effort that can support the proposed ancillary study.
What kinds of activities might an ancillary study include?
Examples of add-on activities mentioned include:
- Extra study visits
- Additional specimen collection
- Add-on imaging
- New assays performed on banked/stored samples
- Additional data linkages
These activities should be tightly integrated with the parent project’s operations and resources.
How should the ancillary study relate to the parent project?
The ancillary study is expected to enhance the value of the parent study and increase scientific yield. It should not derail or disrupt the parent project. The design should explicitly take advantage of the parent project’s population and operational setup.
What scientific scope is this FOA aiming to support?
The ancillary study should address an important NIAMS-relevant scientific question and deepen understanding of diseases and organ systems within the NIAMS mission, with the broader goal of moving the field toward improved diagnosis, treatment, or prevention.
What makes this FOA different from a general ancillary study grant?
A defining feature is the focus on urgency and feasibility within the remaining lifespan of the parent project. Applicants must explain why the work is time-sensitive and why waiting for a standard grant cycle could cause the opportunity to be missed (for example, follow-up ending soon, narrow sample availability windows, or imminent critical data collection time points).
What timeline expectations are described in the FOA?
Applications must include a clear timeline showing that the parent study has enough time left to accommodate the ancillary research activities. The timeline should reflect realistic integration with the parent project’s remaining schedule and operations.
Is documentation of access to the parent project required?
Yes. Because the ancillary study depends on access to the parent project’s participants, data, and/or biospecimens, the application must include documentation that the parent project gives permission for that use. The FOA emphasizes that scientific merit alone is not enough; access and logistics must be confirmed and realistic.
What funding mechanism is used for this opportunity?
This FOA uses the NIH Research Project Grant (R01) mechanism.
Is there a related companion funding opportunity?
Yes. The FOA notes a companion announcement with the same scientific scope using the R21 exploratory/developmental mechanism, identified as RFA-AR-11-013.
How much funding was NIAMS planning to commit, and how many awards were expected?
NIAMS anticipated committing approximately $1.5 million in total costs in fiscal year 2011 to support a combined total of about four to six awards across both the R01 and R21 versions. Awards were contingent on availability of funds and the quality and number of meritorious applications.
Is there an award ceiling mentioned for this opportunity?
Yes. The listing includes an award ceiling of $250,000 (as provided in the source data for this opportunity).
What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA 93.846 (Arthritis, Musculoskeletal and Skin Diseases Research).
What funding activity category does this opportunity fall under?
It falls under the health funding activity category.
Does this opportunity require cost sharing or matching?
No. The opportunity explicitly indicates that it did not require cost sharing or matching.
When was the opportunity posted, and what were the key dates?
Key dates provided include:
- Posted date: September 1, 2010
- Closing date (original and current): April 1, 2011
- Archive date: May 2, 2011
Is this opportunity still open?
No. Based on the provided dates, the opportunity closed on April 1, 2011 and was archived on May 2, 2011.
Who is eligible to apply?
Eligibility is broad and includes many types of domestic and non-domestic organizations, including:
- State governments
- Local governments (including counties, cities/townships, and special district governments)
- Federally recognized tribal governments and other tribal organizations
- Public and state-controlled institutions of higher education
- Private institutions of higher education
- Nonprofit organizations (with or without 501(c)(3) status)
- Small businesses
- Other for-profit organizations (other than small businesses)
- Independent school districts
- Public housing authorities/Indian housing authorities
- U.S. territories or possessions
- Regional organizations
- Foreign organizations
Does the eligibility list reference specific institution types such as MSIs and faith-based organizations?
Yes. The opportunity explicitly references categories such as HBCUs, Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and faith-based or community-based organizations.
What kinds of applicants is this FOA designed for in practical terms?
It is designed for research teams that can identify an important NIAMS-relevant question that can be answered by adding a focused, well-integrated set of measurements or analyses to a large clinical study already in motion, with strong justification for urgency, feasibility within the parent project’s remaining timeframe, and documented access to required participants/materials.
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