Opportunity Information: Apply for RFA AR 19 007
Mechanistic Ancillary Studies to Ongoing Clinical Projects (R21 Clinical Trial Not Allowed) is a National Institutes of Health (NIH) funding opportunity from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) designed to support short, time-sensitive mechanistic studies that can be added onto clinical projects that are already underway. The core idea is to take advantage of the fact that many ongoing clinical trials and observational studies are already enrolling well-characterized participants and collecting valuable clinical data and biospecimens. Instead of starting a brand-new standalone project, this announcement funds an "ancillary" study that rides alongside an existing parent clinical project to answer focused mechanistic questions that are tightly aligned with the NIAMS mission, such as understanding disease biology in arthritis, musculoskeletal conditions, and skin diseases, or related organ systems and pathways within NIAMS scientific priorities.
The parent clinical project can be either an interventional clinical trial or a non-interventional clinical study (for example, an observational cohort) as long as it is actively collecting patient samples and/or clinical data that the ancillary project can use. A strong parent project is expected to provide the essential foundation: a defined cohort of participants, established infrastructure for recruitment and follow-up, existing study operations, and access to clinical information and biological samples. The ancillary study is meant to leverage these resources so that the proposed mechanistic work is feasible within a short time window, cost-efficient, and capable of producing meaningful biological insight without duplicating the substantial effort and expense already invested in building the cohort and collecting data.
The emphasis on "mechanistic" research means the funded work should go beyond descriptive clinical outcomes and aim to explain how a disease process works at a biological level. In practice, that could include studies that examine immune pathways, tissue or cellular phenotypes, molecular signatures, biomarker discovery and validation, or other approaches that clarify disease mechanisms using samples or data from the parent project. NIAMS frames this as a way to enhance the scientific value of the parent study, broaden what can be learned from existing participants and specimens, and ultimately accelerate progress toward better diagnosis, treatment, and prevention by identifying new targets or mechanistic hypotheses that can be pursued in future work.
This opportunity uses the NIH R21 mechanism, which is generally intended for exploratory, developmental projects that can produce high-impact insights with a limited scope and budget. The listing includes an award ceiling of $250,000, signaling that projects should be focused, efficient, and tightly tied to the parent study's resources. A notable feature of this FOA is that it offers an accelerated review and award process, reinforcing the point that these studies are time-sensitive and often need to be initiated quickly to align with enrollment milestones, sample collection schedules, or other operational timelines of the ongoing parent clinical project.
The announcement explicitly states "Clinical Trial Not Allowed," meaning the application itself cannot propose a new clinical trial as the ancillary study. The parent project may be a clinical trial, but the funded ancillary work must not introduce a new interventional clinical trial under this award. Instead, it should function as mechanistic research conducted in conjunction with the ongoing project, typically using collected specimens, additional assays, or analyses that do not constitute launching a new trial.
Eligibility is broad and includes many types of U.S.-based organizations and governmental entities. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations other than federally recognized tribal governments; public housing authorities and Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding institutions of higher education when specified); for-profit organizations other than small businesses; and small businesses. The FOA also highlights additional eligible 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 Asian American Native American Pacific Islander Serving Institutions (AANAPISI), as well as faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.
At the same time, there are important restrictions around foreign participation. Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply as the applicant organization. However, "foreign components" as defined by the NIH Grants Policy Statement are allowed, which typically means a U.S. applicant can include certain foreign activities or collaborations if they meet NIH policy requirements and are justified scientifically.
Administrative details in the provided source data indicate this is a discretionary grant opportunity under the health category, with CFDA number 93.846, and it was issued by NIH under Funding Opportunity Number RFA-AR-19-007. The original closing date listed is April 2, 2019, and the record creation date is April 4, 2018. The overall purpose remains clear regardless of those dates: to create a fast, flexible funding path for adding high-value, mechanistic science onto existing clinical projects so the biomedical community can extract more knowledge from cohorts, data systems, and biospecimens that are already in place.Apply for RFA AR 19 007
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Mechanistic Ancillary Studies to Ongoing Clinical Projects (R21 Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.846.
- This funding opportunity was created on 2018-04-04.
- Applicants must submit their applications by 2019-04-02. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $250,000.00 in funding.
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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Frequently Asked Questions (FAQs)
What is the purpose of the "Mechanistic Ancillary Studies to Ongoing Clinical Projects (R21 Clinical Trial Not Allowed)" opportunity?
This NIH opportunity from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) supports short, time-sensitive mechanistic studies that can be added onto clinical projects that are already underway. The goal is to leverage existing participants, infrastructure, clinical data, and biospecimens from an ongoing parent clinical project to answer focused mechanistic questions aligned with the NIAMS mission.
Which NIH Institute is offering this funding opportunity?
The opportunity is offered by the National Institutes of Health (NIH), specifically through the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
What does "ancillary study" mean in this funding opportunity?
An ancillary study is a project that "rides alongside" an existing parent clinical project rather than starting a brand-new standalone study. It uses the parent project's established cohort, recruitment and follow-up infrastructure, and access to clinical data and/or biospecimens to conduct additional mechanistic research efficiently and within a short timeline.
What kinds of parent clinical projects can an ancillary study be attached to?
The parent clinical project can be either an interventional clinical trial or a non-interventional clinical study (such as an observational cohort), as long as it is actively collecting patient samples and/or clinical data that the ancillary study can use.
Does the parent project need to be actively enrolling participants or collecting samples/data?
Yes. The parent project is expected to be actively collecting patient samples and/or clinical data that the ancillary project can leverage.
What is expected of a "strong" parent clinical project?
A strong parent project should provide the essential foundation for the ancillary work, including a defined cohort of participants, established infrastructure for recruitment and follow-up, existing study operations, and access to clinical information and biological samples.
What does NIAMS mean by "mechanistic" research in this context?
Mechanistic research goes beyond descriptive clinical outcomes and aims to explain how a disease process works at a biological level. The funded ancillary work should be designed to generate biological insight into disease mechanisms using samples and/or data from the parent project.
What are examples of mechanistic topics that could fit this opportunity?
Examples described include studies examining immune pathways, tissue or cellular phenotypes, molecular signatures, biomarker discovery and validation, or other approaches that clarify disease mechanisms using clinical data and/or biospecimens from the parent project.
What scientific areas must the ancillary study align with?
The ancillary study should be tightly aligned with the NIAMS mission and scientific priorities, such as understanding disease biology in arthritis, musculoskeletal conditions, and skin diseases, or related organ systems and pathways within NIAMS priorities.
Why is this opportunity described as "time-sensitive"?
The opportunity is designed for studies that need to be initiated quickly to align with enrollment milestones, sample collection schedules, or operational timelines of the ongoing parent clinical project. It also features an accelerated review and award process to support that timing.
What funding mechanism does this opportunity use?
This opportunity uses the NIH R21 mechanism, which is generally intended for exploratory, developmental projects with limited scope and budget that can still produce high-impact insights.
What is the award ceiling mentioned for this opportunity?
The listing includes an award ceiling of $250,000, indicating projects should be focused, efficient, and closely tied to the parent study's existing resources.
Does this funding opportunity allow proposing a clinical trial as the ancillary study?
No. The announcement explicitly states "Clinical Trial Not Allowed," meaning the application cannot propose a new clinical trial as the ancillary study.
Can the parent clinical project be a clinical trial even though the ancillary study cannot be one?
Yes. The parent project may be a clinical trial, but the ancillary work funded by this award must not introduce a new interventional clinical trial. The ancillary work should function as mechanistic research conducted in conjunction with the ongoing project.
What does "Clinical Trial Not Allowed" imply for the type of ancillary work that can be proposed?
It means the ancillary project should focus on mechanistic assays, analyses, or related research activities that leverage existing or collected specimens and data, without launching a new interventional trial under this award.
Who is eligible to apply (in general terms)?
Eligibility is broad and includes many U.S.-based organizations and government entities, including higher education institutions, nonprofits, for-profits (other than small businesses), small businesses, and various governmental and tribal entities.
Which types of government entities are listed as eligible applicants?
Eligible government applicants include state governments; county, city, or township governments; special district governments; and independent school districts.
Are U.S. colleges and universities eligible?
Yes. The eligible applicant types include public and state-controlled institutions of higher education as well as private institutions of higher education.
Are nonprofit organizations eligible?
Yes. Nonprofit organizations with or without 501(c)(3) status are included among eligible applicants (with the listing noting exclusions in certain cases when institutions of higher education are specified).
Are for-profit organizations eligible?
Yes. For-profit organizations other than small businesses are listed as eligible, and small businesses are also listed as eligible.
Are tribal governments and tribal organizations eligible?
Yes. Federally recognized Native American tribal governments and Native American tribal organizations other than federally recognized tribal governments are listed as eligible.
Are U.S. territories or possessions eligible?
Yes. The eligibility listing includes U.S. territories or possessions.
Are faith-based or community-based organizations eligible?
Yes. The FOA highlights that faith-based or community-based organizations are among the additional eligible categories.
Are minority-serving institutions specifically mentioned as eligible?
Yes. The FOA highlights eligibility for institutions 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 Asian American Native American Pacific Islander Serving Institutions (AANAPISI).
Can a non-U.S. (foreign) organization apply as the applicant?
No. Non-domestic (non-U.S.) entities are not eligible to apply as the applicant organization.
Can a U.S. organization apply if it has a non-domestic component?
No. Non-domestic components of U.S. organizations are not eligible to apply as the applicant organization.
Are any types of foreign involvement allowed at all?
Yes. "Foreign components" (as defined by the NIH Grants Policy Statement) are allowed, meaning a U.S. applicant may include certain foreign activities or collaborations if they meet NIH policy requirements and are scientifically justified.
What is the Funding Opportunity Number for this announcement?
The Funding Opportunity Number is RFA-AR-19-007.
What is the CFDA number associated with this opportunity?
The CFDA number listed is 93.846.
What category is this grant opportunity listed under?
The administrative data describes it as a discretionary grant opportunity under the health category.
What is the listed closing date for this opportunity?
The original closing date listed in the provided information is April 2, 2019.
What is the record creation date in the provided information?
The record creation date listed is April 4, 2018.
How is this opportunity intended to increase the value of existing clinical projects?
It is intended to enhance the scientific value of the parent study by adding focused mechanistic analyses that broaden what can be learned from existing participants, clinical data systems, and biospecimens, without duplicating the time and cost of building a new cohort or standalone infrastructure.
What is the overall long-term goal of funding these ancillary mechanistic studies?
The described aim is to accelerate progress toward better diagnosis, treatment, and prevention by generating meaningful biological insight, identifying new targets, and developing mechanistic hypotheses that can be pursued in future work.
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