Opportunity Information: Apply for PAR 23 026
The Ancillary Studies to Ongoing Clinical Projects (R21 Clinical Trial Not Allowed) funding opportunity (PAR 23-026) is a discretionary NIH grant program designed to support smaller, targeted research projects that add value to clinical studies that are already underway. The emphasis is on "ancillary" work, meaning the proposed research should be clearly tied to an active, existing clinical project and should leverage the parent study's infrastructure, participants, specimens, data systems, or other established resources. This opportunity uses the NIH R21 mechanism, which is commonly used for exploratory or developmental research that can be completed with a limited budget and within a relatively focused scope, particularly when the goal is to answer a specific question or generate preliminary data that can inform larger future studies.
A key limitation is embedded directly in the title: clinical trials are not allowed under this announcement. In practical terms, the application should not propose a new clinical trial, nor should it introduce trial-like elements that would constitute a new interventional study. Instead, the work should be ancillary to an ongoing clinical effort, typically involving analyses of already-collected or prospectively collected samples or data within the boundaries of the existing clinical project, or methodological and mechanistic investigations that do not introduce a new interventional protocol. The project should stand on its own as a scientifically meaningful question while also being feasible because it piggybacks on the parent clinical study.
The sponsoring agency is the National Institutes of Health, and the funding activity area is health (CFDA 93.846). While the listing does not specify an award ceiling or the number of expected awards, the R21 format generally signals a limited, focused budget appropriate for a discrete set of aims rather than a large multi-year program. The opportunity was created on 2022-11-21, and the original closing date shown is 2025-12-05, which indicates applicants should plan around that submission window while also verifying any updated due dates or application cycles in the full NIH notice.
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; and Native American tribal governments that are federally recognized. It also includes public housing authorities/Indian housing authorities, and tribal organizations that are not federally recognized tribal governments. On the nonprofit side, both 501(c)(3) nonprofits (other than institutions of higher education) and nonprofits without 501(c)(3) status (again, other than institutions of higher education) may apply. For-profit organizations other than small businesses are eligible, as are small businesses, and the notice also lists "others," which typically captures additional eligible organization types recognized in NIH policy.
The announcement also explicitly calls out additional eligible applicants, reflecting NIH's inclusion of a wide range of institutions and community-based entities. These include Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs). Faith-based or community-based organizations are also included, as are eligible agencies of the federal government, regional organizations, Indian/Native American tribal governments other than federally recognized ones, and U.S. territories or possessions. This breadth is important because it signals that ancillary studies can be proposed by many different organizational types, including those that may be closely connected to participant communities or that manage key clinical infrastructure.
Foreign eligibility is more restrictive. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply as applicant organizations, and non-domestic components of U.S. organizations are also not eligible to apply. However, the notice states that foreign components, as defined in the NIH Grants Policy Statement, are allowed. In NIH terms, that typically means a U.S. applicant organization can include certain well-justified foreign elements of the work (for example, specific analyses or collaborations conducted abroad) when they are necessary and appropriately structured, even though a non-U.S. institution cannot be the primary applicant.
Overall, this opportunity is best suited for investigators who have access to an ongoing clinical project and can articulate a strong scientific rationale for an add-on study that is efficient, feasible, and clearly dependent on the parent project. Competitive proposals will usually make the relationship to the ongoing clinical study unmistakable, explain what unique value the ancillary work adds, and show that the work can be completed without launching a new clinical trial or altering the parent study in a way that crosses into trial activity.Apply for PAR 23 026
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "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 2022-11-21.
- Applicants must submit their applications by 2025-12-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- 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 Ancillary Studies to Ongoing Clinical Projects (R21 Clinical Trial Not Allowed) opportunity (PAR 23-026)?
This is a discretionary NIH grant opportunity that supports smaller, targeted research projects that add value to clinical studies that are already underway. It uses the NIH R21 mechanism and is intended for focused, exploratory or developmental work that can be completed within a limited scope and budget.
What does "ancillary" mean in this funding opportunity?
"Ancillary" means the proposed research must be clearly tied to an active, existing clinical project and should leverage resources from that parent study, such as its infrastructure, participants, specimens, data systems, or other established assets. The ancillary study should be feasible largely because it can piggyback on what is already in place.
Do I need an ongoing clinical project to apply?
Yes. The proposed research is expected to be connected to an ongoing, active clinical project. The application should make the relationship to the parent clinical study clear and explain why the ancillary work depends on (and benefits from) the existing study.
Can the ancillary project stand on its own scientifically?
Yes. The ancillary study should address a scientifically meaningful question on its own, while also being feasible and efficient specifically because it uses the parent study's existing resources.
Are clinical trials allowed under this announcement?
No. Clinical trials are not allowed. The application should not propose a new clinical trial, and it should not introduce new trial-like interventional elements that would effectively create a new interventional study.
What kinds of activities are generally appropriate if clinical trials are not allowed?
Appropriate activities are those that remain within the boundaries of the existing clinical project and do not introduce a new interventional protocol. Examples described in the opportunity include analyses of already-collected (or prospectively collected) samples or data within the existing clinical project, as well as methodological and mechanistic investigations that leverage the parent study without launching a new trial.
Can the ancillary study collect new data or specimens?
The description indicates ancillary work may involve analyses of already-collected or prospectively collected samples or data, as long as this stays within the boundaries of the existing clinical project and does not become a new interventional clinical trial.
What is the NIH R21 mechanism and what does it imply about project scope?
The R21 is commonly used for exploratory or developmental research. In this opportunity, it signals a limited, focused project designed to answer a specific question or generate preliminary data to inform larger future studies, rather than support a large, multi-year program.
Is there an award ceiling or a specified number of expected awards?
The listing provided does not specify an award ceiling or the number of expected awards.
Who is the sponsoring agency?
The sponsoring agency is the National Institutes of Health (NIH).
What is the funding activity area and CFDA number?
The funding activity area is health, and the CFDA number provided is 93.846.
When was this opportunity created and what is the closing date shown?
The opportunity was created on 2022-11-21. The original closing date shown is 2025-12-05. Applicants should plan around that window and verify whether NIH has posted updated due dates or cycles in the full notice.
Which U.S. organizations are eligible to apply?
Eligibility is broad and includes many U.S.-based organizations and governmental entities, including 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; and Native American tribal governments that are federally recognized.
Are nonprofit organizations eligible?
Yes. Eligible applicants include 501(c)(3) nonprofits (other than institutions of higher education) and nonprofits without 501(c)(3) status (also other than institutions of higher education).
Are for-profit organizations eligible?
Yes. For-profit organizations other than small businesses are eligible, and small businesses are also listed as eligible.
Are public housing authorities or Indian housing authorities eligible?
Yes. Public housing authorities/Indian housing authorities are included in the eligible applicant types.
Are tribal organizations that are not federally recognized eligible?
Yes. The eligible applicant list includes tribal organizations that are not federally recognized tribal governments and also references Indian/Native American tribal governments other than federally recognized ones.
Are minority-serving institutions specifically included?
Yes. The announcement explicitly includes Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), and other institutions reflected in NIH inclusion language.
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are specifically included among eligible applicants.
Can federal government agencies apply?
Yes. Eligible agencies of the federal government are included in the eligible applicant types.
Are U.S. territories or possessions eligible to apply?
Yes. U.S. territories or possessions are listed as eligible.
Can a non-U.S. (foreign) institution apply as the main applicant?
No. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply as the applicant organization.
Can a non-domestic component of a U.S. organization apply?
No. Non-domestic components of U.S. organizations are not eligible to apply as the applicant organization.
Are foreign components allowed in a project led by a U.S. applicant?
Yes. The notice states that foreign components (as defined in the NIH Grants Policy Statement) are allowed, meaning a U.S. applicant may include well-justified foreign elements of work when necessary and appropriately structured, even though a non-U.S. institution cannot be the primary applicant.
What makes a proposal competitive for this opportunity?
Competitive proposals typically make the relationship to the ongoing clinical study unmistakable, explain the unique value the ancillary work adds, and demonstrate that the project can be completed efficiently by leveraging the parent study's resources without launching a new clinical trial or altering the parent study in a way that crosses into trial activity.
What is the main purpose of funding ancillary studies in this program?
The main purpose is to support smaller, targeted research that adds value to an ongoing clinical project, often by answering a specific question or generating preliminary data that can inform larger future studies.
Does the ancillary study need to use the parent study's participants, specimens, or data systems?
The emphasis is on leveraging the parent study's established resources, which can include participants, specimens, data systems, infrastructure, or other existing assets. The application should show how the ancillary study depends on and benefits from those resources.
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