Ancillary Studies to Ongoing Clinical Projects (R01 Clinical Trial Not Allowed) | PAR 24 289

Opportunity Information: Apply for PAR 24 289

The NIH funding opportunity PAR-24-289, titled "Ancillary Studies to Ongoing Clinical Projects (R01 Clinical Trial Not Allowed)," supports research projects that add value to clinical studies already underway by funding well-justified ancillary (add-on) studies. The mechanism is an R01 research project grant, and it is explicitly designated as "Clinical Trial Not Allowed," meaning applicants must propose research that does not meet NIH's definition of a clinical trial. In practice, this is meant for studies that can leverage existing cohorts, infrastructure, specimens, data streams, or established clinical research operations to answer additional scientific questions efficiently, without launching a new interventional clinical trial.

This announcement is a re-issue of PAR-23-025 and was re-issued specifically because NIH has updated how R01 applications are reviewed under the "Simplifying Review of Research Project Grant Applications" initiative. The notice explains that the only changes in the re-issued opportunity are the simplified review changes in Section V (the review and selection information). Everything else about the opportunity remains the same, so the science scope, eligibility framework, and core expectations of an ancillary study FOA are unchanged aside from how reviewers are instructed to evaluate applications under the updated criteria.

Eligible applicants span a broad range of U.S.-based organizations and government entities. This includes state, county, city or township, and 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; and tribal organizations that are not federally recognized. Nonprofit organizations are eligible whether or not they hold 501(c)(3) status, as are public housing authorities/Indian housing authorities. For-profit organizations (other than small businesses) and small businesses are also listed as eligible, along with an "Other" category that NIH often uses to capture additional qualifying entities.

The FOA also highlights several "other eligible applicants" categories often emphasized in NIH opportunities, including 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). It also notes that eligible agencies of the federal government and faith-based or community-based organizations may apply, as well as regional organizations and U.S. territories or possessions. Despite listing "Non-domestic (non-U.S.) Entities (Foreign Organizations)" in an "other eligible" style list, the opportunity clearly states that foreign organizations are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible. In other words, applications must be submitted by eligible domestic entities, and the work cannot be proposed as a non-U.S. component of a U.S. organization under this announcement.

From an administrative standpoint, the opportunity is classified as discretionary funding, uses the grant funding instrument, and falls under the health funding activity category with CFDA number 93.846. The agency is the National Institutes of Health. The opportunity record indicates an award ceiling of $300,000, suggesting an upper bound on the amount that can be requested under the terms of this specific listing. The posted original closing date is 2025-09-05, and the record creation date is 2024-12-09. The expected number of awards is not specified in the provided source data.

Overall, the program is designed for investigators who can make a strong case that an ancillary study will meaningfully enhance the scientific yield of an ongoing clinical project, typically by taking advantage of resources that are already in place (such as enrolled participants, existing protocols for data or specimen collection, or established follow-up). Because clinical trials are not allowed, applicants need to frame proposed human research activities carefully so they remain ancillary research leveraging existing clinical projects rather than introducing a new interventional assignment intended to evaluate the effects of an intervention on health-related outcomes.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Ancillary Studies to Ongoing Clinical Projects (R01 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 2024-12-09.
• Applicants must submit their applications by 2025-09-05. (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 $300,000.00 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.

Apply for PAR 24 289

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