Ancillary Studies to Ongoing Clinical Projects (RP1 Clinical Trial Not Allowed)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Oct 18, 2026
Can you apply?
This grant is for research teams seeking to conduct ancillary studies linked to ongoing clinical projects within the NIH research ecosystem. Eligible applicants typically include academic medical centers, research universities, federally funded research centers, and established research organizations with active clinical research portfolios. This program specifically excludes new RP1 clinical trials; studies must build upon existing clinical projects or studies. The geographic scope is U.S.-based institutions. Eligible activities include secondary data analysis, biomarker studies, mechanistic investigations, health outcomes research, and other scientifically rigorous studies that leverage the existing infrastructure and patient cohorts of ongoing clinical projects. Applications must demonstrate clear scientific merit and a well-defined relationship to a parent clinical study.
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Key dates
- Jun 12, 2025 Applications open
- Oct 15, 2026 Application deadline
- Dec 4, 2026 Award announced
- Dec 4, 2026 Project start
Program description
This Notice of Funding Opportunity (NOFO) solicits applications that propose to conduct time-sensitive ancillary studies in conjunction with privately or publicly funded, active, ongoing clinical projects (parent projects). The parent project can be an interventional clinical trial, or a clinical study such as an observational study, or a disease-specific repository that will be actively collecting patient samples or clinical data. The parent project(s) should provide a cohort of well-characterized patients, infrastructure, data, and biological samples for the ancillary study. The objective of this NOFO is to provide a flexible mechanism to leverage currently funded resources and maximize the return on existing investments in parent projects. Successful ancillary studies will enhance the scientific content and value of the parent projects, improve the research community’s understanding of a disease or organ system and thus may identify novel targets for diagnosis, treatment, and prevention of disease.
Who can apply
Eligible applicants
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (R&R) application form
- Project Narrative (including specific aims, significance, innovation, and approach sections)
- Budget and budget justification
- Biographical sketches (current NIH format) for key personnel
- Letters of support and data-sharing agreements from parent study leadership
- Description of existing participant cohort, study design, and available data
- IRB approval or exemption determination for the ancillary study
- Timeline and feasibility assessment
- Relevant preliminary data or preliminary results
- References cited
Program contact
- 👤 National Institute of Arthritis and Musculoskeletal and Skin Diseases
- 📧 AncillaryStudies@nih.gov
- 📞 Please contact via e-mail.
Funding track record
Recent awards under CFDA 93.846 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$63,962,483
-
$60,038,896
-
$34,166,872
-
$28,848,731
-
$24,598,295
-
$21,654,386
-
$21,510,846
-
$20,225,012
-
$17,794,329
-
$16,915,106
Top States by Funding
- MA 17 awards $143.1M
- CA 14 awards $133.2M
- NC 5 awards $127.9M
- NY 14 awards $127.4M
- PA 11 awards $104.1M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.846). How funding has trended year over year.
| 2018 | $476,478,975 | |
| 2019 | $490,084,446 | |
| 2020 | $505,547,334 | |
| 2021 | $509,241,630 | |
| 2022 | $499,786,367 | |
| 2023 | $548,439,000 | |
| 2024 est. | $545,593,000 | |
| 2025 est. | $541,712,000 |
FAQ
Who is eligible to apply for this grant?
Typically domestic institutions (universities, medical centers, research hospitals, and nonprofits with research capacity) with active clinical projects. Individual researchers should apply through their institutional research office.
What exactly qualifies as an "ancillary study"?
Ancillary studies leverage existing clinical project infrastructure, participant cohorts, or data to address new scientific questions. Examples include secondary data analysis, biomarker studies, mechanistic investigations, and long-term follow-up studies of enrolled participants.
Why does this grant exclude new RP1 clinical trials?
This program is designed to supplement and enhance existing clinical research, not to initiate new primary clinical trials. The restriction keeps the focus on hypothesis-driven research that can be conducted within established projects.
What is the typical funding range and project duration?
NIH R-mechanism grants typically range from $100,000–$500,000 per year depending on the mechanism. Project periods are commonly 2–5 years, though specific limits should be verified in the current RFP.
How competitive are these applications?
These grants are moderately to highly competitive; NIH success rates for R-mechanism ancillary studies typically fall between 15–25%. Strong preliminary data, clear scientific rationale, and demonstrated feasibility are essential.
💡 Tips for applicants
- Establish a clear, compelling relationship between your ancillary study aims and the parent clinical project; reviewers must understand how the study leverages existing infrastructure and why it cannot be conducted independently.
- Provide detailed timeline and feasibility documentation showing that the parent study has sufficient follow-up time, sample size, and data maturity to support your ancillary aims.
- Demonstrate institutional commitment by securing written approval and support from the parent study leadership and data access agreements before submission.
- Use preliminary data strategically; even secondary analyses or pilot work using existing cohorts can strengthen your research significance and approach sections.
- Identify potential conflicts of interest or overlap with other concurrent ancillary studies early and clearly distinguish your specific contributions and innovation from existing related work.
⚠️ Common mistakes
Applications often fail to clearly demonstrate how the ancillary study meaningfully enhances the parent clinical project or addresses a novel scientific question. Reviewers reject proposals that read as exploratory "fishing expeditions" without strong hypotheses or defined research questions. Additionally, many applicants underestimate the importance of securing formal permission and data-sharing agreements from the parent study PIs before submission; NIH requires evidence of feasibility and institutional support.
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