Ancillary Studies to Ongoing Clinical Projects (R21 Clinical Trial Not Allowed)

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Description

This opportunity provides funding for exploratory/developmental (R21) ancillary studies that are time-sensitive and conducted in conjunction with ongoing clinical projects relevant to the mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The parent project may be an interventional clinical trial, observational study, or disease-specific repository that is actively collecting patient samples or clinical data. The goal is to leverage existing cohorts, infrastructure, and data to address novel research questions not covered by the parent project, thereby maximizing the scientific value of ongoing clinical research investments.

Ancillary studies must not propose a clinical trial and should not interfere with the parent project or unduly burden participants. Applications must clearly demonstrate the need for accelerated review and award, and must include documentation of approval from the parent project’s leadership.

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Due Dates

• April 9, 2025: New, renewal, resubmission, and revision applications
• August 6, 2025: New, renewal, resubmission, and revision applications
• December 5, 2025: New, renewal, resubmission, and revision applications

Letters of intent are requested 30 days prior to the application due date.

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Funding Amount

• Direct costs: Up to $400,000 over a two-year period
• Annual limit: No more than $250,000 in direct costs in any single year
• Project period: Maximum of 2 years
• Award type: Grant (R21 mechanism)
• No cost sharing required

The number of awards is contingent on NIH appropriations and the submission of a sufficient number of meritorious applications.

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Eligibility

Eligible applicants include:

• Public and private institutions of higher education
• Nonprofits with or without 501(c)(3) status (excluding higher education institutions)
• For-profit organizations (including small businesses)
• State, county, city, township, and special district governments
• Independent school districts
• Public housing authorities/Indian housing authorities
• Native American tribal governments (federally recognized and other)
• Native American tribal organizations (other than federally recognized)
• Faith-based and community-based organizations
• Regional organizations
• U.S. territories and possessions
• Eligible agencies of the federal government

Note: Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply. Foreign components, as defined by NIH, are allowed.

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Application Process

• Submission: Applications must be submitted electronically via Grants.gov, NIH ASSIST, or an institutional system-to-system solution.
• Instructions: Follow the NIH Research (R) Instructions and the specific requirements in the funding announcement.
• Letter of Intent: Strongly encouraged, due 30 days before the application deadline. Email to NIAMS_LOIs@mail.nih.gov.
• Required components:
  • Research Strategy must include a clear "Timeline" and "Time-Sensitivity Justification."
  • Letter of approval from the parent project’s leadership committee, confirming access to required cohorts, samples, and data.
  • Appendix must include a one-page statement on the parent clinical study and a ≤3-page synopsis of the parent project.
  • Data Management and Sharing Plan is required.
• Review: Applications undergo an accelerated peer review and award process.

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Additional Information

• Scope: Ancillary studies must address research questions not covered by the parent project and must be time-sensitive (e.g., requiring data/sample collection concurrent with the parent project).
• Not responsive: Applications that do not require concurrent data/sample collection, propose secondary analysis of existing datasets, or use only previously collected/preserved samples are not eligible.
• No clinical trials: This opportunity does not support applications proposing clinical trials.
• Junior investigators: Collaborations where a senior investigator from the parent project supports a junior investigator as PI are encouraged.
• Statistical rigor: A statistician should be involved in the application preparation.

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External Links

• Full Funding Announcement (NIH Guide)
• NIAMS Ancillary Studies FAQs
• NIH Application Guide
• Apply via Grants.gov
• NIH Data Management and Sharing Policy

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Contact Information

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