Ancillary Studies to Ongoing Clinical Projects (R01 Clinical Trial Not Allowed) 2025

The National Institutes of Health (NIH), specifically through the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), has reissued a funding opportunity titled "Ancillary Studies to Ongoing Clinical Projects (R01 Clinical Trial Not Allowed)" under funding opportunity number PAR-24-289. This opportunity builds upon the former PAR-23-025 and aims to realign with updated agency priorities as of March 31, 2025. The primary focus of this grant is to support time-sensitive ancillary studies that complement active clinical projects related to the NIAMS mission. These clinical projects may include interventional trials, observational studies, or disease-specific repositories that are actively collecting biological samples or patient data. The ancillary studies are expected to utilize these existing cohorts and resources to explore new scientific questions that extend beyond the scope of the parent project. NIAMS recognizes the unique opportunity that ancillary studies provide for leveraging existing infrastructure and data from ongoing clinical studies. Such studies can help to enhance the scientific output and value of these parent projects by identifying novel biological mechanisms, diagnostic tools, therapeutic targets, or by developing advanced methodologies. The NOFO encourages proposals that are mechanistic in nature but allows for non-mechanistic studies as well. It emphasizes that studies should not replicate activities already being conducted within the parent projects and should not involve new patient recruitment outside of those already enrolled in the parent project. However, limited recruitment of healthy controls is allowed within modest budget constraints. Funding provided through this mechanism is substantial, with direct costs capped at $300,000 annually and a total project period not to exceed four years. The number of awards will depend on NIH appropriations and the quality of applications received. Clinical trials are not permitted under this NOFO. Instead, it supports research that can begin within the existing framework of a parent project and which requires expedited peer review due to the time-sensitive nature of data or sample collection. For example, this may include studies needing access to patient data or samples before recruitment concludes or fresh samples become unavailable. Eligible applicants include a wide range of entities such as public and private higher education institutions, nonprofits, local governments, for-profit organizations (including small businesses), school districts, tribal organizations, and more. Foreign organizations are not eligible to apply, though foreign components of domestic projects may be involved. The application process includes standard NIH registration steps such as SAM, Grants.gov, eRA Commons, and the Unique Entity Identifier (UEI). Applications must conform to NIH submission rules and utilize approved platforms like ASSIST, institutional S2S systems, or Grants.gov Workspace. The application cycle includes multiple due dates: April 9, 2025; August 6, 2025; and December 5, 2025. Letters of intent are requested 30 days prior to each due date. Applicants must include a timeline and justification for the urgency of the ancillary study, as well as a letter of support from a parent study oversight committee. Required appendices include a summary of the parent clinical study and documentation of its alignment with the proposed ancillary work. All applications are reviewed by NIH peer reviewers based on significance, approach, and investigator/environment criteria, with an accelerated review timeline to ensure timely initiation of research. Applicants may contact Dr. Heiyoung Park at parkh1@mail.nih.gov or 301-594-5032 for scientific questions. Peer review inquiries can be directed to Dr. Kathy Salaita at salaitak@mail.nih.gov or 301-594-5033. For financial matters, Teresa N. Do can be reached at dote@mail.nih.gov or 301-594-3512. Applications must be submitted electronically and are subject to NIH data sharing, human subjects, and compliance policies.

Ensure all registrations are complete; secure letter from parent study leadership; justify time-sensitive need for expedited review; adhere to budget cap and appendix requirements.