The National Institutes of Health (NIH) is reissuing a Notice of Funding Opportunity (NOFO) through the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) to support time-sensitive ancillary studies related to ongoing clinical projects. These studies should align with the NIAMS mission and leverage existing clinical trials, observational studies, or disease-specific repositories actively collecting patient data or samples. The objective is to enhance the scientific value of parent projects, improve understanding of diseases within NIAMS' portfolio, and potentially identify new diagnostic, treatment, or prevention targets. The NOFO accelerates the review and award process to accommodate the timeline constraints of parent projects.

Eligible studies must be ancillary to ongoing clinical projects and must not overlap with the parent project’s objectives. Examples of suitable research include investigating novel disease mechanisms, biomarker discovery, therapeutic action mechanisms, or sex differences in disease progression. Studies must use the parent project’s resources efficiently and not unduly burden participants. Proposals for independent data analysis or non-concurrent research with parent projects will not be considered.

Applicants may request up to $300,000 in direct costs annually for a maximum project period of four years. The total number of awards depends on NIH appropriations and the merit of submitted applications. The NOFO supports new and resubmission applications, but not clinical trials. Applicants must provide detailed project plans, justify the time-sensitive nature of the research, and include documentation from parent project leadership confirming access to required resources and feasibility within the parent project timeline.

Eligible applicants include higher education institutions, nonprofits, for-profit organizations, local and tribal governments, and certain foreign entities. Applicants must complete several registrations, including with SAM.gov, Grants.gov, and eRA Commons. Each application must follow NIH’s detailed submission instructions, which include adherence to page limits, inclusion of a data sharing plan, and other required materials. Letters of intent are encouraged but not mandatory.

Applications will undergo an expedited peer review process evaluating significance, rigor, feasibility, investigator expertise, and resource availability. Successful proposals must demonstrate scientific merit, alignment with NIAMS priorities, and the necessity for accelerated review. The review process will also consider human subjects protections, data management plans, and other NIH policy requirements.

Key dates include the earliest submission date of March 9, 2025, and application deadlines on April 9, August 6, and December 5, 2025, for respective review and funding cycles. Applicants are advised to apply early to address potential submission errors. The funding opportunity expires on December 6, 2025. For additional guidance, applicants can contact designated NIH staff for scientific, peer review, or administrative inquiries.