The High Impact Specialized Innovation Programs in Clinical and Translational Science (RC2 Clinical Trials Optional) is a limited competition funding opportunity issued by the National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH). It supports the development and demonstration of specialized research capabilities, platforms, and resources that fill critical gaps or remove roadblocks in clinical and translational science. This initiative targets institutions awarded under the Clinical and Translational Science Award (CTSA) Program UM1 hubs, aiming to advance translational research across various diseases and conditions by promoting innovative, high-impact activities.

This funding opportunity is designed to develop programs that provide transformative resources or methods aligned with the goals of the CTSA Program. These may include tools or approaches in digital health, data science, artificial intelligence, real-world data analytics, novel clinical trial designs, telehealth, and other priority domains. The RC2 awards are intended to serve as foundational programs within CTSA hubs, offering resources that can be scaled and potentially adopted across other hubs. Successful proposals must clearly articulate how they address significant gaps and provide robust justifications for the proposed activities.

The program supports projects with budgets of up to $500,000 in direct costs per year for a maximum of five years. Each RC2 application must be accompanied by three mandatory attachments: a Coordination and Integration Plan between the UM1 and RC2 programs, a Program Milestones table, and a Program Evaluation and Sustainability Plan. Proposals lacking these documents will not be reviewed. Furthermore, the primary CTSA UM1 hub institution, not partner or collaborator institutions, must submit the application, and only two RC2 applications per cycle are allowed from each eligible UM1 hub.

Eligible applicants include institutions with an active or pending UM1 award under PAR-24-272. Only the primary recipient organization of a UM1 award may submit an RC2 application, although investigators from partner organizations may co-direct under the multiple PI model. RC2 applications are accepted on multiple due dates through September 2026, including March 13, 2025; May 28, 2025; and September 29, 2025, among others. Letters of intent are requested 30 days prior to each application deadline.

Evaluation criteria focus on significance, innovation, rigor, feasibility, and integration with the CTSA hub. Applications must also demonstrate how the RC2 program will contribute to the goals of the CTSA Program, support translational research infrastructure, and sustain its impact beyond the funding period. Applicants must follow the standard NIH application guidelines, and awardees will be expected to comply with NIH data management and sharing policies. Applications must be submitted electronically through NIH platforms such as ASSIST or Grants.gov.

For additional information or to discuss project scope and responsiveness, potential applicants are encouraged to contact the NCATS scientific/research contacts listed in the Notice of Funding Opportunity.