Key Dates
Release Date: October 13, 2025
Submission Deadline: December 1, 2025
Anticipated Notification: January 2, 2026
Full NIH Proposal Deadline: May 28, 2026
Background
The Clinical and Translational Science Institute (CTSI) serves as the administrative hub for Duke’s Clinical and Translational Science Award (CTSA), which supports the development, implementation, and dissemination of innovative solutions to accelerate the translation of scientific discoveries into improved healthcare. As a CTSA Hub, Duke University is eligible to apply for the High Impact Specialized Innovation Programs (SIPs) in Clinical and Translational Science (RC2, Clinical Trials Optional) (PAR-25-156). The goal of this program is to support “the development and demonstration of unique hub capabilities, research platforms and/or resources to address in a timely manner critical gap areas and/or roadblocks in clinical and translational science.”
Call for Concepts
CTSI leadership is supporting the submission of up to two SIP RC2 applications from Duke and is inviting brief, 2-page RC2 concept proposals from eligible Duke faculty interested in responding to PAR-25-156. Submitted concepts (due December 1, 2025) will be reviewed internally, and up to two applicants will be selected to prepare full proposals for submission to NIH by the May 28, 2026 SIP RC2 deadline.
SIP RC2 programs are designed to support novel approaches in areas that address specific knowledge gaps, scientific opportunities, new technologies/platforms, data generation and/or analysis, or novel research methods that will advance clinical and translational science (CTS) and research (CTR) at Duke. Successful programs are expected to:
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Establish groundbreaking, high-impact innovations that align with the CTSA Program goals.
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Develop unique resources, platforms, or technologies with wide applicability.
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Support cross-cutting, collaborative science that fundamentally enhances translational research.
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Provide a foundation for future dissemination at other CTSA hubs.
Responsive applications will clearly outline how successful outcomes will be disseminated to and/or implemented at other CTSA hubs and beyond.
Examples of responsive areas include digital health, decentralized or pragmatic clinical trials, AI/ML algorithms, clinical decision support, real-world evidence, innovative trial designs, genomics, telehealth, regulatory science, community engagement, and other high-priority translational needs. For reference, review examples of previously funded projects.
RC2 applications will ultimately be funded by the NIH and accordingly, applicants for this limited submission competition should note that 1) aims of the research are required to align with agency priorities and 2) only biological sex of participants can be collected as part of the research. CTSI will work with the teams ultimately submitting RC2 applications to assure their applications are allowable and aligned under NIH directives. NOTE: the CTSA RC2s are administratively linked to the CTSA UM1 application. A letter of support will be required from the CTSA MPIs, and the application itself will need to be submitted through the CTSI unit (BFR). The CTSI Team will support the submission of the selected applications.
Eligibility
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The Principal Investigator (PI) must hold an appointment and be affiliated with Duke University and be eligible to serve as a PI on NIH grants according to Duke's written policy.
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The research team must demonstrate expertise and experience relevant to the proposed innovation.
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Collaborations across Duke schools, with partner institutions, or with other CTSA hubs are strongly encouraged. Multi-PI projects spanning disciplines are welcome. Applicants are strongly encouraged to propose collaborations with investigators at North Carolina Central University (NCCU). Applicants interested in developing collaborations with NCCU are encouraged to contact the Duke-NCCU Bridge Office.
Concept Proposal Requirements (Limit: 2 pages)
Proposals should include the following:
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Title of Proposed Specialized Innovation Project
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Description of the Critical Barrier or Roadblock being addressed
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Specific Aims of the proposed Specialized Innovation Program
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Integration with Duke CTSI Activities: how the project leverages/enhances existing CTSI resources
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Potential for Dissemination and Implementation to other CTSA hubs
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Key Personnel: provide NIH-style biosketches for all investigators (as attachments)
Formatting: Arial 11 pt, single-spaced, minimum 0.5-inch margins. Combine all materials into one PDF.
Review Process
Concepts will undergo internal review by Duke CTSI leadership and faculty experts. Reviewers will consider the following criteria to evaluate whether the proposed project:
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Addresses a critical problem or barrier in translational science.
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Is led by a strong investigative team with a demonstrated record of clinical and translational research with achievements in methods, procedures, or processes that improve diagnoses, treatments, and strategies.
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Presents specific aims that are well-reasoned, feasible, and appropriate in terms of strategy, methodology, and analysis.
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Supports the development and demonstration of unique hub capabilities.
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Challenges or shifts current practice or paradigms through novel concepts, approaches, or methodologies.
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Provides sustainable, generalizable innovations or insights that increase the efficiency or effectiveness of translation.
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Provides clear dissemination and implementation plans.
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Demonstrates the ability to develop and maintain effective collaborations with partners and other CTSA hubs.
Timeline
Selected applicants will be invited to submit full proposals in alignment with the NIH deadline of May 28, 2026.
Submission Instructions
Submit completed proposals as a single PDF via this Qualtrics Survey.
Contacts
For questions regarding this Limited Submission Competition, please direct inquiries to the appropriate contact listed below.
Area-specific/Programmatic Inquiries:
Biomedical Informatics and Data Science
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Shelley Rusincovitch, MMCi, FAMIA
Email: shelley.rusincovitch@duke.edu
Clinical Research Networks
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Lynn Sutton, MS
Email: lynn.sutton@duke.edu
Community Connections for Health Translation
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Raquel Ruiz, MBA, MAEd
Email: raquel.ruiz@duke.edu
Workforce Development
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Amanda McMillan, MPH, MA
Email: amanda.mcmillan@duke.edu
General Inquiries:
For questions about eligibility, submission requirements, and overall program scope, please contact
CTSI Associate Director, Dr. Joseph McClernon (joseph.mcclernon@duke.edu).
Administrative/Submission Support:
For technical issues with the submission portal, please contact ctsifunding@duke.edu.