Request for Applications: University of Rochester Medicine Clinical and Translational Science Institute Pilot Studies Program

I. Pilot Studies Program Awards

The University of Rochester Medicine Clinical and Translational Science Institute (CTSI) is requesting applications from investigators for funding of pilot projects (Pilot Studies Program) in translational science (TS) designed to address fundamental challenges and barriers that are common to translational research across diseases and health conditions.

This Pilot Studies Program is funded by the Clinical and Translational Science Award (CTSA, an NIH-funded grant). Pilot studies funding is dependent upon the availability of NIH funds.

II. Award Overview

The focus of the awards is on Translational Science Research, NOT Translational Research. Translational research focuses on developing a better scientific understanding of the mechanism or treatment for a specific medical condition (e.g. depression) or disease (e.g. diabetes).

We are looking for Translational science which “is the field that generates scientific and operational innovations that overcome longstanding challenges along the translational research pipeline. These include scientific, operational, financial and administrative innovations that transform the way that research is done, making it faster, more efficient, and more impactful.” (https://ncats.nih.gov/about/about-translational-science)

Where translational research may still address barriers, it does not focus on generalizability of solutions; translational science accelerates movement across the translational research spectrum with a focus on generalizability, dissemination, and implementation. Often translational science research is embedded in translational research¹ and vice versa.

Example

Microfluidic biomarker collection during aerobic exercise

Barrier to be addressed: Biomarker collection from blood and other bodily fluids requires invasive techniques including needles, urine samples, etc. In addition, these collection techniques are often limited to laboratory settings.

TS Project: Sweat captured through wearable patches may be used to identify and measure health-related biomarkers. This non-invasive collection technique will allow important biomarkers to be collected in real world settings with minimal equipment.

(Example taken from Dillon, Pamela, Defining Translational Science – and Why it Matters; CTSI Translational Science Grand Rounds; 14 August 2025)

III. Important Dates

Release Date: August 31, 2026
Pre-submission Consultation Deadline: October 19, 2026
Letter of Intent Deadline: October 26, 2026, at 5pm ET.
Full Proposal Invitations Issued: December 21, 2026
Full Proposal Deadline: February 22, 2027, at 5pm ET.
Funding Notification Letters Sent: April 30, 2027
Anticipated Start Date: August 1, 2027
End Date: July 31, 2028
Please note that the online submission system will reject proposals submitted after 5:00 PM ET.

IV. Award Details

Project Period/Duration

August 1, 2027 through July 31, 2028. Project extensions are not permitted under any circumstances.

Maximum Award Amount

TS01 Translational pilot studies for faculty: $50,000 maximum for one year.
TS03 Mentored pilot studies for trainees: $25,000 for one year.

Number of Awards

TS01 Translational pilot studies for faculty: Up to three pilots will be awarded.
TS03 Mentored pilot studies for trainees: Up to two pilots will be awarded.

Pre-submission Requirements

• Consultations with Pilot Leadership regarding responsiveness of the proposal to the RFA are mandatory and must be completed by October 19, 2026. Contact ctsi@urmc.rochester.edu to schedule a time early on the planning process to discuss the draft proposal, indicating the focus area under which the application will be submitted. Letters of Intent (LOI) that do not meet this requirement will be triaged from review.
• All applicants must watch the first 15 mins of the August 14, 2025, Translational Science Grand Rounds Video and sign-off in the application to that effect.
• Trainee applicants must submit a completed Faculty Sponsor Sign-Off with the LOI.

General Guidelines/Focus

All pilots must explicitly address translational science, a barrier or challenge along the translational research pipeline, within at least one aim. Pilots may focus on a specific condition or disease as an example of how the research strategy being studied can be applied across other conditions or diseases. However, they must address how the solution is generalizable across multiple diseases, conditions, or scientific fields. Applications are strongly encouraged to address translational research problems in the areas of population health, data science or dissemination and implementation.

Each pilot project submission must specifically identify the following:

1. A barrier or challenge along the translational research pipeline.
2. How the proposed translational science research project will address this barrier.
3. How the proposed solution can be applied across multiple diseases, conditions, or scientific fields.

Applications that narrowly address a scientific problem specific to a single discipline that cannot be applied to other areas (e.g., defining the molecular mechanism of ER- PR negative breast cancer) do not qualify for funding under this program.

Pilot Award Categories

1. TS01 Translational pilot studies for faculty from with the focus areas listed below.
   1. Translational Science
   2. Data Science
   3. UNYTE - UNYTE is a network of 17 biomedical research institutions in Upstate New York, led by the CTSI. If the focus area UNYTE Translational Research Network is chosen, the pilot must be a partnership between a UR PI and a PI from another UNYTE institution
2. TS03 Mentored pilot studies for trainees from within the focus areas listed below. All submissions must have a Faculty Sponsor. In addition to serving as the trainee’s Primary Mentor, a Faculty Sponsor takes responsibility for the conduct of both the trainee and the study, is listed as PI or the PI Proxy on the IRB protocol, and oversees the financial management of the project. Trainees are defined as graduate students, medical/dental/nursing students, residents, postdocs or fellows in University of Rochester training programs.
   1. Translational Science
   2. Data Science

Please note that pilot funds must be spent within the award year. There are no extensions due to SMD and NIH budgeting requirements.

Program Focus Areas

Within each Translational Science Pilot Award category (e.g., TS01 and TS03), applications must identify a focus area to better assign reviewers. These focus areas include:

1. General Translational Science: Faculty and Trainee

The primary goal of support provided in the General Translational Science Faculty focus area is to develop the groundwork for subsequent extramural funding. The primary goal of support provided in the General Translational Science Trainee focus area is to obtain the most prestigious fellowship or grant possible following the award, and subsequently to become an independent investigator. The latter is a longer-term goal that strengthens and complements the strategic goals of the University and the Medical Center.

Please note: Applications submitted in response to this RFA may be shared with other URMC pilot programs for possible funding. Also, applications may be shared with UR Ventures for intellectual property review.

2. Data Science: Faculty and Trainee

The Data Science focus area centers on the development of novel data science methods and technologies that address translational research barriers and/or support translational science aims. The emphasis will be on feasibility, applicability to multiple use cases (e.g., disease types, stages in the translational science spectrum, settings), and potential for future extramural funding. Data Science proposals must demonstrate how they will use Data Science and translational science to innovatively overcome a barrier to translational research.

Examples of proposal topics that may be appropriate include, but are not limited to:

• Development of analytic approaches using machine learning or artificial intelligence (ML/AI) techniques
• Use or reuse of large publicly available datasets (e.g., N3C) for analysis
• Novel data processing or integration techniques, particularly for multimodal data
• Investigation of natural language programming (NLP) techniques to mine or analyze text
• Development of new data visualization techniques or approaches
• Optimization of use of validated data science-based tools and technologies

3. UNYTE Awards: Faculty Only

The UNYTE focus area is intended to stimulate new inter-institutional collaborations in health research. Investigators are encouraged to develop an innovative, team-based approach to a problem in health research that reflects the particular strengths of the members and their institutions. The PI of the UNYTE award must have a primary appointment at the University of Rochester and will serve as the contact PI. Proposals must involve a new or expanded collaboration between a University of Rochester faculty member and one or multiple principal investigators (MPIs) from at least one of the participating UNYTE institutions.

Please note: Examples of pilot proposals that may be supported can be viewed here.

Key Principles/Definitions

NCATS defines Translational Science as “the field that generates scientific and operational innovations that overcome longstanding challenges along the translational research pipeline. These include scientific, operational, financial and administrative innovations that transform the way that research is done, making it faster, more efficient, and more impactful.”

UNYTE is a network of 17 biomedical research institutions in Upstate New York, led by the URochester Medicine CTSI. Additional information is available on the UNYTE Translational Research Network website.

V. Eligibility

Principal Investigator (PI) Requirements

Faculty may participate as PI, MPI, or Faculty Sponsor/Primary Mentor on only one submission per award category.

All Faculty Awards: Faculty members with a primary appointment at the University of Rochester are eligible to serve as principal investigators for faculty category awards. If there is an MPI at another institution, the faculty member with the primary appointment at the University of Rochester will be the contact PI for the project.

All Trainee Awards: All UR pre-doctoral students, fellows, postdocs, and residents are eligible for awards in the Trainee category. Faculty members are not eligible to serve as principal investigators for Trainee category awards.

Team Composition

Faculty may participate in multiple submissions per category as co-investigator or co-mentor. Any faculty member who has a current grant with overlapping aims is not eligible to apply.

Trainee proposals must include a clear identification of a Faculty Sponsor/Primary Mentor and any Co-Mentors.

Restrictions

Applicants who have received a pilot award from the CTSI in the prior two years are not eligible to apply.

The project cannot be an add-on to, or an extension of, a parent project supported by another funding source.

Funds will not be awarded to support continuation/renewals of previously funded projects.

Eligible Clinical Trials

The NIH institute funding the CTSI (the National Center for Advancing Translational Sciences, or NCATS), can only provide direct support for clinical trials ranging from Phase 1 through Phase 2A. NCATS defines Phase 2 clinical trials as those that are designed to test drugs for efficacy and side effects in a limited number of patients. Phase 2A trials provide data for exposure-response in patients, while Phase 2B trials provide data for dose-ranging in patients. Therefore, Phase 2B clinical trials or those of subsequent phases are not eligible for the CTSI pilot project program.

VI. Allowable Costs

General Support

The program will support costs normally allowable for NIH-funded research projects, except that funding cannot be used to support faculty salary. Trainee salary support is permitted for all award types but must be justified in the proposal.

Specific Exclusions

Projects or research activities cannot involve a foreign component as defined by NIH.

Indirect Costs (F&A)

Facilities and administrative costs or “indirects” are required for subcontracts with other institutions and will be paid from the direct costs of the award.

Funding Restrictions

The awarded project must be funded solely with CTSI pilot funds. NCATS rules do not permit supplemental funding from other sources.

The project cannot be an add-on to, or an extension of, a parent project supported by another funding source.

Funds will not be awarded to support continuation/renewals of previously funded projects.

Please note that pilot funds must be spent within the award year. There are no extensions due to SMD and NIH budgeting requirements.

VII. Resubmissions

Only one resubmission of a previously submitted proposal is allowed. New proposals must be changed substantively to address prior review concerns.

VIII. Application Instructions

Application Process

Applicants will submit a two-page Letter of Intent (LOI) with Specific Aims which will be reviewed by the CTSI review committee specific to each submission category, and subsequently a limited number of full proposals will be requested. It is critical that research ideas are expressed in the LOI and Specific Aims in such a way that a non-expert can understand the ideas and appreciate their significance and potential impact.

Submission Method

LOI Proposals must be submitted electronically at: https://redcap.urmc.rochester.edu/redcap/surveys/?s=LD8WYCT897J4D7M3

Note: The submission system will reject proposals submitted after the deadline time of October 26, 2026 at 5:00 PM.

Details of the full proposal application procedure will be provided at the time the applicant is invited to submit.

Required Components

1. Complete the required fields in the application submission system, providing the following information:
   • Title of the project. No acronyms are permitted in the title. Please note that, if awarded, the title of the project will be posted on the CTSI website.
   • PI name and contact information – Please note that for Trainee Pilots, the Trainee is considered the PI.
   • For Trainee Pilots, the name of the PI’s Faculty Sponsor/Primary Mentor and contact information. The trainee’s NIH biosketch in the Common Form and specific to the pilot project will need to be uploaded.
   • Co-investigator names and contact information. All MPIs, Co-Mentors, and Co-Investigators need to be listed in the REDCap LOI submission survey.
   • Award Category: TS01 or TS03
   • Focus Area:
     • TS01 - Translational Science, Data Science, or UNYTE
     • TS03 - Translational Science or Data Science
   • Total amount of funding requested
   • Indication as to whether the application is new or a revision
   • Involvement of human subjects or vertebrate animals
   • Name and contact information for the department administrator or grants administrator for the UR contact PI
   • Indicate that the pre-submission requirements have been completed.
   • A signed attestation statement from the PI that there is no funding for the project through another mechanism.
   • For Trainee LOI submissions, a signed Faculty Sponsor sign-off.
   • Three names and e-mail addresses of suggested University of Rochester faculty reviewers. Please note the following reviewer exclusions: 1) they cannot have co-authored peer-reviewed articles with the PI in the last 3 years; 2) they cannot have any active grant funding with any Key Personnel in the application; 3) they cannot have a reporting relationship with the Key Personnel; and 4) the program directors for the focus area under which you are applying are not to be listed as suggested reviewers.
2. LOI, limited to 2 pages, which includes the items below:
   • Project title and names of the PI, MPIs and co-investigators
   • Background and Translational Science Research Significance
     • Context for the proposed research
     • Specific and Measurable Aims. At least one aim must explicitly address a Translational Research problem
     • The project’s potential benefits and innovation.
     • How the proposed project would impact the speed of translational research
     • Translational Research Barrier to be Addressed, Proposed Solution(s), and how the identified principles and solutions can be applied across multiple diseases, conditions, or scientific fields.
   • Research Methods
     • Source of the study data
     • Study design, including research procedures
     • Structure of the study team
     • Approach to Stakeholder engagement (if applicable)
     • Feasibility
3. Additional Information:
   • No additional pages are permitted for a bibliography. Bibliographic information must be included within the two-page LOI.
   • No letters of support are to be submitted with the LOI.

Formatting Guidelines

LOI is limited to 2 pages in Arial 11-point font size, 0.5-inch margins. Please note that the LOI Template, including the headings, must be used and the document uploaded as a PDF.

IX. Proposal Review

Review Committee

The CTSI review committee will be specific to each submission focus area and will be comprised of faculty experts from across the University of Rochester.

Review Process

Review Criteria/Priorities

Priorities for awarding pilot funding are:

• Responsiveness to the requirement of addressing translational science.
• In evaluating responsiveness to the requirement of addressing translational science, the following criteria related to translational science may be considered:
  • This project encourages transformative ideas and risk-taking toward achieving the overall goal of improving the translational process.
  • This project approaches research challenges and development of solutions by seeking commonalities across research on a range of diseases or conditions.
  • The knowledge gained from this project will be generalizable to a variety of diseases or conditions.
  • This project will develop and implement innovations in scientific approaches, methods and/or technologies to accelerate the pace of translational research.
  • This project addresses a common roadblock or bottleneck in translational research.
  • If successful, this project will improve translational research by making it more efficient or effective.

In addition, the following will also be considered:

• Faculty Category - Proposals with the best potential for output (e.g., peer-reviewed publication, extramural grant submission) by the end of the funding period.
• Trainee Category - Proposals that are most likely to be competitive for output subsequent to funding, including training grant submission (e.g., NIH’s Fellowship or K mechanism).
• Data Science Category - In addition to the review priorities for the Faculty and Trainee Categories, respectively, proposals that produce innovative real-world data solutions will receive the highest priority for funding.
• UNYTE Category - In addition to the review priorities for the Faculty Category, proposals that involve substantive and collaborative participation of faculty and facilities from the UR and at least one other UNYTE member institution will receive the highest priority for funding.

X. Requirements if Funds are Awarded

Onboarding Meeting

Attend a mandatory in-person informational onboarding meeting. This meeting will be required for the PI, MPI, Mentor (for Trainee Pilots), and Department Grant Administrator.

Regulatory Approvals

IRB and UCAR Approvals: All IRB and UCAR protocols must be approved prior to expenditure of any funds.

NIH Compliance

1. Delayed-Onset Human Subjects Research: The NIH requires that the CTSI obtain explicit approval from the NIH for any pilot-funded research involving human subjects. Accordingly, the IRB-approved protocol and other materials such as a recruitment and retention plan; protection of human subjects; inclusion across the lifespan; inclusion of women and minorities; and planned enrollment must be submitted to the NIH at least 30 days prior to the project start date. CTSI personnel will work with awardees to meet these requirements.
2. Prior Approval of Vertebrate Animals Research: The NIH requires that the CTSI obtain explicit approval from the NIH for any pilot-funded research involving vertebrate animals. UCAR approval documentation and other materials must be submitted to the NIH at least 30 days prior to the project start date. CTSI personnel will work with awardees to meet these requirements.
3. Single IRB for Multi-Site Projects Using the Same Protocol: If the same protocol will be used to conduct research at multiple sites, NIH requires the use of a single IRB (sIRB). Office for Human Subject Protection staff will provide guidance in this process. Please note: This is only for projects that are not considered Exempt and if proposing sIRB, it needs to be budgeted for in the budget.

Note: Awardees must receive IRB and NCATS approval before the formal NOA with FAO information will be issued.

Clinical Trials

Please review the NIH definition of a clinical trial.

All applicable clinical trials must be registered in clinicaltrials.gov. For more information about registration requirements, see the CTSI Regulatory Support webpages.

Training

1. 2 CFR 200 Procurement Principles Training: All University of Rochester Principal Investigators on the project and each person that will initiate purchases must provide documentation that they have completed the 2 CFR 200 Procurement Principles training available in MyPath.
2. Good Clinical Practice (GCP) training: To satisfy expectations of NCATS, the funder of the CTSA program, award recipients conducting an NIH-defined Clinical Trial must also complete GCP training. The PI must certify that this training has been completed when the delayed-onset human subjects research materials are submitted to NCATS for review.

Data Management and Sharing

All research data generated by the award must comply with the NIH Data Management and Sharing Plan.

Publications

All awardees are expected to make every effort possible to publish findings related to the pilot award. All publications that benefit in whole or in part from support provided by the CTSI must:

1. Comply with the NIH Public Access Policy: Assistance with the compliance process is available through the Miner Library.
2. Acknowledge CTSI grant funding. We recommend use of the following language:
   “The project described in this publication was supported by the University of Rochester CTSA award number UM1 TR005451 from the National Center for Advancing Translational Sciences of the National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.”

Identifiers

ORCID IDs: All key personnel on the project must obtain an ORCID ID which provides a persistent digital identifier that the investigator owns and controls, and that distinguishes the investigator from every other researcher.

Funding

• All awardees must spend 80-95% of allocated funds within the time constraints.
• CTSI funds must be spent between August 1, 2027, and July 31, 2028, so awardees must commit to completing the specific aims of the project within the allowed time period of up to one year. Please note there will be no carry forward of funds.
• Please note: Half of the funds will be allocated at the start of the project; the remaining half will be released once the first half is spent.

Reporting/Presentations

All Pilot awardees must:

• Present their project and progress twice a year in person;
  • Mid-year to the Pilot and CTSI Executive Leadership
  • At Translational Science Grand Rounds after the project period has ended
• Complete the annual CTSI pilot award survey

XI. Contacts

Dedicated Contacts

Consultation Requests regarding pilot responsiveness to RFA and General Inquiries

Karen Grabowski, Administrative Assistant
General Program Information
ctsi@urmc.rochester.edu

Scientific and Peer Review Contacts

OJ Sahler, MD, MS, Pilot Program Co-Lead
Translational Science and UNYTE Focus Areas
oj_sahler@urmc.rochester.edu

Edward Schwarz, PhD, Pilot Program Co-Lead
Translational Science and UNYTE Focus Areas
edward_schwarz@urmc.rochester.edu

Erika Ramsdale, MD, Focus Area Co-Lead
Data Science Focus Area
Erika_Ramsdale@URMC.Rochester.edu

Adam Dziorny, MD, PhD, Focus Area Co- Lead
Data Science Focus Area
Adam_Dziorny@URMC.Rochester.edu

Financial Contact

Mary Lyons, CTSI Manager of Financial Services
mary_lyons@urmc.rochester.edu

Footnotes

[1] Dillon, Pamela, Defining Translational Science – and Why it Matters; URCTSI Translational Science Grand Rounds; 14 August 2025