Novel Biostatistical, Epidemiologic, and Machine Learning Methods Awards Request for Applications

For projects beginning August 1, 2026. The UR Clinical and Translational Science Institute (CTSI) is now requesting applications from investigators for funding of pilot projects (Novel Biostatistical, Epidemiologic, and Machine Learning Methods Pilot Program) in translational science designed to address fundamental challenges and barriers that are common to translational research across diseases and health conditions. A maximum of $25,000 total cost will be awarded for a period of up to one year; it must be clear that the project can be completed within a year; no budget extensions will be granted.

This Pilot 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.

Award Details

Project Period: August 1, 2026 through July 31, 2027. Project extensions are not permitted under any circumstances.

General Guidelines: All pilots must explicitly address a translational science problem within at least one aim. Translational science problems include translational barriers whose solution could be broadly applied to multiple disease states, fields of scientific inquiry, or population health issues. A project that develops an analytic method focused on a narrow problem or single research application using a proposed approach that cannot be applied more broadly would not be responsive to the RFA. Applications are strongly encouraged to address translational science problems in the areas of Biostatistics, Epidemiology, Informatics, Artificial Intelligence or Machine Learning.

Pilot Award Categories:

The NBEMM Pilot Program plans to fund up to two pilots of $25,000 maximum each for one year from within the following focus areas:

1. Biostatistics or Epidemiology
2. Informatics, Artificial Intelligence or Machine Learning

Please note that pilot funds must be spent within the award year. There are no extensions possible due to School of Medicine and Dentistry (SMD) and NIH budgeting requirements.

Only one submission from a faculty member as PI or MPI is permitted in response to this RFA. Applicants will submit a 6-page maximum Research Plan (see submission instructions).

It is critical that research ideas are expressed in such a way that a non-expert can understand the ideas and appreciate their significance and potential impact. Additionally, it must be clear that the specific aims of the project can be completed within the allowed time period.

Concurrent funding of more than one pilot award to an investigator from the pilot funding programs of the UR CTSI is not permitted. Faculty may participate as PI or MPI on only one submission under this RFA. Faculty may participate in multiple submissions as a co-investigator. Any faculty member who has a current grant with overlapping aims is not eligible to apply.

Funds will not be awarded to support continuation/renewals of previously funded projects. Applicants awarded an NBEMM pilot in the prior two years are not eligible to apply.

The pilot grant program is intended to provide seed funding to facilitate new research and future funding. Multidisciplinary research is strongly encouraged.

Projects are not allowed to contain a foreign component, as defined by NIH.

Important Dates

• Release date – March 9, 2026
• Full proposals due – May 4, 2026 at 5 p.m.
• Notifications of award – June 22, 2026
  • Awarded proposals must meet several requirements prior to the start date. See the "Requirements if funds are awarded" section of the RFA for details.
• Anticipated start date – August 1, 2026

Program Information

Goals

The principal goal of this program is to stimulate the development of Novel Biostatistical and Epidemiologic methods or methods that use Informatics, Artificial Intelligence, or Machine Learning to help overcome specifically identified barriers in translational research and significantly enhance the validity and accuracy, scope, or speed of translational research. A high priority of the program is to facilitate novel, cross-disciplinary collaborative research programs both within the Institution and externally. The pilot funding will be targeted at research proposals that demonstrate the potential to catalyze new programs, directions, and funding for methodologies with a translational science component.

The full proposal should briefly but explicitly delineate how the intended project facilitates translational science by addressing a barrier to translational research and how the proposed solution can be applied across multiple diseases, treatments, and/or interventions. Crucial to a successful methodology proposal is its development within the context of solving a real problem in a relevant area of importance. Clinical research, as defined by the NICHD at NIH, aims to advance medical knowledge by studying people, either through direct interaction or through the collection and analysis of blood, tissues, or other samples. A working definition of translational research (Rubio et al, 2010) includes: T1 research (“expedites the movement between basic research and patient-oriented research that leads to new or improved scientific understanding or standards of care”), T2 research (“facilitates the movement between patient-oriented research and population-based research that leads to better patient outcomes, the implementation of best practices, and improved health status in communities”) and T3 research (“promotes interaction between laboratory-based research and population-based research to stimulate a robust scientific understanding of human health and disease”).

Eligibility

All faculty members with a primary appointment at the University of Rochester are eligible to serve as principal investigators. Co-investigators may be from institutions other than the University of Rochester. Investigators who have received a Novel Biostatistical and Epidemiologic Methods award in the prior two years are not eligible to apply.

Allowable Costs

The project must be funded solely with CTSI pilot funds. NIH 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. The program will support costs normally allowable for NIH-funded research projects, including faculty salary, except as detailed below. Facilities and administrative costs or “indirects” are required for subcontracts with other institutions and will be paid from the direct costs of the award. Although collaborative research efforts are highly encouraged, salary support for co-investigators holding primary appointments outside of the UR is discouraged. Related budgetary requests will be reviewed on a case-by-case basis and need to be approved by the chair of the PI’s primary department.

Resubmissions

Only one resubmission of a previously submitted proposal is allowed. New proposals need to be substantively revised to address prior review concerns and the change in priorities in the RFA.

Submitting a Proposal

General Instructions

• Use NIH format guidelines except as indicated below.
• Use PHS 398 form pages as found on the Department of Health and Human Services resource page.
• 11-point font minimum
• All figures and tables must be contained within the 6-page body of the Research Plan. Figures and tables must be easily readable when the page is printed out on 8.5“ by 11” paper.
• No appendices are permitted.
• No letters of support are permitted, except when data will be supplied in the future by a non-investigator.
• Proposals must be submitted in one document in PDF format.
• Please note the following conditions regarding this funding program, as detailed in the RFA:
  • Research activities must be funded solely with CTSI pilot funds. NIH 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/renewal of a previously funded project.
  • Awards under this RFA will be for the project period of August 1, 2026 - July 31, 2027. No carryforward will be permitted.

Format of the Application

The following PHS 398 Forms must be submitted in the order below:

• Form Page 1 – Face Page (items 1-7 only). Please note that, if awarded, the proposal title as it reads on the face page will be posted on the CTSI website. The Face Page must indicate whether human subjects or vertebrate animals are involved in the project, and must indicate whether the research is a clinical trial.
• Form Page 1 Continued – For multiple PDs/PIs (if needed)
• Form Page 2 – Project Summary, Relevance, Performance Site(s), Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells
• Additional Performances Sites Page (if needed)
• Form Page 4 – Detailed Budget for the entire project period. Include effort for all positions, whether funding is requested or not. Please note that the grant application may be returned unreviewed if the budget is not completed per NIH guidelines.
  • If assistance is needed, please contact Mary Lyons at mary_lyons@urmc.rochester.edu.
• Budget justification on a PHS 398 continuation page.
• If there is a subaward, include the following documents in the order indicated below:
  1. Scope of Work to be performed by the subaward institution. Creation of this document should be a joint effort between the UR PI and the subaward PI.
  2. Subaward Budget on Form Page 4 (Detailed Budget)
  3. Subaward Budget Justification
  4. Form Page 1 Face Page signed by the institutional signing official or a consortium letter of intent signed by the institutional signing official.
  5. PHS 398 Checklist Page for indirect costs
  6. Attachment 3B: Research Subaward Agreement: Subrecipient Contacts.
• Biographical Sketch Format Page for PI, MPIs, and co-investigators. For this year only, this may be submitted in either the Common Form or the NIH’s previous biosketch format.
• Resources Format Page
• Translational Science Criteria: NCATS, the NIH institute funding the pilot projects through the CTSI, requires the pilot projects to be translational science projects. The following information should be integrated across your proposal:
  • Brief explanation of the Translational Research Barrier being addressed
  • Proposed solution to the Translational Research Barrier
  • Explanation of how the proposed solution is generalizable across multiple diseases, conditions, or scientific fields
• Research Plan (6-page limit)
• Use PHS 398 Continuation Format Page, except if using LaTeX (rather than Word) to generate the PDF. If you use LaTeX to generate the PDF, please note the following:
  • You must comply with the margins on the NIH’s PHS 398 continuation page (0.8” top margin, and 0.5” left, right, and bottom margins).
  • Pages must be numbered within the six-page body of the Research Plan.
  • The PDF of your Research Plan must be combined with the other components of the full proposal and submitted as one single PDF.
• The following sections are limited to a total of 2½ pages:
  • Specific Aims
  • Background
  • Identification of 1) a barrier in Translational Research; 2) how the proposal will address this barrier; and 3) how the proposed solution to the barrier can be applied across a range of diseases, treatments, and interventions.
  • Facilitation of clinical or translational research
  • Responsiveness to the priorities of the NBEMM program
  • Significance and opportunities for catalyzing new funding
• The remaining 3½ pages will contain:
  • Research Plan and Methods. Please note that sufficient detail about the timeline for accomplishing all steps in the proposal to assure its completion in 12 months is necessary.
  • Potential Problems and Alternatives
• All acronyms or unusual terminology should be defined.
• Pages must be numbered within the 6-page body of the proposal
• Only one additional page or less is allowed for a bibliography.
• If data will be supplied in the future by a non-investigator, a support letter is required. This letter must be included in the full proposal PDF, right after the bibliography.
• CTSI Sign-off Form. This form requires sign-off by the chair of the PI’s department. As is required for ORPA sign-off, all MPIs, co-investigators, and their department chairs must sign the sign-off form.This form will be uploaded separately from the proposal. Please note that the CTSI sign-off form is CTSI-specific. Therefore, the sign-off form and proposal do not go to ORPA for sign-off.
• Funding Attestation. An attestation that there is no current extramural or other University-sponsored pilot funding of this project is required. If there is pending funding that would overlap with this project, please describe it.
• Subaward: If there is a subaward, indirect costs are required and must be paid from the award. Please contact Mary Lyons at mary_lyons@urmc.rochester.edu with any questions regarding a subaward.
• Single IRB: If the same protocol will be used to conduct your non-exempt human subjects research at multiple sites, NIH requires the use of a single IRB. Please note that there may be costs associated with the use of a single IRB that would need to be included in your budget. Office for Human Subject Protection staff will be able to provide guidance regarding the use of a single IRB and the associated costs.
• Maximum Budget:$25,000 for a one-year period.

Allowable Costs

• The research activities must be funded solely with CTSI pilot funds. NCATS, the NIH institute funding the CTSI, will not permit supplementation of funds from other sources for pilot projects supported with NCATS funding. We strongly recommend discussing the budget and restrictions with your grants administrator prior to submission.
• The program will support costs normally allowable for NIH-funded research projects, including faculty salary, except as detailed below.
• Funding cannot be used to purchase a computer, laptop, monitor, etc.
• Facilities and administrative costs or “indirect costs” are required for subawards with other institutions and must be paid from the award. These are the only indirect costs that need to be reflected in the budget.
• No carryforward is permitted; therefore all funds must be spent during the funding period. Accordingly, if publication costs are included in the budget, these costs must be paid during the funding period.

Delayed Onset Human Subjects Research

This applies only if you are awarded funding and your project involves live vertebrate animals research. Please note that CTSI NBEMM awards involving human subjects research must comply with NIH rules for “delayed onset human subjects research.” “Delayed onset human subjects research” is defined as a situation where human subjects research is expected to be supported by an NIH grant, but definite plans for that research cannot be provided in the grant application. If awarded, the grantee must provide specific information to be sent to the NIH at least 30 days prior to the planned commencement of human subjects research.

NIH-Defined Clinical Trial

Consult the NIH’s definition of a clinical trial when completing question 4c on the Face Page. It is crucial that you consult the NIH’s definition of a clinical trial before completing this question. Improperly categorizing your research may result in a delay in starting your research if the NIH finds during review of your delayed onset human subjects research materials that you have not categorized your research correctly.

Prior Approval of Research Involving Vertebrate Animals

This applies only if you are awarded funding and your project involves live vertebrate animals research. Please note that CTSI NBEMM awards involving live vertebrate animals research must comply with NIH rules for prior approval. If awarded, requests for prior approval of planned research involving vertebrate animals must be submitted in writing to the NIH no later than 30 days before the proposed implementation of research involving live vertebrate animals.

Proposal Submission and Notification of Award

The deadline for submission of the full proposal is Monday, May 4, at 5:00 PM. The submission system will reject proposals submitted after the deadline time. Submit the full proposal through this REDCap form.

Submission will consist of providing basic information about the proposal, including whether a foreign component is involved, and uploading the following documents:

• Full proposal
• PI funding attestation
• CTSI sign-off form

Notifications of award are anticipated to be sent by June 22, 2026.

Proposal Review

Projects supported by this funding program must address a translational challenge or barrier and meet the definition of translational science research. Translational Science is the field of investigation focused on understanding the scientific and operational principles underlying each step of the translational research process. Translational science is disease universal because it focuses on the scientific and operational bottlenecks that are common to translational research for most or all diseases. A key tenet of translational science is to understand common causes of inefficiency and failure in translational research, with the goal of developing generalizable principles and methods to accelerate translational research.

All proposals must identify a translational challenge or barrier within at least one aim and must specify how the identified solution to the problem can be applied across a range of diseases, treatments, or interventions, as well as how the proposal will impact the speed of translational research.

Review Priorities

Priorities for awarding pilot funding are listed below. 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:

1. This project encourages transformative ideas and risk-taking toward achieving the overall goal of improving the translational process.
2. This project approaches research challenges and the development of solutions by seeking commonalities across research on a range of diseases and conditions.
3. The knowledge gained from this project will be generalizable to a variety of diseases.
4. This project will develop and implement innovations in scientific approaches, methods, and/or technologies to accelerate the pace of translational research.
5. This project addresses a common roadblock or bottleneck in translational research.
6. If successful, this project will improve translational research by making it more efficient or effective.
7. If successful, this project will yield information that will accelerate translational research.

In addition, the following will also be considered:

1. Quality of the proposed science.
2. Team is interdisciplinary.
3. Novelty, rigor, and feasibility of the proposed methodology.
4. Potential impact on clinical and translational science, including how the proposed methodology will help to solve a real issue in an important area.
5. Potential to lead to or facilitate new funding and other outputs such as publications.

Review Process

Full proposals, which consist of six-page grant applications in NIH format, are reviewed by either:

• The UR CTSI review committee specific to each submission category and other selected ad hoc experts who subject the proposals to rigorous scientific review, or
• Researchers associated with another CTSA through an exchange program.

Reviewers will review to ensure the requirements of addressing translational science and other review priorities for each focus area are included in the submissions.

Following the review process, the scores and funding recommendations are sent to the UR CTSI Executive Team for a final review and decision on funding of the proposals most aligned with Translational Science, as well as having the best potential for future funding and other outputs (i.e., publications, grants).

Requirements if funds are awarded

1. IRB and UCAR Approvals:All IRB and UCAR protocols ;must be approved prior to expenditure of any funds.
2. Single IRB for Multi-Site Projects Using the Same Protocol: If the same protocol will be used to conduct your research at multiple sites, NIH requires the use of a single IRB. Office for Human Subject Protection staff will provide guidance in this process.
3. Delayed Onset Human Subjects Research:The NIH requires that the UR 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. UR CTSI personnel will work with awardees to meet these requirements.
4. Prior Approval of Vertebrate Animals Research: The NIH requires that the UR 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. UR CTSI personnel will work with awardees to meet these requirements.
5. 2 CFR 200 Procurement Principles Training: All University of Rochester Principal Investigators on the project and each person who will initiate purchases must provide documentation that they have completed the 2 CFR 200 Procurement Principles training available in MyPath.
6. Data Management and Sharing: All research data generated by the award must comply with the NIH Data Management and Sharing Plan.
7. Publications: Awardees are expected to publish their findings. All publications that benefit in whole or in part from support provided by the UR CTSI must:
   1. Comply with the NIH Public Access Policy:Assistance with the compliance process is available through the Miner Library.
   2. Acknowledge UR CTSI grant funding. Where relevant, awardees are expected to publish novel code in software repositories (e.g., CTSI GitHub). 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."

8. 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.
9. Clinical Trials: To satisfy expectations of NCATS, the funder of the CTSA program, award recipients conducting an NIH-defined Clinical Trial must also complete Good Clinical Practice (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. Please review the NIH definition of a clinical trial.
   1. All applicable clinical trials must be registered in clinicaltrials.gov. For more information about registration requirements, see the ClinicalTrials.gov support page.

Contacts

If you have questions regarding this RFA, please contact one of the following.

Consultation requests regarding pilot responsiveness to the RFA and general inquiries

Mary Little Mary_little@urmc.rochester.edu

Scientific and peer review contacts

Biostatistics or Epidemiology

Robert Strawderman, ScD robert_strawderman@urmc.rochester.edu

James McMahon, PhD James_Mcmahon@URMC.Rochester.edu

Informatics, Artificial Intelligence or Machine Learning

Dongmei Li, PhD Dongmei_Li@URMC.Rochester.edu

Financial contact

Mary Lyons mary_lyons@urmc.rochester.edu