Fall 2025 RFA Info

TRANSCEND Overview

• TRANSCEND is a Clinical & Translational Research Development (CTR-D) program
• The goal of TRANSCEND is to bring together researchers and clinicians across North Dakota to develop unique and innovative means of combating disease and other health issues in the state
• TRANSCEND is supported by the National Institute of General Medical Sciences of the National Institutes of Health under Award Number 1P20GM155890-01
• Two grant mechanisms: Pilot Project & Developmental

Pilot Project Overview

• The Pilot Projects Grant is intended to provide support to allow researchers to pursue novel hypotheses
• We anticipate supporting 4-5 new Pilot Project awards at an amount of $75,000 total costs (direct + indirect) for one year with an anticipated start date of July 1, 2026
• Applications should focus on clinical and translational research
• Preclinical studies will be considered only if there is a clear path to progress to clinical research

Developmental Project Overview

• The Developmental Projects Grant is intended for projects with existing significant preliminary data in support of a novel hypothesis
• Specifically, Developmental Projects are targeted toward current and prior Pilot Grant awardees and toward individuals who may already have significant pilot data
• We anticipate supporting 1-2 new Developmental Projects awards at an amount of $100,000 total costs (direct + indirect) per year, for two years, with an anticipated start date of July 1, 2026
• Applications should focus on T2-T4translational research, although T1 studies will be considered if there is a clear plan to progress to T2-T4

Eligibility

• Faculty and clinicians at participating TRANSCEND institutions who have applied and been accepted into the TRANSCEND Portal network https://pathfinder.med.und.edu/
• Investigators with a Principal Investigator (PI) role from other NIH IDeA funding mechanisms are not eligible for a PI role on TRANSCEND awards
• Previous TRANSCEND Pilot Project awardees are not eligible to apply for a second Pilot Project award
• For full Application: must meet with 1) Navigator, 2) Professional Development Core, 3) Health Research Core, 4) Research Design, Compliance, and Data Management Core, and 5) Community Engagement and Outreach Core
• Funding must be used within North Dakota, unless it is a special service cost
• Patients/patient data must be from North Dakota
• Proposals that do not involve individual patients/persons (i.e., purely laboratory-based investigations that do not involve identifiable patient samples and/or purely data analysis applications that involve anonymous participants) are not eligible

Due Dates

• Letter of Intent due: August 8, 2025
• Selected full initial applications due: October 10, 2025
• Final submission to NIH: March 6, 2026
• Anticipated award start date: July 1, 2026

Priority Research Areas

• It is incumbent on the applicant to demonstrate the importance of his/her selected problem to North Dakota and North Dakotans.

Criteria for Evaluation

• Relevance to the research priorities and TRANSCEND mission
• Potential for a path to extramural grant submission
• Strength of the investigative personnel and any collaborators
• Strength of significance, innovation, approach, and environment

Conditions for Funding

• Single PI with no concurrent funding from other IDeA programs
• Participate in mentored grant writing program
• Clearly established milestones, including biannual progress reports and project completion survey
• Allow for budget and term adjustments as needed and comply with new requirements that arise
• Oral presentation at annual TRANSCEND Symposium
• Any publications arising from TRANSCEND support must cite the grant, 1P20GM155890-01

Letter of Intent (LOI)

• Explain briefly the nature or focus of the research that will be proposed, the relevance to North Dakota populations, and, if applicable, how it fits the research priorities identified by TRANSCEND
• Include a description of both the PI and any collaborator(s) roles in the proposed research
• One page, single spaced, 11 pt. font or greater, ½ inch margins on all sides
• TAKE HOME: Explain your proposed project in a clear and succinct manner
• PDF to Health Research Core Coordinator, Savannah Macias-Daugherty (Savannah.M.Daugherty@UND.edu)
• LOIs will be evaluated based on relevance to the research priorities and the TRANSCEND mission, potential for a path to extramural grant submission, strength of the investigative team and any collaborators, and strength of significance, innovation, approach, and environment
• LOI applicants will be notified the week of August 11, 2025 if they are invited to prepare and submit a full application

Initial Application: Pilot

Full Application Text

Major Pieces:

• Specific Aims
• Research Strategy
• Bibliography and References Cited
• Budget and Budget Justification

Other Pieces and Forms:

• Biographical Sketches
• Letters of Support
• Form Page 1
• Form Page 2
• PHS 398 Checklist

Conditional Documents:

• Other Support Documents
• Response to review if resubmission
• Vertebrate Animals Section
• Consortium/Contractual Arrangements
• Research Sharing Plan
• Authentication of Key Biological and/or Chemical Resources

Initial Application: Developmental

Full Application Text

• Nearly the same format as Pilot
• Contrast: 6-page Research Strategy compared to 3-page

Other Requirements

• Studies requiring IRB, IBC, and/or IACUC approval -> approval secured before submitting final applications to NIH and include letters verifying approval
• All proposals recommended by the TRANSCEND review panels will require approval by NIH prior to initiation
• Studies with human subjects:
  • Written protocol addressing the risks and protections for human subjects, in accordance with NIH’s Instructions for Preparing the Human Subjects Section of the Research Plan
  • Institutional Review Board (IRB) approval
  • Human Subjects Training education courses through CITI Program
  • Create Inclusion Data Record (IDR) and enter inclusion data in Inclusion Management System (IMS)
• Studies with clinical trials:
  • Specific plans for data and safety monitoring
  • Good Clinical Practice (GCP) courses through CITI Program
• Studies with vertebrate animals:
  • Animal Care and Use education courses through the CITI Program

Support

Health Research Core (HRC)

• Savannah Macias-Daugherty, Core Coordinator (Savannah.M.Daugherty@und.edu)

Research Design, Compliance, and Data Management Core (RDCDC)

• Miranda Leitheiser, Core Coordinator, Project Manager (Miranda.Leitheiser@SanfordHealth.org)
• Mitchell Lonneman, Core Coordinator, Project Manager (Mitchell.Lonneman2@SanfordHealth.org)
• Kent Ripplinger, Database Navigator (Kent.P.Ripplinger.2@und.edu)
• Mark Williamson, Statistician (Mark.Williamson.2@und.edu)

Professional Development Core (PDC)

• Jamie (Scholl) Bushman, TRANSCEND Navigator (Jamie.Scholl@USD.edu)

Community Engagement and Outreach Core (CEOC)

• Brian Helland, Core Coordinator (Brian.Helland@und.edu)

Administrative Core (Admin Core)

• Nicole Voigt, TRANSCEND Project Coordinator (Nicole.Voigt@und.edu)

Previously Funded Projects (Year 1)

AI-Powered Risk Prediction to Improve Outcomes in Transcatheter Aortic Value Replacement

1. Exploring Physical and Mental Effects of Victimization Among Women in North Dakota
2. Social and Affective Neuroscience of Loneliness
3. Promoting Radon Testing among Mothers of Infants: A Translational Clinical Trial
4. Identifying the Key Reward and Punishment Processes Maintaining Anorexia Nervosa
5. Molecular Profiling of CD8+T Cells in the Tumor Microenvironment to Overcome Immune Evasion
6. Impact of Pharmacogenomic Testing on Medication Outcomes in Long-Term Care
7. Evaluation of the Impact of Methadone Medication Dispensing Unit in a ND Community Pharmacy

FAQs

Who reviews LOIs and Applications?

• The Health Research Core reviews LOIs
• Full applications are sent to external reviewers

How can I get connected to a collaborator?

• Check out Pathfinder, or connect with core coordinators

Do I need to have an IRB approved before submitting?

• No, we ask that you have any relevant approvals (IRB, IBC, IACUC) drafted, so if your project moves forward, it can be approved in a timely manner before final submission to the NIH

How can I tell if my project is considered Clinical and Translational research?

• Rule of thumb: needs to involve identifiable humans
• Examples: tumor samples from patients, behavioral survey, clinical trial
• Connect with core coordinators if unsure

• Co-investigators must be a faculty member or clinician at one of the partner institutions. You can have other research members/staff that do not fit the faculty title.

• From the NIH: "Though most NIH grants go to U.S.-based institutions, you do not need U.S. affiliation or citizenship to become either a grantee institution or a PI for many types of NIH awards. The main exceptions are fellowships, career development awards (with one minor exception), and training grants, for which you must be a U.S. citizen or a permanent resident (have a Permanent Resident Card, Form I-551)."

• The PI and Co-Is need to be approved on the TRANSCEND portal. Collaborators and students are welcome to register as well, but are not required to.

• Yes. Jamie Scholl is the Navigator, who can specifically help with finding collaborators.