Letter of Intent (LOI)

LOI will be submitted electronically (link available in March/ April 2025).

1 page letter of intent (LOI) is required and must include the following:

• Name(s) of the PI and co-PI(s)

• Name of PI/Co-PI's institution(s)

• Project title

• Abstract (500 words or less)

• Detailed description of how the project meets the definition of a Translational Science (TS) project

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When drafting the LOI, researchers are encouraged to reach out to iTHRIV with questions (e.g. to ensure the proposal fits the framework of a TS project). After review and approval of the LOI, investigators will be provided a link to submit the full application.

 

The purpose of the mandatory LOI is to ensure that the proposed project is a TS project. During the LOI review, if appropriate, iTHRIV will provide suggestions to the investigator to adjust the focus of the proposal so it fits the framework of a TS project.

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Proposal

To prepare a competitive application, researchers are strongly encouraged to consult the iTHRIV integrated Biostatistics, Epidemiology, Research Design and Informatics (iBERDI team) for assistance throughout the lifecycle of the project (design, implementation, data analyses, data management and sharing).

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Upon approval of the LOI, teams should follow the instructions to submit a single PDF containing the following:

1. Abstract (500 words or less)

a.  **Use non-medical terminology to describe your research project and its potential impact. This abstract will help our community reviewers better understand the proposal.

2. 5-page project description (includes all of the following categories)

a.  Specific Aims

b.  Research Plan

c.  Impact statement, specifically describing how the proposal will impact the field of translational science (An impact statement is a short, convincing explanation of how the project can have a positive effect on a larger community)

d.  Justification that this is a TS project

e.  Expected outcomes

f.   Plan for Community Engagement (see section on Community Engagement Studio requirements)

g.  Project timeline

h.  Limitations of proposed research

i.  A clear description of future research direction (including follow-on funding and how the discovery will be validated)

j.  Dissemination plan for project outcomes

3. Data Management and Sharing Plan (DMSP) 3-page limit, not considered part of the 5-page project description. The NIH expects researchers to maximize the appropriate sharing of scientific data, taking into account factors such as legal, ethical, or technical issues that may limit the extent of data sharing and preservation. This iTHRIV portal page includes a blank NIH template for writing a DMSP. Awardees are expected to utilize the iTHRIV Research Data Commons to maximize discoverability and reuse of the data by the research community.

a.  Additional resources for UVA researchers:

i.  Sample of UVA Data Sharing Plan Lanugage Leveraging the iTHRIV Commons  

ii. The UVA Claude Moore Health Science Library provides additional guidance and consultation 

b. Additional resources for Carilion Clinic researcher are available through the Research and Development Office.

c. Additional resources for Virginia Tech researchers:

i. NIH Data Management and Sharing Guide

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​4. References (not considered part of the 5-page project description)

5. NIH Biosketch for all Key Personnel.  Please utilize the most current Rev 10/2021 version

6. NIH Formatted budget and budget justification (please use these versions)

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Budget Guidelines

1.  Project period is maximum of one year. Anticipated funding start date: After funded teams are notified (~8/15/2025), and as soon as the necessary IRB/ IACUC approval is obtained (no later than 1/1/2026).

2.  For multi-institutional projects: a separate budget and budget justification for each institution is REQUIRED. Combined total cannot exceed $50,000.

3.  PI/Co-PI effort is NOT required on the budget. Pilot awards are ideally suited to provide support for research staff, supplies, etc.

4.  Consortium Commitment forms should not be submitted with the proposal.

5.  Collaborators listed on the application who are not employed by an iTHRIV participating institution may not receive CTS pilot funds.

6.  At least one Community Engagement Studio (CES) is required for each project (see below for details). Applicants must include the costs for compensating community members participating in each CES in the project budget (Estimated $500 per CES). The CES should be listed in only one site budget for multi-institutional projects. 

7.  The provided budget and budget justification templates must be utilized (templates located above). 

8.  Indirects are NOT allowed. Only direct costs should be included in the budgets.

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Please contact the following individuals at each institution for grant management review and support for this proposal submission process (have sign off from your institution):

1.  Carilion Clinic: Vera Hollen - vlhollen@carilionclinic.org

2.  UVA: Contact the Grant Administrator for your Department or School

3.  Virginia Tech: Jessica Crawford - crawjd@vt.edu

4.  Center for Open Science, Virginia Cooperative Extension, Virginia Department of Health, Virginia State University: TBD, please contact Kayla Calvo krc7d@virginia.edu

*These grant administrators should contact the iTHRIV Finance Director Kayla Calvo (krc7d@virginia.edu) with any additional questions.

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Regulatory Approvals

1.  Awardees must obtain all applicable regulatory approvals (e.g. IRB, IACUC) and meet all compliance requirements prior to receiving funds for research involving human subjects or vertebrate animals and maintain approvals during the entire length of the award. Teams selected for funding are required to provide proof of IRB/IACUC submission within 1 month of receiving the notice of intent to fund letter. IRB/ IACUC approval is required by 1/1/2026.

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2.  When applying for IRB/IACUC approval, indicate that this research project is supported by the NIH/NCATS (National Center for Advancing Translational Sciences).

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3.  IRB/IACUC approval(s) must be kept current and active for the duration of the award period. Copies of all approval letters and the approved documents need to be sent to the iTHRIV CTS Pilot Studies Program Manager, Medard Ng (htn3u@uvahealth.org).​

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4.  Any multi-site non-exempt human subject research study will be required to follow the NIH mandate for use of a single IRB. 

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5.  All funded proposals involving human subjects or vertebrate animals will require submission to and review by NCATS before the project begins. Teams who are awarded funding will meet with the Pilot Studies Program Manager for guidance through this process. The approval process can take several weeks to one month.

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6.  CTS pilot projects which meet the NIH definition of a clinical trial (see below), must be registered on clinicaltrials.gov and must maintain compliance through the reporting of results of the project on the NIH site.

​a.  NIH Clinical Trial definition: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

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Proposal Review Process

• Letters of Intent will be reviewed and approved by the CTS Pilot Program Team.

• All applications will be reviewed administratively for completeness and eligibility. The applications will then be evaluated by reviewers from iTHRIV institutions and a community member using an NIH-style rubric and  study section format.

• All applicants (funded or unfunded) will receive reviewers’ comments.

• Applications will be reviewed based on the NIH simplified peer review framework: importance of the research (significance, innovation), rigor and feasibility (approach), expertise and resources (investigator, environment).

• Preferences will be given to applications: (a) that are judged to have a high potential for leading to external funding (b) that plan to address a challenge in the translational science process, and (c) with team science collaborations across two or more iTHRIV institutions.

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Community Engagement Studios 

All iTHRIV funded pilot projects will be required to conduct at least one Community Engagement Studio during their project period.  A Community Engagement Studio (CES) is a facilitated round table discussion that brings together health researchers and patients/consumers/other non-academic stakeholders. ​

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Each Community Engagement Studio session assembles a customized panel of community experts who share their perspectives on a research topic.

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Potential topics:

• Shaping a research question or proposal.

• Enhancing study design, addressing issues related to research implementation, or planning for dissemination.

• Addressing potential barriers or challenges, such as recruitment or retention.

• Improving the cultural and linguistic appropriateness of research documents (e.g., recruitment materials, consent documents, or surveys).

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iTHRIV CESs give community members an effective and active role in health research and give researchers an avenue to consult with patients/the public before, during, and after their research project takes place.

 

Community expert participants are compensated for their time in Community Engagement Studios. At least one CES is required for each project. Applicants must include the costs for compensating community members participating in each CES in the project budget (Estimated $500 per CES). The CES should be listed in only one site budget for multi-institutional projects. 

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Information Session

An information session about the iTHRIV CTS Pilot Studies program and the proposal submission process will occur on April 8, 2025 at noon EST on Zoom: Click here to register in advance for this session. All applicants are strongly encouraged to attend this session. The session will be recorded and available for viewing.

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Translational Science (TS) Ideas Workshops

Purpose:

1. Provide researchers the opportunity to receive feedback on whether their projects align with the translational science (TS) framework, and to offer suggestions for better alignment.

2. Educate researchers on TS through interactive discussions.

 

The workshops (2/18/2025; 3/18/2025; 4/1/2025; 4/15/2025) will be moderated by experts who are leaders in TS.

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Click here to register in advance for these workshops. All applicants for the iTHRIV CTS Pilot Studies Program are strongly encouraged to attend whether or not they are seeking feedback on their project proposals at this time. Understanding translational science concepts vs. translational research will be paramount to submitting a well formulated proposal. Workshops will NOT be recorded.

 

Applicants who wish to receive feedback on their projects must submit an abstract 1 week prior to the session they are registered to attend. Up to 4 abstracts may be discussed per workshop. Abstracts will be accepted on a first-come, first-serve basis and all attendees will be bound by confidentiality and respect for the intellectual property of the submitting researcher.

Abstracts should be submitted by email to Medard Ng at htn3u@uvahealth.org.

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QUESTIONS? NEED HELP FINDING A PARTNER FOR A PROJECT? ​

• Antonio Abbater, MD, PhD, iTHRIV Pilot Studies Program Director,

antonio.abbate@virginia.edu

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• Medard Ng, iTHRIV Pilot Studies Program Manager,

htn3u@uvahealth.org

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• Kayla Calvo, iTHRIV Grant Administrator,

 krc7d@virginia.edu

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​​​Click here to learn about the 2023 funded projects