Pilot Translational and Clinical Studies Program

Proposed 2021 Timeline

Overview:

The iTHRIV Pilot Translational and Clinical Studies Program is a core component of the NIH-funded Clinical and Translational Sciences Award (CTSA), the integrated Translational Health Research Institute of Virginia (iTHRIV). iTHRIV is a statewide collaborative research network with a mission of using data to improve health.  It is comprised of 4 research institutions, Carilion Clinic, Inova Health, the University of Virginia, and Virginia Tech.

 

The goal of the iTHRIV Pilot Studies Program is to support innovative approaches to clinical and translational research to foster collaborative research across the iTHRIV partner institutions.  By providing teams with early-stage pilot funding, iTHRIV aims to provide resources to accelerate discovery, generate preliminary data, and support translational science through partnerships across the Commonwealth of Virginia.

Proposals can include the full range of translation from the laboratory to the clinical area.  Areas of particular interest include:

  • Innovative uses of data science to improve health,

  • Research focused on health disparities,

  • Team science collaborations across two or more iTHRIV partner institutions.

iTHRIV has a total of $200,000 to distribute and the number of projects funded will depend on the quality of proposals and funding request amounts.  Projects are required to be completed within one year. 

Budget Request Options:

  • Single-site iTHRIV Institution Investigator: up to $25,000 in direct costs, or

  • Multi-site iTHRIV Institution Investigators (Requires a minimum of 2 iTHRIV institutions): up to $50,000 in direct costs

 

Application Process:

 

Eligibility

 

  • All proposals must involve an interdisciplinary team. Multiple PIs or co-PIs are encouraged.

  • Any faculty member eligible to serve as a PI on external grants and contracts at their iTHRIV institution may serve as the contact PI for an application.

  • Multi-institutional projects must include at least 2 separate iTHRIV institutions (Carilion Clinic, Inova, UVA, VT)

  • All projects involving human subjects or vertebrate animals must provide proper regulatory approvals prior to initiation of the research, but not prior to submission of the proposal.

 

June 28th, 2021:

RFP Release

August 30th, 2021

5 pm ET

Application Deadline

February 1, 2022:

Anticipated project start

July 6th, 2021

4 pm ET

Zoom information session

October 25th, 2021: 

Anticipated award notification date

Proposal

 

Applications MUST be submitted by 5:00 pm ET on Monday, August 30, 2021

 

Complete proposals should be submitted to iTHRIVAdmin@hscmail.mcc.virginia.edu.

Teams should submit a single PDF containing the following:

 

  • Application Coversheet (Please download and save before completing)

  • Abstract (500 words or less)

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

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

    • Specific Aims

    • Impact

    • Research Plan

    • Description of Team

    • Plan for Community Engagement

    • Timeline

    • Plan for Follow-on funding

  • Resource and Data Sharing Plan(1 page limit)

This should include your plans for dissemination of data from your project as well as plans for sharing any other resources including model organisms or genomic data sharing.

  • NIH formatted budget and budget justification (use templates provided here)

  • NIH-style biosketch for each key personnel (please utilize the new 12/2020 version)

 

*References should be included but are not considered in part of the 5 page project description.

Budget Guidelines

 

  • Project period is one year; no-cost extensions are permitted.
  • For multi-institutional projects: a budget and budget justification for each institution is REQUIRED.
  • PI/Co-PI effort is NOT required on the budget. Pilot awards are ideally suited to provide support for research staff, supplies, etc.
  • Consortium agreements are not required between iTHRIV institutions
  • Publications costs are NOT allowed
  • One Community Engaged Studio is required for each project, and this should be budgeted in only one site budget for multi-institutional projects. Please include $500 in the budget for a Community Engaged Studio (see section below for more details about Community Engaged Studios)
  • Budget and budget justification templates provided must be utilized
  • Anticipated funding dates: Feb, 1, 2022- Jan 31, 2023
  • Indirects are unallowable. Only Direct costs should be included in the budgets.

 

 

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

* These grant administrators can then contact Kayla Calvo (KRC7D@hscmail.mcc.virginia.edu) with any additional questions.

Regulatory Approvals

  • Awardees must obtain all applicable regulatory approvals (e.g. IRB, IACUC, or Radiation Safety) and meet all compliance requirements prior to receiving funds and maintain approvals during the entire length of the award.
  • When applying for IRB/IACUC approval, indicate that this research is supported by the National Institutes of Health (iTHRIV Award number UL1TR003015). Funding source: NIH/NCATS.
  • IRB/IACUC approval(s) must be kept current and active for the duration of the award period. Copies of all approval letters need to be sent to Medard Ng, PhD, Research Quality Manager- HTN3U@hscmail.mcc.virginia.edu         
  • Any multi-site, non-exempt human subject research study will be required to follow the NIH mandate for use of a single IRB of record.
  • All funded proposals which involve human subjects or vertebrate animals will require submission to and review of the project by NCATS prior to beginning the project. Teams who are awarded funding will meet with the Research Quality Manager for guidance through this process. The approval process can take several weeks to 1 months’ time. In order to protect against delays, all applicants are urged to seek IRB or IACUC approval concurrent with the submission of the pilot application.
  • If your project is an NIH-defined clinical trial (see below), you must register your project and report results on clinicaltrials.gov.

 

​​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

 

Please Note: iTHRIV has a four-way Master Research Collaboration Agreement in place between all institutions. This agreement should be utilized to expedite MTA’s and DUA’s between iTHRIV institutions.

 

 

Proposal Review Process

 

iTHRIV Pilot Studies applications will receive an administrative review for completeness and eligibility, then all applications will be evaluated by reviewers from all four institutions and a community member. The top proposals will be reviewed and approved for funding by the iTHRIV Leadership Council.

 

Applications will be evaluated based on the following criteria:

  • Does the project involve an innovative approach to an important clinical problem?
  • Is the project supported by appropriate preliminary data supporting the feasibility of translation to the clinic?
  • Does the project employ a team science approach and include personnel with the required expertise?Priority will be given to multi-site collaborative projects.
  • Is the project likely to lead to follow-on funding and/or translation to clinic?

 

Community Engaged Studios

 

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

 

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

 

Potential topics:

  • Shaping a research question or proposal.
  • Enhancing study design, implementation, or 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).

 

iTHRIV CES gives community members an effective and active role in health care research and gives 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 Engaged Studios.  All pilot project applications must include costs for this in the budget ($500).

Please Note: The iTHRIV team will assist in this process.

Please click here for additional information.

 

 

Information Session

 

An optional information session about the iTHRIV Pilot Studies program and the proposal submission process, will occur on July 6th, 2021 at 4 pm ET on Zoom: Click here to register in advance for this session.  All applicants are strongly encouraged to attend this session.

 

 

Submission Checklist

 

            ☐Completed and Signed Application Coversheet

            ☐Abstract

            ☐Project Proposal/ Research Plan (5 page maximum)

            ☐References

            ☐Resource and Data Sharing Plan

            ☐NIH-style biosketch for each key personnel

            ☐Separate Budget(s) and Budget justification(s) for each institution

           

                 

 

Frequently Asked Questions

1) What does community engagement mean?

  • Identifying and communicating with stakeholders and end-users of the research process.

 

2) Are indirects allowed to be included in the budget?

  • No

 

3) Are references considered part of the 5-page project description?

  • No, references are separate as are the abstract, resource and data sharing plan, budget, budget justification, and NIH biosketches.

4) Are PI’s or Co-I’s required to have budgeted effort on this proposal?

  • No, PI effort is discouraged, with this limited funding iTHRIV anticipates the majority of the funding will be needed for supplies, support staff, statistical support, etc.

5) Do proposals require review prior to submission by the grants and contracts office?

  • For UVA budgets (even if it is considered a sub-award) - No, but departmental research administrator review is highly recommended and a signature is required.
  • For all other institutions-follow institution guidelines and policies.
  • Consortium agreements are NOT needed. Please contact Kayla Calvo (KRC7D@hscmail.mcc.virginia.edu) for further clarification.

6) If this is a multi-institution project, are separate budgets and budget justifications required?

  • Yes, see question #2 for information regarding indirect rates.

 

7) If this is a multi-institution project, are the budgets required to be split evenly between institutions?

  • No, the budgets should be comparable to the work being done at each site.

8) Does any information about the Community Engagement Studio have to be included in the Research Plan?

  • No, but there must be a description about the overall plan for community engagement and $500 does need to be included in the budget and budget justification for the completion of a Community Engagement Studio.

 

 

Watch the recorded information session below

Here is an example of a successfully funded project

Additional questions? Contact: