Overview

The Tufts CTSI Clinical and Translational Research Center (CTRC) Voucher Program seeks proposals for clinical studies requiring modest support in order to complete a study or generate preliminary data to support a proposal for a larger, more definitive study. Support is limited to $5,000 per project. Awards may be used to cover direct costs for clinical support using the resources of the CTRC (e.g., to offset costs associated with use of CTRC space, sample processing services, and personnel for research study participant evaluations). Please see a list of CTRC services here.

The Voucher Program funds seed human subjects projects having a preliminary hypothesis underlying the research and a defined plan and timeline for the completion of the study, and for seeking extramural funding (e.g., NIH, National Science Foundation, Patient-Centered Outcomes Research Institute, Agency for Healthcare Research and Quality, or other funders) for a follow-on study.

Request for Applications

Tufts CTSI is pleased to announce that the application period for the initial competition of the CTRC Voucher Program is now open.

Selected projects will be funded for up to 18 months beginning November 1, 2018.

This Request for Applications seeks to support innovative pilot and other modest studies that are expected to support future proposals for larger, more definitive studies.

Summary of Key Dates

  • Application available: Monday, June 18, 2018
  • Initial Competition Final Application Due: Friday, August 31, 2018
    • There will be at least one additional competition prior to May 1, 2019, depending on demand
  • Award Announcement: late October, 2018
  • Project period ends: projects are expected to be completed within approximately 12-18 months
  • Final Project Report Due: 60 days following study completion

Who is eligible?

Eligible applicants include members of Tufts CTSI’s partners and collaborators, which span academic partners, affiliated hospitals, community organizations, industry, and nonprofit organizations.

Eligibility

Eligible applicants include members of Tufts CTSI’s partners and collaborators, which span academic partners, affiliated hospitals, community organizations, industry, and nonprofit organizations.

Proposals must designate a Principal Investigator (PI) with a primary appointment or position at a Tufts CTSI academic, medical, or nonprofit research partner/collaborator institution. Other research team members may include collaborators who are not affiliated with a Tufts CTSI partner/collaborator, but they cannot receive funding under this mechanism.

At the time of award, the applicant must have an eRA Commons Username to meet federal reporting guidelines.

Eligibility Criteria

  1. Academic rank of Assistant Professor or Instructor
    –or—
    Nurse employed at Tufts Medical Center >2 years, with a graduate degree, and two letters of support from manager/director that include commitment to provide protected time to conduct the research.
  2. No current extramural funding for the proposed project.
    1. Exception: studies funded with modest foundation awards requiring voucher program support to complete the study may be eligible.
  3. No bridge funding shall be provided for proposed projects between extramural funding.
  4. Divisional/departmental commitment to sufficient protected time for the investigator to conduct the study.

How to Apply

Prior to submission, applicants should access the online system to download the Voucher Program application templates. Once the required documents have been completed, they should be uploaded as part of the application. Please access the templates and submit completed applications here.

Required documents:

  • Research Strategy:
    • Project abstract (250 words or less)
    • Specific aims (maximum half a page)
    • Research strategy, including rationale and research procedures (maximum three pages)
    • Collaborators, if any, and their roles on the project (maximum one page)
    • Overview of CTRC study support services needed (maximum half a page)
    • Bibliography (maximum one page)
  • Signature page (one signature page per application)
  • NIH format biosketches of senior/key personnel (maximum five pages per biosketch)
  • Chair/chief letter of support/commitment (maximum two pages per letter)

A detailed budget and budget justification are not required at the time of application submission. Rather than attempt to provide an exact budget, applicants should briefly describe the extent and types of services needed. Although not required, if a detailed protocol is available, it can be uploaded as part of the application.

Applicants are encouraged, but not required, to request a Biostatistics, Epidemiology, and Research Design (BERD) Center study design consultation prior to submitting a proposal. Please request a consultation here.

Scientific Review Criteria

Each application will be reviewed according to the following criteria:

  1. 9-point rating scale (1 = exceptional; 9 = poor).
  2. b. Scored Review Criteria:
    1. Significance
    2. Investigator(s)
    3. Innovation
    4. Impact
    5. Approach
    6. Environment
    7. Future Plans
  3. Roughly equivalent priority for:
    1. Projects for which the sole barrier to moving forward is funding
    2. New projects from an investigator
    3. New investigator with no prior funding
    4. Review committee shall prioritize using these and other review parameters

Grant and Funding Review

Applicants submitting meritorious proposals will be contacted for a discussion regarding budgetary needs. Funding recommendations will be made by the CTRC Voucher Review Committee to Tufts CTSI Senior Leadership Team, which will approve funding based upon available funds.

Investigator Requirements Upon Proposal Funding

Regulatory Approvals

IRB approval must be secured by awardees prior to enrolling research study participants.

Training

Key Personnel and individuals on NIH awards and contracts who are responsible for the design or conduct of the studies involving human participants are required to submit certificates of competition for Human Subject Research training prior to award start.

All investigators and clinical trial site staff who are responsible for the conduct, management, and oversight of NIH-funded clinical trials must submit a certificate completion for Good Clinical Practice (GCP) training prior to award start.

Reporting

Award recipients will be required to submit a final report on the project, due to Tufts CTSI within 60 days of study completion. They will also be required to report study progress and outcomes annually using a Tufts CTSI-provided online tool for at least five years after the funding ends. Outcomes to be reported include professional presentations, published manuscripts, subsequent funding applications and awards, research products and associated intellectual property protections, and activities to implement findings into clinical care or public health.

Publication Requirements

All publications resulting from pilot studies must cite Tufts CTSI and comply with the NIH Public Access Policy. Guidelines for citations are available here.

Questions?

Please send any questions to voucher@tuftsctsi.org.