Overview

The Tufts CTSI Clinical and Translational Research Center (CTRC) Voucher Program offers direct research support to unfunded or underfunded non-industry clinical studies and trials. The program aims to accelerate and facilitate implementation of such studies and trials by providing access to CTRC’s specialized clinical services and state-of-the-art facilities available 24 hours a day, seven days a week, at in- and out-patient facilities at Tufts Medical Center.

The program is currently prioritizing COVID-19 research projects and encourages the use of CTRC Voucher Awards to augment Tufts CTSI COVID-19 Pilot Studies Program projects. More information on the COVID-19 Pilot Studies Program can be found here.

PLEASE NOTE: Applicants must adhere to all home institutional PRIOR APPROVAL requirements regarding COVID-19 research as it applies to data requests, biorepository/samples, clinical trials, registries, etc.

The program is primarily intended to support seed human subjects projects that require modest assistance in order to complete a study or generate preliminary data necessary for publishing research findings and for securing future intramural or extramural funding. Priority will be given to projects that can demonstrate the potential to address translational blocks or impediments to the translation of clinical research into improvements in health.

Eligible applicants include clinical, health services, and basic science investigators working in different areas of clinical research. Proposals must designate a Principal Investigator with a primary position or faculty appointment at Tufts Medical Center or Tufts University. Research teams may include collaborators affiliated with other medical, academic, non-for-profit, or community organizations. Voucher support is limited to $5,000 of in-kind services per project. Awardees may use vouchers to offset expenses for clinical and translational research services, such as patient recruitment, routine and specialized nursing, sample collection and processing, study coordination, regulatory assistance, medical administration, and use of clinical facilities and equipment.

Selected projects will be supported for a period of 12 to 18 months from the award notification date.

CTRC Sample Processing During COVID-19

In response to the urgent need for sample processing (relating to, or pre-dating, COVID-19), the Tufts Clinical and Translational Research Center (CTRC) Voucher Program offers a new, expedited process called CTRC Sample Processing During COVID-19 to support sample processing for federal and other non-profit studies on a case-by-case basis. Learn more and apply for assistance here.

Request for Applications

The applications for the 2020 CTRC Voucher Program will be accepted on a rolling basis until further notice.

To apply, please click here.

Summary of Key Dates

  • Scientific review: applicants submitting COVID-19 research projects will be notified within one week of the application submission date and applicants submitting non-COVID-19 research projects will be notified within three weeks of the application submission date.
  • Award period: projects are expected to be completed within 18 months of the funding notification date.
  • Final project reports due: 90 days following study completion based on the project timeline.

How to Apply

Complete applications and any accompanying materials must be submitted online using the REDCap submission form. The application consists of fields to be filled in online and three application-specific forms, which must be completed and uploaded as part of the application. The CTRC Voucher Program submission form and application-specific templates are available here.

Application Outline

  • Project description (500 words or less)
  • Specific aims (maximum half a page)
  • Research strategy, including a description of the study rationale and the study analytic plan (maximum three pages)
  • Overview of collaborators’ roles, if applicable (maximum one page)
  • Description of CTRC support services needed (maximum half a page)
  • Bibliography (maximum one page)
  • Curriculum Vitae or NIH-format biosketch for senior/key personnel (maximum five pages)
  • Chair/chief letter(s) of support/commitment (maximum two pages per letter)
  • Research protocol, if available (optional)

Available Resources and Services

Applicants are encouraged to work with CTRC during the project proposal development phase. The CTRC team can answer any questions regarding the voucher program and offer guidance to investigators on the most appropriate and cost-effective services to meet their individual research needs. In addition, they can connect applicants to other Tufts CTSI service providers who can provide methodological and technical support, recommend additional project team members, as well as assist teams with project design and planning. Those interested in taking advantage of Tufts CTSI’s free pre-award resources and services can request an in-person or virtual consultation by submitting a service request here.

The CTRC Voucher Program

About the CTRC

The CTRC provides investigators with the infrastructure to conduct a range of state-of-the-art clinical studies and trials in neonatal, pediatric, adult, and geriatric research participants. The CTRC also offers resources to facilitate clinical research for studying the causes and progression of human disease and for translation of biomedical research to prevent, treat, or cure disease. It is led by experienced clinicians and is staffed by specialized clinical research nurses, research assistants, and research study coordinators qualified to provide support for every aspect of a clinical study and trial.

The CTRC services are available to research teams across Tufts CTSI partner and collaborator institutions, but must include an investigator with a primary position or faculty appointment at Tufts Medical Center or Tufts University and a research protocol approved by the Tufts IRB. They may access CTRC’s resources and services at in- and out-patient facilities at Tufts Medical Center and across its affiliate locations of care. CTRC’s services include, but are not limited to, protocol design, regulatory and coordinating services, patient recruitment, subject randomization, data collection, routine and specialized nursing, sample collection, medical administration, and patient follow-up. To see a detailed list of CTRC’s expert services, please click here.

About the CTRC Voucher Program

The CTRC is committed to accelerating and facilitating implementation of clinical studies and trials by providing support across the full patient lifespan and ensuring a positive experience for everyone involved. Its services range from initial clinical, epidemiologic, and scientific consultations to complete support required throughout all key stages of clinical study or trial implementation. Launched in 2018, the CTRC Voucher Program offers vouchers for in-kind services for up to $5,000 to support a range of seed human subjects projects that require modest assistance in order to complete a study or generate enough preliminary data to support a proposal for a larger, more definitive study. The program is designed to benefit new and established investigators and research teams with limited research funds.

Eligibility

Eligibility Criteria

  1. Investigator with a primary position or faculty appointment at Tufts Medical Center or Tufts University, including research-active clinical nurse with a graduate degree.
  2. No current funding for the proposed project except for modest non-industry intramural or extramural seed funding which would complement CTRC services.

Research Team Members

Research team members may include collaborators from other organizations, but they cannot receive vouchers under this funding mechanism. At the time of award, key personnel must have an Electronic Research Administration (eRA) Commons usernames to meet federal reporting guidelines.

Application Review Process and Selection Criteria

Scientific Review

Complete applications will be reviewed and rated using the 9-point rating scale (1=exceptional; 9 =poor). The review process will follow the NIH guidelines based on the following criteria:

  1. Relevance – ability to demonstrate a clear translational path and explicit relevance to improved health.
  2. Significance – quality and merit of the proposed research project.
  3. Innovation – potential for impact through development of novel solutions and processes.
  4. Investigator(s) – qualifications of the investigator/research team to carry out proposed research.
  5. Environment – availability of resources to support proposed research.
  6. Approach – scientific rigor of the proposed clinical or methodological design plan to meet proposed objectives and goals.
  7. Future Plans – clear articulation of next steps for future research, dissemination of project results, and seeking subsequent funding.

Funding Decision

Applications will be reviewed for scientific merit, alignment with Tufts CTSI’s mission, and justification of need. Applicants submitting meritorious proposals may be contacted for a discussion regarding support service needs. Voucher awardees will be selected by the Tufts CTSI Senior Leadership Team based on the CTRC’s Directors’ recommendations, overall impact score, and available resources. Priority will be given to promising projects that address a critical need in translational science that currently have little or no funding. All applicants will be informed of the outcome of their submission via email.

Research Collaboration Team Review

In addition to review by the CTRC Voucher Program Review Committee and Tufts CTSI Senior Leadership Team, applications may be reviewed by the Tufts CTSI Research Collaboration Team to identify projects for further development and submission to other funding announcements, and/or to identify potential collaborators. Applicants may be contacted by Tufts CTSI Navigators or other members of the Research Collaboration Team for future research opportunities.

Confidentiality and Non-Disclosure

All proposals will be deemed proprietary and confidential and will be protected against any unauthorized use and any unauthorized or uncontrolled disclosure beyond Tufts CTSI.

Requirements Upon Proposal Selection

Institutional and Regulatory Approvals

The voucher award is contingent upon receipt of all necessary approvals through the Institutional Review Board at Tufts Medical Center and Tufts University (Tufts Health Sciences IRB). While such approvals are not required at the time of the proposal submission, voucher award recipients will be expected to initiate the approval application process promptly after receiving their notice of award.

Training

Key personnel involved in the design or conduct of human subjects research are required to complete human subjects protections training prior to project start. Investigators and clinical trial site staff responsible for the conduct, management, and oversight of studies that meet the NIH definition of a clinical trial are also required to be trained in Good Clinical Practice (GCP). If necessary, GCP training should be refreshed in order to remain current with NIH regulations, standards, and guidelines.

Final Reports and Long-term Outcomes Tracking

CTRC Voucher recipients will be required to submit a final summary report on the project, due to Tufts CTSI within 90 days of study completion based on the project deliverables timeline. In addition, they will be required to report study outcomes annually using an online tool for at least five years after the voucher support ends. Outcomes to be reported will 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.

Citation Requirements

All publications, projects, posters, patents, trademarks, or other tangible outcomes resulting from Tufts CTSI funding and services must cite Tufts CTSI NIH Clinical and Translational Science Award (UL1TR002544) and comply with the NIH Public Access Policy. All publications resulting from the research supported by this grant must be submitted via the NIH Manuscript Submission System and assigned a PubMed Central (PMC) identifier.

Questions?

Need further assistance? We are here to help. Please contact us at voucher@tuftsctsi.org.

Ronald D. Perrone, MD, Scientific Director of the Clinical and Translational Research Center

Alice Rushforth, PhD, Tufts CTSI Executive Director