Overview

The Tufts Clinical and Translational Science Institute (CTSI) COVID-19 Pilot Studies Program seeks proposals for innovative, high-impact, translational science projects from the basic, clinical, and/or applied sciences to address the urgent need for research on the 2019 Coronavirus (COVID-19). Proposed approaches could include studies that: 1) advance cutting-edge COVID-19 prevention practices; 2) support translation of new diagnostics, treatments, and behavioral interventions into clinical care; 3) increase the overall effectiveness and quality of COVID-19 health care and public health interventions; or, 4) assess the impact of COVID-19- related health policies.

Selected projects will be funded for one year, beginning May 1, 2020 and ending April 30, 2021, pending institutional and National Institutes of Health (NIH) approval.

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.

Who is eligible?

To be eligible for the Pilot Studies Program grant, the Principal Investigator (PI) must have a primary appointment or position at a Tufts CTSI academic, medical, not-for-profit, or community partner or collaborator organization. Applicant research teams may include collaborators who are and who are not affiliated with Tufts CTSI.

Request for Applications

The application period for the Tufts CTSI COVID-19 Pilot Studies Program is now closed.

Key Pre-Award Dates

  • Application submission period begins: Friday, April 3, 2020
  • Application submission period ends: Monday, April 13, 2020.
  • Award announcements: Friday, April 17, 2020

How to Apply

The Pilot Studies Program application consists of fields to be filled in online and three program-specific forms, which must be completed and uploaded as part of the application in REDCap.

Application Outline

  • Project abstract (maximum 250 words)
  • Background and significance (maximum one-half page)
  • Specific aims (maximum one page)
  • Research procedures (including recruitment and analysis plans as applicable) (maximum two pages)
  • Study Feasibility (maximum one page)
  • Description of Clinical and Translational Support Services (optional – maximum one-half page)
  • Plan and timeline for dissemination of research findings and for seeking extramural funding (maximum one-half page)
  • Bibliography (maximum one-half page)

Forms

  • Applicant certification and authorization
  • Budget and budget justification (one per eligible site)
  • NIH-format biosketch(es) for senior/key personnel (maximum five pages per biosketch)
  • Letter(s) of support/commitment (as applicable)

Available Resources and Services

Applicants are strongly encouraged, but not required, to access Tufts CTSI research resources and services to enhance proposal development by advancing study design, fostering collaboration, and identifying infrastructure support. If you would like to speak to a member of Tufts CTSI, please request a consultation at https://informatics.tuftsctsi.org/pims/request.htm#/.

The Tufts CTSI Pilot Studies Program

About Tufts CTSI

Supported by the National Center for Advancing Translational Sciences (NCATS), Tufts CTSI is one of more than 50 Clinical and Translational Science Awards (CTSAs) institutions that impacts health by promoting clinical and translational science. Translation, as defined by NCATS, is the process of turning observations in the laboratory, clinic, and community into interventions that improve the health of individuals and populations – from diagnostics and therapeutics to medical procedures, behavioral interventions, and, ultimately, health policy. To learn more about translational science and translational spectrum for Tufts CTSI, please click here. 

Eligibility

Principal Investigators and Research Team Members

Eligible applicants include members of Tufts CTSI-affiliated institutions, which span academic partners, affiliated hospitals, for-profit and not-for-profit collaborators, and community-based organizations. Proposals must designate a Principal Investigator (PI) with a primary appointment or position at a Tufts CTSI partner or collaborator institution. Research teams may include other key personnel members who contribute to the scientific development and execution of a project in a substantive, measurable way, but subcontracts are not allowed under this Requests for Applications. Please refer to the list of Tufts CTSI partners and collaborators listed below.

Eligible Sites

Academic Partners and Collaborators

  • Brandeis University
  • Massachusetts General Hospital Institute of Health Professions
  • Massachusetts Institute of Technology
  • Northeastern University
  • RAND Corporation
  • The Jackson Laboratory
  • Tufts University

Clinical Partners and Collaborators

  • Baystate Medical Center
  • Lahey Hospital and Medical Center
  • Maine Medical Center
  • New England Baptist Hospital
  • Newton-Wellesley Hospital
  • St. Elizabeth’s Medical Center
  • Tufts Medical Center

For-profit and Not-for-Profit Partners and Collaborators

  • Blue Cross Blue Shield of Massachusetts
  • Massachusetts Biotechnology Council
  • Novartis
  • Pfizer, Inc.
  • Tufts Health Plan

PLEASE NOTE: For-profit institutions are eligible as participant sites, but they cannot receive funding.

Community Partners and Collaborators

  • Action for Boston Community Development
  • Asian Community Development Corporation
  • Asian Task Force Against Domestic Violence
  • Asian Women for Health
  • Boston Chinatown Neighborhood Center
  • Center for Information and Study on Clinical Research Participation
  • Greater Boston Chinese Golden Age Center
  • Health Resources in Action
  • Museum of Science, Boston
  • New England Quality Care Alliance

Eligibility Criteria

  1. Principal Investigator with a position or faculty appointment at a Tufts CTSI partner or collaborating institution (research teams may include collaborators who are and who are not affiliated with Tufts CTSI).
  2. No current funding for the proposed project or only modest intramural or extramural funding that will be enhanced by the pilot activities.

Budget Guidance and Requirements

Funding Amounts

Awards will be made to eligible individuals or research teams for up to $25,000 per award. We anticipate funding two Pilot Study Awards.

In addition to $25,000 in Pilot Studies funds, proposals including an investigator with a primary position or faculty appointment at Tufts Medical Center or Tufts University may leverage the Clinical and Translational Research Center (CTRC) Voucher Program for an additional $5,000 of in-kind research services to support their research projects. For more information about the CTRC Voucher program and available services, please click here. Eligible Pilot Studies applicants do NOT need to complete the CTRC Voucher program application to apply for these funds, but may apply through the online Pilot Studies application by submitting a summary of the CTRC in-kind services they are requesting in Research Strategy component of the application.

Allowable Costs

For all awards, applicants may only request direct costs that are necessary and reasonable to complete the work described in their applications. Such direct costs may include key personnel and support staff salaries and fringe benefits; consultant services; clinical support; stipends or compensation for stakeholders involved in the project; participant incentives; and laboratory research supplies/analyses. All costs should be justified. Indirect costs are not allowed and will not be covered.

Cost Sharing

Cost sharing is the portion of pilot project costs that are not paid for by the pilot project budget.
Cost sharing for investigator salaries is discouraged and will be allowed only with written approval of both the appropriate department chair and senior administrator.

Subcontracts

Subcontracts may not be included in the budget.

Application Review Process and Considerations

Application Review Criteria

All complete applications, will be reviewed by a Scientific Review Committee and rated using the 9-point rating scale (1=exceptional; 9 =poor). The review process will follow the NIH scoring guidelines and each application will receive an overall impact score. The Committee will consider the significance of the proposal, innovation, investigators, environment, approach, and feasibility in determining the overall impact score. Significant emphasis will be placed on study feasibility and applicants should specifically address:

  • If the proposed study includes prospective data collection and participant informed consent, how access to participants and obtaining informed consent will be managed in the context of the large number of projected COVID-19 research projects being deployed.
  • Approach for limiting or eliminating the use of personal protective equipment (PPE), and the amounts and source of PPE should it be required for the study.
  • Need for, availability, and source of required biological samples (e.g., blood).
  • Need for, availability, and source of critical supplies (e.g., media, swabs, test kits, etc.).
  • Need for and access to laboratory space and core facilities at the home institution.
  • Availability of research staff.

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.

Funding Decision

Final funding decisions will be made independently by the Tufts CTSI Senior Leadership Team based on recommendations of the Scientific Review Committee, the overall impact score, budget justification, and available funds. All applicants will be informed of the outcome of their submission via email.

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, the Scientific Training and Review Committee, and Stakeholder Expert Panel.

Questions?

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

 Aviva Must, PhD, Director of the Pilot Studies Program

Daniel Jay, PhD, Associate Director of the Pilot Studies Program

Alice Rushforth, PhD, Tufts CTSI Executive Director