Overview

The Biostatistics, Epidemiology, and Research Design (BERD) Center seeks to support innovative and promising human subjects research projects that would benefit from statistical analysis and computational modeling assistance. Qualified projects include pilot or other modest studies that are expected to generate future grant proposals for larger studies and/or publications in peer-reviewed journals. Proposed projects must have a preliminary hypothesis underlying the research and a defined plan and timeline for the publication and dissemination of all research results and for seeking future extramural funding for a follow-on study.

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 appointment at a Tufts CTSI partner or collaborator institution. Vouchers will provide up to 20 hours of statistical analyses and computational modeling per project. Selected projects will be supported beginning May 1, 2019 for a period of 12 to 18 months.

Request for Applications

The application period for the initial competition of the BERD Center Voucher Program will open on Monday, February 25.

Applications will be accepted through Friday, March 29, 2019.

Summary of Key Dates

  • Application available: February 25, 2019
  • Applications due: March 29, 2019
  • Award announcement: late April 2019
  • Projects begin: May 1, 2019
  • Projects end: by October 31, 2020
  • Final project report due: 90 days following study completion based on the project timeline

Who is eligible?

Eligible applicants include investigators with a position or faculty appointment at one of Tufts CTSI’s partners and collaborators, or a research-active clinical nurse with a graduate degree who is employed by a Tufts CTSI-affiliated hospital or medical center.

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 four application-specific forms, which must be completed and uploaded as part of the application. The BERD Voucher Program submission form and application-specific templates are available here.

Application Outline

  • Project description (250 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 BERD Center study support services needed (maximum half a page)
  • Bibliography (maximum one page)
  • Curriculum Vitae or NIH-format biosketch (maximum five pages)
  • Chair/chief letter of support/commitment (maximum two pages per letter)
  • Research protocol, if available (optional)

Available Resources and Services

The BERD Center team is available to answer questions and offer guidance in-person on Wednesdays from 8:00 to 9:00 AM at Tufts CTSI in downtown Boston (35 Kneeland Street, 10th Floor) or by phone on Fridays from noon to 1:00 PM. To schedule a call, please email info@tuftsctsi.org with your name, department, phone number, and a brief description of your question/project. Alternatively, applicants may request an in-person or virtual consultation, free of charge, at any time by submitting a service request.

About the BERD Center

The BERD Center is a joint program between Tufts CTSI and the Institute for Clinical Research and Health Policy Studies (ICRHPS). BERD statisticians and epidemiologists hold faculty and scientific staff appointments at Tufts Medical Center and Tufts University School of Medicine. They provide pre- and post-award services, including guidance in framing research questions, developing study designs, selecting and conducting statistical analyses appropriate for research aims, calculating and justifying sample size, evaluating threats to study validity, and addressing human subject concerns.

About the BERD Voucher Program

The BERD Center is committed to promoting innovation and excellence across the spectrum of translational and patient-oriented research. Launched in 2019, the BERD Voucher Program offers up to 20 hours of statistical analysis and computational modeling support to promising research projects that could be advanced with the help of experienced statisticians and epidemiologists. The program is designed to benefit new and established investigators and research teams with limited research funds. It prioritizes projects for which a major barrier to moving forward is funding for statistical analysis. As part of the program, BERD faculty and staff work collaboratively with voucher recipients to select and perform the most suitable analysis for the aims of the research project, thus increasing the likelihood that their projects result in publications in peer-reviewed journals.

Eligibility

Proposals must designate a Principal Investigator (PI) with a primary position or appointment at a Tufts CTSI partner or collaborator institution.

Eligible Sites

  • Action for Boston Community Development
  • Asian Community Development Corporation
  • Asian Task Force Against Domestic Violence
  • Asian Women for Health
  • Baystate Medical Center
  • Blue Cross Blue Shield of Massachusetts
  • Boston Chinatown Neighborhood Center
  • Brandeis University
  • Center for Information and Study on Clinical Research Participation
  • Greater Boston Chinese Golden Age Center
  • Health Resources in Action
  • Institute for Clinical Research and Health Policy Studies
  • Lahey Hospital and Medical Center
  • Maine Medical Center
  • Massachusetts Biotechnology Council
  • Massachusetts Institute of Technology
  • MGH Institute of Health Professions
  • Museum of Science, Boston
  • New England Quality Care Alliance
  • Newton-Wellesley Hospital
  • Northeastern University
  • Novartis
  • Pfizer, Inc.
  • RAND Corporation
  • Elizabeth’s Medical Center
  • The Jackson Laboratory
  • Tufts Center for the Study of Drug Development
  • Tufts Health Plan
  • Tufts Medical Center
  • Tufts University

Eligibility Criteria

  1. Investigator with a position or faculty appointment at a Tufts CTSI-affiliated institution
    –or—
    Research-active clinical nurse employed by a Tufts CTSI-affiliated hospital or medical center (must have a graduate degree)
  2. No current funding for the proposed project except for modest intramural or extramural seed funding which would complement BERD services

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. Approach – scientific rigor of the proposed clinical or methodological design plan to meet proposed objectives and goals.
  6. Future Plans – clear articulation of next steps.

Funding Decision

Voucher awardees will be selected by the Tufts CTSI Senior Leadership Team based on the BERD Center Directors’ recommendations, overall impact score, and available resources. The program will prioritize projects for which the sole barrier to moving forward is funding for statistical analysis. Roughly equivalent priority will be given to:

  1. New projects from investigators/research teams with prior experience of collaborating with BERD
  2. Projects proposed by investigators/research teams with no prior experience of collaborating with BERD

All applicants will be informed of the outcome of their submission via email. In addition, applicants submitting meritorious proposals may be contacted for a discussion regarding support service needs.

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 and the BERD Voucher Program Review Committee.

Requirements Upon Proposal Selection

Institutional and Regulatory Approvals

If applicable, projects involving human subjects as research participants must have required Institutional Review Board (IRB) approvals. If necessary, proof of exempt status determination must be obtained.

Training

Investigators and other 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

Voucher recipients will be required to submit a final 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 funding 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 and comply with the NIH Public Access Policy. Guidelines for citations are available here.

Questions?

Please send any questions to voucher@tuftsctsi.org.