Selected Tufts CTSI Pilot Studies Program projects will be funded for one year, beginning May 1, 2020 and ending April 30, 2021, pending NIH/NCATS approval.
Post-Award Key Dates
- Award period begins: Friday, May 1, 2020 (pending NIH approval)
- Award period ends: Friday, April 30, 2021
- Final project reports due: Thursday, July 29, 2021
- Final project presentation: Fall 2021
Investigator Agreements Upon Proposal Funding
At the time of funding decision, but prior to the award start, Tufts CTSI’s resource and service providers will review all funded proposals and, where relevant, will provide research teams with recommendations to advance the quality and efficiency of their research projects. Reviews include:
- Research Study Design: Tufts CTSI’s Biostatistics, Epidemiology, and Research Design (BERD) Center will make recommendations to investigators regarding optimal study design and data collection approaches with the goal of maximizing the project’s potential for publication and subsequent funding. BERD Center staff will also offer feedback and advice on the project’s analysis plans (e.g., methodological approaches, budgeting, and estimated time for completion). Award recipients conducting studies involving large data sets and requiring complex computational modeling may be contacted at the early project stages to offer input on the data collection, management, and analysis.
- Stakeholder Engagement: Tufts CTSI believes clinical and translational research is most relevant and impactful when it addresses issues important to patients, communities, clinicians, caregivers, and others who make medical and health decisions. Fully accruing these benefits in translational research requires having a range of individuals on the research team, what we term “broadly-engaged team science.” Broadly-engaged team science has the potential to enhance protocol development, speed study enrollment, improve the transparency of research, build public trust, and accelerate the adoption of research results into practice. To support broadly-engaged team science, the Tufts CTSI Stakeholder and Community Engagement Program Team will provide recommendations on the inclusion of stakeholders in all aspects of the research project.
- Research Process Improvement: The Tufts CTSI Research Process Improvement Team will provide recommendations on enhancing the quality and efficiency of the research study. The team will consult with investigators to ensure successful protocol design and implementation by collaboratively identifying and resolving issues that threaten successful study completion. The team will address study workflow issues at multiple points, including: 1) study start-up; 2) participant interactions; 3) visit workflow; 4) billing workflow; 5) sample collection and processing; 6) data collection and management; and 7) study closeout.
Institutional and Regulatory Approvals
Release of funds is contingent upon receipt of all necessary local institutional and regulatory approvals. While such approvals are not required at the time of proposal submission, award recipients will be expected to initiate the approval application process promptly after receiving their notice of award. If applicable, proof of exempt or exclusion status determination must be obtained.
NIH/NCATS Prior Approval Process for Research Involving Human and/or Animal Subjects
In addition to receiving local regulatory approvals, projects involving human and/or animal subjects may not begin until the appropriate NIH/NCATS approvals are received. Award recipients will be required to submit their local Institutional Review Board (IRB) and/or Institutional Animal Care and Use Committee (IACUC) approvals and any supplemental documentation to Tufts CTSI as soon as possible to ensure adequate time for review by the funding agency, NIH/NCATS. Generally, the NIH/NCATS prior approval process takes at least 30 days. If a request is returned for any reason, the 30-day turnaround time resets. To ensure all approvals are obtained by the award start date, applicants are strongly encouraged to contact any participating IRB and/or IACUC offices ahead of time to discuss potential issues that may arise.
- Requirements for Research Involving Human Subjects: Award recipients conducting research on human subjects and/or human cell lines and tissue repositories, including research that is otherwise exempt, are required to comply with requirements for the NCATS Human Subject Research Prior Approval. (PLEASE NOTE: (a) The Inclusion Across the Lifespan policy of the NIH is now in effect. Award recipients will be expected to include all individuals, including children and older adults, in their clinical research in a manner appropriate to the scientific question under study, unless there are scientific or ethical reasons to exclude them; (b) Research projects carried out at more than one site are required to use a single IRB (sIRB) of record to conduct the ethical review of non-exempt human subject research funded by the NIH. This NIH sIRB policy applies to the domestic sites of multi-site studies where each site will conduct the same protocol).
- Requirements for Research Involving Animal Subjects: Award recipients conducting research on animal subjects must comply with requirements for the NCATS Prior Approval for Planned Research Involving Live Vertebrate Animals. These requirements apply to work involving animals obtained or euthanized for tissue harvest and/or generation of custom antibodies. (PLEASE NOTE: Research projects carried out at more than one site are required to provide a description of activities involving the care and use of animals for each site. This rule applies to non-Tufts CTSI-affiliated institutions subcontracted by award recipients.)
The Tufts CTSI Research Collaboration Team provides scientific support for award recipients to aid in their successful conversion to research funding. At the time of the award, a Research Collaboration Team member will be assigned to each research team as the project’s “coach” to provide scientific and logistical support and to help address translational roadblocks. Award recipients will be expected to collaborate with their project coaches by providing progress updates, presenting future plans for publication/results dissemination and subsequent grant submission based upon findings, and discussing any challenges they may face during project implementation. At month 15-to-18 post-award, each research team will be required to make a presentation on its pilot project at a meeting open to the broader scientific community (e.g., Tufts CTSI Translational Research Day).
Reporting and Long-Term Outcomes Tracking
Award recipients will be required to submit a final report and a final invention statement and certification form (HHS 568). Tufts CTSI will provide a final report template to be completed. Form HHS and its instructions are available here. Both documents will be due within 90 days following the expiration or termination date of the grant award.
In addition, award recipients will be required to report study outcomes annually using an online tool for at least five (5) 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.
Please note that NIH requires reporting of pilot study outcomes. Pilot award recipient’s failure to complete annual reporting may preclude future Tufts CTSI funding to the award recipient and their institution, school, or department.
All publications, projects, posters, patents, trademarks, or other tangible outcomes resulting from Tufts CTSI’s funding and services must cite Tufts CTSI’s NIH CTSA award (UL1TR002544) and comply with the NIH Public Access Policy. Tufts CTSI relies on these citations as a critical performance measure when reporting annual productivity to NIH. Detailed guidelines for citations are available here.
Future Pilot Review Commitment
Award recipients will be expected to serve as reviewers for future Tufts CTSI Pilot Studies Program applications.
Carryover, Extensions, and Over-Expenditures
Carryover of expenses is not allowed. Funds not expended by April 30, 2021 will revert to Tufts CTSI. An assignment account must be provided to cover any over-expenditure. Project extensions are strongly discouraged, but will be considered on a limited basis at the discretion of Tufts CTSI.