Selected Tufts CTSI Pilot Studies Program projects will be funded for one year, beginning May 1, 2019 and ending April 30, 2020, pending NIH approval.
Post-Award Key Dates
- Pilot project award begins: May 1, 2019 (pending NIH approval)
- Award period ends: April 30, 2020
- Final project reports due: July 29, 2020
- Final Pilot Studies presentation: Fall 2020
Investigator Agreements Upon Proposal Funding
At the time of funding decision, but prior to the award start, Tufts CTSI resource and service providers will review all funded proposals and provide research teams with recommendations to advance the quality and efficiency of their research project. Reviews include:
- Research Study Design: Tufts CTSI’s BERD Center will make recommendations to investigators regarding optimal study design and data collection approaches with the goal of maximizing project potential for publication and subsequent funding. BERD Center staff will offer feedback and advice on project analysis plans including analysis, methodological approaches, budgeting, and estimated time for completion. Research projects with significant data analysis requirements may be eligible for additional, free BERD Center data analysis services. The goal of these additional free services is to support publication of research results.
- 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 enhances protocol development, speeds study enrollment, improves the transparency of research, builds public trust, and accelerates 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 Program 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 will be contingent upon receipt of all necessary institutional and regulatory approvals. While such approvals are not required at the time of proposal submission, pilot award recipients are encouraged to initiate the approval application process promptly after receiving their notice of award. If applicable, proof of exempt status determination must be obtained.
Requirements for Research Involving Human Subjects
Award recipients conducting research on human subjects and/or human cell lines and tissue repositories must also comply with requirements for the NIH/NCATS Prior Approval Request for Delayed Onset Research Involving Human Subjects. They will be required to submit their Institutional Review Board (IRB) approvals and any supplemental documentation to Tufts CTSI as soon as possible to ensure adequate time for review by the funding agency, NIH/NCATS. Projects may not begin until both IRB and NIH/NCATS approvals are received. Generally, the NIH/NCATS prior approval process takes approximately 30 days. If a request is returned for any reason, the 30-day turnaround time resets. To ensure that all approvals are obtained by the grant start date, applicants are strongly encouraged to contact any participating IRB offices ahead of time to discuss potential issues that may arise.
Please note that 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 policy applies to the domestic sites of multi-site studies where each site will conduct the same protocol. Guidelines on sIRB policy for multi-site research projects are available here. Additionally, studies that meet the NIH definition of a clinical trial, are required to submit a Human Subjects and Clinical Trials Information Form (FORMS-E) prior to award start.
NEW NIH POLICY: Award recipients conducting research involving human subjects, including research that is otherwise exempt, must comply with a new NIH policy on the Inclusion Across the Lifespan. They will be required to ensure that individuals of all ages, including children and older adults, are included in their human subjects research unless there are scientific or ethical reasons to exclude them.
The Tufts CTSI Research Collaboration Team provides scientific support for pilot 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 “coach” to provide scientific and logistical support. 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 that will be 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.
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 his/her institution, school, or department.
All publications, projects, posters, patents, trademarks, or other tangible outcomes resulting from Tufts CTSI funding and services must cite Tufts CTSI’s NIH CTSA award 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, 2020 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.