Selected Tufts CTSI Pilot Studies Program projects will be funded for one year, beginning May 1, 2022 and ending April 30, 2023, pending NCATS approval.
Biostatistics, Epidemiology, and Research Design (BERD) Center Review
All funded projects will be reviewed by the Tufts CTSI BERD Center. Where relevant, BERD Center staff will provide research teams with recommendations regarding optimal study design and data collection approaches with the goal of maximizing the project’s potential for publication and subsequent funding. They 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 data collection, management, and analysis.
Institutional and Regulatory Approvals
Project start and release of funds are 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 upon receiving their notice of award. If applicable, proof of exempt status determination must be obtained. All applicable local regulatory approvals and/or determination letters must be received by no later than March 2022.
NCATS Prior Approval Requirements
In addition to receiving local regulatory approvals, projects involving human and/or animal subjects as well as projects that involve a foreign component, as defined by NIH, are required to seek and receive NCATS prior authorization. To ensure all requirements are met by the award start date, applicants and award recipients are strongly encouraged to carefully review the NCATS guidelines to ensure their prior approval requests are complete and discuss any potential concerns with Tufts CTSI Pilot Studies Program staff ahead of time.
- Research Involving Human Subjects and/or Human Cell Lines and Tissue Repositories: Projects involving human subjects are required to comply with requirements for the NCATS Human Subject Research Prior Approval. Specifically, award recipients conducting human subjects research, including research that is otherwise exempt under Title 45 Part 46 of the Code of Federal Regulations, will be required to submit their IRB approvals and any applicable NCATS-required documentation to Tufts CTSI before their projects can begin. Additionally, those whose research is deemed to be greater than minimal risk or meet the criteria for an NIH-defined clinical trial may not begin their projects until NCATS official prior approval for their projects is received. Generally, the NCATS human subjects research prior approval process takes 30 days. However, if a request is returned for any reason and if approval is sought for a clinical, the turnaround time may take longer.
- Research Involving Animal Subjects: Projects involving animal subjects are required to 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. 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 organization subcontracted by award recipients. Generally, the animal subjects NCATS prior approval process takes 30 days.
- Non-human and Non-animal Subjects Research: Projects that neither involve human nor animal subjects are not required to seek NCATS prior approval. However, if requested, award recipients will be required to provide proof of exclusion status determination issued by the IRB and/or IACUC.
- Research Involving a Foreign Component: Projects involving a foreign component, as defined by NIH, are required to adhere to the NIH Grants Policy Statement. This requirement applies to all projects regardless whether grant funds are to be expended to support elements or segments of the project outside the United States, either by the award recipient or by a researcher employed by a foreign organization. The prior approval process will involve a primary review by NCATS, and, unless rejected by NCATS, a secondary review through the NIH Fogarty International Center and/or U.S. Department of State. Due to the requirements for a multi-step review and oversight, award recipients proposing research involving a foreign component should anticipate the process to take up to two to three months, possibly resulting in rejection of their request.