2025 Request for Applications

Overview

The Tufts CTSI Small Grants to Advance Translational Science (S-GATS) Program invites proposals for innovative and collaborative projects aimed at advancing the science of translation. The program seeks to address fundamental obstacles commonly encountered in translational research across various diseases and health conditions, while also encouraging the exploration of novel opportunities and pathways.

The S-GATS Program encompasses the broad scope of translational science research, welcoming projects that address specific translational challenges—such as inaccurate predictions of drug toxicity or efficacy, poor data interoperability, and ineffective clinical trial recruitment—as well as those that seek to leverage untapped opportunities within translational science.

The primary goal of an S-GATS project is to advance translational research by addressing common barriers to translation and/or exploring novel opportunities. Successful applicants are expected to:

  • Identify a Translational Challenge or Opportunity: Clearly define a translational challenge, roadblock, or opportunity that the project aims to address. This may involve addressing a known obstacle or exploring new pathways for advancement in translational science.
  • Propose a Proof-of-Concept Study: Design a proof-of-concept study that demonstrates, in one or more use cases, an innovative and broadly applicable disease-agnostic and/or disease-universal research product(s). These products may include research methods, technologies, operational processes, medical treatments, and behavioral interventions, and should have the potential to significantly enhance translation of pre-clinical, clinical, health services, and policy research into tangible improvements in clinical care and health outcomes.
  • Develop a Dissemination and/or Implementation Plan: Provide a preliminary strategy for disseminating and/or implementing the developed product(s), ensuring that other investigators, clinicians, and key interest holders can effectively adopt and utilize the product(s) in their own translational research or clinical practice.

The application process requires an initial submission of a competitive Letter of Intent (LOI), due on Tuesday, October 8, 2024, and, if invited, a full proposal, due on Thursday, December 19, 2024. To ensure that the proposed research projects are responsive to the 2025 RFA, prospective applicants must consult with the S-GATS Program team prior to the LOI submission. A link to the LOI submission form will be provided following this consultation.

Award Information

Number of Awards: Four to six projects (depending on award budgets)

Award Ceiling: $50,000 in direct costs. Cost sharing and indirect costs are not allowed.

Project Period: May 1, 2025 through April 30, 2026. Project extensions are not allowed under any circumstances.

Key Dates:

  • Translational Science Is Improving the Process information sessions (recommended):
    • Tuesday, September 10, 2024 at 8:30 AM
    • Thursday, September 12, 2024 at 4:00 PM
  • Competitive Letter of Intent due (required): Tuesday, October 8, 2024 at 11:59 PM
  • Invitation to submit full proposal: by Thursday, November 14, 2024
  • Proposal due (by invitation only): Thursday, December 19, 2024 at 11:59 PM
  • Award announcement: March 2025

About the S-GATS Program

Established in 2022, the Small Grants to Advance Translational Science (S-GATS) Program is a funding opportunity available through Tufts CTSI and supported by the National Center for Advancing Translational Sciences (NCATS), one of the centers at the National Institutes of Health (NIH). It aims to enhance the efficiency and effectiveness of translational research. NCATS defines a core principle of translational science as understanding and addressing common causes of inefficiency and failure across various targets, diseases, and therapeutic areas. By tackling these shared challenges and exploring new opportunities, the S-GATS Program seeks to improve health outcomes, extend life, and reduce the burden of illness and disability.

In alignment with translational science principles identified by NCATS, the S-GATS Program supports innovative translational science projects that build the evidence base for effective scientific and operational approaches in translational research. The program is designed to accelerate the pace of such research by funding the development of research products that have broad, target/disease-agnostic or target/disease-universal applications. It prioritizes actionable research that addresses unmet scientific needs, improves community health outcomes, and/or advances health equity for marginalized, underserved, and underrepresented populations. In line with the NCATS mission and local priorities, the program funds projects across the full translational spectrum, from T.5 to T4.

To be considered for funding, applicants need to: 1) specify the common translational research challenge to be addressed or opportunity to be explored; 2) present a proof-of-concept study that demonstrates, through one or more use cases, innovative and broadly applicable research product(s); and 3) provide a preliminary plan for the near-future broad and intentional dissemination and/or implementation of the research findings ensuring that other investigators can adopt and utilize the developed products in their own translational research. To support collective action for health improvement, they should also have an integrated strategy for engaging key interest holders, such as community members, patient advocates, healthcare providers, policy makers, regulatory bodies, and industry representatives, relevant to their proposed translational science projects. Engagement of these interest holders should extend beyond traditional team science, encompassing a broad and inclusive approach throughout various stages of the research process and dissemination/implementation efforts.

Examples of Projects that May Be Supported

  • Improving Clinical Research Efficiency: Innovate or validate research methods or processes to overcome scientific uncertainties and operational inefficiencies, speeding up the delivery of new treatments and interventions to patients. Examples:
    • Create a roadmap for leveraging historical data in rare genetic disorder trials to reduce time and resource burdens
    • Compare collaborative approaches for developing informed consent materials that improve comprehension among study participants with limited English proficiency
    • Evaluate a framework for the development of performance standards to establish confidence in alternative test systems and models
    • Validate a self-administered neurocognitive screening tool to expand participation of underrepresented populations in clinical trials
  • Advancing Data Science and Artificial Intelligence: Create or integrate cutting-edge data tools to enhance accessibility, transparency, and decision-making, providing data-driven insights to scientists, clinicians, and patients. Examples:
    • Develop a computerized clinical decision support tool to reduce unnecessary diagnostic imaging
    • Create a searchable database from a retrospective analysis of neuroradiology errors to inform error-reducing strategies
    • Standardize geographic data validation processes in electronic health records to improve public health responses
    • Integrate medical and oral health records through advanced health informatics solutions for holistic patient care
  • Accelerating Dissemination and Implementation: Transform how innovations, scientific discoveries, and evidence-based interventions are disseminated or adopted in health care and community settings. Examples:
    • Develop a behavioral change framework to reduce over-treatment of mental disorders in private practice
    • Assess economic evaluation tools for implementing oral health interventions in low-income communities
    • Create culture-centered dietary interventions to prevent chronic diseases
    • Test a protocol for including community-based organizations in crafting lay summaries
  • Enhancing Predictive Efficacy and Toxicology: Develop advanced models that mimic human biology to improve drug testing, reduce patient risks, and deepen understanding of disease mechanisms. Examples:
    • Develop organoid models to predict chemotherapeutic toxicity and efficacy of drugs
    • Build a reference dataset for interpreting of high-throughput transcriptomic screens in toxicity testing
    • Incorporate genetic diversity into cell-based test systems to predict neurotoxic responses
    • Develop methods for extracting imaging features in pathology studies of animal models
  • De-risking Therapeutic Development: Develop advanced models and manage drug discovery programs to cut risks, time, and costs in translating research breakthroughs into treatments. Examples:
    • Develop a bioinformatics integration platform to expedite preclinical drug discovery studies
    • Optimize drug repurposing strategies with a focus on rare diseases
    • Innovate needleless auto-injector systems through refined tissue testing protocols
    • Assess public-private models for advancing ‘first-in-class’ therapeutic agents
  • Building Network Capacity and Competence: Foster cross-disciplinary collaborations and create novel training paradigms to equip researchers with skills for engaging in translational science. Examples:
    • Adopt a hub-and-spoke network model for delivering specialized care to medically underserved rural communities
    • Create a toolkit for adapting data hackathons in diverse healthcare settings
    • Develop a virtual peer-to-peer mentorship framework to support capacity building in translational science
    • Design resources for training research staff in best practices for remote or decentralized clinical trials

Applicant Eligibility

Applications must designate a Principal Investigator (PI) with a primary appointment or position at one of the Tufts CTSI partner or collaborator organizations listed below. Medical residents, fellows, post-doctoral fellows, or medical students are not eligible to serve as PIs. However, they may be included in key personnel along with collaborators not affiliated with Tufts CTSI.

Eligible Sites

  • Asian Community Development Corporation

 

  • Asian Task Force Against Domestic Violence
  • Asian Women for Health
  • Authentic Caribbean Foundation
  • Brandeis University
  • Boston Chinatown Neighborhood Center
  • Boston Public Health Commission
  • Care at Home
  • Center for Information and Study on Clinical Research Participation
  • Cooperative Services Inc. Support & Development
  • Critical Path Institute
  • Greater Boston Chinese Golden Age Center
  • Greater Boston Section of the National Council of Negro Women
  • Kaiser Permanente Center Health Research
  • Lahey Hospital and Medical Center
  • Lowell General Hospital
  • Maine Medical Center
  • Massachusetts Biotechnology Education Foundation
  • Massachusetts Institute of Technology
  • MelroseWakefield Hospital
  • MGH Institute of Health Professions
  • Museum of Science, Boston
  • Newton-Wellesley Hospital
  • Northeastern University
  • Novartis Pharmaceuticals
  • Pfizer, Inc.
  • Point32Health
  • RAND Corporation
  • The Jackson Laboratory
  • Tufts Medical Center/Tufts Medicine
  • Tufts University
  • University of Pittsburgh
  • Urban College of Boston

Project Eligibility

Applicants must propose projects focused on advancing the science of translation and not just be translational in nature. This call for proposals is intentionally broad to encourage a diversity of approaches, welcoming both those tackling entrenched roadblocks and those seeking to open new avenues in translational research. Applicants must seek to understand a scientific or operational principle underlying a step of the translational process, thereby making the development and dissemination of interventions that improve human health more predictable and efficient. Although critically important, basic, discovery-oriented science projects, or projects focused on crossing a particular step of the translational process for a particular target or disease, are not supported.

If proposed, clinical trial activities must not go beyond the end of Phase IIB with the exception of Phase III clinical trials for treatment of rare diseases. Any research projects or research activities that involve a foreign component, as defined by NIH (e.g., performing a specific element or segment of a project outside of the U.S., with assistance of a collaborator employed by a foreign entity or a non-U.S. vendor, and/or with support or resources from a foreign entity), are allowable but generally not encouraged. If included, such components must be disclosed during the LOI stage and be well-justified.

Proposed budgets must be between $25,000 and $50,000 in direct costs and must be fully supported with the Tufts CTSI funds awarded through S-GATS funding mechanism. They cannot be add-ons to, or an extension of a parent project supported by another funding source. Indirect costs and cost sharing, including the use of supplemental funding or third-party in-kind contributions, are not allowed. If research space is provided by the institution for inpatient and or outpatient participant evaluations, the applicant will be asked to describe the space, its potential availability, and if applicable, hourly or overnight rates to be charged to support research activities.

All awards will be made via a subaward mechanism from Tufts University directly to the project PI’s home institution. Collaborations with investigators and partners at other institutions are allowed, with funding for these collaborators awarded through separate subawards also made by Tufts University. Due to restrictions set by the Tufts CTSI’s funding agency on the parent award, unspent funds cannot be carried forward at the end of the budget period.

Application Process

The S-GATS Program accepts full proposals by invitation only. All applicants are required to submit a competitive LOI presenting a concise description of their planned proposal. The LOI should describe the project and its proposed methods of study in adequate detail so that their merit and translational science focus can be assessed. Applicants are required to consult with the S-GATS Program staff prior to submission of the initial LOI. Sign up for a virtual consultation at sgats@tuftsmedicine.org.

How to Apply

The 2025 S-GATS Program has a two-step application process that includes a competitive LOI and, if invited, a final proposal. Both must be submitted via Tufts CTSI’s REDCap online submission portal. Unique LOI and proposal submission links will be provided by the S-GATS Program staff. Incomplete and late submissions will not be accepted.

  • Competitive Letter of Intent: The LOI should total no more than three pages in length, including any references. The submission should also include a biosketch of the Lead Principal Investigator. Detailed instructions and application templates will be provided by the S-GATS Program staff. LOI submissions will be accepted through Tuesday, October 8, 2024.
  • Proposal (by invitation): All LOI applicants will be notified whether or not their projects are chosen to move forward to the proposal stage no later than Thursday, November 14, 2024. For applicants submitting full proposals, detailed proposal instructions and program-specific form templates will be available in REDCap on November 13, 2024. Full proposals must be submitted by Thursday, December 19, 2024.

Letter of Intent Review

The LOI review process is designed to help identify the most promising and scientifically sound translational science projects to move forward and to support further project development. All competitive LOIs will undergo an administrative review by the S-GATS Program staff for their alignment with the program’s objectives. Project ideas that are deemed responsive to the 2025 RFA will be reviewed and scored by at least two scientific peer reviewers for their translational relevance, scientific rationale and rigor, feasibility, clarity, and potential for impact. Successful projects will be selected in consultation with the Tufts CTSI Research Collaboration Team,  Biostatistics, Epidemiology, and Research Design (BERD) Center, Dissemination and Implementation Core, Evaluation and Continuous Improvement, and Community and Stakeholder Engagement programs, as appropriate.

Application Review 

All applications will be peer-reviewed by at least two reviewers with relevant expertise. The reviewers will be primarily selected from the pool of Tufts CTSI Scientific Review Committee members, which includes past Tufts CTSI award recipients. They may also include reviewers from Tufts CTSI partner organizations and Clinical and Translational Science Awards (CTSA) External Reviewer Consortium (CEREC) II, of which Tufts CTSI is a part. The review process will follow NIH guidelines for peer review using the criteria listed below.

Translational Challenge and Opportunity Identification – Evaluates the clarity, relevance, and potential impact of the translational challenge or opportunity the project seeks to address.

  • Is the translational challenge, roadblock, or opportunity clearly defined and well-articulated?
  • Does the project address critical unmet needs or unexplored pathways in translational science?

Innovation and Scalability – Assesses the originality, interdisciplinary collaboration, and potential scalability of the proposed solutions.

  • Does the project propose an innovative solution to the identified challenge or opportunity that could advance the science of translation?
  • Can the project’s findings be adapted and scaled for implementation in diverse real-world settings?
  • Does the project engage relevant non-academic partners and interest-holders to enhance translational research impact?
  • Is there a clear, actionable plan for disseminating results beyond traditional academic channels and facilitating adoption in various settings?

Proof-of-Concept Study Design – Evaluates the rigor, appropriateness, and potential impact of the proposed study design.

  • Is the study design well-constructed, with appropriate methodologies to address the research questions?
  • Is there a strong rationale for the chosen methods, including data analysis techniques?
  • Does the proposal address potential challenges and outline alternative strategies?
  • Will the project contribute to translational science, even if the initial objectives are not fully met (e.g., through insights gained from unexpected outcomes)?

Feasibility – Assesses the practicality of the project concerning the timeline, budget, and resource availability.

  • Is the project realistic and achievable within the 12-month timeframe and $50,000 budget?
  • Are the necessary resources, expertise, and skills in place to support successful project execution?
  • Does the project have a well-defined management and organizational strategy?

Overall Impact and Advancement of Translational Science – Evaluates the project’s potential to produce significant advancements in the science of translation with a focus on long-term impact and sustainability.

  • How likely is the project to contribute to significant advancements in translational research and/or improve clinical care or health outcomes?
  • Does the project have the potential to generate broadly applicable and sustainable outcomes?
  • Is there a clear pathway to real-world application and broader scientific impact?

 

Tufts CTSI Stakeholder Expert Panel Review

All applicants invited to submit a full proposal must develop a plan for engaging relevant interest holder groups, including in dissemination activities. This plan, included as part of the full proposal, will be reviewed separately by at least two members of the Tufts CTSI Stakeholder Expert Panel. Composed of community members with diverse professional and cultural backgrounds, the panel will evaluate the applicant’s ability to identify relevant interest holder groups, align the project and its outcomes with the interests, priorities, and broader concerns of these groups, and implement a rigorous and effective engagement strategy.

Interest Holder Identification – Assesses the applicant’s ability to identify relevant interest holder groups and define their roles in the research project and result dissemination.

  • Are key interest holders clearly identified, including those who can inform and participate in dissemination and implementation, with sufficient detail to understand their roles in the project?
  • Does the plan provide a strong rationale for engaging the identified interest holder groups throughout the project and in future dissemination and/or implementation activities?
  • Does the plan describe involvement of historically underrepresented groups, such as those from underserved, under-resourced, marginalized, and/or hard-to-reach communities?
  • If applicable, does the plan describe how the identified interest holders were involved in the project’s conceptualization and research design?

Relevance – Evaluates the alignment of the project and its outcomes with the interests, priorities, and broader concerns of identified groups and the public.

  • Does the plan clearly articulate the project’s relevance and value to the identified interest holders and/or specific populations, supported by logical reasoning?
  • How will these interest holders and/or populations benefit from the research outcomes, and does the plan include strategies for appropriate follow-up?
  • If successful, how likely is it that the project’s outcomes will be disseminated and applied beyond traditional academic channels?

Engagement Approach – Assesses the rigor and effectiveness of the proposed plan for interest holder engagement in achieving project objectives.

  • Does the engagement plan align with and support the overall objectives of the research project, including the application of interest holders’ knowledge and expertise?
  • Does the plan demonstrate intentional and meaningful involvement of the identified interest holder groups and outline how they will contribute to identifying factors affecting future dissemination and implementation?
  • Does the engagement strategy foster strong, collaborative relationships based on mutual trust, and include a communication strategy that is adequate and tailored to each interest holder group?
  • Is the plan realistic and flexible, with a high likelihood of successful implementation within the project’s timeframe and budget, and adaptable to changing circumstances?

Funding Decision and Announcement

Final funding decisions will be made by the Tufts CTSI Senior Leadership Team based on recommendations of the Scientific Review Committee with input of Stakeholder Expert Panel. Key funding considerations include the overall impact score, project feasibility, clear strategy and intentional focus on health equity, budget justification, available funds, and distribution across the translational spectrum. A minimum of four and a maximum of six research projects will be funded. The final number of awards will be dependent on the volume of meritorious applications received and their individual budget requirements. All applicants will be informed of the outcome of their submission via email. Reviewers’ comments will be provided to all primary applicants, regardless of whether or not they are awarded funding.

Research Collaboration Team Review

In addition to review by the S-GATS Program Scientific Review Committee and Tufts CTSI Program Leaders, applications may be reviewed by the Tufts CTSI Research Collaboration Team to identify projects for further development and submission to other funding announcements, and/or to identify potential collaborators. Applicants may be contacted by Tufts CTSI Navigators or other members of the Research Collaboration Team for future research opportunities.

Confidentiality and Non-Disclosure

All applications will be treated as proprietary and confidential. Efforts will be made to safeguard them against unauthorized use and any disclosure beyond Tufts CTSI and the 2025 S-GATS review committees.

Award Procedures and Requirements

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 no later than 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 April 2025.

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 S-GATS 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 a minimum of 30 days. However, if a request is returned for any reason and if approval is sought for a clinical trial, the turnaround time by NCATS may take longer. Note: Human subjects research projects involving a foreign component require a separate prior approval and must receive that approval from NCATS before they are submitted for prior approval to conduct human subjects research.
  • 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 both Tufts CTSI- and non-Tufts CTSI-affiliated organizations subcontracted by award recipients. Generally, the animal subjects NCATS prior approval process takes a minimum of 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 of the amount of funds 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.

Ongoing Research Support and Progress Tracking

Prior to project launch, award recipients will be assigned a support team that will provide on-going scientific and logistical support and help address roadblocks that may arise. The support teams will be co-led by the Tufts CTSI S-GATS Program, Research Collaboration Team, and Research Process Improvement faculty and staff. Additional Tufts CTSI service providers, including, but not limited to, biostatisticians, recruitment and retention specialists, and informatics experts, may be involved on an as-needed basis. Award recipients will be expected to collaborate with their support teams 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 S-GATS project at a meeting open to the broader scientific community (e.g., Tufts CTSI Translational Science Day).

Reporting and Long-Term Outcomes Tracking

Award recipients will be required to submit an interim report, a final report, and a final invention statement and certification form (HHS 568). Tufts CTSI will provide report templates to be completed. Form HHS and its instructions are available here. The final report and the HHS 568 forms will be due within 90 days following the expiration or termination date of the award.

In addition, award recipients 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, but may not be limited to, 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. Award recipient’s failure to complete annual reporting may preclude future Tufts CTSI funding to the award recipient and their organization, school, or department.

Citation Requirements

All publications, projects, posters, patents, trademarks, or other tangible outcomes resulting from Tufts CTSI’s funding and services must acknowledge Tufts CTSI’s NIH CTSA award (UM1TR004398) and comply with the NIH Public Access Policy. Tufts CTSI relies on these citations as a critical performance measure when reporting annual productivity to NCATS. Detailed guidelines for citations are available here.

Post-Award Dissemination and Implementation Support

Tufts CTSI will provide access to dissemination and implementation resources and services to help disseminate and/or implement a projects’ outcomes and results to help close the gap between research discovery and application in healthcare delivery. Award recipients may request such support at any point during the award period.

Additionally, Tufts CTSI will make funding available for journal fees, including publication processing and open access charges. Award recipients may request such support once a manuscript has been accepted for publication in a peer-reviewed journal. It will be made available for each research team for two years after the project end date, provided they comply with the NIH Public Access Policy and appropriately acknowledge Tufts CTSI’s NIH CTSA award. Such support will be limited to two eligible publications per research project. To maximize the impact and visibility of research findings, Tufts CTSI may offer funding to support dissemination of study results in comparable open access platforms.

Future Review Commitment

If invited, award recipients will be expected to serve as scientific peer-reviewers for the Tufts CTSI S-GATS Program and/or similar programs at collaborating hubs that are part of the CTSA External Reviewer Consortium II (Boston University CTSI, Clinical and Translational Science Collaborative at Case Western Reserve University, CTSI at Children’s National, Duke CTSI, Indiana CTSI, Penn State CTSI, UCLA CTSI, University at Buffalo CTSI, and University of Kentucky Center for Clinical and Translational Science).

Additional Resources

Questions?

We are here to help. Please contact us at sgats@tuftsmedicine.org.