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Grant Details

https://www.grants.gov/search-results-detail/356316

Grant Analysis

Purpose & Target

This grant aims to fund Clinical and Translational Science Award (CTSA) Program 'hubs,' which are integrated research and training environments. The core objective is to accelerate the translation of scientific discoveries into improved health outcomes for individuals and communities by fostering scientific and operational innovations in clinical and translational science. The primary target recipients are established medical research institutions and academic health centers, or non-profit research organizations that conduct clinical and translational research. They function as 'hubs' within a national consortium. The size is not defined by employee count but by their capacity to operate as a central institution with integrated research and training environments, potentially collaborating with multiple partner and collaborating institutions. This grant is SECTOR-AGNOSTIC in terms of disease or condition, focusing on the science of translation rather than specific diseases. However, it is research-specific, focusing on clinical and translational science. The geographic scope is the United States (domestic organizations only). Foreign components are allowed, but foreign organizations cannot apply as the prime recipient. Key filtering criteria include: applicant must be an eligible U.S.-based institution type, include a graduate school accredited in clinical/translational science, and commit at least two months of effort per PD/PI. This is a recurring funding opportunity (reissue of PAR-21-293) with multiple annual application deadlines, part of the broader National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) Program.

Financial Structure

  • Funding Amounts:
    • The grant uses a tiered system for maximum direct costs (DC) per year. The tiers range from $2,600,000 to $6,500,000 annually. The specific tier is determined by the sum of the applicant institution's and any partnering institution's 5-year average of most current NIH direct cost funding.
    • Previous CTSA UL1 award recipients may request up to 95% of their last budget period's direct cost level, exclusive of administrative supplements/competitive revisions and subaward F&A.
  • Currency: USD (United States Dollar).
  • Minimum Grant Amount:
    • For Clinical and Translational Science Pilot Module projects: between $25,000 and $50,000 direct costs each.
    • For Clinical and Translational Science Research Program (Element E) projects: not less than $125,000 direct costs per year per project.
  • Maximum Grant Amount:
    • The maximum direct cost for the overall UM1 budget is $6,500,000 per year (top tier).
    • For Clinical and Translational Science Research Program (Element E): direct costs for this element must not exceed $500,000 per year.
  • Co-financing/Matching Fund Obligations:
    • No cost sharing is required. Voluntary committed cost share is neither required nor recommended.
    • Pilot projects must be fully supported with NIH funds awarded through this funding announcement; no other funding sources may be used for these specific projects.
  • Eligible Cost Categories:
    • Personnel costs (e.g., PDs/PIs, Module Leaders, Co-Leaders, support staff, dedicated QA/QC position, Hub Liaison Team (HLT) scientific/operational leads, data science personnel).
    • General research expenses.
    • Costs for central administration of resources and services.
    • Fiscal management and reporting activities.
    • Travel expenses for up to five people to attend the annual CTSA Program meeting.
    • Costs for coordination, implementation, education, and training related to workforce development.
    • Direct costs for Clinical and Translational Science Pilot projects.
    • Direct costs for the single initial discrete CTS research project within Element E.
    • Costs for establishing and operating internal and external advisory committees.
  • Ineligible Cost Categories:
    • Monetary institutional commitment (i.e., voluntary committed cost share).
    • Space to conduct research (e.g., inpatient/outpatient participant evaluation space).
    • Inpatient and outpatient care costs.
    • Clinical trials beyond Phase IIB, with the exception of Phase III clinical trials for treatment of rare diseases.
    • Personnel effort on the UM1 solely supporting leadership/administration of a single optional companion or required award if not directly tied to UM1 specific activities.
  • Financial Reporting:
    • Annual Research Performance Progress Report (RPPR) and financial statements are required.
    • A final RPPR, invention statement, and expenditure data are required for closeout of the award.

Eligibility Requirements

  • Eligible Organization Types:
    • Higher Education Institutions: Public/State Controlled, Private.
    • Nonprofits: 501(c)(3) IRS Status and others.
    • For-Profit Organizations: Small Businesses and other For-Profit Organizations.
    • Local Governments: State, County, City or Township, Special District, Indian/Native American Tribal (Federally Recognized and others).
    • Federal Governments: Eligible Agencies of the Federal Government, U.S. Territory or Possession.
    • Other: Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations (other than Federally recognized tribal governments), Faith-based or Community-based Organizations, Regional Organizations.
  • Specific Qualifications:
    • The applicant organization (or a partnering institution) must include a graduate school accredited to award higher degrees related to clinical or translational science (e.g., M.S. or Ph.D. in Clinical Research, Public Health, Pharmacology, Nursing, Informatics, Health Economics, or Epidemiology).
    • The Contact PD/PI must be designated as the Strategic Management Module Leader and must be an experienced clinician/scientist with authority/influence to promote translational and clinical research.
    • Module and Program Leaders/Co-Leaders must have appropriate expertise and qualifications.
  • Organizational Structure:
    • Applications are submitted by a single applicant institution (the 'hub') which receives and administers the award.
    • Partnering Institutions are required to be effectively integrated and necessary for strategic goals. A partnering institution can only be included in one CTSA UM1 hub application (or UL1 award).
    • Collaborating Institutions have a significant role and can be included in multiple CTSA UM1 hub applications.
    • Consortium required: Yes, this NOFO is part of a required set of companion applications: the Clinical and Translational Science Award (UM1) and a companion Institutional Career Development Award (K12).
  • Geographic Requirements:
    • Domestic (U.S.) organizations only. Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic components of U.S. Organizations are also not eligible to apply. However, foreign components, as defined by NIH, are allowed.
  • Temporal Requirements:
    • Organizations with active grants funded under PAR-15-304, PAR-18-464, PAR-18-940 & PAR-21-293 that have more than 16 months of support remaining on the submission deadline are not eligible.
  • Key Personnel Requirements:
    • All Program Directors/Principal Investigators (PD(s)/PI(s)) must commit at least two months effort each (preferably 3-6 months). Applications failing this will be non-responsive and not reviewed.
    • The UM1 PD(s)/PI(s) cannot be PD(s)/PI(s) on the required companion K12 or optional T32/R25 applications. They can be PD(s)/PI(s) on the optional RC2.
  • Exclusion Criteria/Disqualifying Factors:
    • Applications that do not answer 'Yes' to Human Subjects involvement.
    • Applications where PDs/PIs do not commit at least two months effort.
    • Applications that lack the required institutional research career development K12 companion application.
    • Applications that do not submit all of the required attachments.
    • Applications that do not describe a single, detailed initial project for Element E with a detailed budget.
    • Applications that include Partner(s) which are already Partners on another active UL1 or UM1 award or application.
    • Applications submitted as not having clinical trials, but NIH determines that clinical trials are present.
    • Applications from Foreign Organizations.

Application Process

  • Application Process Timeline and Deadlines:
    • Letter of Intent Due Date: 30 days before the application due date (encouraged, not required or binding).
    • Application Due Dates (all by 5:00 PM local time of applicant organization):
      • March 13, 2025
      • May 28, 2025
      • September 29, 2025
      • January 28, 2026
      • May 28, 2026
      • September 28, 2026
      • January 28, 2027
      • May 28, 2027
      • September 28, 2027
    • Expiration Date of the funding opportunity: September 29, 2027.
  • Required Documentation and Submission Materials:
    • SF424(R&R) Forms.
    • Cover Letter Attachment: Must list all applications that are part of the collaborative set.
    • SF424(R&R) Project/Performance Site Locations: Enter primary site only.
    • SF424(R&R) Other Project Information: Includes several required 'Other Attachments' (specific filenames required):
      1. 'Institution' (organizational charts for hub and relationships with partners - 1 file).
      2. 'Hub’s Senior Leadership' (information and roles of Contact PD/PIs, Module/Program Leaders - 1 page).
      3. 'Information on Hub Partners and Collaborators' (table listing contributions and justifications - 3 pages).
      4. 'Resources to Achieve CTSA Objectives' (table of specific resources - 5 pages).
      5. 'Clinical Trial Experience' (brief description of clinical trials in the 6 months prior to application - 5 pages).
      6. 'Clinical and Translational Science Track Record' (accomplishments and progress over the past 5 years - 5 pages).
      7. 'Coordination and Integration Plan' (plan for partnership between UM1 and required/optional companion applications - 3 pages).
    • SF424(R&R) Senior/Key Person Profile.
    • R&R Budget: A single, detailed budget broken out by Element and Module, with justifications.
    • R&R Subaward Budget (if applicable).
    • PHS 398 Cover Page Supplement.
    • PHS 398 Research Plan:
      • Specific Aims (1 page): For the entire UM1 application.
      • Research Strategy: Narrative sections for each Element:
        • Element A: Overview (6 pages).
        • Element B: Strategic Management (12 pages).
        • Element C: Training and Outreach (12 pages).
        • Element D: Clinical and Translational Science Resources and Pilots (18 pages).
        • Element E: Clinical and Translational Science Research Program (12 pages total; 2 for overall program description, 10 for the detailed initial discrete project).
    • Letters of Support: Required from all Partnering Institutions (signed by an Authorized Organizational Representative, affirming role and unique relationship). Optional for Collaborating Institutions with substantial involvement. Letters of assurance for off-site activities. A limit of 30 letters is encouraged.
    • Resource Sharing Plan.
    • Data Management and Sharing Plan (DMSP): Must address all UM1 Elements and Modules that may generate data.
    • Appendix: Limited to blank questionnaires or surveys.
    • PHS Human Subjects and Clinical Trials Information: Applicants must answer 'Yes' to human subjects involvement and complete all related sections.
    • PHS Assignment Request Form.
  • Submission Format and Platform: Electronic submission via NIH ASSIST, Grants.gov Workspace, or an institutional System-to-System (S2S) solution. Applications are checked for completeness and compliance upon submission.
  • Types of Support Offered: The primary support type is funding through a Cooperative Agreement (UM1). The program also facilitates mentorship and networking opportunities through its consortium activities.
  • Project Implementation Timeline:
    • Overall Project Period: Maximum of 7 years.
    • Clinical and Translational Science Pilot Module: Individual pilot projects cannot exceed 12 months.
    • Clinical and Translational Science Research Program (Element E): The initial discrete project is suggested for 2-3 years, with a maximum duration of 7 years.
  • Reporting Obligations:
    • Annual Research Performance Progress Report (RPPR) and financial statements are required.
    • Progress on Pilot projects must be reported annually with the RPPR.
    • A final RPPR, invention statement, and expenditure data are required for closeout.
    • Registration and results submission to ClinicalTrials.gov are required for NIH-defined clinical trials.
  • Post-Award Requirements:
    • Adherence to the NIH Grants Policy Statement and the specific terms and conditions outlined in the Notice of Award.
    • Prior approval from NIH is required before initiating human subjects research and/or live vertebrate animal research for both Pilot projects (Element D) and subsequent Element E research projects.
    • Mandatory disclosure of any information related to violations of federal criminal law involving fraud, bribery, or gratuity that could affect the federal award.

Evaluation Criteria

  • Overall Impact: Reviewers assess the likelihood of the project exerting a sustained, powerful influence on the research field(s).
  • Scored Review Criteria (each receives a separate score):
    • Significance: How important are the proposed activities and their potential impact?
    • Investigator(s): Do the PD(s)/PI(s) and the team have the appropriate experience, qualifications, and leadership?
    • Innovation: Does the project challenge existing paradigms or develop new methodologies or technologies?
    • Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate?
    • Environment: Is the institutional support and research environment conducive to success?
  • Additional Review Criteria (considered for overall impact, but not separately scored):
    • Study Timeline: Appropriateness and feasibility.
    • Protections for Human Subjects: Justification for involvement, adequacy of protection against risks, potential benefits, importance of knowledge, data/safety monitoring. For exempt research, justification for exemption, characteristics of involvement, and material sources.
    • Inclusion of Women, Minorities, and Individuals Across the Lifespan: Evaluation of proposed plans for inclusion (or justified exclusion) based on sex, race, ethnicity, and age, aligned with scientific goals and research strategy. This indicates a strong emphasis on diversity and inclusion as a cross-cutting theme.
    • Vertebrate Animals: Description of procedures, justification for species, and measures to limit discomfort.
    • Biohazards: Assessment of potential hazards and proposed protections.
    • Resubmissions: Evaluation of changes made and responses to previous comments.
    • Revisions: Appropriateness of proposed expansion of scope.
  • Non-scored Additional Review Considerations:
    • Resource Sharing Plans: Reasonableness of the plan or rationale for not sharing.
    • Authentication of Key Biological and/or Chemical Resources: Plans for validity.
    • Budget and Period of Support: Justification and reasonableness of the budget.
  • Competitive Advantage Factors:
    • Demonstrated expertise and capabilities in various CTS areas.
    • A clear vision and strategic goals that integrate with the CTSA Program nationally.
    • A strong leadership team with experience in complex CTS programs and collaboration.
    • Engaged and effective organizational governance and leadership structures.
    • Robust institutional commitment (non-monetary).
    • A research-friendly environment where patients, clinicians, and other stakeholders are easily engaged.
    • A strong commitment to reducing health challenges through research.
    • A culture of collaboration within the applicant hub and across the broader CTSA Program.
    • Capacity to adopt and implement innovative policies and infrastructure that improve human subject protections and minimize investigator burden.
    • The ability to develop and disseminate tools and strategies that address identified 'chokepoints' in the translational process.
    • A commitment to broad-based CTS research workforce development.
    • Well-integrated informatics and digital health capabilities, embracing Open Science and FAIR principles.
    • A high-quality, impactful CTS research project in Element E that provides generalizable innovations and insights.

Compliance & Special Requirements

  • Regulatory Compliance Requirements:
    • Adherence to Federal Regulations (2 CFR Part 200, 42 CFR Part 52) and the NIH Grants Policy Statement.
    • Compliance with Good Clinical Practice (GCP) and quality principles is essential for all clinical research activities.
    • Human Subject Protections: Applicants must affirm human subjects involvement. Compliance with 45 CFR Part 46 (including any applicable exemptions) is mandatory. Prior NIH approval is specifically required for human subjects research deemed 'Greater Than Minimal Risk' or meeting the criteria for an NIH-defined Clinical Trial.
    • Vertebrate Animal Research: Prior NIH approval is required for any research involving live vertebrate animals.
    • FDA Requirements: Clinical research projects involving investigational therapeutics, vaccines, or devices must comply with IND (Investigational New Drug) or IDE (Investigational Device Exemption) requirements.
    • Nondiscrimination laws must be followed, as agreed upon during SAM.gov registration.
  • Data Protection and Privacy Standards:
    • Ensuring the privacy and security of study data, especially when involving human subjects, is paramount.
    • A comprehensive Data Management and Sharing Plan (DMSP) is required, covering all UM1 Elements and Modules that may generate data.
    • The program encourages and expects adherence to Open Science and Data Sharing principles, specifically the F.A.I.R. principles (Findable, Accessible, Interoperable, Reusable).
    • Encouraged to use the Fast Healthcare Interoperability Resources (FHIR®) standard and Common Data Elements (CDEs) to optimize data collection, integration, and sharing.
  • Intellectual Property Policies:
    • Recipients retain custody of and primary rights to the data and software developed under these awards, subject to Government policies regarding rights of access.
    • Applicants should address policies for defining intellectual property ownership of research and scholarly outputs, data, and software sharing.
  • Technology Specifications:
    • Applicants are expected to demonstrate robust informatics and digital health capabilities.
    • There is an expectation of progressive plans toward a standards-based, interoperable network in a cloud environment to facilitate sharing of informatics assets (data, software, algorithms) across the consortium.
    • Utilization and expansion of research Enterprise Data Warehouses (EDW), integration of data from diverse external sources, and competent management of EDW teams.
    • Use of research computing or high-performance computing (HPC), and engagement with standard terminologies.
  • Risk Management and Security:
    • An Emergency Plan is required, detailing how the hub will pivot to a virtual leadership structure and rapidly realign activities to support public health emergencies or other urgent needs.
    • A Succession Plan is necessary for key leadership positions, including the PI(s)/MPI(s), Module, and Program Leaders/Co-Leaders.
    • A dedicated Quality Assurance/Quality Control (QA/QC) position (at least 9 calendar months effort) is required to perform quality reviews of CTSA-related submissions to NCATS and other compliance documents.
  • Unique Aspects:
    • This funding is awarded as a Cooperative Agreement (UM1), signifying substantial Federal scientific or programmatic involvement from NIH/NCATS staff throughout the project period, which is distinct from traditional grants.
    • The grant focuses on Translational Science (developing generalizable principles to improve research efficiency) rather than solely translational research (applying discoveries to specific diseases), adopting a disease-agnostic approach.
    • Applicants will integrate into a national, collaborative consortium of CTSA 'hubs', fostering multi-hub collaboration, sharing innovations, and leveraging collective strengths across the U.S.
    • A required companion application: Applicants MUST submit a companion Institutional Career Development Award (K12) application concurrently with the UM1 application, as the UM1 cannot be awarded without it.
  • Potential Challenges:
    • Navigating the complex partnership requirements and restrictions, particularly that a partnering institution can only be on one UM1/UL1 award/application at a time.
    • Ensuring both the UM1 and the required K12 companion application are competitive and submitted correctly.
    • Strict limitations on clinical trial funding (no support for trials beyond Phase IIB, except Phase III for rare diseases).
    • Managing the substantial NIH programmatic involvement and shared responsibilities inherent in a cooperative agreement.
    • The need for a highly detailed budget breakdown by Element and Module, which can be complex.
  • Strategic Opportunities:
    • Opportunity to become a pivotal 'hub' within a national network of leading research institutions, significantly influencing the trajectory of translational science.
    • Access to and leveraging NCATS-provided resources and services, such as public cloud services and high-performance computing.
    • Engage in a highly collaborative environment to facilitate multi-center research, harmonize standards, share curricula, and enhance training across institutions.
    • Contribute directly to rapid response efforts for urgent public health needs and shape future public health strategies.
  • Cross-cutting Considerations:
    • Team Science: A strong emphasis is placed on collaborative efforts among researchers and across disciplinary boundaries.
    • Patient and Community Engagement: Crucial for advancing CTS, with specific focus on recruiting under-studied populations and involving patients as full collaborators throughout the research process.
    • Health Equity: Explicit commitment to accelerating CTS research that addresses health conditions disproportionately affecting rural, minority, and other under-studied populations, promoting inclusive research practices.
    • Continuous Improvement: A strong focus on implementing and utilizing Continuous Quality Improvement (CQI) programs and methodologies to enhance research processes and outcomes.

Grant Details

clinical research translational science biomedical research public health healthcare medical institutions academic health centers research and development innovation health informatics data science digital health consortium cooperative agreement training capacity building patient engagement community engagement rare diseases clinical trials human subjects workforce development nih ncats um1 k12 r25 t32 rc2 grants research health equity open science fair principles cqi team science
Clinical and Translational Science Award (UM1 Clinical Trial Optional)
PAR-24-272
Clinical and Translational Science Award (CTSA) Program
UNIVERSITY NGO ENTERPRISE PUBLIC OTHER
US
HEALTHCARE TECHNOLOGY EDUCATION OTHER
DEVELOPMENT GROWTH MATURE
500+ OTHER
SDG3 SDG9 SDG17
FUNDING RESEARCH_DEVELOPMENT TRAINING_EDUCATION CAPACITY_BUILDING PILOT_PROJECTS INNOVATION_COMMERCIALIZATION NETWORKING
True
None
25000.00
6500000.00
USD
100.00
Sept. 28, 2027, 9 p.m.
March 2025 - September 2027