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Grant Details

https://www.grants.gov/search-results-detail/357165

Grant Analysis

Purpose & Target

  • Core objective: Accelerate the development and testing of evidence-based cancer-related interventions using pragmatic trial designs.
  • Focus: Improve cancer-related outcomes across the cancer control continuum in diverse populations and settings in the United States.
  • Target recipient: Diverse U.S.-based organizations, including higher education, non-profits, for-profits, and government entities.
  • SECTOR-SPECIFIC: Healthcare, Public Health, Cancer Research.
  • Geographic scope: United States. Foreign organizations and foreign components of U.S. organizations are not eligible to apply for primary awards.
  • Key filtering criteria: Must propose a clinical trial, specifically a pragmatic trial, for cancer-related interventions. Not for drug/device development or explanatory trials.
  • Grant frequency/context: A specific Notice of Funding Opportunity (NOFO) that is a reissue of a previous PAR, indicating a recurring focus area for NCI.

Financial Structure

  • Funding instrument: Cooperative Agreement (UG3/UH3 Phased Award).
  • Maximum annual direct costs: $500,000 for UG3 phase (max 2 years), $750,000 for UH3 phase (max 4 years).
  • Total project period: Up to 6 years (2 years UG3 + 4 years UH3).
  • Co-financing/Matching funds: Not required.
  • Eligible costs: Pre-award costs allowable as per NIH Grants Policy Statement Section 7.9.1.
  • Indirect cost policies: Follow NIH Grants Policy Statement.
  • Payment mechanism: Awards are made, and funds may be requested from the designated HHS payment system.
  • Currency: USD.
  • Funding rate: Implied 100.0% of eligible direct costs up to the stated limits, as cost sharing is not required.

Eligibility Requirements

  • Organization Types
    • Eligible: Higher Education Institutions (public/state controlled, private), Nonprofits (with/without 501(c)(3) status), For-Profit Organizations (Small Businesses, others), Local Governments (State, County, City/Township, Special District, Federally Recognized/Other Indian/Native American Tribal Governments), Federal Governments (Eligible Agencies), and Other (Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations, Faith-based or Community-based Organizations, Regional Organizations).
    • Ineligible: Non-domestic (non-U.S.) Entities (Foreign Organizations). Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
    • Note: Foreign components (e.g., a specific research site or partner abroad) are allowed if part of an otherwise eligible U.S. organization.
  • Project Specifics
    • Must propose a clinical trial.
    • Must be a pragmatic trial designed to determine intervention effects in 'usual' contexts, focusing on informing decision-making.
    • Must include at least one intervention condition and at least one control or comparison condition.
    • Must propose milestones for both the UG3 (preparatory) and UH3 (pragmatic trial) phases.
    • Exclusion Criteria: Applications that propose to test cancer-related therapies, imaging, diagnostics, biologics, or devices (e.g., first-in-human studies or drug/device safety trials) are non-responsive and will not be reviewed.
  • Required Registrations
    • System for Award Management (SAM) with active registration (annual renewal required).
    • Unique Entity Identifier (UEI) obtained via SAM.gov.
    • eRA Commons account for the organization (Signing Official) and for the Program Director/Principal Investigator (PD/PI).
    • Grants.gov registration.
    • Note: Registration processes can take 6+ weeks; start early.

Application Process

  • Key Dates and Deadlines
    • Open Date (Earliest Submission Date): January 14, 2025.
    • Application Due Dates (by 5:00 PM local time of applicant organization):
      • New Applications: February 14, 2025; June 14, 2025; October 17, 2025.
      • Renewal/Resubmission/Revision: March 14, 2025; July 14, 2025; November 17, 2025.
    • Latest Submission Deadline: 2025-11-17 17:00:00.
    • Letter of Intent (encouraged, not required): 30 days prior to application due date.
    • Expiration Date: November 18, 2025.
  • Application Submission
    • Submission Methods: NIH ASSIST, institutional system-to-system (S2S), or Grants.gov Workspace.
    • Format: Electronic submission only. Paper applications not accepted.
  • Required Documentation and Materials
    • SF424(R&R) forms (Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile).
    • R&R Budget and R&R Subaward Budget forms.
    • PHS 398 Cover Page Supplement.
    • PHS 398 Research Plan including:
      • Specific Aims: Overall goals, rationale for addressing gap in cancer-related interventions, distinct aims for UG3 and UH3.
      • Research Strategy (max 25 pages): Significance, Investigator, Innovation, Approach (detailed for UG3 activities and UH3 pragmatic trial).
      • Milestones and Timelines: Required for UG3/UH3 phases, clearly specified, quantifiable.
      • Health Disparities: How minority health/health disparity populations are integrated (if applicable).
      • Letters of Support: From key partners and decision makers (patients, community advisory boards, practitioners, healthcare systems, etc.).
      • Resource Sharing Plan.
      • Data Management and Sharing Plan (required for all applications generating scientific data).
    • PHS Human Subjects and Clinical Trials Information form (required for all clinical trials).
    • PHS Assignment Request Form.
  • Review and Selection Process
    • Initial scientific and technical merit review by a Scientific Review Group.
    • Second level review by appropriate national Advisory Council or Board.
    • Funding decisions based on scientific merit, availability of funds, and relevance to program priorities.
  • Post-Award Requirements
    • Annual Research Performance Progress Report (RPPR).
    • Financial statements.
    • Final RPPR, invention statement, and expenditure data for closeout.
    • Compliance with NIH reporting and monitoring requirements.
  • Support Offered
    • Substantial NIH programmatic involvement from NCI staff (Project Scientists) providing scientific input, coordinating activities, promoting collaboration.

Evaluation Criteria

  • Overall Impact
    • Assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s).
  • Scored Review Criteria
    • Importance of the Research (Significance and Innovation):
      • Significance of the health problem and justification for proposed cancer-related intervention's impact.
      • Evidence that the problem and outcome are a priority among key collaborators/decision-makers.
      • How the intervention fills a gap in evidence-based cancer interventions, supported by compelling information/data.
    • Rigor and Feasibility (Approach):
      • Description of proposed activities for UG3 phase (pilot testing, refining intervention, finalizing plans for pragmatic trial).
      • Description of the proposed pragmatic trial for UH3 phase (design elements, justification of control/comparison, statistical/data analytic plans, power analyses, sample size, handling missing data, rigor of randomized/non-randomized design).
      • Adherence to NIH Policy on Good Clinical Practice Training.
      • Inclusion of clear, specified, quantifiable, and scientifically justified milestones for both UG3 (for transition to UH3) and UH3 (annual).
    • Expertise and Resources (Investigator(s) and Environment):
      • Demonstration of multidisciplinary scientific expertise of the research team.
      • Evidence of appropriate collaborators and decision makers involved, and successful collaboration.
  • Additional Review Criteria (Not Scored, but Considered)
    • Protections for Human Subjects: Justification for involvement, proposed protections, potential benefits, importance of knowledge, data and safety monitoring for clinical trials.
    • Vertebrate Animals: Justification for use, appropriateness of species, interventions to minimize discomfort, justification for euthanasia method (if applicable).
    • Biohazards: Evaluation of hazards and proposed protections.
  • Additional Review Considerations (Not Scored)
    • Authentication of Key Biological and/or Chemical Resources: Plans for validating resources.
    • Budget and Period of Support: Justification and reasonableness of requested budget and project period.
  • Other
    • Applications are encouraged to focus on including minority health populations and populations experiencing health disparities, and settings/communities with limited resources.

Compliance & Special Requirements

  • Regulatory Compliance
    • Adherence to NIH Grants Policy Statement, 2 CFR Part 200 (Uniform Administrative Requirements).
    • Compliance with all applicable non-discrimination laws, requiring submission of HHS-690 Assurance of Compliance.
    • Compliance with federal statutes and regulations relevant to federal financial assistance.
    • For health IT activities, use of health IT meeting standards in 45 CFR part 170, Subpart B, and certified under ONC Health IT Certification Program (if applicable).
    • Reporting of violations of federal criminal law (fraud, bribery, gratuity) to the NIH Chief Grants Management Officer and HHS Office of Inspector Grant Self Disclosure Program.
  • Research Ethics and Oversight
    • Human Subjects Research: Compliance with 45 CFR Part 46, requiring Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval.
    • Data and Safety Monitoring: Required for all human biomedical and behavioral intervention studies (clinical trials).
    • Investigational New Drug (IND) or Investigational Device Exemption (IDE): Required for projects involving investigational therapeutics/devices.
  • Data Management and Intellectual Property
    • Data Management and Sharing Plan: Required for all research generating scientific data, consistent with the 2023 NIH Policy.
    • Intellectual Property: Recipients retain custody and primary rights to data and software developed under the award, subject to Government access policies.
  • Cybersecurity
    • If handling HHS-owned/operated information or PII/PHI, recipients must develop plans/procedures modeled after the NIST Cybersecurity framework.
  • Programmatic Structure
    • UG3/UH3 Phased Cooperative Agreement: This award mechanism involves two distinct phases. The UG3 phase (up to 2 years) focuses on preparatory activities and refining the intervention. Transition to the UH3 phase (up to 4 years) for the main pragmatic trial is contingent on meeting UG3 milestones and administrative review.
    • Substantial Federal Involvement: NIH/NCI staff will be actively involved scientifically and programmatically, providing guidance and coordination, beyond a typical oversight role.
    • Dispute Resolution: A specific procedure is outlined for disagreements between recipients and NIH on scientific or programmatic matters.
  • Strategic Focus
    • Strong encouragement to focus on minority health populations and populations experiencing health disparities, as well as settings and communities with limited resources.

Grant Details

pragmatic trials cancer control cancer intervention clinical trial public health health disparities health equity cancer survivorship behavioral research epidemiology genomics healthcare delivery nci nih ug3 uh3 cooperative agreement implementation science cancer prevention early detection treatment quality of life health outcomes united states u.s. research medical research health disease prevention treatment patient care community health health systems pilot studies research methodology data sharing clinical research underserved populations minority populations rural health health technology evidence-based interventions
Pragmatic Trials across the Cancer Control Continuum (UG3/UH3 Clinical Trial Required)
PAR-25-072
National Institutes of Health (NIH) - National Cancer Institute (NCI)
UNIVERSITY NONPROFIT FOR_PROFIT PUBLIC OTHER
US
HEALTHCARE SOCIAL TECHNOLOGY OTHER
DEVELOPMENT EARLY_MARKET
OTHER
SDG3 SDG10
FUNDING RESEARCH_DEVELOPMENT MENTORSHIP CAPACITY_BUILDING
None
None
500000.00
750000.00
USD
100.00
Nov. 17, 2025, 5 p.m.
March 2026 - May 2026