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Grant Details

https://www.grants.gov/search-results-detail/356690

Grant Analysis

Purpose & Target

To test interventions that expand cancer screening and preventive services in NIH-designated health disparity populations by addressing barriers and facilitators at multiple socio-ecological levels. - Explicit identification of target recipient type and size: Primarily research institutions, non-profits, and government entities of various sizes capable of conducting clinical trials. - SECTOR-SPECIFIC - Geographic scope and any location requirements: United States, including U.S. Territories and Possessions. Non-U.S. entities are ineligible. - Key filtering criteria for initial grant screening: Must be a clinical trial, focus on cancer screening/prevention, target health disparity populations, and address multi-level barriers. - Grant frequency and program context: Recurring opportunity (multiple deadlines annually) as part of the NIH's ADVANCE initiative to increase randomized intervention research in health disparities.

Financial Structure

  • Budget: Application budgets are not limited but must reflect the actual needs of the proposed project.
  • Currency: USD
  • Min Funding: None specified.
  • Max Funding: None specified.
  • Funding Rate: None
  • Cost Sharing: Not required.
  • Co-financing: No explicit co-financing requirement.
  • Eligible Costs: Pre-award costs are allowable as described in the NIH Grants Policy Statement. All NIH awards are subject to the terms and conditions, cost principles described in the NIH Grants Policy Statement.
  • Indirect Costs: Included in overall budget consideration (consortium F&A explicitly mentioned as excludable for $500k threshold).
  • Financial Reporting: Annual Research Performance Progress Report (RPPR) and financial statements required. Final RPPR, invention statement, and expenditure data for closeout.
  • Audit Requirements: Subject to 2 CFR Part 200 Audit Requirements.

Eligibility Requirements

Eligible Organization Types
  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education
  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)
  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession
  • 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
Geographic and Regulatory Requirements
  • Non-domestic (non-U.S.) Entities are not eligible to apply.
  • Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
  • Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
  • Must comply with 2 CFR Part 200, NIH Grants Policy Statement, and applicable nondiscrimination laws.
Technical Requirements
  • Clinical Trial Required: Only applications proposing clinical trial(s) will be accepted.
  • Program Director/Principal Investigator(s) (PD/PI) must have an eRA Commons account.
  • Organizations must complete and maintain active registrations in:
  • System for Award Management (SAM)
  • Unique Entity Identifier (UEI) (issued via SAM.gov)
  • eRA Commons
  • Grants.gov
  • Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) code to register in SAM.
Exclusion Criteria
  • Projects that do not focus on NIH-designated health disparity populations.
  • Projects that do not prospectively test an intervention that promotes screening and/or preventive services.
  • Projects that are exclusively observational or qualitative research.
  • Research that only addresses cancer treatment.
  • Research that tests new screening tools or preventive services (e.g., development or testing of new vaccines).
  • Research that addresses social determinants of health without assessing health outcomes.
  • Applications that are duplicate or highly overlapping with other applications under review at the same time.
  • Applications missing required registrations or failing to comply with instructions.

Application Process

Application Deadlines and Submission
  • Latest application deadline: 2027-01-07 17:00:00 (5:00 PM local time of applicant organization).
  • Other deadlines:
  • New applications: 2025-02-05, 2025-06-05, 2025-10-05, 2026-02-05, 2026-06-05, 2026-10-05.
  • Renewal/Resubmission/Revision: 2025-03-05, 2025-07-05, 2025-11-05, 2026-03-05, 2026-07-05, 2026-11-05.
  • AIDS-related applications: 2025-05-07, 2025-09-07, 2026-01-07, 2026-05-07, 2026-09-07.
  • Expiration Date of NOFO: 2027-01-08.
  • Submission Platform: NIH ASSIST, institutional system-to-system (S2S), or Grants.gov Workspace.
  • Tracking: eRA Commons.
  • Corrections: Applicants are encouraged to apply early to make corrections before the due date.
Required Documentation and Materials
  • Standard SF424(R&R) application forms.
  • Standard PHS 398 forms (Cover Page Supplement, Research Plan, Human Subjects and Clinical Trials Information, Assignment Request Form).
  • Research Plan must include:
  • Identification of health disparity population(s) and associated disparities.
  • Conceptual model of intervention promoting services and/or reducing disparities at two or more socio-ecological levels (patient, clinician, healthcare setting, neighborhood/community).
  • Identification and roles of healthcare and community partners.
  • Data analytic plan for multi-level factors, intervention effects, and outcomes.
  • Resource Sharing Plan: Required.
  • Data Management and Sharing Plan: Required for all applications, regardless of direct costs.
  • Appendix: Limited to blank questionnaires or blank surveys. No publications or other material allowed.
Post-Award Requirements and Compliance
  • Annual Research Performance Progress Report (RPPR).
  • Financial statements as required.
  • Final RPPR, invention statement, and expenditure data for closeout.
  • Registration and results submission for applicable clinical trials on ClinicalTrials.gov.
  • Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval of all protocols.
  • Data and Safety Monitoring for human biomedical and behavioral intervention studies.
  • Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements, if applicable.
Application Assistance
  • eRA Service Desk: For system-related issues (ASSIST, eRA Commons, errors).
  • General Grants Information: For application instructions, processes, NIH grant resources.
  • Grants.gov Customer Support: For Grants.gov registration and Workspace.
  • Scientific/Research Contacts: Available for specific program-related questions and for discussing applications requesting $500,000+ direct costs.

Evaluation Criteria

Overall Impact
  • Reviewers assess 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): Evaluates the project's potential to advance scientific knowledge and address critical health disparities.
  • Rigor and Feasibility (Approach): Assesses the soundness of the proposed methodology, study design (must be a clinical trial), and feasibility of achieving objectives.
  • Expertise and Resources (Investigator(s) and Environment): Examines the qualifications of the research team and the adequacy of the institutional environment and resources.
Additional Review Criteria (considered, but not scored)
  • Protections for Human Subjects: Adequacy of measures to protect human participants.
  • Vertebrate Animals: Justification and care plans if animals are involved.
  • Biohazards: Assessment of risks and proposed protection measures.
  • Resubmissions: Evaluation of improvements made from previous submissions.
  • Renewals: Assessment of progress from the prior funding period.
  • Revisions: Appropriateness of proposed scope expansion.
Additional Review Considerations (considered, but not scored)
  • Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring validity of resources.
  • Budget and Period of Support: Justification and reasonableness of requested funds and duration relative to the proposed research.
Selection Criteria and Priorities
  • Scientific and technical merit as determined by peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities (e.g., specific interests of NCI, NIDCR, NIMHD, ODP, ORWH).
  • Reviewers will not consider race, ethnicity, age, or sex of a researcher, award participant, or trainee.

Compliance & Special Requirements

Regulatory Compliance
  • Compliance with 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards).
  • Adherence to all provisions of the NIH Grants Policy Statement.
  • Compliance with all applicable nondiscrimination laws.
  • Mandatory Disclosure of any violations of federal criminal law involving fraud, bribery, or gratuity potentially affecting the federal award (2 CFR 200.113).
Ethical and Safety Standards
  • Protection of human subjects and compliance with IRB/IEC requirements.
  • Data and Safety Monitoring for all NIH-supported clinical trials.
  • Adherence to Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements where applicable.
  • Assessment and protection plans for Biohazards if involved in research.
  • Evaluation of Vertebrate Animals involvement, if applicable.
Data Management and Sharing
  • Implementation of an approved Data Management and Sharing Plan consistent with the 2023 NIH Policy.
  • Registration and results reporting of all clinical trials on ClinicalTrials.gov.
Special Project Requirements
  • Clinical Trial Required: Applications must include at least one NIH-defined clinical trial.
  • Intervention focus: Must test interventions to expand cancer screening and preventive services in NIH-designated health disparity populations.
  • Multi-level approach: Interventions should address barriers and facilitators at two or more of the following levels: patient, clinician, healthcare setting, and neighborhood/community.
  • Collaboration: Leveraging collaborations with community partners and service providers is encouraged.
  • Scalability and Sustainability: NCI is interested in interventions with high potential for future scalability and sustainability.
Uniqueness and Challenges
  • This is a targeted R01 opportunity specifically for clinical trials aimed at reducing cancer disparities.
  • It requires a multi-level intervention approach, which can add complexity to design and measurement.
  • Explicit exclusion criteria for non-responsive applications mean careful alignment with the NOFO's scope is critical.
  • Requires robust data management and sharing plans, and rigorous human subjects protections.

Grant Details

healthcare public health cancer research health disparities medical research clinical trials social science community health preventive services intervention research data management clinical data health disparity populations underserved communities women's health racial/ethnic minorities r01 research project grant united states us territories cancer screening cancer prevention health equity public health interventions behavioral science social determinants of health
Interventions to expand cancer screening and preventive services to ADVANCE health in populations that experience health disparities (R01, Clinical Trial Required)
PAR-25-098
National Institutes of Health (NIH) - ADVANCE Initiative
UNIVERSITY NGO OTHER SME ENTERPRISE PUBLIC
US
HEALTHCARE SOCIAL OTHER
DEVELOPMENT GROWTH
OTHER
SDG3 SDG10
FUNDING RESEARCH_DEVELOPMENT CAPACITY_BUILDING
None
None
None
USD
None
Jan. 7, 2027, 5 p.m.
July 2025 - January 2027 (Review & Award Cycles listed)