This grant supports multi-level intervention studies to overcome individual and system-level barriers in healthcare transitions for childhood and adolescent cancer survivors.
The goal is to develop and test strategies promoting high-quality transitional care and continued engagement of survivors into adulthood.
This is a SECTOR-SPECIFIC grant focused on healthcare and medical research.
Eligible recipients are diverse organizational types (universities, nonprofits, for-profits, governments) located in the United States.
Key filtering criteria include a focus on human subjects research, cancer survivorship, and the explicit requirement for multidisciplinary research teams.
This is a reissue of a prior funding opportunity, indicating it may recur.
Financial Structure
Total funding commitment for this and prior issuance: $10,000,000 total across FY 2025 and FY 2026.
Anticipated number of awards: Up to 12 awards across prior and current issuance.
Maximum direct costs per year: Limited to $499,000.
Maximum total direct costs per project (over 5 years): Up to $2,495,000 (calculated as $499,000/year * 5 years).
Minimum funding amount: Not specified.
Currency: USD.
Funding rate: Not explicitly stated, but typically NIH grants cover eligible costs.
Cost sharing/matching funds: Not required.
Pre-award costs: Allowable only as described in the NIH Grants Policy Statement.
Financial reporting: Annual Research Performance Progress Report (RPPR) and financial statements required. A final RPPR, invention statement, and expenditure data are required for closeout.
Audit requirements: Subject to 2 CFR Part 200, Uniform Administrative Requirements.
For-Profit Organizations (Small Businesses, Other For-Profit)
Local Governments (State, County, City/Township, Special District, Federally Recognized Indian/Native American Tribal, Other Indian/Native American Tribal)
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)
Foreign Organizations: Not eligible to apply as the primary applicant.
Non-domestic components of U.S. Organizations: Not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed as part of a U.S. organization's application.
Registration and Certification
All applicant organizations must complete and maintain active registrations prior to submission:
System for Award Management (SAM)
Unique Entity Identifier (UEI) (issued via SAM.gov)
Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) code to register in SAM.
All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must have an eRA Commons account.
Project Focus Requirements
Applications must focus on the evaluation of strategies or the development and testing of interventions related to healthcare transitions for childhood and adolescent cancer survivors.
Projects must include human subjects.
Study designs must consider eventual scalability, sustainability, and integration of the intervention into real-world settings.
Applications must reflect multidisciplinary research. (Applications that do not reflect multidisciplinary research are non-responsive and will not be reviewed).
Studies must focus on issues specific to childhood cancer survivors, not general care coordination issues.
Exclusions
Applications will be considered non-responsive and will not be reviewed if they:
Do not include human subjects.
Focus on interventions or models of care that do not consider eventual scalability, sustainability, and integration of the intervention to real-world settings.
Do not reflect multidisciplinary research.
Application Process
Application Timeline
Posted Date: December 16, 2024
Open Date (Earliest Submission Date): September 17, 2025
Letter of Intent Due Date(s): 30 days prior to the application due date (strongly recommended, but not required).
Application Due Date: October 17, 2025, by 5:00 PM local time of applicant organization.
No late applications will be accepted.
Expiration Date: October 18, 2025.
Earliest Start Date: July 2026.
Scientific Merit Review: March 2026.
Advisory Council Review: May 2026.
Application Submission
Applications must be submitted electronically via one of the following methods:
Prior registration with SAM, UEI, eRA Commons, and Grants.gov is mandatory and can take 6+ weeks.
The PD(s)/PI(s) must include their eRA Commons ID in the application.
Applicants are encouraged to apply early to allow time for error correction.
Required Documentation and Materials
Standard application forms (SF424(R&R) Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile, R&R or Modular Budget, R&R Subaward Budget, PHS 398 Cover Page Supplement, PHS Human Subjects and Clinical Trials Information form).
Research Plan (PHS 398 Research Plan):
Research Strategy (within Significance, Innovation, Investigator(s), and Approach sections):
Explain how the research addresses needs/gaps for survivors' transitions.
Justify study design, rigor, statistical power, and how the intervention considers scalability, sustainability, and real-world integration.
Address inclusion of minority health and health disparity populations, if applicable.
Letters of Support: Required from consortium/site participants, collaborators, and stakeholders involved in engagement efforts.
Resource Sharing Plan (as per NIH Application Guide).
Data Management and Sharing Plan (required for all applications, regardless of direct costs).
Appendix: Only limited materials allowed (e.g., blank questionnaires/surveys). No publications.
Project Implementation and Reporting
Grant Duration: Proposed project period must not exceed 5 years.
Reporting: Annual Research Performance Progress Report (RPPR) and financial statements are required.
Closeout: Final RPPR, invention statement, and expenditure data are required.
Monitoring and Evaluation: Data and safety monitoring is required for all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials).
Application Assistance
eRA Service Desk: For system-related questions (ASSIST, eRA Commons, errors).
General Grants Information: For application instructions and NIH resources.
Grants.gov Customer Support: For registration and Workspace issues.
Scientific/Research Contact: Lynn S. Adams, PhD, NCI (for scientific inquiries).
For system issues threatening on-time submission, follow 'Dealing with System Issues' guidance.
Evaluation Criteria
Overall Impact
Reviewers will provide an overall impact score based on the project's likelihood to exert a sustained, powerful influence on the research field, considering the scored and additional review criteria.
Scored Review Criteria
Each of these factors receives a separate score, contributing to the overall impact score:
Factor 1: Importance of the Research (Significance and Innovation)
Significance: How well the research addresses a pressing need or knowledge gap for pediatric/adolescent survivors transitioning to adult care.
Innovation: Whether the application proposes novel theoretical concepts, approaches, methodologies, instrumentation, or interventions that shift current paradigms, or a substantial refinement/improvement.
Factor 2: Rigor and Feasibility (Approach)
Approach: Clarity and justification of the study design, efforts to ensure scientific rigor, and consideration of statistical power.
Scalability, Sustainability, and Integration: How the study design addresses the eventual scalability, sustainability, and integration of the intervention into real-world settings.
Health Disparities: If applicable, how minority health and health disparity populations or data are integrated, and potential opportunities to reduce cancer burden in health disparities.
Factor 3: Expertise and Resources (Investigator(s) and Environment)
Investigator(s): Suitability of the investigative team to conduct the research, with emphasis on how collective expertise in multidisciplinary teams will achieve project aims.
Environment: Adequacy of the scientific environment, institutional support, and other resources available.
Additional Review Criteria (No separate score, but considered for overall impact)
Protections for Human Subjects
Vertebrate Animals (if applicable)
Biohazards (if applicable)
Resubmissions: Evaluation of the full application as presented.
Renewals: Evaluation of progress made in the last funding period.
Other Review Considerations
Authentication of Key Biological and/or Chemical Resources.
Budget and Period of Support: Justification and reasonableness of the budget and requested project period in relation to the proposed research.
Scientific and technical merit, availability of funds, and relevance to program priorities are considered in funding decisions.
Compliance & Special Requirements
Regulatory Compliance
All awards are subject to the terms and conditions outlined in the NIH Grants Policy Statement.
Compliance with 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards) is mandatory.
Recipients must comply with all applicable nondiscrimination laws and submit an Assurance of Compliance (HHS-690).
If the project involves health IT, it must meet standards in 45 CFR part 170, Subpart B, and if applicable for eligible clinicians/hospitals, health IT must be certified under the ONC Health IT Certification Program.
Clinical Trials: If applicable, registration and results reporting on ClinicalTrials.gov are required.
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval of all protocols is required for human subjects research.
Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements apply if investigational therapeutics/devices are used.
Data Management and Security
A Data Management and Sharing Plan is required and must be implemented as described upon approval.
If recipients/subrecipients have access to HHS systems or PII/PHI, they must develop plans and procedures modeled after the NIST Cybersecurity framework.
Data and safety monitoring is required for all human biomedical and behavioral intervention studies.
Ethical Standards
Strict adherence to protections for human subjects and ethical research practices is expected.
Intellectual Property
Intellectual property policies are generally governed by NIH policies; however, the NOFO references requirements for submitting an invention statement at closeout.
Unique Aspects and Strategic Opportunities
This RFA is a reissue (RFA-CA-24-027), indicating continued agency priority in this area.
Strong encouragement for studies that address barriers contributing to disparities in health outcomes for childhood cancer survivors and/or focus on high-risk groups (e.g., uninsured/under-insured).
Integration of existing transition frameworks into interventions is encouraged.
Leveraging existing information technologies (electronic health records, clinical decision support, telehealth) is encouraged.
Multi-level studies (individual and system level) are encouraged.
Incorporation of patient feedback into intervention planning and testing is encouraged.
Studies including primary care and considering the effect of payment mechanisms on transition are encouraged.
The research should align with the STAR Reauthorization Act of 2023, which authorizes NCI to support research on model systems of care for pediatric cancer survivors, including transition and care coordination.
Grant Details
cancer survivorship
childhood cancer
adolescent cancer
healthcare transitions
pediatric care
adult care
intervention studies
health disparities
minority health
public health
medical research
clinical trials optional
multidisciplinary research
scalability
sustainability
real-world implementation
patient engagement
care coordination
health IT
electronic health records
telehealth
NIST cybersecurity
data management
NIH
NCI
R01 grant
US funding
social determinants of health
quality of life
chronic illness
surveillance
risk-based care
federally recognized tribal governme
faith-based organizations
community-based organizations
higher education institutions
nonprofits
for-profit organizations
small businesses
local governments
federal governments
human subjects research
Addressing Barriers to Healthcare Transitions for Survivors of Childhood and Adolescent Cancers (R01 Clinical Trial Optional)
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