The Research Opportunities in Established Cancer Epidemiology Cohort Studies (U01 Clinical Trial Not Allowed) funding opportunity, reissued as PAR-25-275, is offered by the National Cancer Institute (NCI) under the National Institutes of Health (NIH). It supports hypothesis-driven research using data from established cancer epidemiology cohorts (CECs) to address significant scientific questions across the cancer control continuum. These studies must have completed their initial participant recruitment phase. Projects are expected to include cohort maintenance, follow-up activities, and sharing of resources while investigating questions related to cancer etiology, outcomes, and interventions.
The primary objective is to reduce cancer risk, incidence, morbidity, and mortality while enhancing the quality of life for cancer survivors. Research should leverage existing cohort data to address innovative hypotheses, particularly for understudied populations, rare cancers, and novel exposures. Cohort support must align with scientific goals and not merely focus on infrastructure. Proposals that lack hypothesis-based research, recruit new participants, or use cohorts already funded under specific prior initiatives will be deemed non-responsive.
Eligible applicants include domestic and foreign organizations such as higher education institutions, nonprofits, for-profit entities, state and local governments, and tribal organizations. Non-domestic entities and components are also eligible. Applications must follow NIH registration requirements for SAM.gov, eRA Commons, and Grants.gov, which may take several weeks to complete.
Budgets are not capped but must reflect project needs, with a maximum project period of five years. Applications requesting $500,000 or more in direct costs in any year require pre-submission consultation with NCI staff, while requests exceeding $700,000 mandate a consultation at least 12 weeks before submission. Projects must allocate resources for personnel participation in NCI Cohort Consortium meetings.
Applications must include specific aims, a robust research strategy, and a resource sharing plan compliant with NIH policies. Proposals should address cohort data quality, biospecimen handling, participant retention, and cancer case ascertainment. Applicants must align their work with FAIR principles for data sharing and ensure compliance with the NIH Genomic Data Sharing Policy.
Submissions will be evaluated on scientific merit, feasibility, innovation, and alignment with NOFO objectives. Review criteria include the significance of the research questions, rigor of the study design, appropriateness of the study population, and the qualifications of the investigative team. Applications are due by **February 28, 2025**, with awards expected by December 2025. Applicants are encouraged to contact NCI staff for guidance and attend a pre-application webinar. Further details are available through designated NIH contacts and resources.
