Jun 2, 2025, 08:26

Innovative Biospecimen Science Technologies for Basic and Clinical Cancer Research (R61 Clinical Trial Not Allowed)

Supports Phase I (R61) exploratory/developmental projects to create highly innovative tools, devices, instrumentation, assays, and associated methods that improve the collection, handling, processing, preservation, and/or storage of cancer-relevant biospecimens and their derivatives. Applications must propose novel capabilities to preserve sample integrity, establish rigorous quality assessment/quality control metrics, or mitigate pre-analytical degradation of targeted analytes. These technologies should accelerate and enhance research in cancer biology, early detection and screening, clinical diagnosis, treatment, epidemiology, and/or health-disparities research. Projects that merely apply existing technologies without significant technical innovation will be deemed nonresponsive.

Eligibility Criteria

Eligible organizations:
- U.S. and foreign institutions of higher education;
- Nonprofit organizations (with or without 501(c)(3) status);
- For-profit entities (including small businesses);
- Local, state, and tribal governments;
- Faith-based or community organizations;
- Public housing authorities/Indian housing authorities;
- Independent school districts;
- Regional organizations.
PD/PI requirements: Must have an eRA Commons account.
Project scope: Early-stage (inception through preliminary development) biospecimen science technology development (no clinical trials).
Preliminary data: Not required but accepted. If feasibility is already established, consider the R33 companion (RFA-CA-25-004).
Nonresponsive applications:
- Biological/clinical hypothesis–driven projects without novel technical innovation;
- Proof-of-concept technologies ready for validation;
- Whole-body or in vivo imaging instrumentation;
- Clinical trials or toxicology beyond technology validation;
- Biomarker discovery/validation;
- Drug or therapy development;
- Software/informatics-only solutions without integration into a device or method;
- Lacks well-defined, quantitative performance measures.

Funding Details

Mechanism: R61 Phase I Exploratory/Developmental Grant
Direct costs: Up to 150,000 USD per year
Project period: Up to 3 years
Estimated awards (FY 2026): ~4, totaling 1,000,000 USD
Clinical trials: Not allowed
Budget constraints: Funds must be used for early-stage development and feasibility testing; pre-award costs allowed only as described in NIH Grants Policy Statement.

Key Deadlines

Letter of Intent: 30 days prior to application due date
Application Due Dates & Review Timelines:
- October 3, 2025 (Submit by 5:00 PM local time) → Scientific Merit Review: February 2026 → Advisory Council: May 2026 → Earliest Start: July 2026
Expiration Date: October 4, 2025