Cooperative Agreement for In Vivo High-Resolution Imaging for Inner Ear Visualization (U01 Clinical Trial Required)

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Description

This opportunity supports high-risk clinical trials aimed at developing or significantly improving in vivo high-resolution structural and functional imaging technologies for the living human inner ear. The goal is to enable detailed, non-invasive visualization of auditory and vestibular structures (e.g., hair cells, otoliths, membranes, ions, vasculature) in awake patients, advancing both diagnosis and treatment of inner ear disorders.

Projects may focus on:

• Improving the resolution of current imaging modalities (e.g., MRI, micro-CT, OCT, super-resolution microscopy, photoacoustic imaging)
• Developing new imaging techniques, probes, or contrast agents
• Translating imaging technologies into clinical settings, including device development and clinical studies in humans

A multidisciplinary team approach is strongly encouraged. Only clinical trials that require FDA oversight, are intended to establish efficacy, or pose higher risks to participants are eligible. Low-risk trials should apply to the companion R01 (see External Links).

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Due Dates

• Earliest Submission Date: May 3, 2025
• Letter of Intent: 30 days prior to each application due date
• Application Due Dates:
  • June 3, 2025
  • October 1, 2025
  • June 3, 2026
  • October 1, 2026
• Expiration Date: October 2, 2026

All applications are due by 5:00 PM local time of the applicant organization. No late applications are accepted.

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Funding Amount

• Maximum Direct Costs: Less than $500,000 per year (prior approval required for higher budgets)
• Project Period: Up to 5 years
• Estimated Number of Awards: 2–4 (across this and companion R01 opportunity)
• Total Program Funding: ~$3 million in FY25; $2 million planned for FY26 and FY27

Application budgets must reflect the actual needs of the proposed project.

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Eligibility

Eligible applicants include:

• Public and private institutions of higher education
• Nonprofits (with or without 501(c)(3) status)
• For-profit organizations (including small businesses)
• State, county, city, township, and special district governments
• Independent school districts
• Native American tribal governments and organizations (federally recognized and other)
• Public housing authorities/Indian housing authorities
• Faith-based and community-based organizations
• Regional organizations
• U.S. territories and possessions
• Non-domestic (non-U.S.) entities and components

Individuals: Any qualified individual(s) with the skills, knowledge, and resources to carry out the proposed research may apply.

Note: Only one clinical trial may be proposed per application. Low-risk trials not requiring FDA oversight should apply to the companion R01.

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Application Process

• Required Registrations: SAM, eRA Commons, Grants.gov
• Submission: Electronic only, via Grants.gov or NIH ASSIST
• Letter of Intent: Strongly encouraged; submit to the scientific contact at least 30 days before the due date
• Application Format: Follow the NIH SF424 (R&R) Application Guide and the specific instructions in the funding announcement
• Key Attachments:
  • Research Strategy (addressing five required points on imaging improvement, clinical translation, and impact)
  • Data Management and Sharing Plan
  • Milestones and contingency plans for the clinical trial
  • FDA documentation (if applicable)
  • Trial Management Plan (for multi-site trials)
  • Data Quality Auditing Plan (for Phase II/III/IV trials)
  • Post-trial Transition Plan for participants

Consultation with NIDCD staff at least 10 weeks prior to submission is strongly encouraged.

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Additional Information

• Clinical Trial Requirement: Only trials requiring FDA oversight, intended to establish efficacy, or with higher participant risk are eligible.
• Companion R01: For low-risk or non-FDA-regulated trials, see RFA-DC-25-005.
• Review Criteria: Significance, innovation, rigor, feasibility, investigator expertise, and environment. Applications must include a robust recruitment and retention plan, milestones, and a data and safety monitoring plan.
• Data Sharing: All applications must include a Data Management and Sharing Plan.
• ClinicalTrials.gov Registration: Required prior to enrollment of the first participant.

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External Links

• Full Funding Announcement (NIH Guide)
• Apply via Grants.gov
• NIDCD Clinical Trials Information
• NIH Application Guide
• Companion R01 (Clinical Trial Optional)

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Contact Information

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