NIDCD Low Risk Clinical Trials in Communication Disorders (R01 Clinical Trial Required)
Funds available for low risk clinical trials on communication disorders, meeting budget limits, not requiring FDA oversight, and aiming to identify effective interventions.
This grant is no longer accepting proposals
National Institutes of Health has archived this opportunity.
Funder: National Institutes of Health
Due Dates: June 5, 2025 (New) | July 5, 2025 (Renewal/Resubmission/Revision) | September 7, 2025 (AIDS) | October 5, 2025 (New) | November 5, 2025 (Renewal/Resubmission/Revision) | January 7, 2026 (AIDS) | Additional standard NIH due dates through January 7, 2027
Funding Amounts: Up to $500,000 in direct costs per year; maximum project period 5 years; modular or detailed budget allowed
Summary: Supports investigator-initiated, low risk clinical trials to advance interventions for communication disorders, within NIDCD’s mission, that do not require FDA oversight and are not intended to establish efficacy.
Key Information: Applications must not exceed $500,000 in direct costs/year and must not require FDA IND/IDE; only low risk trials are eligible.
Description
This opportunity from the National Institute on Deafness and Other Communication Disorders (NIDCD) supports investigator-initiated, low risk clinical trials in the field of communication disorders, including hearing, balance, taste, smell, voice, speech, and language. The goal is to generate clinical findings that inform the development of interventions with significant clinical and public health impact. Trials must be hypothesis-driven, well-designed, and well-executed, and should provide data necessary to inform future studies or subsequent clinical trials.
Eligible trials must:
- Not require FDA oversight (i.e., no IND or IDE required).
- Pose low risk to participants (risks no greater than those encountered in routine care).
- Not be intended or powered to formally establish efficacy (not NIH-defined Phase III).
- Stay within the budget limits of this opportunity.
This program also supports Basic Science Experimental Studies involving Humans (BESH) that meet the NIH definition of a clinical trial and basic research.
High risk trials, those requiring FDA oversight, or those intended to establish efficacy should apply to the companion U01 mechanism (PAR-24-050).
