Atom | NIDCD Low Risk Clinical Trials in Communication Disorders (R01 Clinical Trial Required)

Funder: National Institutes of Health

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).

Due Dates

New Applications: June 5, 2025 | October 5, 2025 | February 5, 2026 | June 5, 2026 | October 5, 2026
Renewal/Resubmission/Revision: July 5, 2025 | November 5, 2025 | March 5, 2026 | July 5, 2026 | November 5, 2026
AIDS-related Applications: September 7, 2025 | January 7, 2026 | May 7, 2026 | September 7, 2026 | January 7, 2027
Expiration Date: January 8, 2028

All applications are due by 5:00 PM local time of the applicant organization. See NIH standard due dates for more details.

Funding Amount

Direct Costs: Less than $500,000 per year (excluding consortium F&A).
Project Period: Up to 5 years.
Budget: Modular or detailed budget allowed, depending on total direct costs and applicant type.
Number of Awards: Contingent on NIH appropriations and the number of meritorious applications.

Applicants requesting $500,000 or more in direct costs in any year must contact a Scientific/Research Contact at least 10 weeks before submission.

Eligibility

Eligible applicants include:

Public and private institutions of higher education (domestic and foreign)
Nonprofits (with or without 501(c)(3) status)
For-profit organizations (including small businesses)
State, county, city, township, and special district governments
Native American tribal governments and organizations (federally recognized and other)
Independent school districts
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 of U.S. organizations

Individuals: Any qualified individual with the skills, knowledge, and resources necessary to carry out the proposed research as PD/PI is eligible to apply.

Note: Foreign organizations and components are eligible.

Application Process

Submission: Applications must be submitted electronically via Grants.gov using ASSIST, Grants.gov Workspace, or an institutional system-to-system solution.
Required Registrations: Applicant organizations must have active registrations in SAM, eRA Commons, and Grants.gov.
Application Guide: Follow the NIH SF424 (R&R) Application Guide and the specific instructions in the funding announcement.
Clinical Trial Registration: All clinical trials must be registered in ClinicalTrials.gov prior to enrollment of the first participant.
Data Management and Sharing Plan: Required for all applications generating scientific data.
Consultation: Applicants are encouraged to consult with NIDCD program staff at least 10 weeks prior to submission, especially for new or resubmission applications.

Additional Information

Scope: Only one clinical trial should be proposed per application.
Not Supported: Applications that do not address NIDCD’s mission, exceed budget limits, require FDA oversight, or are intended to establish efficacy (Phase III) are not responsive.
Review Criteria: Scientific merit, significance, investigator qualifications, innovation, approach, and environment.
Data and Safety Monitoring: Required for all clinical trials; a plan must be included in the application.
Reporting: Annual progress reports (RPPR) and financial statements are required.

External Links

Contact Information

Topic	Contact Person	Email	Phone
Scientific/Research Contact	Dr. Trinh T. Ly	trinh.ly@nih.gov	301-435-4085
Grants Management Contact	Samantha Tempchin	samantha.tempchin@nih.gov	301-435-1404
General Grants Info	NIH Grants Information	GrantsInfo@nih.gov	301-480-7075
Application Submission Help	eRA Service Desk	eRA Helpdesk	301-402-7469 or 866-504-9552
Grants.gov Support	Grants.gov Customer Support	support@grants.gov	800-518-4726

For additional contacts, see Section VII. Agency Contacts in the full announcement.