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

The NIDCD Low Risk Clinical Trials in Communication Disorders (R01 Clinical Trial Required) grant is administered by the National Institute on Deafness and Other Communication Disorders (NIDCD), part of the National Institutes of Health (NIH) within the U.S. Department of Health and Human Services. The NIDCD focuses on advancing scientific understanding and treatments for disorders related to hearing, balance, taste, smell, voice, speech, and language. This specific opportunity supports investigator-initiated, low-risk clinical trials that aim to produce significant clinical findings or generate data to inform future studies related to communication disorders. This grant is intended for hypothesis-driven studies with low risk to participants, not requiring FDA oversight, and not classified as NIH-defined Phase III Clinical Trials. The proposed trials should not aim to change health policies or standards of care directly but should generate essential data that informs later research. Additionally, the grant also accepts Basic Experimental Studies involving Humans (BESH) that fit the NIH clinical trial definition but serve basic science objectives. Studies involving higher risk or requiring FDA oversight should instead apply under the companion U01 mechanism (PAR-24-050). Applications must propose only one clinical trial per submission. Each application must conform to NIH’s policies, including data management, human subjects protections, and appropriate registrations such as SAM, eRA Commons, and Grants.gov. Applications must adhere to a strict budget cap of under $500,000 in direct costs per year for a maximum period of five years. Eligible applicants include a broad range of institutions, including higher education institutions, nonprofits, for-profit organizations, tribal and local governments, and foreign organizations. The application process involves multiple standard NIH due dates, including February 5, June 5, and October 5 each year, with corresponding review and funding cycles. While Letters of Intent are not required, applicants are encouraged to consult with NIDCD at least 10 weeks prior to submission to confirm that their study aligns with the institute’s priorities. Detailed evaluation criteria include the significance of the study, investigator qualifications, innovation, approach, and environmental support. Applications must be submitted via one of several platforms including NIH ASSIST, Grants.gov Workspace, or institutional systems. Specific review criteria include the scientific merit of the proposal, the appropriateness of the study design, statistical methods, human subjects protections, and the feasibility of the study timeline. Additional considerations include policies for data sharing, protections for human subjects, and inclusiveness across demographic categories. For application or scientific inquiries, applicants can contact Dr. Trinh T. Ly at trinh.ly@nih.gov or 301-435-4085. Questions about financial or grants management should be directed to Samantha Tempchin at samantha.tempchin@nih.gov or 301-435-1404. The updated expiration date for this opportunity is May 24, 2025, replacing the originally planned expiration in January 2028. The NIH strongly advises early submission to ensure ample time for addressing any errors during the process.