The National Institutes of Health (NIH), through its National Institute on Deafness and Other Communication Disorders (NIDCD), has announced a reissued funding opportunity for low-risk clinical trials in communication disorders under the grant number PAR-24-051. This opportunity, aligned with NIDCD’s strategic mission, seeks to support well-designed, low-risk clinical trials that aim to produce critical scientific evidence to inform subsequent, more advanced research. Eligible trials must relate to disorders involving hearing, balance, taste, smell, voice, speech, or language. The clinical trials must not require FDA oversight, be classified as NIH-defined Phase III clinical trials, or present high risks to subjects. Additionally, basic science experimental studies involving humans that fall within the NIH clinical trial definition and qualify as basic research are eligible.

Applications for this funding must adhere strictly to NIH's application procedures and conform to all guidance outlined in the SF424 (R&R) Application Guide. Applications that do not meet these requirements risk being delayed or not reviewed. Application submission options include NIH’s ASSIST system, Grants.gov Workspace, or institutional system-to-system (S2S) solutions. The earliest submission date is January 5, 2024, and the current expiration date for this opportunity is June 6, 2025, as updated in the notice NOT-DC-25-025. Standard NIH submission dates apply, with due dates in February, June, and October annually.

The award budget for this opportunity is capped at less than $500,000 in direct costs per year, with a maximum project duration of five years. Funding is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Cost-sharing is not required. All applicants must complete required registrations including SAM, eRA Commons, and Grants.gov, and ensure the consistency of information across these platforms.

Eligibility for this grant is broad, encompassing higher education institutions, non-profits, for-profits, and government entities, including foreign organizations. Applicants may submit more than one application if each is scientifically distinct. However, duplicate or highly overlapping applications will not be accepted if under concurrent review.

Applications will be evaluated based on standard NIH review criteria, including significance, innovation, investigator(s), approach, and environment. Additional considerations include study design, data management, and protections for human subjects. Peer reviews and advisory council evaluations will determine funding decisions. The application must include a detailed study design, data management and sharing plan, and address all ethical, administrative, and logistical considerations.

For technical and scientific questions, applicants are encouraged to contact Trinh T. Ly, MD (trinh.ly@nih.gov) at NIDCD. For financial queries, Samantha Tempchin (samantha.tempchin@nih.gov) is the designated contact. It is advised to consult NIDCD staff at least 10 weeks prior to submission to ensure the trial aligns with NIDCD priorities.