NIDCD Clinical Research Center Grant (P50 Clinical Trial Optional)

The National Institutes of Health, through the National Institute on Deafness and Other Communication Disorders, has released a reissue of its Clinical Research Center Grant (P50 Clinical Trial Optional), announced under PAR-25-445. This grant program seeks to fund integrated, multidisciplinary clinical research centers focused on advancing the understanding, diagnosis, prevention, treatment, and management of human sensory and communication disorders. These include conditions affecting hearing, balance, smell, taste, voice, speech, and language. The P50 mechanism is designed to support centers that combine multiple research projects under a unifying theme, reinforced by administrative and optional scientific cores, to deliver outcomes with impact beyond the sum of their individual components. Applicants must propose a cohesive program built on three to four synergistic projects addressing a central theme relevant to NIDCD’s mission. Required elements include an administrative core, while scientific cores are optional but may be added to provide infrastructure support for shared resources. An external advisory committee is also required to provide oversight and guidance. The program welcomes research involving individuals with sensory and communication disorders or their data and tissues, with limited exceptions for studies involving unaffected individuals, those at risk, or non-human models, provided strong justification is given. Clinical trials may be proposed but are limited to low-risk designs or basic experimental studies involving humans. Funding is available for new, renewal, resubmission, and revision applications. New applications are capped at $1.5 million in direct costs annually, while renewals may request up to 10 percent above the prior year’s budget or a maximum of $2 million. Project periods may not exceed five years. The number of awards depends on NIH appropriations and the volume of meritorious applications. Applications that do not meet the structural and scientific requirements of this program will be deemed nonresponsive and withdrawn without review. Eligible applicants include U.S.-based higher education institutions, nonprofits, for-profit entities, state and local governments, tribal governments, independent school districts, housing authorities, and other community organizations. Foreign organizations and foreign subawards or subcontracts are not eligible under this notice. However, foreign components and collaborations that do not involve direct funding may be included. All applicant institutions must be registered with SAM.gov, eRA Commons, and Grants.gov. Principal investigators must have active eRA Commons accounts. Applications may be submitted via ASSIST or institutional system-to-system solutions through Grants.gov. There is no pre-application requirement such as a letter of intent. Applications are due on a cyclical schedule: November 4, 2025; February 2, 2026; June 2, 2026; October 2, 2026; February 2, 2027; June 2, 2027; October 1, 2027; February 2, 2028; and June 2, 2028. All deadlines are at 5:00 PM local time of the applicant organization. Reviews will follow NIH’s dual peer review system, with scientific merit reviews leading to advisory council reviews. Awards will follow in July 2026 for the first cycle, with subsequent earliest start dates aligned to later deadlines. Applications will be reviewed on significance, innovation, approach, investigator qualifications, and environment, as well as integration across projects, administrative efficiency, and the role of advisory committees. Proposals with clinical trials will be assessed for risk, design, statistical methods, and protections for human subjects. Renewal applications must demonstrate substantial progress since the prior award period. NIH policies on data sharing, human subjects protections, and safety monitoring apply. Prospective applicants are strongly encouraged to contact NIDCD program staff prior to submission, especially if proposing a clinical trial or complex core structures. Scientific questions should be directed to Dr. Holly L. Storkel at holly.storkel@nih.gov or (301) 496-5061. Grants management questions may be addressed to Samantha Tempchin at samantha.tempchin@nih.gov or (301) 435-1404. Technical submission assistance is available through the eRA Service Desk and Grants.gov support services.