NIDCD Clinical Research Center Grant (P50 Clinical Trial Optional)

The National Institute on Deafness and Other Communication Disorders (NIDCD), part of the National Institutes of Health (NIH), is offering Clinical Research Center Grants (P50), optionally involving clinical trials, to advance the study of communication disorders. The main objective of this funding is to support interdisciplinary research centers focused on hearing, balance, smell, taste, voice, speech, and language disorders. Applications are encouraged that align with NIDCD's research priority areas, which include understanding normal human communication systems, addressing communication disorders, improving diagnostic and treatment methods, and enhancing health outcomes. This funding opportunity supports both new and renewal applications, with budgets capped at $1,500,000 per year in direct costs for new applications. Renewal applications can request an increase of up to 10% above the last year’s budget, or a maximum of $2,000,000 per year. The project period can be up to five years, and awards will depend on the availability of funds and the submission of strong proposals. Importantly, while proposals may include clinical trials, these must be low-risk trials that do not require FDA oversight. Eligible applicants include higher education institutions, non-profit organizations, for-profit organizations, and government entities, though foreign institutions are not eligible. The research must center around individuals with communication disorders or related biological materials, and projects must have a well-defined central theme that integrates multiple research components. Each research project must be clearly related to this unifying theme, and the entire Center should employ a multidisciplinary approach to achieving its objectives. Applications must include an administrative core to manage the center's activities, which can also support other cores like scientific or technical service units. The proposed research should demonstrate synergy and substantial interaction among different projects within the center. Centers must also have an external advisory committee that provides scientific oversight and guides the research plan. Research with non-human subjects is limited and only allowed when necessary to facilitate translational research. Applicants should follow strict guidelines for submission, including using the NIH ASSIST system or an equivalent institutional submission system. Key dates include a letter of intent due 30 days before the application deadline, with application deadlines extending until February 2025. The evaluation criteria focus on scientific merit, significance, innovation, approach, and the qualifications of the investigators. The proposed studies must demonstrate potential for advancing the field of communication disorders, and applicants are encouraged to contact relevant NIH staff early in the process to discuss the proposed clinical trial's risk level and alignment with programmatic priorities. Reviewers will assess each application's impact based on the likelihood of advancing knowledge in the field, the quality of the proposed research team, and the proposed project's innovation and approach. For projects involving clinical trials, specific considerations include the trial's design, safety, feasibility, and potential to inform future studies. Successful applicants will be required to comply with NIH policies, including data management and sharing, as well as clinical trial registration requirements.