NIDCD Clinical Research Center Grant (P50 Clinical Trial Optional)

The National Institute on Deafness and Other Communication Disorders (NIDCD) at the National Institutes of Health (NIH) invites new, resubmission, revision or renewal applications for Clinical Research Center Grants (P50) in the mission areas of hearing, balance, smell, taste, voice, speech, or language. The P50 Clinical Research Center provides a vehicle for integrated, multidisciplinary approaches to critical clinical research questions that advance the study of prevention, pathogenesis, pathophysiology, diagnosis, treatment, management or epidemiology of a disease or disorder of hearing, balance, smell, taste, voice, speech, or language. The P50 provides an avenue for forming a multi-disciplinary team that is intended to bring innovative ideas and distinct perspectives to the generation and evaluation of high impact solutions to complex clinical problems. Responsive applications must include a multi-disciplinary team collaborating on a synergistic set of 3-4 research projects addressing a unifying theme. The synergistic and substantial integration of research projects is intended to generate breakthrough solutions to the unifying problem. The research efforts are further supported by an administrative core and 1-2 optional scientific cores to ensure rigorous and efficient progress towards the center’s unifying theme. Overall, the clinical research center provides a whole that will have impact beyond the sum of its parts.

Required Elements

Given the complexity of the P50 Clinical Research Centers, applicants are strongly encouraged to communicate with the scientific/research contact listed at the end of this funding opportunity for guidance on responsiveness to the following required elements. Applications that are not responsive or incomplete (e.g., are missing required elements) will be withdrawn and will not be reviewed.

To be responsive to this funding opportunity, a Clinical Research Center must include the following required conceptual and structural elements.

Clinical Research
For this funding opportunity, the research being conducted must have a clinical focus, usually defined as research involving individuals with sensory and/or communication disorders or data/tissues from individuals with a sensory and/or communication disorder. Examples include (but are not limited to) studies of the prevention, pathogenesis, pathophysiology, diagnosis, treatment, management or epidemiology of a disease or disorder of hearing, balance, smell, taste, voice, speech, or language. Although the intent is that all the research will involve individuals with sensory and/or communication disorders or data/tissues from individuals with sensory and/or communication disorders, when the clinical research goal(s) warrant(s) departures from this intent, alternatives are possible with appropriate and strong scientific justification and in consultation with NIDCD staff. In particular, studies with normal human subjects (e.g., those without a sensory or communication disorder) may be included in the research with appropriate justification that the inclusion of such data are essential for the clinical research goal(s) and/or the interpretation of the results (e.g., studies focusing on detection, diagnostic methods, or epidemiology). Likewise, for certain clinical research objectives (e.g., studies focusing on prevention), individuals at-risk for sensory and/or communication disorders may be included when strongly justified. Non-human research may be supported when the translational nature of the research is clearly articulated. Non-human research will be limited to (at most) one project. Across these alternative scenarios, there is an expectation that the majority of the research will focus on individuals with sensory and/or communication disorders and/or data/tissues from individuals with sensory and/or communication disorders.

Clinical trials, as defined by NIH, are optional. When a clinical trial is included, only low-risk clinical trials or Basic Science Experimental Studies involving Humans will be funded through this mechanism. Low-risk clinical trials: do not require FDA oversight, are not an NIH defined Phase III Clinical Trial, have low risks to subjects, and intend to gather scientific data/evidence to inform subsequent studies. This NOFO also supports Basic Science Experimental Studies involving Humans (https://grants.nih.gov/policy-and-compliance/policy-topics/clinical-trials/beshBESH). These studies fall within the NIH definition of a clinical trial and meet the definition of basic research. For more information about clinical trials at NIDCD, see https://www.nidcd.nih.gov/research/clinical-studies/researchers-professionals.