Core B: Human subjects

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PROJECT SUMMARY/ABSTRACT – CORE B The Clinical Research Center is supported by Core B (Human Subjects). Core B (Aim B.1) is responsible for recruitment of female and male human subjects representing the population of the local community for participation in (1) the longitudinal study of age-related hearing loss, (2) experiments proposed in Project 3 and Project 4, (3) donation of DNA for experiments proposed in Project 1, and (4) donation of human temporal bones for experiments proposed in Project 1 and Project 2. Core B (Aim B.2) manages the collection, storage, and analysis of demographic, audiologic, and biologic/medical data and tissue (blood and DNA) from human subjects. These data define the basic audiologic profile of each subject, supplemented by measures that may be associated with this profile, and are organized into a searchable database, which provides key information needed to recruit subjects according to the enrollment criteria for each scientific project. Together with Aim B.1, the goal is to ensure the scientific projects enroll the required numbers of subjects with various audiologic profiles, obtain the required numbers of DNA samples, and acquire sufficient numbers of human temporal bones. Core B (Aim B.3) coordinates subject schedules for the human subject protocol (longitudinal measures and annual evaluations), Otolaryngology clinic visits, and laboratory visits for blood draws for clinical chemistries and DNA. Because of the strong links among projects, there is substantial overlap of needs for subject participation. Thus, Core B makes efficient use of subjects' testing time and coordinates storage of their data to optimize data access and analyses for the scientific projects.