CORE--HUMAN SUBJECTS

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The major objective of the Human Subjects Core (HSC) is to coordinate and facilitate activities required in the use of human subjects. In particular the Human Subjects Core has three specific aims: (1) To establish, maintain, and facilitate access to human subjects and related data sets for projects consistent with the overall goals of the OAIC; (2) To provide baseline assessments of self-reported functional status, health conditions, health care system utilization, and social psychological factors to be used for preliminary subject selection; (3) To provide training and consultation to OAIC researchers on issues related to recruitment, retention and adherence of human subjects and the evaluation of such efforts and issues of measurement of quality of life and other potential social-psychological outcomes to intervention trials. The proposed OAIC HSC was established in 1989. Activities include conducting recruitment and screening and maintaining the existing subject registry of approximately 1,600 persons and associated longitudinal database. Two of the proposed OAIC intervention development studies will utilize the USC resources for recruitment and preliminary eligibility screening of human subjects. The total number of participants required by the Projects is 683. Alexander's project requires 216 persons over the age of 70 who meet performance-based eligibility criteria. Richardson's project requires 457 persons between the ages of 50 and 80 who meet electrodiagnostic criteria for diffuse, primarily axonal, polyneuropathy. The HSC will also work with the IDS investigators in monitoring subject status during the exercise programs as well as assessing adherence during the at home phases of the programs. The HSC has proposed significant new effort in increasing minority participation in OAIC supported research studies. The two-pronged initiative for local recruitment and linkages to other researchers focusing on minority aging populations is detailed.