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 and retention 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 will be built upon the Human Subjects Core established and in operation since 1989 as part of the Michigan Claude D. Pepper Geriatrics Research and Training Center. In the transition from a GRTC, the HSC services will change from the broad-based support over 60 research projects to a three-tiered prioritized system of support. First priority will be given to the intervention development studies, second priority will be given to OAIC pilot projects, and third priority will be given to other externally funded projects. Activities of the HSC include conducting recruitment and screening and maintaining the existing subject registry of approximately 2,000 persons and associated longitudinal database. The transition to an OAIC will also necessitate a greater emphasis on issues of recruitment and retention as well as quality of life measurement in studies supported by the HSC than previously existed. The HSC will assist OAIC researchers in this transition by providing training and consultation in these issues. Three of the proposed OAIC intervention development studies will rely upon the HSC to recruit and conduct preliminary eligibility screening of human subjects. The total number of participants required by the projects is 565. Alexander's project requires 225 persons over the age of 70 who experience bed or chair transfer difficulties. Ashton-Miller's project requires 250 women between the ages of 65 and 84 who have stress or mixed stress and urge incontinence. Supiano's study requires 55 participants between the ages of 60 and 85 who have impaired myocardial contractility and 35 normal controls. Targeted recruitment strategies are proposed for each of the intervention studies. On the basis of various health condition prevalence rates and projected rates of participation, it is estimated that from 2,200 to 2,600 older adults will have to be contacted in these targeted recruitments. Persons screened for the intervention development studies will be added to and maintained in the existing HSC subject registry.
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