CORE--HUMAN SUBJECTS

人类受试者核心（HSC）的主要目标是协调和 促进使用人类受试者所需的活动。 在 特别是人类主题核心有三个具体目标：（1） 建立、维护和促进对人类受试者和相关 符合OAIC总体目标的项目数据集;（2） 提供自我报告的功能状态、健康 条件、卫生保健系统利用和社会心理 初步选题的因素;（3）提供 就下列问题向国际移民组织研究人员提供培训和咨询： 招募和保留人类受试者，并对此类受试者进行评价 衡量生活质量和其他潜力的努力和问题 干预试验的社会心理结果。 拟议的OAIC HSC将建立在人类受试者核心基础上 自1989年以来，作为密歇根州克劳德D. 佩珀老年医学研究和培训中心。 的转变中 GRTC，HSC服务将从基础广泛的支持转变为超过60 研究项目的三个层次的优先支持系统。 第一 将优先考虑干预发展研究， 将优先考虑OAIC试点项目，第三个优先事项将是 其他外部资助项目。 HSC的活动包括 进行招募和筛选，并维持现有受试者 登记了大约2 000人， 数据库 向审咨委过渡还需要更大的 强调征聘和留用以及生活质量问题 与以前相比，HSC支持的研究中的测量。 的 HSC将通过提供培训，协助OAIC研究人员完成这一过渡 在这些问题上进行磋商。 三个拟议的OAIC干预发展研究将依赖于 健康服务中心负责招募和初步筛选 科目 计划所需的参加者总数为 565. 亚历山大的项目需要225名70岁以上的人， 遇到床或椅子转移困难。 阿什顿-米勒项目 需要250名年龄在65岁到84岁之间的妇女，她们有压力或混合压力。 压力性和急迫性尿失禁。 Supiano的研究需要55名参与者 年龄在60岁到85岁之间，心肌收缩力受损 正常对照组35例。 提出了有针对性的征聘战略， 每项干预研究。 在各种健康的基础上 条件患病率和预计参与率，它是 据估计，2,200至2,600名老年人将不得不接触， 在这些有针对性的招聘中。 接受干预筛查的人数 将在现有的HSC中增加并保留发展研究 受试者登记处。

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.