CORE--HUMAN SUBJECTS

核心——人类主体

• 批准号: 6352543
• 负责人: JERSEY LIANG
• 金额: $ 19.62万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-01 至 2001-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6352543
• 关键词: aging; biomedical facility; clinical research; functional ability; geriatrics; health care service utilization; human data; human old age (65+); human subject; mass screening; medical outreach /case finding; patient /disease registry; quality of life; training

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.

人类主体核心(HSC)的主要目标是协调和促进使用人类主体所需的活动。特别是，人类受试者核心有三个具体目标：(1)建立、维持和便利获取符合OAIC总体目标的项目的人类受试者和相关数据集；(2)提供自我报告的功能状况、健康状况、医疗保健系统利用情况和社会心理因素的基线评估，用于初步选择受试者；(3)就与招募、保留和坚持人类受试者有关的问题，向OAIC研究人员提供培训和咨询，并评估这些努力以及干预试验的生活质量和其他潜在社会心理结果的衡量问题。建议成立的东区议会健康服务中心于1989年成立。活动包括进行征聘和筛选，以及维持现有的约1600人的主题登记册和相关的纵向数据库。两项拟议的OAIC干预发展研究将利用南加州大学的资源对人类受试者进行招募和初步资格筛选。这些项目所需的参与者总数为683人。Alexander的项目要求216名70岁以上的人符合基于绩效的资格标准。理查森的项目要求457名年龄在50岁到80岁之间的人符合弥漫性、主要是轴索性多发性神经病的电诊断标准。HSC还将与入侵检测系统调查人员合作，在演习计划期间监测受试者状态，并在计划的在家阶段评估遵守情况。高管会建议在增加少数群体参与OAIC资助的研究方面做出重大的新努力。双管齐下的倡议，当地招募和与其他研究人员的联系，重点是少数族裔老龄化人口是详细的。