CORE--HUMAN SUBJECTS

核心——人类主体

• 批准号: 6651215
• 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: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2003-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6651215
• 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。特别是，人类受试者核心具有三个具体目标： (1) 为符合 OAIC 总体目标的项目建立、维护和促进对人类受试者和相关数据集的访问； (2) 提供自我报告的功能状态、健康状况、医疗保健系统利用率和社会心理因素的基线评估，用于初步受试者选择； (3) 就人类受试者的招募、保留和依从性相关问题以及此类努力的评估以及干预试验的生活质量和其他潜在社会心理结果的测量问题向 OAIC 研究人员提供培训和咨询。拟议的 OAIC HSC 成立于 1989 年。活动包括进行招募和筛选以及维护现有约 1,600 人的受试者登记册和相关的纵向数据库。拟议的 OAIC 干预开发研究中的两项将利用南加州大学的资源进行人类受试者的招募和初步资格筛选。该项目所需的参与者总数为 683 人。Alexander 的项目需要 216 名 70 岁以上且符合基于绩效的资格标准的人员。 Richardson 的项目需要 457 名年龄在 50 岁至 80 岁之间且符合弥漫性（主要是轴突性）多发性神经病电诊断标准的人。 HSC 还将与 IDS 调查员合作，监测锻炼计划期间受试者的状态，并评估计划在家阶段的依从性。 HSC 提出了重大的新努力，以增加少数民族参与 OAIC 支持的研究。详细介绍了当地招募和与其他关注少数族裔老龄化人口的其他研究人员建立联系的双管齐下的举措。