CORE--HUMAN SUBJECTS

核心——人类主体

• 批准号: 6482379
• 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: 2001
• 资助国家: 美国
• 起止时间: 2001-09-01 至 2002-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6482379
• 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有三个具体目标：（1）建立、维护和促进与OAIC总体目标一致的项目的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和生活质量测量问题以及干预试验的其他潜在社会心理结果，向OAIC研究人员提供培训和咨询。拟议中的审计和调查处高级别委员会成立于1989年。活动包括进行招募和筛选，并维持现有约1 600人的受试者登记册和相关的纵向数据库。两项拟议的OAIC干预开发研究将利用USC资源进行人类受试者的招募和初步资格筛选。项目所需的参与者总数为683人。 亚历山大的项目需要216名70岁以上的人，他们符合基于业绩的资格标准。Richardson的项目需要457名年龄在50到80岁之间的人，他们符合弥漫性，主要是轴突性，多发性神经病的电诊断标准。HSC还将与IDS研究人员合作，在锻炼计划期间监测受试者状态，并在计划的家庭阶段评估依从性。人道主义事务委员会提出了新的重大努力，以增加少数民族参与OAIC支持的研究。详细介绍了当地招聘和与其他研究人员联系的双管齐下的举措，重点是少数民族老龄化人口。