Kathe B A, Chan Y K, Buehler D A, Evans J H, Fehm P
Control Clin Trials. 1981 Dec;2(4):267-74. doi: 10.1016/0197-2456(81)90017-9.
Four VA Cooperative Studies Program Coordinating Centers have been established by the Cooperative Studies Program of the Medical Research Service of the Veterans Administration. Affiliated with each Coordinating Center is a Human Rights Committee (HRC). These HRCs function similarly to the Institutional Review Board but differ from it in many significant ways. This paper presents the organizational structures, the responsibilities, and the inherent dynamics of the HRCs. With clear and defined objectives and guidelines, the HRCs monitor the multicenter cooperative studies conducted within the VA health care system. The HRCs strive to balance the need for protecting patients' rights and welfare with the need for research. Its specific role is to ensure that multicenter trials are planned, implemented, and evaluated such that the rights and welfare of study subjects are protected. This is accomplished by reviewing the content and the procedures of the informed consent during the planning stage as well as by the site visits and continuing reviews during the ongoing phase of each cooperative study.
退伍军人管理局医学研究服务处的合作研究项目设立了四个退伍军人事务部合作研究项目协调中心。每个协调中心都附属一个人权委员会（HRC）。这些人权委员会的职能与机构审查委员会类似，但在许多重要方面与之不同。本文介绍了人权委员会的组织结构、职责和内在动态。有着明确界定的目标和指导方针，人权委员会对退伍军人事务部医疗保健系统内开展的多中心合作研究进行监督。人权委员会努力在保护患者权利和福利的需求与研究需求之间取得平衡。其具体作用是确保多中心试验的规划、实施和评估能保护研究对象的权利和福利。这是通过在规划阶段审查知情同意书的内容和程序以及在每项合作研究的进行阶段进行现场考察和持续审查来实现的。
