Integrated Human Research Subjects Protection Project

综合人类研究对象保护项目

• 批准号: 6777902
• 负责人: ROSS E MCKINNEY
• 金额: $ 25万
• 依托单位: DUKE UNIVERSITY
• 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 2005-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6777902
• 关键词: Internet; automated data processing; behavioral /social science research tag; clinical research; computer network; computer program /software; computer system design /evaluation; data management; health care personnel; health science research support; health services research tag; information systems; patient safety /medical error; training; university

Human Research Subjects Protection is a vital interest for a large and widely distributed, research intense academic health care operation like the Duke University Health System. The challenges to optimizing research subject protection include making certain that all faculty are aware of critical issues in research subject protection, such as the definition of research, and insuring that their training is up-to-date. Duke has a unique opportunity to create an integrated system of human research subject protection based on the simultaneous implementation of three new software systems: 1) an electronic IRB system utilizing Webridge Extranet Portal software; 2) a common research data repository that stores information on all Duke faculty, including compliance information; 3) a university-wide intention to implement Zope as the standard content management program. As these common platforms are implemented, it provides an opportunity to integrally include human subjects protection components. Whenever an investigator electronically submits a new protocol or grant application, the recipient office's software can query the Research Data Repository (RDR) to determine whether the investigator has up-to-date training and conflict of interest information. Software indicators can be set if there are outstanding issues within any Duke office regarding a compliance issue, although the most important issues will be those related to human research subjects protection. Another example would be if a faculty member submitted a protocol involving a novel drug or device. The eIRB software could query the Regulatory Support Office database to be certain the issue of an IND or IDE had been internally addressed. This integrated approach should be a model for other institutions planning a similar move to system-wide electronic document management. In addition, the fact that Intranet-based electronic submission can occur over a wide geographic range means that other regional programs, like the National Institute for Environmental Health Sciences (ten miles from Duke), can consider collaborating, and in the long term, other institutions could direct their investigators to web-based teaching modules at Duke (or elsewhere) when appropriate.

对于像杜克大学医疗系统这样的大型、分布广泛、研究密集的学术医疗保健机构来说，人类研究对象的保护至关重要。优化研究课题保护的挑战包括确保所有教师都了解研究课题保护的关键问题，例如研究的定义，并确保他们的培训是最新的。杜克大学拥有独特的机会，可以在同时实施三个新软件系统的基础上创建人类研究对象保护的集成系统：1）利用Webridge Extranet Portal软件的电子IRB系统； 2）一个通用的研究数据存储库，存储所有杜克大学教员的信息，包括合规信息； 3) 全校范围内实施 Zope 作为标准内容的意图 管理计划。随着这些通用平台的实施，它提供了集成人体保护组件的机会。每当研究者以电子方式提交新方案或拨款申请时，接收办公室的软件就可以查询研究数据存储库 (RDR)，以确定研究者是否拥有最新的培训和利益冲突信息。如果杜克大学办公室内存在有关合规问题的突出问题，则可以设置软件指标，尽管最重要的问题将是与人类研究对象保护相关的问题。另一个例子是，如果一名教员提交了一份涉及新药或设备的方案。电子IRB 软件可以查询监管支持办公室数据库，以确定 IND 或 IDE 的问题已在内部得到解决。这种综合方法应该成为其他计划向全系统电子文件管理采取类似举措的机构的典范。此外，基于内联网的电子提交可以在广泛的地理范围内进行，这意味着其他区域项目，例如国家环境健康科学研究所（距离杜克大学十英里）可以考虑合作，从长远来看，其他机构可以在适当的时候将其研究人员引导到杜克大学（或其他地方）基于网络的教学模块。