Human Subjects Research Enhancements Programs

人类受试者研究增强计划

• 批准号: 6591182
• 负责人: William Rosner
• 金额: $ 14.96万
• 依托单位: ST. LUKE'S-ROOSEVELT INST FOR HLTH SCIS
• 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 2004-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6591182
• 关键词: Internet; educational resource design /development; health science research; health science research support; information dissemination; information systems; interactive multimedia; medical education

The Institutional Review Board at St. Luke's-Roosevelt Hospital Center (SLRHC) is responsible for the protection of human subjects in clinical research. Its activities must be responsive to federal, state and local hospital regulations as well as to the judgments of both its professional and community members. In response to increased public and governmental scrutiny of research on humans, further regulations have been added and old regulations have been more specifically defined and enforced. In several well-publicized examples, all research at a number of large institutions was closed down pending corrective action. There has been little or no increase in funds to support these activities. In addition, the government has increased the care with which it ensures the integrity of IRB decisions. New mandates have been established and old ones expanded. There are new educational requirements dealing with the protection of human subjects and a real understanding of conflict of interest. SLRHC has put in place activities supporting both of these important mandates, as well as systems to monitor compliance. The government, the main source of these new unfunded mandates, has stated that, for federally supported studies, all money for support of the IRBs is included in the overhead for that particular institution. However, planning for most ongoing investigations did not foresee the increase in costs consequent to these new mandates and have had to find additional sources of funds with which to support these important activities. We propose to strengthen the oversight of research on human subjects by instituting mechanisms to improve the accuracy, speed and effectiveness of the IRB and to provide on-going education in the protection of human subjects for both IRB members and the research community. We will: (1) Create a web site containing up-to-date guidelines, forms and regulations. The site will expedite IRB applications with technology designed to minimize errors and omissions and thus result in more efficient and rapid process; (2) Enhance the existing IRB database and link it to the web site so that it is automatically updated when an application is completed. The database also will be upgraded to make it more searchable and to permit a greater variety of reports to be generated; (3) Provide on-line education for both members of the IRB and researchers. Monthly review of new policies and/or clarification of old policies will be posted. Readers will be engaged with quizzes on current pertinent issues and ethical case histories. All such monthly reviews and quizzes will be archived for review. All of the above activities will be designed to be continued after the completion of the initial year of support.

圣卢克 - 罗斯福医院中心（SLRHC）的机构审查委员会负责临床研究中的人类受试者。它的活动必须对联邦，州和地方医院的法规以及其专业和社区成员的判断做出回应。为了应对公众和政府对人类研究的审查，添加了进一步的法规，旧法规越来越多 专门定义和执行。在几个盛大的示例中，许多大型机构的所有研究都在纠正措施之前关闭。支持这些活动的资金几乎没有增加或没有增加。此外，政府增加了确保IRB决策完整性的护理。已经建立了新的授权，并扩大了旧任务。有关于保护的新教育要求 人类主体和对利益冲突的真正理解。 SLRHC已经进行了支持这两项重要任务的活动，以及监控合规性的系统。政府是这些新的无资金授权的主要来源，他指出，对于联邦支持的研究，所有用于支持IRB的资金都包括在该特定机构的开销中。但是，对大多数正在进行的调查的计划并没有预见到这些新任务造成的成本增加，因此必须找到支持这些重要活动的其他资金来源。我们建议通过提高IRB的准确性，速度和有效性，并为IRB成员和研究社区提供保护人类受试者的持续教育，以提高IRB的准确性，速度和有效性，以增强对人类受试者的研究的监督。 我们将：（1）创建一个包含最新指南，表格和法规的网站。该站点将使用旨在最大程度地减少错误和遗漏的技术来加快IRB应用程序，从而导致更有效和快速的过程； （2）增强现有的IRB数据库并将其链接到网站，以便在完成应用程序完成后自动更新它。该数据库还将升级以使其更具搜索性并允许更大的种类 要生成的报告； （3）为IRB成员和研究人员提供在线教育。将发布对新政策和/或澄清旧政策的每月审查。读者将在当前相关问题和道德案例历史上进行测验。所有这样的月度评论和测验都将存档以进行审查。上述所有活动将在支持最初的一年后继续进行。