Human Rresearch Subjects Protections Program

人类研究对象保护计划

• 批准号: 6591469
• 负责人: WILLIAM B APPLEGATE
• 金额: $ 24.98万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 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/6591469
• 关键词: ethics; experimental designs; health science research analysis /evaluation; health science research support; online computer; patient safety /medical error; technology /technique development

In recent years, human subjects research has come under increasing scrutiny. This has resulted in demands for enhanced protection of research subjects and increased oversight of human research. Wake Forest University School of Medicine (WFUSM) is committed to maintaining the highest ethical standards and compliance with federal regulation. To meet this commitment, the WFUSM Institutional Review Board (IRB) is actively engaged in developing procedures and programs to ensure the protection of human research subjects. We propose the following aims to further strengthen the protection of human research subjects at WFUSM and to prepare for national IRB accreditation: 1) technology development to improve IRB infrastructure by allowing electronic submission of new protocols, continuing review, amendments and adverse events, and the ability to make IRB approved consents electronically accessible; 2) enhanced compliance oversight through the addition of a compliance specialist to increase the continuing oversight of IRB approved protocols; and 3) an external audit to identify strengths and weakness and provide recommendations for improvement.

近年来，人类受试者研究受到越来越多的关注。这就要求加强对研究对象的保护，并加强对人类研究的监督。维克森林大学医学院（WFUSM）致力于保持最高的道德标准和遵守联邦法规。为了履行这一承诺，WFUSM机构审查委员会（IRB）积极参与制定程序和计划，以确保对人类研究受试者的保护。我们提出了以下目标，以进一步加强对WFUSM人类研究受试者的保护，并为国家IRB认证做准备：1）技术开发，以改善IRB基础设施，允许电子提交新方案，持续审查，修正案和不良事件，并能够使IRB批准的同意书以电子方式访问; 2）通过增加一名合规专家加强对以下方面的持续监督， 机构审查委员会批准的方案;以及3）外部审计，以识别优点和缺点并提供 改进建议。