Human Rresearch Subjects Protections Program

近年来，人类受试者的研究受到了越来越多的关注。这导致了对加强保护研究对象和加强对人类研究的监督的要求。维克森林大学医学院(WFUSM)致力于保持最高的道德标准并遵守联邦法规。为了履行这一承诺，WFUSM机构审查委员会(IRB)正在积极参与制定程序和计划，以确保对人类研究对象的保护。我们提出以下目标，以进一步加强对WFUSM人类研究对象的保护，并为国家IRB认证做准备：1)技术开发，通过允许以电子方式提交新方案、持续审查、修订和不良事件，改善IRB基础设施，并使IRB批准的同意书能够以电子方式获取；2)通过增加一名合规专家来加强合规监督，以加强对 IRB批准的协议；以及3)外部审计，以确定优势和劣势并提供 改进建议。

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.