Human Research Subjects Protections Program Outreach

人类研究对象保护计划外展

• 批准号: 6779004
• 负责人: WILLIAM B APPLEGATE
• 金额: $ 13.71万
• 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 2005-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6779004
• 关键词: clinical research; health science research analysis /evaluation; health science research support; informatics; patient safety /medical error; training

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 Health Sciences (WFUHS) is committed to maintaining the highest ethical standards and compliance with federal regulation for the protection of human research subjects. To meet this commitment, the WFUHS Institutional Review Board (IRB) has begun working with other area academic and medical institutions to develop joint IRB and educational activities. Development and expansion of coordinated IRB activities helps ensure the safety, rights and welfare of research subjects while decreasing the overall impact on institutional resources. We propose the following aims to further strengthen the protection of human research subjects and to develop coordinated educational and IRB activities with other local institutions: (1) Expand the implementation of systems for the electronic submission, review and tracking of research protocols (technology development) to support coordination of IRB activities with the Salisbury Veterans Administration Medical Center and other area academic and medical institutions (2) Develop new educational programs that focus on current topics related to the protection of research subjects and promote the availability of these programs to area investigators, administrators and IRB members. This proposal will strengthen the protection of human subjects by means that will be sustained by the institution after the award.

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。维克森林大学健康科学（WFUHS）致力于保持最高的道德标准，并遵守联邦法规，以保护人类研究受试者。为了履行这一承诺，WFUHS机构审查委员会（IRB）已开始与其他地区的学术和医疗机构合作，共同开展IRB和教育活动。协调IRB活动的发展和扩展有助于确保研究受试者的安全、权利和福利，同时减少对机构资源的总体影响。我们提出以下目标，以进一步加强对人类研究受试者的保护，并与其他当地机构开展协调的教育和IRB活动：（1）扩大实施电子提交系统，审查和跟踪研究方案（技术开发）支持与索尔兹伯里退伍军人管理局医疗中心以及其他地区学术和医疗机构协调IRB活动（2）制定新的教育计划，重点关注与研究受试者保护相关的当前主题，并向地区研究者、管理人员和IRB成员推广这些计划。该提案将通过奖励后由机构维持的方式加强对人类受试者的保护。