Human Subjects Research Enhancements Program

人类受试者研究增强计划

• 批准号: 6591810
• 负责人: James Patrick
• 金额: $ 25万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 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 2003-09-10
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6591810
• 关键词: computer data analysis; computer program /software; computer system design /evaluation; continuing education; data management; education evaluation /planning; ethics; health related legal; health science research support

Baylor College of Medicine (BCM) has experienced tremendous growth during the last five years. The total research budget of the school has doubled to more than $320 million. Although the College has remained steadfast in its commitment to the highest ethical standards in the conduct of human research, it resources have been challenged by the dramatic increase in the variety and volume of clinical investigation and in the heightened public pressures to assure ethical conduct of research. In anticipation of ever growing and changing demands in response to scientific inquiry, the Office of Research at BCM developed a new approach to managing information and documentation of human research subject protections. In August 2001, BCM instituted an electronic protocol management system, the Biomedical Research Assurance Information Network (BRAIN). BRAIN permits electronic submission of protocols for initial and continuing IRB review and facilitates reporting and tracking all key actions for each protocol. The Office of Research Assurance and Compliance Services in cooperation with the IRB Chairs and members has since begun to develop a more formalized program for measuring performance of institutional components in maintaining a clinical research environment which fosters; 1) research that minimizes all possible risks to subjects; 2) respectful informed consent; 3) knowledgeable research personnel; and 4) informed and knowledgeable research volunteers. The financial resources from a funded application would allow BCM to expand the types of data that are collected from this electronic platform, to establish data-driven performance improvement standards guided by regulatory, accreditation and bestpractice criteria, and to develop enduring products for ongoing education of the community, research participants, research personnel and IRB members and staff. The specific objectives of this initiative are as follows; 1) develop local programming and educational enhancements to the BRAIN system to provide additional online guidance and education to investigators at the time of protocol development and submission via BRAIN; 2) develop education resources utilizing a variety of media to enhance the community's understanding of the ethical issues as well as the protections programs in place to assure the highest possible standards; 3) expand the BRAIN system to provide more in depth analysis of data for all active human protocols as part of a performance improvement and safety monitoring plan (examples include assessment of protections for vulnerable populations, categorization of all adverse events, specific study designs, etc.); 4) develop educational and reporting tools to enhance IRB continuing review; 5) analyze the data reporting and educational enhancements to BRAIN to determine if they meet performance goals related to the support of an ethical institution-wide research environment.

贝勒医学院（Baylor College of Medicine）在过去五年中经历了巨大的增长。学校的总研究预算翻了一番，超过3.2亿美元。虽然学院一直坚定地致力于人类研究行为的最高道德标准，但它的资源受到了临床研究的种类和数量急剧增加的挑战，并受到公众压力的挑战，以确保研究的道德行为。在不断增长和不断变化的需求，以应对科学调查的预期，研究办公室在研究开发了一种新的方法来管理人类研究受试者保护的信息和文件。2001年8月，生物医学研究所建立了一个电子协议管理系统，即生物医学研究保障信息网。BRAIN允许以电子方式提交协议， 初始和持续IRB审查，并促进报告和跟踪每个方案的所有关键行动。此后，研究保证和合规服务办公室与IRB主席和成员合作，开始制定一项更正式的计划，以衡量机构组成部分在维持临床研究环境方面的表现，该环境促进：1）最大限度地降低受试者所有可能风险的研究; 2）尊重知情同意; 3）知识渊博的研究人员; 4）知情和知识渊博的研究志愿者。获得资助的应用程序所提供的财政资源将使信息和通信技术研究所能够扩大从这一电子平台收集的数据类型，建立以监管、认证和最佳做法标准为指导的数据驱动的绩效改进标准，并开发持久的产品，供社区、研究参与者、 研究人员和IRB成员和工作人员。该计划的具体目标如下：1）开发BRAIN系统的本地编程和教育增强功能，以便在方案制定和通过BRAIN提交时为研究者提供额外的在线指导和教育;（二）开发教育资源，利用各种媒体，提高社区对道德问题的理解，以及保护方案，以确保3）扩展BRAIN系统，以提供对所有现行人类协议数据的更深入分析，作为性能改进和安全监测计划的一部分（例如，评估对弱势群体的保护，对所有不良事件进行分类，具体研究设计等）; 4)开发教育和报告工具，以加强IRB的持续审查; 5）分析数据报告和对BRAIN的教育改进，以确定它们是否满足与支持伦理机构范围的研究环境相关的绩效目标。