Human Subjects Research Enhancements Program

贝勒医学院(BCM)在过去五年中经历了巨大的增长。该学院的总研究预算翻了一番，超过3.2亿美元。尽管学院一直坚定不移地致力于人类研究的最高道德标准，但临床研究的种类和数量急剧增加，以及确保研究行为符合道德的公众压力加大，对信息技术资源构成了挑战。为了应对科学研究不断增长和变化的需求，BCM研究办公室开发了一种新的方法来管理人类研究对象保护的信息和文档。2001年8月，BCM建立了一个电子方案管理系统，即生物医学研究保障信息网(BRAIN)。Brain允许以电子方式提交协议 初始和持续的IRB审查，并促进报告和跟踪每个协议的所有关键行动。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)将受试者的所有可能风险降至最低的研究；2)尊重知情同意；3)知识渊博的研究人员；以及4)知情和知识渊博的研究志愿者。来自资助应用程序的财政资源将使BCM能够扩大从这个电子平台收集的数据类型，建立以监管、认证和最佳实践标准为指导的数据驱动的绩效改进标准，并为社区、研究参与者、 研究人员和IRB成员和工作人员。这一倡议的具体目标如下：1)发展对大脑系统的本地规划和教育增强，以便在通过大脑制定和提交方案时向调查人员提供额外的在线指导和教育；2)利用各种媒体开发教育资源，以加强社区对伦理问题以及确保最高标准的保护方案的了解；3)扩大大脑系统，作为绩效改进和安全监测计划的一部分，为所有活跃的人类方案提供更深入的数据分析(例如，评估对脆弱人群的保护、对所有不良事件的分类、具体的研究设计等)； 4)开发教育和报告工具，以加强IRB的持续审查；5)分析对Brain的数据报告和教育增强，以确定它们是否满足与支持道德机构范围的研究环境有关的绩效目标。

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.