Human Subjects Research Enhancements Program

贝勒医学院(BCM)在过去五年中经历了临床研究活动的巨大增长。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。为了应对这种科学研究的爆炸性增长，BCM的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初始和持续IRB审查方案，并促进报告和跟踪所有关键行动 每种协议。研究保障和合规服务办公室与IRB主席和成员合作，启动了一项计划，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)将对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。资金来源 通过RFA 02-003提供的信息使BCM能够显著扩展临床研究人员在方案制定期间、IRB成员在方案审查期间以及普通公众的大脑教育组成部分。这一应用程序的资金来源将使BCM能够进一步扩大从该电子平台收集的数据类型，促进利益冲突的报告，建立以监管、认证和最佳做法标准为指导的以数据为导向的业绩改进标准，并与休斯顿地区的IRBs共享已经开发的教育材料。这项倡议的具体目标如下：1)开发一个与Brain相连的电子利益冲突报告、跟踪和管理系统，使更多 IRB和利益冲突委员会之间的有效沟通，并加强了当前的人类受试者保护举措；2)将医学术语的通用分层词典纳入大脑系统，以在医学和临床研究规程的平铺语言描述和不良事件报告中提供一致性，以改进流程和合规性监测，并改进调查人员、IRB和社区之间的沟通；3)开发和实施单独的服务职能，侧重于持续评估伦理、监管和认证标准；4)向德克萨斯医学中心和休斯顿地区目前与贝勒医学院有有限或没有正式联系的机构IRB提供保证和合规性咨询服务和教育材料。

Baylor College of Medicine (BCM) has experienced tremendous growth in clinical research activities during the last five years. 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. To respond to this explosion of 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 initiated a 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. Funding provided through RFA 02-003 has allowed BCM to significantly expand the educational components of BRAIN for clinical research personnel during protocol development, for IRB members during protocol review and for the general public. The financial resources from funding of this application would allow BCM to further expand the types of data that are collected from this electronic platform, to facilitate conflict of interest reporting, to establish data-driven performance improvement standards guided by regulatory, accreditation and best-practice criteria, and to share the educational materials already developed with IRBs in the Houston area. The specific objectives of this initiative are as follows; 1) to develop an electronic conflict of interest reporting, tracking and management system linked to BRAIN that allows more effective communication between the IRB and the Conflict of Interest Committee and that augments current human subjects protections initiatives; 2) to incorporate a common hierarchical dictionary of medical terms into the BRAIN system to provide consistency in the medical and lay language descriptions of clinical research protocols and in adverse event reports to improve process and compliance monitoring and communication among investigators, IRB and the community; 3) to develop and implement a separate service function focused on ongoing assessment of ethical, regulatory and accreditation standards; 4) to provide Assurances and Compliances consultative services and educational materials developed at BCM to Texas Medical Center and Houston area institutional IRBs that currently have either limited or no formal affiliations with Baylor College of Medicine.