Human Subjects Research Enhancements Program

人类受试者研究增强计划

• 批准号: 6778791
• 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 2006-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6778791
• 关键词: clinical research; 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; human rights; informed consent

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.

贝勒医学院（Baylor College of Medicine）在过去的五年中经历了临床研究活动的巨大增长。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。为了应对科学调查的爆炸式增长，研究办公室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档。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方案，以供初始和持续IRB审查，并便于报告和跟踪所有关键行动， 每个协议。研究保证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护临床研究环境方面的绩效，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;以及4）知情和知识渊博的研究志愿者。资金 通过RFA 02-003提供的信息，使研究中心能够在方案制定期间为临床研究人员、在方案审查期间为IRB成员以及为公众显著扩展BRAIN的教育内容。为这一应用程序提供资金所产生的财政资源，将使监测和报告局能够进一步扩大从这一电子平台收集的数据类型，促进利益冲突报告，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，并与休斯顿地区的审查机构分享已经开发的教育材料。这一举措的具体目标如下：（1）开发一个与BRAIN连接的电子利益冲突报告、跟踪和管理系统， IRB和利益冲突委员会之间的有效沟通，并增强当前人类受试者保护措施; 2）将通用的医学术语分层词典纳入BRAIN系统，以提供临床研究方案和不良事件报告的医学和非专业语言描述的一致性，从而改善研究者、IRB和社区之间的流程和合规性监测和沟通; 3）开发和实施一个单独的服务功能，重点是对伦理、监管和认证标准进行持续评估; 4）提供在德克萨斯州医疗中心和休斯顿地区机构IRB开发的Asphilis和Compliances咨询服务和教育材料，这些机构IRB目前与贝勒医学院的关系有限或没有正式关系。