Enhancement of Human Subjects Research Protection

最近几份国家报告指出，机构审查委员会(IRBs)未能 充分保护受试者。在很大程度上，这是由于过去30年来临床研究的数量显著增加，而IRB工作人员的规模并没有随之增加。此外，由于HIPAA的立法授权，IRBs很快将被要求在做出隐私决定方面发挥重要作用。通过部署更新的基于计算机的技术来适应数据生成的大规模增长，可以显著提高效率。去年，圣路易斯大学开发了它自己的新的基于计算机的协议数据管理系统(PDMS)的第一阶段。该大学对该系统的重大投资使IRB办公室能够跟踪调查员培训，生成议程和 会议记录，创建持续审查提醒函和其他相关文档。在RFA的部分支持下，进一步开发PDMS将包括跟踪严重不良事件的模块、IRB方案审查的电子链接以批准申请，以及制定质量改进矩阵。此外，RFA的资金将使我们能够解决在我们自己的机构和其他地方参与研究的社区数据收集者缺乏足够的培训材料的问题。在与IRB成员和支持人员以及调查人员和社区工作人员协商后，我们的健康传播研究实验室的工作人员将创建教学材料，该实验室是圣路易斯大学英才中心，被公认为健康传播研究的全国领先者。由人类研究增强计划资金支持的最后一项活动将是一名经验丰富的医生的工作，他将作为研究对象 倡导者。这样的人将与新的和目前无人支持的调查人员以及被招募参加他们进行的研究的受试者一起工作。RSA将协助这类调查人员拟定议定书，其确定的一项重要任务是确保研究的机密性以及身体和心理福利。此外，研究对象和工作人员将可以使用该人员讨论安全问题和关注事项，以及密切监测这些研究的不良事件。 在RFA期满后，该大学致力于支持这三项活动，并与其他IRBs分享其在促进更有效地保护人类主体方面的经验。

Several recent national reports identify Institutional Review Boards (IRBs) as having failed to adequately protect subjects. In large part, this is due to significant increases in the last three decades in the amount of clinical research, without concomitant increases in the size of IRB staffs. Moreover, IRBs soon will be required to play major roles in making privacy decisions as a result of HIPAA legislative mandates. Significant efficiencies can result through the deployment of newer computer based technologies to accommodate large-scale increases in data generation. Last year Saint Louis University developed the initial phase of its own new computer based Protocol Data Management System (PDMS). The University's major investment in the system has enabled the IRB office to track investigator training, generate agendas and meeting notes, create continuing review reminder letters and other related documents. Further needed development of PDMS with partial support from the RFA will include modules for tracking serious adverse events, electronic linking of IRB protocol reviews to grant applications and development of quality improvement matrices. In addition, the RFA funding will allow us to address the absence of adequate training materials for community data collectors involved in research at our own both institution and elsewhere. In consultation with IRB members and support staff, and with investigators and community workers, creation of instructional materials will be carried out by the staff of our Health Communication Research Laboratory, a Saint Louis University Center of Excellence that is recognized as a national leader in health communication research. The final activity to be supported with funds from the Human Research Enhancements Program will be the work of an experienced physician who will serve as a Research Subject Advocate. Such an individual will work with new and currently unsupported investigators as well as with the subjects recruited to participate in studies conducted by them. The RSA will assist such investigators in the preparation of protocols with a significant identified task being that of insuring the confidentiality and physical and psychological welfare of research. In addition, the individual will be available to research subjects and staff to discuss safety issues and concerns, as well as closely monitoring adverse events on these studies. Upon the expiration of the RFA, the University is committed to support these three activities and share its experiences with other IRBs in promoting more effective human subjects protection.