Web-Based Human Subjects Protocol and Training Program

我们建议开发两个新的计划伯克利分校：一个基于网络的系统，人类受试者的研究协议审查和数据管理;和一个新的计划，为研究人员提供培训，在人类受试者研究的道德行为。一个由校园计算机服务专业人员、一名具有网页设计经验的培训专业人员和一名组织发展专业人员组成的小组将在保护人类受试者委员会系主任的指导下工作。 研究协议系统（RePS）提供了一个安全访问所有研究协议的门户网站：人类，动物，辐射和生物危害。研究人员、评审员和管理员能够编写、编辑、评审、跟踪和存储协议。入口设计和动物协议模块已经完成，并正在进行最后测试;计划于2002年夏季推出。我们申请资金来开发人体实验模块。团队成员将与教师和研究人员合作，设计界面，形式和内容。该方案将是一个实时文件，可以修改以反映变化，每个方案的历史记录将在线存储。该协议系统将提供扫描问卷和其他研究文件并与特定协议链接的能力。提案中包括建设 与赞助项目办公室数据库的接口（该数据库将支持NIH提案的即时审查）和与财务利益冲突委员会数据库的接口。我们将聘请一名组织发展专业人员来分析和简化与人体受试者研究管理相关的业务流程。 还要求提供资金，以配合人类受试者协议模块开发一个新的培训方案。这将使我们有机会将有效的培训纳入方案提交和审查过程。具有网页设计经验的培训师将设计培训计划和材料，包括现行法规和最佳实践。培训计划将强调伯克利研究人员特别关注的问题，例如不涉及侵入性程序的人类受试者研究的风险评估。

We propose to develop two new programs for the Berkeley campus: a web-based system for human subjects research protocol review and data management; and a new program to provide researchers with training in the ethical conduct of human subjects research. A team composed of campus computing services professionals, a training professional with web design experience and an organizational development professional will work under the direction of the Faculty Chair of the Committee for the Protection of Human Subjects. The Research Protocol System (RePS) provides a web portal for secure access to all research protocols: human, animal, radiation and biohazard. Researchers, reviewers and administrators are able to write, edit, review, track and store protocols. The portal design and animal protocol module are complete and in final testing; rollout is scheduled for Summer 2002. We request funds to develop the human subjects module. Team members will work with faculty and research staff to design the interface, forms and content. The protocol will be a live document that can be amended to reflect changes, and a record of each prototcol's history will be stored on-line. The protocol system will provide the capability for questionnaires and other research documents to be scanned and linked to a specific protocol. Included in the proposal is construction of an interface with the Sponsored Projects Office database (which will support Just-in-Time review of NIH proposals) and an interface to the Financial Conflict of Interest Committee database. We will hire an organizational development professional to analyze and streamline business processes related to human subjects research administration. Funds are also requested to develop a new training program in tandem with the human subjects protocol module. This will give us the opportunity to incorporate effective training into the protocol submission and review process. A trainer with experience in web design will design the training program and materials to include current regulations and best practices. The training program will emphasize issues of particular concern to Berkeley researchers, for example risk assessment in human subjects research that does not involve invasive procedures.