SCCISARS 2: An e-Solution to Protect Human Subjects

具体目标：南加州大学(USC)和洛杉矶儿童医院(CHLA)正在合作开发电子软件，以增强保护人类研究对象的系统，南加州大学和洛杉矶儿童医院IRB提交和审查系统(SCCISARS)。选择了Webridge遵从性外联网，以提供方案准备、IRB提交和审查、持续审查和归档过程的电子自动化。此自定义第一阶段版本 从OD-02-003获得的资金不提供直接的教育支持。这项建议的目的是：(1)大幅加强SCCISARS，以教育调查人员、研究人员、IRB成员和IRB工作人员，使用关于联邦、州和机构对人类受试者进行研究的要求的实时指导。这将包括与申请提交和审查过程直接相关的大量教育内容。(2)为培训和实施SCCISARS提供资源。(3)提供资源，以便在IRB会议上以电子方式审查项目。(4)开发一个单元，协助调查人员撰写知情同意文件。(5)与另外两个机构合作，与洛杉矶县卫生服务部公共卫生和艾滋病项目洛杉矶办事处共享IRB提交和审查系统。研究设计和方法：SCCISARS是一个基于Web的应用程序，研究人员和工作人员在其中准备研究方案，附加必要的文件，并提交审查。使用基于网络的界面将项目提供给IRB工作人员、审查员和IRB成员。审查员和委员会的调查结果；与研究人员的通信；持续的审查活动；以及发生在同一基于网络的界面内的不良事件报告。为了教育调查人员、工作人员和IRB成员，环境敏感材料将直接嵌入SCCISARS申请和审查表格中。这些组成部分将提供直接的信息指导以及指向HHS和FDA条例的相关部分的上下文链接；道德指导文件，包括贝尔蒙特报告、纽伦堡准则和赫尔辛基宣言；OHRP和FDA指导文件；选定的参考文献和重印；以及内部政策和程序。在新开发的计算机化系统上采用和培训用户的执行战略提供了网上培训、快速浏览指南以及确定和培训“超级用户”，这些“超级用户”将作为其本国部门和工作组的资源。将为每个IRB购买包括笔记本电脑和网络在内的设备，以便对项目进行在线审查。将与Webridge合作，开发知情同意书面模块。

Specific Aims: The University of Southern California (USC) and Childrens Hospital Los Angeles (CHLA) are collaborating on electronic software to enhance the systems for the protection of human research subjects, the University of Southern California and Childrens Hospital Los Angeles IRB Submission and Review System, (SCCISARS). Webridge Compliance Extranet was selected to provide the electronic automation of the processes of protocol preparation, IRB submissionand review, continuing review, and archival. This customized Phase I version acquired with the funding from OD-02-003 provides no direct educational support. The aims of this proposal are to: (1) Substantially enhance SCCISARS to educate investigators, research staff, IRB members and IRB staff using real-time guidance about federal, State and institutional requirements for conducting research with human subjects. This will include substantial educational components directly associated with the application submission and review process. (2) Provide resources for training and implementation of SCCISARS. (3) Provide resources for electronic review of projects at IRB Meetings. (4) Develop a module to assist investigators with writing informed consent documents. (5) Collaborate with two additional institutions sharing the IRB submission and review system with the County of Los Angeles Department of Health Services Office of Public Health and AIDS Project Los Angeles. Research Design and Methods: SCCISARS is a WEB-based application where investigators and staff prepare research proposals, attach necessary documents, and submit for review. Projects are provided to IRB staff, reviewers and IRB members using the WEB-based interface. Reviewers and committee findings; correspondence to and from the investigator; continuing review activities; and adverse event reporting occuring within the same WEB-based interface. To educate investigators, staff, and IRB members context-sensitive materials will be built directly into SCCISARS application and review forms. These components will provide direct informative guidance as well as contextual links to relevant sections of the HHS and FDA Regulations; ethical guidance documents including the Belmont Report, Nuremberg Code and Declaration of Helsinki; OHRP and FDA guidance documents; selected references and reprints; and to internal policies and procedures. The implementation strategy for the introduction of and user training on a newly developed computerized system offers web-based training, quick-glance guidesheets, and identification and training of "Super Users" who would be available as resources to their home departments and work groups. Equipment including laptop computers and networking will be acquired for each IRB to permit online review of projects. In collaboration with Webridge, an informed consent writing module will be developed.