Human Research Protections Program Enhancements

该项目的目的是对加州大学圣迭戈分校现有的人类研究保护计划(HRPP)基础设施和教育产品进行改进，以提高人类受试者保护的质量和有效性。包括与保护人类研究参与者相关的四个主要概念领域的具体增强项目：1)HRPP计划的运作；2)参与研究的办公室和计划之间的沟通和协调；3)加强对进行涉及人类受试者的研究的研究人员的教育；以及4)促进在潜在研究志愿者中识别和管理决策能力受损的最新水平。将通过创建与最先进的电子文件管理系统相关联的无纸化IRB提交和审查基础设施来加强计划的运作。加强沟通和协调将重点放在一个新的在线不良事件报告系统上，该系统自动通知相关 并在报告不良事件后立即提供不良事件的详细情况。教育方面的改进将包括针对研究人员和IRB成员的教育活动，以及对当前基于网络的教育内容的改进。在决策能力受损的受试者群体中评估和获得知情同意将是多媒体开发项目的重点。每个拟议的增强项目都旨在符合RFA OD-02-003的精神和文字，因为每个项目都将“持久增强机构及其研究人员的质量保证能力，以支持和监测人类受试者在临床研究中的使用和安全。”

The aim of this project is to develop enhancements to UCSD's current Human Research Protections Program (HRPP) infrastructure and educational offerings that improve the quality and effectiveness of human subjects protections. Included are specific enhancement projects that fall into four major conceptual areas relevant to the protection of human research participants: 1) HRPP program operations; 2) communications and coordination among offices and programs involved in research; 3) enhanced education for researchers performing research involving human subjects; and 4) advancing the state of the art in recognizing and managing impaired decisional capacity among potential research volunteers. Program operations will be enhanced by creating a paperless IRB submission and review infrastructure associated with a state of the art electronic document management system. Communications and coordination enhancements will focus on a new online Adverse Event reporting system that automatically notifies relevant administrative offices and makes available the details about Adverse Events as soon as those events are reported. Educational enhancements will include both educational events for researchers and IRB members, and enhancement of current web-based educational content. Assessing and obtaining informed consent in subject populations with impaired decisional capacity will be the focus of a multimedia development project. Each of the proposed enhancement projects is designed to conform to both the spirit and letter of RFA OD-02-003, in that each will create "lasting enhancements to the quality assurance capacities of the institution and its investigators to support and monitor the use and safety of human subjects in clinical research."