Human Research Protections Program Enhancements

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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."