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.
