The Ohio State University is strongly committed to responsible research conduct and has centralized many research compliance activities in the Office of Responsible Research Practices (ORRP). To strengthen its human research protection program, the University has undertaken a major reorganization of the ORRP and invested additional ongoing resources. The institution has a long-term goal of seeking AAHRPP accreditation for its human research protection program. This application will outline the progress made and challenges encountered during the first year of the ORRP reorganization, year 1 of the HSREP award. Key elements of the reorganization and the HSREP funded activities included: a) additional professional / paraprofessional staff and enhanced operational support; b) formation of a new educational unit to deliver a comprehensive education program to individuals involved in human subjects research c) updated IRB and ORRP procedures and IRB submission forms, and d) development of a new electronic database to enhance protocol tracking and communication. During year 2, a formalized continuous quality improvement (CQI) program will be established. To enhance post IRB approval compliance, the proposed CQI program will incorporate internal audits and expanded education for ORRP staff, investigators, and key research personnel. The Collaborative IRB Training Initiative web-based software will be used and two educational series (programming for junior investigators / study coordinators; programming for IRB staff) will be held. Specific content for the seminars will be driven by internal audit findings. A strong institutional commitment assures continued funding for the proposed activities that will become permanent ORRP programming. The proposal also describes specific plans for outreach activities to human subjects protections colleagues at the Ohio University (Athens, OH), Miami University (Miami, OH), Columbus Children's Hospital (Columbus, OH), and Riverside Methodist Hospital (Columbus, OH). Products of year 1 and year 2 funding (database software, SOPs, staff orientation tools, enhanced continuing review tools) will be shared with these institutions.
