The long-term objective is to enhance the human research protection program at the University of Oklahoma, and to accelerate our progress to a model program. The specific aims are: (1) to establish and maintain a second full-time position of Education Coordinator, who will be based at the Norman campus of the University of Oklahoma and will complement and collaborate with the Education Coordinator based at the Health Sciences Center, (2) to undertake and maintain an ongoing effort of outreach to institutions and organizations involved in human subjects research, but who do not have the resources or capabilities to establish ongoing educational efforts of their own, and (3) to establish and maintain a full-time position of Monitoring/Audit Coordinator for the monitoring and auditing of human subject research, with an emphasis on clinical research. The new Education Coordinator will be responsible for the development and maintenance of a comprehensive, multi-faceted curriculum on the protection of human subjects focused on social/behavioral research for the Norman campus, and outreach to Cameron University, Lawton, Oklahoma. This education will be directed to faculty and research staff on these campuses, and for the IRB members and IRB of the Norman campus, and therefore, will complement the ongoing parallel educational efforts for biomedical researchers, IRB members and IRB staff at the Health Sciences Center. The curriculum will include a variety of techniques and sources including seminars, workshops, web-based instruction and participation in satellite broadcasts. We also will establish a full -time position of Monitoring/Audit Coordinator who will develop, implement, and maintain a standard operating process for the monitoring and auditing of human subject research, with an emphasis on clinical research. Both Education Coordinators will work closely with the Monitoring/Audit Coordinator, and with the Director of Compliance, so that the findings of study audits will be incorporated into educational programs to achieve a process of continuous quality improvement. Thus, through a multi-faceted, educational curriculum directed at all individuals involved with human subject research, including an ongoing program of outreach, and an enhanced process for monitoring and auditing of research studies, the strength of protection for human subjects will be enhanced further. The University of Oklahoma is committed to maintaining these initiatives after the term of this award.

S07RR018224

2002-09-01

2006-08-31