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 full-time position of Education Coordinator, (2) to establish and maintain a university-wide Data Safety Monitoring Board (DSMB) for clinical research, (3) to establish and maintain a full-time position of DSMB/Adverse Event Coordinator, and (4) to strengthen the safety monitoring of clinical research projects by implementing a standardized operating process for the monitoring, reporting and review of adverse events through the coordinated efforts of the DSMB, IRB, and university-wide Compliance Office. The Education Coordinator will be responsible for the development and maintenance of a comprehensive, multi-faceted curriculum on protection of human subjects in research targeted to researchers, study coordinators, IRB members and IRB staff from all campuses of the University of Oklahoma. The curriculum will include a variety of techniques and sources including seminars, workshops, web-based instruction and participation in satellite broadcasts. The Education Coordinator will also work closely with the Director of Compliance, so that the findings of study audits can be incorporated into educational programs with the goal of quality improvement. We also will establish a university-wide DSMB. Working closely with the Principal Investigator and the Director for Human Research Protection, the DSMB/Adverse Event Coordinator will develop a standard operating process for the monitoring, reporting and review of adverse events in all human research projects at the University of Oklahoma. Thus, through two strategies, a multi-faceted, educational curriculum directed at all individuals involved with human subject research, and an enhanced process for safety monitoring, 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.
