Traditionally the IRB (committee) has maintained an arm's length relationship with the investigators to which the committee's oversight is being provided. However, the expectation for interaction between the IRB administrative office and investigators is steadily and significantly increasing. Regulatory obligations and guidance notwithstanding, the interface between IRB professionals and investigators outside the confines of the IRB offices is currently being shaped. It is clearly in the best interests of the subject, the investigator and the institution to work collaboratively, consistently and efficiently to raise the level of effectiveness of human subjects' protections. This proposal describes a new process by which this goal can be effected. We will assemble a team of experienced IRB professionals who will make site visits to investigative groups under the jurisdiction of the Vanderbilt University and St. Thomas Hospital IRB's to develop a collaborative interaction designed to employ the principles of quality assurance and continuous quality improvement (QA/CQI) to clinical research. As designed, this program also enhances the quality, efficiency and collegiality of IRB-investigator interactions. Thus, the goals of this program are to provide educational resources, self-assessment tools, and technological support that are user-friendly to help clinical investigators recognize the components of ethical clinical research, adherence to good clinical practice (GCP) guidelines and appropriate local, state and federal regulations and apply these in their day-to-day activities.
