June 28, 2004

RE:  JHM IRB Routine Monitoring Visits

As you know, The Office of Human Subjects Research has been working hard to help faculty meet the many regulatory requirements associated with human subject research. Our latest effort in this regard is that we have now added a monitoring function to the Regulatory Team within the Office.  The Regulatory Team is headed by Barbara Starklauf, the Assistant Dean for Human Research Subjects Compliance.  Those of you who have had WIRB-approved protocols are familiar with the periodic visits that WIRB staff make to assure that the research is following the approved protocol and to answer any questions that the study staff may have.  The JHM IRB will now have a similar capability.  Periodic routine monitoring visits will be scheduled as faculty time allows in cooperation with the PI.

Further details of the monitoring program and answers to commonly asked questions may be found in the attached description of the program http://irb.jhmi.edu/Guidelines/MonitoringVisits.html.

Please contact Barbara Starklauf, Assistant Dean for Human Subject Research Compliance, if you have any additional questions about the monitoring program. She may be reached at 5-3008 or bstark@jhmi.edu. 

Thanks for your help with this new initiative. 

Michael J. Klag, MD, MPH
Vice Dean for Clinical Investigation