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JHM Research WebNotes | Dear Colleagues: On September 14, 2009, we will implement our quarterly updates to the eIRB system. I am writing to advise you of three important changes with the September update. First, investigators will have the option of converting “paper” studies (those originally submitted to the JHM-IRB on paper forms) to an eIRB application. This step will allow use of the eIRB system by all JHM components that must track approved research. I encourage you to convert your paper study at the time of continuing review. Please submit your application at least 8 weeks prior to your study expiration date to allow sufficient time for the IRB review. Instructions and help guidance are posted on the eIRB website. For studies in data analysis only, you will be guided through an abbreviated version of the application. For studies that are still enrolling or in follow-up, you will need to complete the full application. On January 1, 2011, the IRB will stop accepting paper continuing reviews or changes in research; all paper studies must be converted in eIRB prior to this date. Please note that this conversion process does not apply to studies approved by WIRB. Currently, there are 2500 active studies in the eIRB system and 692 paper studies. Second, the September update includes a new application page to be completed for studies that involve imaging procedures. After consulting with Radiology, researchers and the IRBs, I have approved a new policy on incidental research imaging findings, “Policy No. OHSR.1 Organization Policy on Incidental Findings Associated with Research Imaging Procedures”. An incidental research imaging finding is defined by JHM policy as a finding in a research participant discovered in the course of research for which there is a potential health importance. A finding is considered incidental if it is not the main target of the study protocol. If a study includes imaging of clinical quality, the policy requires an image reader for the study. The image reader must be credentialed by a JHHS entity to perform this duty and may or may not be a member of the study team. The new eIRB application page and a new JHM IRB guidance, “Plans for Detecting and Managing Incidental Findings Associated with Research Imaging Procedures” will help researchers determine the requirements for image reading and incidental findings disclosure. Finally, Department and Division Chairs will automatically receive a notification from the eIRB system when a new eIRB application from their Department or Division is submitted without an identified funding source. This will allow the Chairs to discuss with the investigator any concerns about the conduct of the research without an identified source to cover the effort. For help with the paper conversion process or if you have questions about the September update, please contact the eIRB help desk at jhmeirb@jhmi.edu or call 410-955-3008. Daniel E. Ford, M.D., M.P.H.
Vice Dean for Clinical Investigation |
