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OHSR.1 Organization Policy on Incidental Findings Associated with Research Imaging Procedures

August 2009

It is the policy of the Organization that a research protocol which will include imaging procedures must include the following two elements:  1) a statement on whether or not imaging procedures conducted as part of the research will be of clinical quality, and 2) a plan for managing incidental findings.  An incidental research imaging finding is defined at JHM as a finding in a research participant discovered in the course of research for which there is a potential health importance.  An incidental finding is beyond the aims of the study.  Incidental findings are most commonly discovered through research-directed imaging procedures.  Such procedures include MRI scans, CT scans, Ultrasound, PET scans, arteriograms, x-rays, fluoroscopy, or any other test that produces a clinical image. All plans for detecting and managing incidental findings associated with research-directed imaging procedures must be approved by the JHM IRBs.  The JHM IRBs are authorized to require additional steps in the plan on a case-by-case basis.