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. |
