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OHSR.1 Organization Policy on Incidental Findings Associated with Research Imaging Procedures
An incidental finding is one discovered in the course of research which is beyond the aims of the study for which there is a potential health importance for the research participant.
It is the policy of the Organization that a human subjects research application which includes imaging procedures for research purposes must include the following:
1)A statement regarding whether the research imaging procedures conducted as part of the research will be of clinical quality; and,
2)If the imaging is of clinical quality, a plan for detecting and managing the reporting of incidental findings to research participants and/or their physicians in a timely manner.
The following imaging procedures are generally deemed to be of clinical quality and capable of yielding clinically significant incidental findings:
- Computed Tomography (CT)
- Magnetic Resonance Imaging (MRI)
- Positron Emission Tomography (PET)
- Ultrasound (includes all echo procedures generating images)
- Multigated Acquisition Scan (MUGA)
- Optical Coherence Tomography (OCT) with Angiography
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. For additional information, please see Plans for Detecting and Managing Incidental Findings Associated with Research Imaging Procedures.