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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.