April 2016

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:

• X-rays
• Computed Tomography (CT)
• Magnetic Resonance Imaging (MRI)
• Positron Emission Tomography (PET)
• Ultrasound (includes all echo procedures generating images)
• Angiography
• Multigated Acquisition Scan (MUGA)
• Fluoroscopy
• 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.