April 2016

Applications submitted to the JHM IRBs must state whether or not an imaging procedure conducted as part of a research protocol will produce an image of clinical quality. Any images or report of those images that will become part of a research participant's medical record should be considered to be of clinical quality. Because JHM is responsible for the interpretation and follow-up of the information derived from clinical images, applications that intend to involve imaging of clinical quality must include a plan that will be followed if an incidental finding is detected.

An incidental research imaging finding is defined by Policy No. OHSR.1 Organization Policy on Incidental Findings Associated with Research Imaging Procedures at JHM as a finding in an image of a research participant discovered in the course of research for which there is a potential health importance.

Effective September 2009, the eIRB application, Incidental Findings includes required questions that must be completed to describe the plan to the IRB. Please note the following clarifications:

The plan for research studies that involve multiple or sequential scans or imaging in normal volunteers does not have to include a clinical reading for each scan as long as there is a similar scan that is not older than one year and was read as clinically normal. The plan should explain how the investigator would document that a clinical reading had occurred in the past year.

Plans should include the specific time frame for scheduling the clinical readings of research scans. The proposed time frame should be justified and in general should not exceed a maximum of two weeks post-imaging.

Consent form requirements

The consent form must contain IRB approved statements about the possibility of incidental findings. Sample consent form language is noted below:

Sample consent form language for paragraph entitled Incidental Finding: Incidental Finding

The (INSERT SPECIFIC TYPE OF IMAGING, e.g., MRI).you are having as part of this research study will be reviewed by a qualified person just as it would be if you were having the (INSERT SPECIFIC TYPE OF IMAGING, e.g., MRI) as part of your routine medical care.

There is a possibility that while reviewing your (INSERT SPECIFIC TYPE OF IMAGING, e.g., MRI) we may see an abnormality that we did not expect to see in this study. This is what is called an "incidental finding."

We will let you know (INSERT or your legal representative if appropriate for the study) if we see such an incidental finding. Depending on the type of incidental finding, we may contact you by mail or by phone. In the case of a potential serious emergency, someone may go to your home.

A qualified person (usually a member of the research team) will talk to you if there is an incidental finding. You do not have an option to decline information about an incidental finding.

If you want, we will give information about this incidental finding to your primary doctor or we will refer you to an appropriate doctor for further evaluation.

• An incidental finding may cause you to feel anxious.
• Since an incidental finding will be part of your medical record, it may affect your current or future life or health insurance coverage. This risk will vary depending on the type of insurance plan involved.

The costs for any care that will be needed to diagnose or treat an incidental finding would not be paid for by this research study. These costs would be your responsibility.