Incidental Findings Guidance
Version Date: April 29, 2010
Health Sciences IRBs Guidelines for Handling Incidental Findings in Research Protocols Involving Brain Imaging
Inherent in brain imaging studies is the risk that incidental findings will be detected which may be of certain or uncertain clinical significance. The incidence of detected abnormalities when imaging the brain is widely variable depending on a number of factors including age of subjects, health status, the technology used and the expertise of the individual reviewing the image. There are no generally accepted national guidelines on handling the potential for incidental findings in research involving brain imaging.
The recommendations in this guidance document pertain to brain imaging studies only.
However, it may serve as a model for handling incidental findings which may be inherent in other research studies, such as non-brain imaging and genetic testing. These guidelines apply to all brain imaging studies (e.g., MRI, CT, PET). It is not expected that research studies which were approved before these guidelines became effective on April 29, 2010, will necessarily comply with these guidelines.
Options for Review and Disclosure of Incidental Findings. The following options exist with regard to the review of images for, and disclosure to subjects of, incidental findings. The IRB may not permit all options for all types of protocols. In the Initial Review Application, the PI should indicate which option is being proposed. Model consent form language for each option is provided at the end of this document.
- Disclose no incidental findings to subjects, whether clinically significant or not.
- Images do not need to be read by a qualified reviewer.
- Research participants must be informed in the consent document that the images will not be reviewed by a neuroradiologist and no incidental findings will be reported to them.
- Note that in some cases, the PI may become aware of a condition which is of such clear clinical significance (e.g. brain tumor), that he/she feels ethically compelled to tell the subject. In this case, the PI should report the matter to the IRB immediately for assistance in determining how to proceed with potential reporting.
- Disclose findings to subjects only of clear clinical significance.
- All images must be read by a qualified reviewer. PIs should include information about the reviewer(s) in the IRB application.
- Research participants must be informed in the consent document that they will be told of findings of clear clinical significance, but will not be told of findings of uncertain clinical significance (e.g. venous anomaly), or of no known clinical significance (e.g. arachnoid cyst).
- Disclose findings to subjects of clear clinical significance, and allow subjects the option of also learning of findings that are of uncertain or no known clinical significance.
- All images must be read by a qualified individual. PIs should include information about the reviewer(s) in the IRB application.
- Check boxes may be used to allow subjects to document in the consent form whether they would also like to be told of findings of uncertain or no known clinical significance.
Individuals Qualified to Review Brain Images when Incidental Findings will be Reported to Subjects.
- Research images should be reviewed by a qualified reviewer. All qualified reviewers are approved by the Chief of Neuroradiology. These will generally be faculty in neuroradiology, or board certified radiologists currently in training in neuroradiology. A fee will be charged by the Department of Radiology for the qualified reviewer’s time spent reading the images.
- In some cases, other physicians who are PIs or co-investigators on the protocol may be qualified to read scans, such as some neurologists and neurosurgeons. These physicians must be approved by the Chief of Neuroradiology as qualified reviewers unless the IRB approves an alternate mechanism for determining an individual is a qualified reviewer.
- In some cases, a central reading facility is used, such as
in a multisite trial. In this case, the PI should include in his/her IRB
application a description of the central reading facility and any information
available on the qualifications of the central readers. The PI should also
include a description of whether and how the central readers will communicate
incidental findings of known or unknown clinical significance to the PI.
The IRB initial review application should note whether the PI intends to send all scans to a reviewer already approved by the Chief of Neuroradiology, or whether there is a PI or co-investigator on the protocol who may be qualified to read scans. If the latter, the initial review application should indicate whether such individual has been approved by the Chief of Neuroradiology as a qualified reviewer, whether a request for approval has been made, or whether the PI is seeking approval through the IRB.
Informed Consent Requirements when Research Involves Brain Images.
The consent process for research studies involving brain images must address the following issues:
- The possibility of incidental findings.
- The potential benefits/risks of disclosure of incidental findings. (Note that the potential benefit from a disclosure of an incidental finding should not be included in advertising or recruitment for the study).
- That research images cannot be assumed to be of clinical quality and, therefore, cannot substitute for a clinical evaluation. Subjects experiencing symptoms for which clinical imaging may be appropriate should be advised to see their primary care physician.
- Whether research subjects will be informed of any incidental findings. If subjects will be informed of clinically significant findings:
- Permission should be obtained for the qualified individual who will review the images to also review subjects’ medical records to assist him/her in interpreting the image and its clinical significance;
- If the subject has listed a primary care provider to contact in the consent form, permission may also be obtained to contact the PCP for additional information about the subject’s health;
- If a central reading facility is used, subjects should be informed that while images may be taken at UW Hospital or a UW Medical Foundation clinic, those images will not be read by a UW physician, but rather by a central reader, and that subjects will only be informed of incidental findings which are communicated to the PI by the central reader.
- Subjects also may be given the option to be told of findings of uncertain clinical significance or of no known clinical significance (this may be done via a check box);
- Subjects should be given the option of having their primary care physician informed of the findings. (Note that if subjects are told that their research images will not appear in their medical record, they must be informed that if they choose to have their primary care physician notified of the findings, the PI can no longer assure the subject that the images and report will not appear in his/her medical record);
- If the research study involves a series of brain imaging, subjects should be informed if not all of the images will be read by a qualified reviewer (see D. 7. below).
- Whether the results of research imaging will be placed in the research participant’s medical record. (If the participants are told that images will not be placed in their medical record, then the PI and qualified reviewer must provide details in the IRB application regarding where the images and reports will be stored. Use of HealthLink, PACS, or the UWHC/UWMF dictation system will generally not be acceptable if there is a commitment to keep the results out of the medical record.).
Procedures for Review of Brain Imaging and Disclosure of Incidental Findings.
If images will be read by a qualified reviewer and incidental findings will be reported to subjects, the following procedures must be followed. The IRB application should describe how these procedures will be implemented for the research study.
- Clinically significant results must be reported to subject no later than 37 calendar days from the day the imaging was completed (30 days are allowed for the reading of the image and 7 days are allowed from the date the image was read nto contact the research participant).
- The communication should be made by the qualified reviewer directly to the research subject, and to the subject’s primary care physician if requested by the subject.
- The communication should be orally first, and followed up in writing with a record of what was sent, to whom, by whom, and when. A copy of that writing should be kept in the subject’s research file. Email communication is acceptable. If the subject cannot be contacted orally first, the letter or email to the subject should state only that the image was abnormal and should instruct the subject who to call for more information.
- Personal images should generally not be released to research participants. If participants want a souvenir image, they may be given a “generic” normal image or a personal “surface” image.
- Subjects should be provided with information about available resources for the condition for which he/she is diagnosed (e.g. advocacy organizations, support groups, neurosurgeons, neurologists).
- There is no duty to provide financial support for follow up care. If subjects request financial support, they may be directed to UWHC Patient Relations for assistance in finding financial support options.
- If the research study involves a series of imaging, such images only need to be read by a qualified reviewer at six month intervals (e.g. the first image would be read and no additional images would be read unless six months has passed since the first image was completed).