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.
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).
Incidental findings sample consent language available here.See Also: