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Practical approaches to incidental findings in brain imaging research

From the Stanford Center for Biomedical Ethics (J.I., M.K.C., M.P.K.), Department of Pediatrics (Medical Genetics) (J.I., M.K.C.), Department of Radiology (M.P.K., G.H.G.), and the Program in Neuroscience (M.P.K.), Stanford University, CA; National Institute of Neurological Disorders and Stroke (E.E.), National Institute of Mental Health (P.B.), and National Institute for Biomedical Imaging and Bioengineering (B.S.), NIH, Bethesda, MD; Department of Bioethics (P.J.F.), Cleveland Clinic Foundation, OH; Legal Department (J.K.), Johns Hopkins Hospital and Health System, Baltimore, MD; Department of Bioethics (R.M.), Albert Einstein College of Medicine, Bronx, NY; Department of Neurosurgery (D.B.M.), Michigan Head and Spine Institute; Law School, Medical School, and Center for Bioethics (S.M.W.), University of Minnesota; and University of Iowa Hospital (T.G.), Iowa City.

Address correspondence and reprint requests to Dr. Judy Illes, National Core for Neuroethics, University of British Columbia, 2211 Wesbrook Mall, Koerner S124, Vancouver, BC, V6T 2B5 Canada jilles{at}interchange.ubc.ca.

A decade of empirical work in brain imaging, genomics, and other areas of research has yielded new knowledge about the frequency of incidental findings, investigator responsibility, and risks and benefits of disclosure. Straightforward guidance for handling such findings of possible clinical significance, however, has been elusive. In early work focusing on imaging studies of the brain, we suggested that investigators and institutional review boards must anticipate and articulate plans for handling incidental findings. Here we provide a detailed analysis of different approaches to the problem and evaluate their merits in the context of the goals and setting of the research and the involvement of neurologists, radiologists, and other physicians. Protecting subject welfare and privacy, as well as ensuring scientific integrity, are the highest priorities in making choices about how to handle incidental findings. Forethought and clarity will enable these goals without overburdening research conducted within or outside the medical setting.

*Equal authors in alphabetical order.

Equal authors in alphabetical order.

The Detection and Disclosure of Incidental Findings in Neuroimaging Research workshop was supported by the National Institute of Neurological Disorders and Stroke (NINDS), the National Institute on Drug Abuse (NIDA), the National Institute of Biomedical Imaging and BioEngineering, the National Institute on Aging (NIA), and the National Institute of Mental Health, and NINDS grant R01 NS045831 (J. Illes, PI). Support for early work on incidental findings from The Greenwall Foundation is also acknowledged. Continuing work by S.M. Wolf, J. Illes, and L. Parker on incidental findings in neuroimaging and other domains is supported by 1R01 HG003178 (S. Wolf, PI).

Disclosure: The authors report no conflicts of interest.

Disclaimer: Look page 389.

This article is based on the Detection and Disclosure of Incidental Findings in Neuroimaging Research workshop (NIH and Stanford University); Bethesda, MD; January 6–7, 2005.

Received November 21, 2006. Accepted in final form May 22, 2007.

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