Discovery and disclosure of incidental findings in neuroimaging research

Judy Illes, Matthew P Kirschen, Kim Karetsky, Megan Kelly, Arnold Saha, John E Desmond, Thomas A Raffin, Gary H Glover, Scott W Atlas, Judy Illes, Matthew P Kirschen, Kim Karetsky, Megan Kelly, Arnold Saha, John E Desmond, Thomas A Raffin, Gary H Glover, Scott W Atlas

Abstract

Purpose: To examine different protocols for handling incidental findings on brain research MRIs, and provide a platform for establishing formal discussions of related ethical and policy issues.

Materials and methods: Corresponding authors identified from a database of peer-reviewed publications in 1991-2002 involving functional MRI (fMRI), alone or in combination with other imaging modalities, were invited to participate in this web-based survey. The survey asked questions regarding knowledge and handling of incidental findings, as well as characteristics of the scanning environment, training required, IRB protocol requirements, and neuroradiologist involvement.

Results: Seventy-four investigators who conduct MRI studies in the United States and abroad responded. Eighty-two percent (54/66) reported discovering incidental findings in their studies, such as arteriovenous malformations, brain tumors, and developmental abnormalities. Substantial variability was found in the procedures for handling and communicating findings to subjects, neuroradiologist involvement, personnel permitted to operate equipment, and training.

Conclusion: Guidelines for minimum and optimum standards for detecting and communicating incidental findings on brain MRI research are needed.

Figures

Figure 1
Figure 1
Research personnel at different career levels who are permitted to conduct scans.
Figure 2
Figure 2
Neuroradiologist involvement. a: Frequency of neuroradiological review of research scans when neuroradiology involvement is not an IRB requirement. b: Lag time for neuroradiological readings of research scans. c: Frequency and type of neuroradiologist compensation.

References

    1. Katzman GL, Dagher AP, Patronas NJ. Incidental findings on brain magnetic resonance imaging from 1000 asymptomatic volunteers. JAMA. 1999;282:36–39.
    1. Kim BS, Illes J, Kaplan RT, Reiss A, Atlas SW. Incidental findings on pediatric MR images of the brain. AJNR Am J Neuroradiol. 2002;23:1674–1677.
    1. Illes J, Desmond JE, Huang LF, Raffin TA, Atlas SW. Ethical and practical considerations in managing incidental findings in functional magnetic resonance imaging. Brain Cogn. 2002;50:358–365.
    1. Illes J, Rosen AC, Huang L, et al. Ethical consideration of incidental findings on adult brain MRI in research. Neurology. 2004;62:888–890.
    1. Illes J, Kirschen MP, Gabrieli JD. From neuroimaging to neuroethics. Nat Neurosci. 2003;6:205.
    1. Illes J. Neuroethics in a new era of neuroimaging. AJNR Am J Neuroradiol. 2003;24:1739–1741.
    1. Illes J, Kirschen M. New prospects and ethical challenges for neuroimaging within and outside the health care system. AJNR Am J Neuroradiol. 2003;24:1932–1934.
    1. Cakir B, Karakas HM, Unlu E, Tuncbilek N. Asymptomatic choroid plexus cysts in the lateral ventricles: an incidental finding on diffusion-weighted MRI. Neuroradiology. 2002;44:830–833.
    1. Krsek M, Weiss V. Incidental findings of expansive processes in the sellar region. Cas Lek Cesk. 2003;142:14–18.
    1. Molitch ME. Incidental pituitary adenomas. Am J Med Sci. 1993;306:262–264.
    1. McDonnell GV, Cabrera-Gomez J, Calne DB, Li DK, Oger J. Clinical presentation of primary progressive multiple sclerosis 10 years after the incidental finding of typical magnetic resonance imaging brain lesions: the subclinical stage of primary progressive multiple sclerosis may last 10 years. Mult Scler. 2003;9:204–209.
    1. Reilly PR, Boshar MF, Holtzman SH. Ethical issues in genetic research: disclosure and informed consent. Nat Genet. 1997;15:16–20.
    1. Boendermaker PM, Pols J, Scherpbier AJ. Unexpected pathologic findings during skills training or assessment. Acad Med. 1998;73:1126.
    1. Farah MJ, Illes J, Cook-Deegan R, et al. Neurocognitive enhancement: what can we do and what should we do? Nat Rev Neurosci. 2004;5:421–425.

Source: PubMed

3
Tilaa