Ethical and Practical Considerations in the Management of Incidental Findings in Pediatric MRI Studies

doi:10.1097/01.chi.0000222786.49477.a8

Journal of the American Academy of Child & Adolescent Psychiatry

Volume 45, Issue 8, August 2006, Pages 1000-1006

https://doi.org/10.1097/01.chi.0000222786.49477.a8 Get rights and content

ABSTRACT

Objective:

The authors examined the ethical and practical management issues resulting from the detection of incidental abnormal findings on magnetic resonance imaging (MRI) research studies in healthy pediatric volunteers.

Method:

A retrospective examination of the findings from 60 clinical reports of research MRI scans from a cohort of healthy pediatric volunteers (ages 10-21) was conducted.

Results:

A neuroradiologist noted incidental abnormalities in 8 (13%) of 60 subjects. Of these eight children, three (5%) adolescents were found to have abnormalities (possible tumor, possible vascular malformation, and unidentified bright object in white matter, respectively) that were judged to require further diagnostic workup. In the first two cases, follow-up MRI ruled out the possibility of a tumor or vascular malformation. In the third case, a follow-up MRI 24 months later found that the white matter abnormality remained stable and was thus deemed to be of no clinical significance.

Conclusions:

In healthy children who are participating in research MRI protocols, it is ethically difficult to determine whether films should be read clinically. Based on this retrospective analysis, there would have been no risk(s) associated with not reading the films. In contrast, considerable anxiety was generated as a consequence of having the scans clinically read by a neuroradiologist because of the reporting of incidental abnormalities that later turned out to be false positives. Also, the detection of no abnormality on a research-quality scan could imply erroneously to some subjects that no abnormality was present, which may have been falsely reassuring.

Section snippets

METHOD

Recruitment and diagnostic procedures have been described in detail elsewhere (Kumra et al., 2004, Kumra et al., 2005). In brief, healthy volunteers were recruited from the community through medical clinics, churches, libraries, and community and recreation centers. Any physical or neurological disorder that could potentially affect brain development and lifetime history of any significant psychiatric disorder in the probands and/or first-degree relatives was exclusionary. Healthy volunteers

RESULTS

We retrospectively reviewed the clinical reports between February 2002 and August 2005 of 60 healthy children and adolescents (ages 10-21) who participated in research MRI studies at our center. We found incidental abnormalities in 8 (13%) of 60 cases. All of these abnormalities were communicated back to the child or adolescent, their parent, and the primary care physician.

In three subjects, the clinical neuroradiologist noted abnormalities that required further evaluation. These abnormalities

DISCUSSION

In this case series, we found that 8 (13%) of 60 healthy pediatric volunteers had unexpected MRI abnormalities that were detected by a clinical neuroradiologist in children who were participating as healthy volunteers in a research MRI study. These data are comparable to previously published data (Kim et al., 2002). Although the majority of these unexpected findings required no additional follow-up other than communication of the structural anomaly to the primary care physician, three (5%)

Limitations

There are a number of limitations that should be emphasized for this study. Healthy volunteers were recruited for this study in response to advertisements posted in pediatricians' offices or community centers rather than using a more sophisticated epidemiologically based sampling methodology. Although the mean IQ for the normal controls from our sample was 107, which is within the average range, all of the children and adolescents were from higher parental socioeconomic status backgrounds

Clinical Implications

In this article, we have discussed whether having MRI scans read by a clinical neuroradiologist serves to better protect research subjects or inadvertently to harm them by informing them that they may be at risk of a medical disorder when they actually have none. From a legal perspective, by telling potential subjects that we may see “something” on their MRI scans, we are in essence telling them that we are looking for “something” and both the neuroradiologist and the research investigator

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Incidental findings from whole-body imaging in population-based studies potentially carry medical relevance and are, for the most part, experienced as unsolicited and unexpected. Given that these features are shared with secondary findings in genetic and genomic contexts, it is somewhat intuitive that the legal and ethical discourse on incidental findings from imaging would be highly relevant to comparable debates about the management of genomic findings that are not directly related to the primary focus of the research. In this chapter we explore issues raised by incidental findings in the context of imaging research that are also relevant to secondary findings in the context of genomics. These issues will be discussed separately, but in truth they tend to overlap with one another and are fundamentally connected. The purpose of this discussion is not only to explore how the debate on dealing with incidental findings from imaging informs the modern debate on secondary findings in genomics and genetics but also to set the stage for the rest of the book by laying out the practical and ethical challenges that need to be addressed in all types of biomedical research that generate additional findings of potential medical relevance and, therefore, of potential interest to participants.
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Domains of Contemporary and Future Ethical Dilemmas
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Prevalence of incidental intracranial findings on magnetic resonance imaging: a systematic review and meta-analysis
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This work was supported in part by grants from NARSAD (S.K., as a Lieber Investigator) and the National Institute of Mental Health to Dr. Kumra ( MH01990 ). The authors thank Ruth Macklin, Ph.D., Cynthia Hahn, C.I.P., and the two anonymous reviewers for their helpful suggestions on this manuscript.

Disclosure: The authors have no financial relationships to disclose.

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ARTICLESEthical and Practical Considerations in the Management of Incidental Findings in Pediatric MRI Studies

ABSTRACT

Objective:

Method:

Results:

Conclusions:

Section snippets

METHOD

RESULTS

DISCUSSION

Limitations

Clinical Implications

Brain Cogn

Brain Cogn

J Am Acad Child Adolesc Psychiatry

Biol Psychiatry

J Am Acad Child Adolesc Psychiatry

J Am Acad Child Adolesc Psychiatry

Psychiatry Res

White matter development during childhood and adolescence: a cross-sectional diffusion tensor imaging study

Cereb Cortex

Use of “unidentified bright objects” on MRI for diagnosis of neurofibromatosis 1 in children

Neurology

Structural magnetic resonance imaging of the adolescent brain

Ann N Y Acad Sci

ARTICLES
Ethical and Practical Considerations in the Management of Incidental Findings in Pediatric MRI Studies