Journal of the American Academy of Child & Adolescent Psychiatry
ARTICLESEthical and Practical Considerations in the Management of Incidental Findings in Pediatric MRI Studies
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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Concept, history, and state of debate
2020, Secondary Findings in Genomic ResearchBiomedical ethics and clinical oversight in multisite observational neuroimaging studies with children and adolescents: The ABCD experience
2018, Developmental Cognitive NeuroscienceCitation Excerpt :Over the course of MRI studies, some subjects without known or suspected neurological disorders will be observed to have brain anomalies (e.g., Sullivan et al., 2016). Neurological anomalies as an unanticipated finding raises issues pertaining to the clinical monitoring of MRI findings in observational research, determinations about whether particular findings have clinical significance, and the circumstances under which findings need to be communicated to minor subjects and parents (Cole et al., 2015; Cramer et al., 2011; Kumra et al., 2006; Shoemaker et al., 2016). In MRI research with children, adolescents and young adults, the incidence of neurological anomalies has been reported to be 10–13% (Gur et al., 2013: 10.6%; Seki et al., 2010: 11%; Sullivan et al., 2016: 11.8%; Kumra et al., 2006: 13%).
Neuroethical issues in clinical neuroscience research
2013, Handbook of Clinical NeurologyCitation Excerpt :The probability and magnitude of these risks may be significantly increased when participants are vulnerable. During the last decade, much clarity has been achieved through empiric research (Kim et al., 2002; Illes et al., 2004; Kirschen et al., 2006; Morris et al., 2009; Booth et al., 2010; Jordan et al., 2010; Lumbreras et al., 2010; Palmour et al., 2011) and consensus discussions ( Illes et al., 2002, 2004, 2006, 2008; Illes, 2006; Kirschen et al., 2006; Brown and Hasso, 2008; Illes and Chin, 2008; Parker, 2008; Wolf et al., 2008; Morris et al., 2009) concerning the ethics of incidental findings in neuroimaging research with healthy adult human subjects, and to a lesser extent in children (Kim et al., 2002; Kumra et al., 2006; Wilfond and Carpenter, 2008). Only recently have efforts explicitly tackled the difficult problem of incidental findings in research involving persons who suffer from mood and anxiety disorders (Borgelt et al., 2013).
Domains of Contemporary and Future Ethical Dilemmas
2023, Canadian Psychology
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.