Disclosing incidental findings in brain research: The rights of minors in decision‐making

Abstract

MRI is used routinely in research with children to generate new knowledge about brain development. The detection of unexpected brain abnormalities (incidental findings; IFs) in these studies presents unique challenges. While key issues surrounding incidence and significance, duty of care, and burden of disclosure have been addressed substantially for adults, less empirical data and normative analyses exist for minors who participate in minimal risk research. To identify ethical concerns and fill existing gaps, we conducted a comprehensive review of papers that focused explicitly on the discovery of IFs in minors. The discourse in the 21 papers retrieved for this analysis amply covered practical issues such as informed consent and screening, difficulties in ascertaining clinical significance, the economic costs and burden of responsibility on researchers, and risks (physical or psychological). However, we found little discussion about the involvement of minors in decisions about disclosure of IFs in the brain, especially for IFs of low clinical significance. In response, we propose a framework for managing IFs that integrates practical considerations with explicit appreciation of rights along the continuum of maturity. This capacity-adjusted framework emphasizes the importance of involving competent minors and respecting their right to make decisions about disclosure.

Structural brain anomalies in healthy adolescents in the NCANDA cohort: relation to neuropsychological test performance, sex, and ethnicity

“…Of critical value is the continued radiological reading obtained through longitudinal study to enable followup of questionable anomalies and detection of emergent, clinically serious abnormalities. Discovery of asymptomatic brain structural anomalies, even when no clinical action is indicated, can be disconcerting to the individual and responsible family members, raising a disclosure dilemma (cf., Wolf et al 2008; Illes 2008; Kumra et al 2006; Di Pietro and Illes 2013): refrain from relating the incidental findings to avoid unnecessary alarm or anxiety; or alternatively, relate the neuroradiological findings as “normal variants” to the study volunteers and family, thereby equipping them with knowledge for the future should they have the occasion for a brain scan following an illness or accident that the incidental findings predated the later event. Finally, it is critical to recognize that 1) research-grade MRI protocols are not FDA-approved, clinical-grade protocols and, therefore, cannot be used for definitive diagnosis and 2) a negative reading does not necessarily confirm absence of pathology.…”

“…Thus, use of high field, high-resolution protocols in ongoing and future MRI studies of healthy brain development will undoubtedly uncover more instances of normal morphology and abnormal anatomy, i.e., dysmorphology (Kaiser et al 2015). Given the burden that knowledge of brain structural anomalies imposes on parents and participants, having quantitative data about the functional correlates of these anomalies should contribute to objectivity and direction in relating diagnostic information and to ethical considerations regarding whether and how to report findings (Wolf et al 2008; Illes 2008; Kumra et al 2006; Di Pietro and Illes 2013). …”

Incidental findings on routine brain MRI scans in preterm infants

“…Further and prospective observations may corroborate the indication for advanced neuroimaging in VLBW babies as a part of specific national health policies, like it happens for newborns with seizures, hypotonia, hypoxic-ischaemic encephalopathy and significant facial dysmorphisms. Meanwhile, it can still be advisable to inform the parents about the possibility of brain IF on MRI at TEA, although no uniform strategy is currently suggested 11 22…”

Cognitive Enhancement

“…A framework for the handling and communication of such incidental findings is necessary today as there is more research now directed towards generating new knowledge on cognition and cognitive circuitry specifically related to healthy individuals and what might comprise a normal brain and its function. Awareness of this ethical situation is growing and should be manageable (Scott et al 2012;Di Pietro and Illes 2013).…”