2018
DOI: 10.1016/j.dcn.2017.06.005
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Biomedical ethics and clinical oversight in multisite observational neuroimaging studies with children and adolescents: The ABCD experience

Abstract: Observational neuroimaging studies with children and adolescents may identify neurological anomalies and other clinically relevant findings. Planning for the management of this information involves ethical considerations that may influence informed consent, confidentiality, and communication with participants about assessment results. Biomedical ethics principles include respect for autonomy, beneficence, non-maleficence, and justice. Each project presents unique challenges. The Adolescent Brain and Cognitive … Show more

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Cited by 91 publications
(67 citation statements)
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References 49 publications
(61 reference statements)
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“…18,19 The ABCD biomedical ethics framework was developed to ensure a coherent and consistent mandate, with sufficient flexibility to ensure compliance with state- and institution-specific research ethics board requirements, and all procedures were approved by site-level institution research ethics boards. 20 All experimental procedures were in compliance with the Declaration of Helsinki and subsequent revisions.…”
Section: Methodsmentioning
confidence: 99%
“…18,19 The ABCD biomedical ethics framework was developed to ensure a coherent and consistent mandate, with sufficient flexibility to ensure compliance with state- and institution-specific research ethics board requirements, and all procedures were approved by site-level institution research ethics boards. 20 All experimental procedures were in compliance with the Declaration of Helsinki and subsequent revisions.…”
Section: Methodsmentioning
confidence: 99%
“…Parents or guardians provided written informed consent after the procedures had been fully explained and children assented before participation in the study. 43…”
Section: Methodsmentioning
confidence: 99%
“…All participants were administered assessments to obtain data on the respective youth's brain morphology, cognitive function, substance use, demographics, and environment 8 . Written informed consent was obtained from all parents, and all children provided assent to a research protocol approved by the institutional review board at each data collection site (https:// abcdstudy.org/study-sites/) 9 .…”
Section: Participantsmentioning
confidence: 99%