Bioethics and medical oversight in multi-site observational neuroimaging studies with children and adolescents: 10 years of ABCD experience.

ABCD is an observational study of development and health from childhood through young adulthood. The ABCD Bioethics and Medical Oversight Advisory Group (BMO) has engaged in reviewing and advising the ABCD organization on ethical and clinical oversight issues from the initial planning of the study to the present. Anticipated ethical and clinical oversight issues included the confidentiality of participant substance use, identifying and reporting neuroanatomical anomalies, responding to imminent potential self-harm, and mandatory reporting of child maltreatment. Issues introduced by protocol updates have included return of results for metabolic syndrome and cardiovascular health risk indicators, genetic anomalies identified by DNA analyses, and a proposal to collect information from Electronic Health Records (EHR). Each site engages Site Clinicians to provide expertise and oversight in accordance with ABCD guidelines. Site-specific Emergency Management Plans and more detailed Standard Operating Procedures have been developed and implemented in several areas of concern. The ABCD Site Clinician Network has provided a forum for discussing these issues. We also discuss collaborating with the ABCD Crisis and Communications group about a data misuse incident. At present, ABCD participants are transitioning from adolescence to young adulthood, raising additional issues on consent, return of results, and procedures for addressing mental and physical health concerns. For the past ten years, we describe the implementation of the ABCD bioethics and medical oversight guidelines, the concerns and options considered, and anticipated issues arising from planned initiatives.