Informed Consent and the Protection of Human Subjects in Genomic Research with Children and Families

Abstract

Consideration of the ethics of genetic testing of children under research auspices is complex under any circumstances. Because of contemporary issues that affect such analysis, any attempt to parse the topic must be very exacting. Such issues include the following: (1) the increasing volume of pediatric research, which will presumably lead to an increase in genetic research in this population; (2) the ongoing debate in genetics research about the obligations of researchers to share the individual results of molecular testing with subjects (and presumably, families, when such subjects are children); (3) how to best understand the data that has come from studies about the possible harms to individual children of receiving genetic testing results; and (4) the best ways to apply traditional bioethical analysis about participation of children in clinical research to enrolling children in such studies that include genetic testing. All of these issues impact the ways that investigators should approach the enrollment process for children into genetic studies. Discussions within this chapter will address how each topic must be conceptualized as the expected increase of pediatric research studies that include molecular genetic testing provides the research community with challenges to adequately inform parents and children about the implications of enrolling in such studies. (PsycInfo Database Record (c) 2021 APA, all rights reserved) (Source: chapter)