The specific aim of this project is to determine what criteria should govern return of individual results of pediatric genomic research, using analysis of US law and international guidelines regarding decision making for and by minors as the foundation. This issue, which has received remarkably little attention, must be resolved if this research, which is vital to understanding the contributions of genetic variation to the health of children, is to proceed. In order to develop these criteria, it will be necessary to draw upon a host of ethical, legal, and sociocultural factors, using standard legal analytic tools. ? There is a long tradition within genetics, embodied in policy statements, such as those by the American Society of Human Genetics, the American College of Medical Genetics, and the American Academy of Pediatrics, of performing genetic tests on minors only when the results would alter the minor's immediate medical care. These limits are justified in part by the claim that, in the absence of need for immediate intervention, the minor should be allowed to decide about genetic testing upon reaching adulthood. ? More generally, decisions regarding the health care of children are treated differently from those of adults because children, as a matter of law, typically cannot make their own health care decisions. Procedurally, ethical and legal decision making authority, instead, is allocated among: 1) Parents who have broad authority to make choices among available options that affect their children. The scope of parental permission for their children's care, however, is not as broad as their discretion with regard to their own health care;2) Clinicians who have an independent obligation to the welfare of the minor, which is bounded by the standards of clinical practice as well as legal requirements;3) Minors who many hold have an increasingly important ethical and legal voice as they mature;and 4) In cases of abuse, neglect, or need to protect public health, the state. Substantively, defining the minor's best interest is often contested. One issue that is particularly challenging is deciding what weight should be given to various potential benefits from returning results, ranging from immediate benefit to the minor's health or reproductive information for the minor's later use to benefits that redound primarily to the family unit as a whole or exclusively to the parents or even to other minors of the same age or with the same condition. ? Research involving minors is subject to more legal and ethical requirements and limitations than apply to adults. This project brings together three internationally known lawyers, each of whom has written extensively about legal and policy issues in genomics research and in pediatrics, as well as an internationally known pediatrician- philosopher as a consultant, to define the applicable legal rules and to develop guidelines for returning results of genomic research involving minors.
Determining what criteria should govern the return of individual results of pediatric genomics research has to date received remarkably little attention. This issue must be resolved if this research, which is vital to understanding the contributions of genetic variation to the health of children, is to proceed. This project brings together three internationally known lawyers, each of whom has written extensively about legal and policy issues in genomics research and in pediatrics, as well as an internationally known pediatrician-philosopher as a consultant, to define the applicable legal rules and to develop guidelines for returning results of genomic research involving minors.
|Brothers, Kyle B; East, Kelly M; Kelley, Whitley V et al. (2017) Eliciting preferences on secondary findings: the Preferences Instrument for Genomic Secondary Results. Genet Med 19:337-344|
|Pereira, Stacey; Oliver Robinson, Jill; McGuire, Amy L (2016) Return of individual genomic research results: what do consent forms tell participants? Eur J Hum Genet 24:1524-1529|
|Brothers, Kyle B; Holm, Ingrid A; Childerhose, Janet E et al. (2016) When Participants in Genomic Research Grow Up: Contact and Consent at the Age of Majority. J Pediatr 168:226-31.e1|
|Green, Robert C; Goddard, Katrina A B; Jarvik, Gail P et al. (2016) Clinical Sequencing Exploratory Research Consortium: Accelerating Evidence-Based Practice of Genomic Medicine. Am J Hum Genet 98:1051-1066|
|Amendola, Laura M; Jarvik, Gail P; Leo, Michael C et al. (2016) Performance of ACMG-AMP Variant-Interpretation Guidelines among Nine Laboratories in the Clinical Sequencing Exploratory Research Consortium. Am J Hum Genet 98:1067-1076|
|Amendola, Laura M; Lautenbach, Denise; Scollon, Sarah et al. (2015) Illustrative case studies in the return of exome and genome sequencing results. Per Med 12:283-295|
|Zawati, Ma'n H; Parry, David; Knoppers, Bartha Maria (2014) The best interests of the child and the return of results in genetic research: international comparative perspectives. BMC Med Ethics 15:72|
|Clayton, Ellen Wright; McCullough, Laurence B; Biesecker, Leslie G et al. (2014) Addressing the ethical challenges in genetic testing and sequencing of children. Am J Bioeth 14:3-9|
|Gray, Stacy W; Martins, Yolanda; Feuerman, Lindsay Z et al. (2014) Social and behavioral research in genomic sequencing: approaches from the Clinical Sequencing Exploratory Research Consortium Outcomes and Measures Working Group. Genet Med 16:727-35|
|Hazin, Ribhi; Brothers, Kyle B; Malin, Bradley A et al. (2013) Ethical, legal, and social implications of incorporating genomic information into electronic health records. Genet Med 15:810-6|
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