Returning Research Results of Pediatric Genomic Research to Participants

描述(由申请者提供)：该项目的具体目标是以对美国法律和国际指南的分析为基础，确定应以什么标准来管理儿科基因组研究的个人结果的返还。如果这项对了解基因变异对儿童健康的贡献至关重要的研究要继续下去，这个问题必须得到解决，这个问题得到了极少的关注。为了制定这些标准，有必要利用许多伦理、法律和社会文化因素，使用标准的法律分析工具。 遗传学有一个悠久的传统，体现在政策声明中，例如美国人类遗传学学会、美国医学遗传学学会和美国儿科学会的政策声明，即只有在结果会改变未成年人目前的医疗保健时，才对未成年人进行基因测试。这些限制的部分理由是，在没有立即干预的需要的情况下，应该允许未成年人在成年后决定是否进行基因测试。 更广泛地说，关于儿童保健的决定与对待成年人的决定不同，因为根据法律，儿童通常不能自己作出保健决定。相反，在程序上，伦理和法律的决策权被分配给：1)拥有广泛权力的父母，他们可以在影响孩子的可用选项中做出选择。然而，父母允许照顾子女的范围并不像他们在自己的保健方面的裁量权那样广泛；2)对未成年人的福利负有独立义务的临床医生，这受到临床实践标准和法律要求的约束；3)许多人持有的未成年人，随着他们的成熟，拥有越来越重要的道德和法律发言权；以及4)在虐待、忽视或需要保护公共健康的情况下，国家。从实质上说，界定未成年人的最佳利益往往是有争议的。一个特别具有挑战性的问题是，决定应对返回结果带来的各种潜在惠益给予多大的权重，从直接惠及未成年人的健康或生殖信息以供未成年人以后使用，到主要惠及整个家庭单位或仅惠及父母或甚至其他同龄或有相同疾病的未成年人的惠益。 与成年人相比，涉及未成年人的研究受到更多的法律和伦理要求和限制。 该项目汇集了三名国际知名律师，他们每人都撰写了大量关于基因组研究和儿科学方面的法律和政策问题的文章，以及一位国际知名的儿科医生和哲学家作为顾问，以确定适用的法律规则，并为涉及未成年人的基因组研究结果的退回制定指导方针。 与公共卫生相关：到目前为止，确定应该用什么标准来管理儿科基因组学研究的个别结果的返回，得到的关注非常少。如果要继续这项研究，就必须解决这个问题。这项研究对于了解基因变异对儿童健康的贡献至关重要。该项目汇集了三名国际知名律师，他们每人都撰写了大量关于基因组研究和儿科学方面的法律和政策问题的文章，以及一位国际知名的儿科医生和哲学家作为顾问，以确定适用的法律规则，并为涉及未成年人的基因组研究结果的退回制定指导方针。

DESCRIPTION (provided by applicant): 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. PUBLIC HEALTH RELEVANCE: 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.