Returning Research Results of Pediatric Genomic Research to Participants

项目摘要：本项目的具体目标是确定应采用什么标准来管理退货 儿科基因组研究的个别结果，使用美国法律和国际指南的分析 以未成年人决策为基础。这一问题已经引起了人们的广泛关注 如果这项研究对理解基因的贡献至关重要，那么必须解决的问题很少 对儿童健康的变化，是继续进行的。为了制定这些标准，有必要制定 使用标准的法律分析工具，对一系列道德、法律和社会文化因素进行分析。 遗传学有着悠久的传统，体现在政策声明中，例如美国人的政策声明 人类遗传学学会、美国医学遗传学学会和美国医学遗传学学会 儿科，只有在结果会改变未成年人的直接情况下才对未成年人进行基因测试 医疗护理。这些限制的部分理由是，在没有立即需要的情况下， 干预，应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，有关儿童保健的决定与成年人的不同。 因为从法律上讲，儿童通常不能自己做出医疗保健决定。在程序上， 相反，道德和法律的决策权被分配给：1)拥有广泛权力的父母 有权在影响其子女的可用选项中作出选择。父母的范围 然而，允许照顾他们的孩子，并不像他们自己的自由裁量权那样宽泛 医疗保健；2)对未成年人的福利负有独立义务的临床医生，这是有限制的 根据临床实践标准以及法律要求；3)未成年人多持有 随着道德和法律声音的成熟，它们变得越来越重要；以及4)在滥用、忽视或需要 保护公众健康，保护国家。从实质上说，界定未成年人的最佳利益往往是有争议的。一 一个特别具有挑战性的问题是决定应该对各种潜在利益给予多大的权重 从返回结果，从直接受益到未成年人的健康或生殖信息 未成年人后来用于主要有益于整个家庭单位或完全有益于 父母，甚至是其他同龄或有相同病症的未成年人。 ？涉及未成年人的研究受到更多法律和道德要求和限制 成年人。 这个项目汇集了三位国际知名的律师，他们每个人都写了大量关于 基因组研究和儿科领域的法律和政策问题，以及一位国际知名的儿科医生- 作为顾问的哲学家，定义适用的法律规则并制定返回结果的指导方针 涉及未成年人的基因组研究。

PROJECT SUMMARY: 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.