Returning Research Results of Pediatric Genomic Research to Participants

描述（由申请人提供）：本项目的具体目的是确定什么标准应该管理儿科基因组研究的个人结果的回报，使用美国法律和国际指南的分析，为未成年人和未成年人的决策作为基础。这一问题很少受到关注，如果这项研究要继续下去，就必须解决这个问题，而这项研究对于了解遗传变异对儿童健康的贡献至关重要。为了制定这些标准，有必要利用标准的法律的分析工具，借鉴一系列道德、法律的和社会文化因素。 遗传学有一个悠久的传统，体现在政策声明中，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，只有在结果会改变未成年人的直接医疗护理时才对未成年人进行基因测试。这些限制的部分理由是，在不需要立即干预的情况下，应允许未成年人在成年后决定是否进行基因检测。 更一般地说，有关儿童保健的决定与成人的决定受到不同的对待，因为作为一个法律问题，儿童通常不能作出自己的保健决定。相反，在程序上、道德上和法律的决策权分配给：1）父母有广泛的权力在影响其子女的现有选择中作出选择。然而，父母允许其子女照顾的范围不如他们对自己的保健的自由裁量权那么广泛; 2）对未成年人的福利负有独立义务的临床医生，这种义务受到临床实践标准以及法律的要求的限制; 3）随着年龄的增长，许多未成年人拥有越来越重要的道德和法律的声音;（4）在虐待、忽视或需要保护公共健康的情况下，由国家负责。从实质上讲，界定未成年人的最大利益往往是有争议的。一个特别具有挑战性的问题是，如何确定对返回结果的各种潜在利益的重视程度，从未成年人的健康或生殖信息供未成年人以后使用的直接利益，到主要对整个家庭单位或专门对父母或甚至对同龄或有同样条件的其他未成年人的利益。 涉及未成年人的研究比适用于成年人的研究受到更多的法律的和道德要求和限制。 该项目汇集了三位国际知名律师，他们都撰写了大量关于基因组学研究和儿科学方面的法律的和政策问题的文章，还邀请了一位国际知名的儿科哲学家担任顾问，以确定适用的法律的规则，并制定关于退还涉及未成年人的基因组研究结果的准则。 公共卫生相关性：决定什么标准应该管理返回的儿科基因组学研究的个人结果迄今已收到显着很少的关注。这项研究对于了解遗传变异对儿童健康的贡献至关重要，如果要继续下去，就必须解决这个问题。该项目汇集了三位国际知名律师，他们都撰写了大量关于基因组学研究和儿科学方面的法律的和政策问题的文章，还邀请了一位国际知名的儿科哲学家担任顾问，以确定适用的法律的规则，并制定关于退还涉及未成年人的基因组研究结果的准则。

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.