Returning Research Results of Pediatric Genomic Research to Participants

将儿科基因组研究的研究结果返回给参与者

• 批准号: 8240780
• 负责人: ELLEN WRIGHT CLAYTON
• 金额: $ 20.4万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-23 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8240780
• 关键词: Academy; Address; Adult; Affect; Age; American; Attention; Authorization documentation; Caring; Child; Child Care; Child health care; Childhood; Clinical; Consensus; Decision Making; Ethics; Family; Foundations; Genetic; Genetic Variation; Genetic screening method; Genomics; Guidelines; Health; Health Services Research; Healthcare; Human; Human Genetics; Individual; International; Intervention; Laws; Lawyers; Legal; Medical; Medical Genetics; Minor; Parents; Participant; Pediatrics; Policies; Public Health; Regulation; Research; Social Welfare; Societies; United States; Voice; Weight; Writing; abuse neglect; authority; clinical practice; college; exome; genome sequencing; interest; pediatrician; reproductive; tool

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.

描述（由申请人提供）：该项目的具体目的是通过对美国法律和有关未成年人决策的国际准则的分析作为基础，确定儿科基因组研究的个人结果返回应遵循哪些标准。这项研究对于了解遗传变异对儿童健康的贡献至关重要，如果要继续进行这项研究，这个问题受到的关注非常少。为了制定这些标准，有必要利用标准的法律分析工具，借鉴一系列道德、法律和社会文化因素。 遗传学界有一个悠久的传统，体现在政策声明中，例如美国人类遗传学会、美国医学遗传学学院和美国儿科学会的政策声明，即仅当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检测。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。 更一般而言，有关儿童医疗保健的决定与成人的医疗保健决定的处理方式不同，因为从法律角度来看，儿童通常无法做出自己的医疗保健决定。相反，在程序上，道德和法律决策权分配给： 1) 父母拥有广泛的权力，可以在影响其孩子的可用选项中做出选择。然而，父母对子女照顾的许可范围并不像他们对自己的医疗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，该义务受临床实践标准和法律要求的约束； 3）随着未成年人的成熟，他们在道德和法律上的发言权越来越重要； 4) 在滥用、忽视或需要保护公众健康的情况下，国家。从本质上讲，未成年人最大利益的定义常常存在争议。一个特别具有挑战性的问题是决定应该对返回结果的各种潜在利益给予何种权重，从对未成年人健康或供未成年人以后使用的生殖信息的直接利益，到主要有利于整个家庭单位或专门有利于父母，甚至有利于同龄或有相同状况的其他未成年人的利益。 涉及未成年人的研究比适用于成人的研究受到更多的法律和道德要求和限制。 该项目汇集了三位国际知名律师，每位律师都撰写了大量有关基因组学研究和儿科法律和政策问题的文章，并聘请了一位国际知名儿科哲学家作为顾问，以定义适用的法律规则并制定涉及未成年人的基因组研究结果返回的指南。 公共健康相关性：迄今为止，确定应采用哪些标准来管理儿科基因组学研究的个体结果的返回几乎没有受到关注。这项研究对于了解遗传变异对儿童健康的贡献至关重要，如果要继续进行，就必须解决这个问题。该项目汇集了三位国际知名律师，每位律师都撰写了大量有关基因组学研究和儿科法律和政策问题的文章，并聘请了一位国际知名儿科哲学家作为顾问，以定义适用的法律规则并制定涉及未成年人的基因组研究结果返回的指南。