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: 8337379
• 负责人: ELLEN WRIGHT CLAYTON
• 金额: $ 18.46万
• 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 2014-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8337379
• 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

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.

项目摘要：该项目的具体目标是确定应采用哪些标准来管理退货 使用美国法律和国际指南分析得出的儿科基因组研究的个别结果 将未成年人的决策作为基础。这个问题，受到了极大的关注 如果这项研究对于理解遗传的贡献至关重要，那么就必须解决这个问题。 为了孩子的健康，我们必须继续努力。为了制定这些标准，有必要绘制 使用标准的法律分析工具，基于一系列道德、法律和社会文化因素。 ¿ 遗传学领域有着悠久的传统，体现在政策声明中，例如美国的政策声明 人类遗传学学会、美国医学遗传学学会和美国遗传学会 儿科，仅当结果会改变未成年人的直接健康状况时才对未成年人进行基因检测 医疗保健。这些限制的部分理由是，在不需要立即采取行动的情况下， 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受到不同的对待 因为从法律上讲，儿童通常无法自己做出医疗保健决定。从程序上来说， 相反，道德和法律决策权分配给： 1) 拥有广泛权力的父母 有权在影响其子女的可用选项中做出选择。家长的范围 然而，他们对孩子的照顾的许可并不像他们对自己的自由裁量权那么广泛 卫生保健; 2) 对未成年人的福利负有独立义务的临床医生，该义务是有界限的 符合临床实践标准以及法律要求； 3）许多人持有的未成年人有 随着它们的成熟，道德和法律的声音变得越来越重要； 4) 在虐待、忽视或需要的情况下 保护公众健康，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 特别具有挑战性的问题是决定应该对各种潜在利益给予何种重视 返回结果，范围从直接利益到未成年人的健康或生殖信息 未成年人后来使用的福利主要有利于整个家庭单位或专门有利于整个家庭 父母，甚至同龄或具有相同状况的其他未成年人。 ¿ 涉及未成年人的研究比适用于未成年人的研究受到更多的法律和道德要求和限制 成年人。 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的法律和政策问题，以及国际知名的儿科医生- 哲学家作为顾问，定义适用的法律规则并制定返回结果的指南 涉及未成年人的基因组研究。

项目成果

Currents in contemporary bioethics. Identifying consanguinity through routine genomic analysis: reporting requirements.

当代生物伦理学的潮流。

• DOI: 10.1111/j.1748-720x.2012.00731.x
• 发表时间: 2012
• 期刊: The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics
• 作者: McGuire,AmyL;Wang,MelodyJ;Probst,FrankJ
• 通讯作者: Probst,FrankJ

The best interests of the child and the return of results in genetic research: international comparative perspectives.

儿童的最大利益和基因研究结果的回报：国际比较视角。

• DOI: 10.1186/1472-6939-15-72
• 发表时间: 2014
• 期刊: BMC medical ethics
• 影响因子: 2.7
• 作者: Zawati,Ma'nH;Parry,David;Knoppers,BarthaMaria
• 通讯作者: Knoppers,BarthaMaria

Return of individual genomic research results: what do consent forms tell participants?

• DOI: 10.1038/ejhg.2016.76
• 发表时间: 2016-11-01
• 期刊: EUROPEAN JOURNAL OF HUMAN GENETICS
• 影响因子: 5.2
• 作者: Pereira, Stacey;Robinson, Jill Oliver;McGuire, Amy L.
• 通讯作者: McGuire, Amy L.