Guidelines for return of research results from pediatric genomic studies: deliberations of the Boston Children's Hospital Gene Partnership Informed Cohort Oversight Board
Guidelines for return of research results from pediatric genomic studies: deliberations of the Boston Children's Hospital Gene Partnership Informed Cohort Oversight Board
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DOI：
10.1038/gim.2013.190
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发表时间：
2014-07-01
影响因子：
8.8
通讯作者：
Taylor, Patrick
中科院分区：
文献类型：
--
作者：
Holm, Ingrid A.;Savage, Sarah K.;Taylor, Patrick
目的：将个体结果返回给基因组研究参与者的方法可变地集中在可操作性、分享义务或参与者的偏好上。我们在波士顿儿童医院的小组通过实施基因伙伴关系，一个基于“知情队列”模型的基因组研究存储库，根据参与者的偏好提供结果返回，从而优先考虑参与者的偏好。认识到伦理监督的重要性，基因伙伴关系知情队列监督委员会于2009年成立。方法：在3年多的时间里，知情队列监督委员会制定了个人基因组研究结果返回的指导方针。结果：知情队列监督委员会将其指导原则定义为：通过返回与参与者偏好一致的结果，尊重儿科参与者正在发展的自主权和父母的决策权，并保护参与者免受伤害。确定了潜在危害和消除危害的策略。制定了考虑儿童发展和家庭动态的参与者偏好的指导方针。知情队列监督委员会同意，为了防止伤害，包括与干扰儿童未来自主性有关的伤害，无论参与者的偏好如何，结果都不应退还。结论：知情队列监督委员会为结果的返回制定了指导方针，尊重父母、儿童和成年参与者的偏好，同时寻求防止伤害。
Purpose: Approaches to return individual results to participants in genomic research variably focus on actionability, duty to share, or participants' preferences. Our group at Boston Children's Hospital has prioritized participants' preferences by implementing the Gene Partnership, a genomic research repository, based on the "Informed Cohort" model that offers return of results in accordance with participant preferences. Recognizing that ethical oversight is essential, the Gene Partnership Informed Cohort Oversight Board was convened in 2009.Methods: Over 3 years, the Informed Cohort Oversight Board developed guidelines for the return of individual genomic research results.Results: The Informed Cohort Oversight Board defined its guiding principles as follows: to respect the developing autonomy of pediatric participants and parental decision-making authority by returning results consistent with participants' preferences and to protect participants from harm. Potential harms and strategies to eliminate harm were identified. Guidelines were developed for participant preferences that consider the child's development and family dynamics. The Informed Cohort Oversight Board agreed that to prevent harm, including harms related to interfering with a child's future autonomy, there will be results that should not be returned regardless of participant preferences.Conclusion: The Informed Cohort Oversight Board developed guidelines for the return of results that respect the preferences of parents, children, and adult participants while seeking to protect against harm.