Secondary uses and the governance of de-identified data: Lessons from the human genome diversity panel
Secondary uses and the governance of de-identified data: Lessons from the human genome diversity panel
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DOI：
10.1186/1472-6939-12-16
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发表时间：
2011-09-26
影响因子：
2.7
通讯作者：
Lee, Sandra S-J
中科院分区：
文献类型：
--
作者：
Fullerton, Stephanie M.;Lee, Sandra S-J
背景：美国和欧洲最近对监管指南的改变使二级研究的监督变得复杂，因为它使大多数未识别数据的使用不受人类受试者的监督。为了确定这些指南对参与者和社区的危害，本文探索了一个有限监督的未确定的DNA样本收集的二次使用：人类基因组多样性项目(HGDP)-人类基因组多样性中心，CEPH(CEPH)人类基因组多样性小组。方法：使用关键词和引用参考文献搜索的组合，我们检索了2002-2009年间发表的英文科学文章，报道了对HGDP多样性小组样本和/或数据的分析。然后，我们审阅了每一篇文章，以确定样本和/或数据应用到的具体研究用途。根据收集支持的研究的类型和种类对二次用途进行分类。结果：从148篇同行评议的文章中确定了广泛的二次用途。虽然这些用途中的绝大多数与收集的初衷是一致的，但少数已发表的报告描述了其主要发现可能被视为有争议的、令人反感的或在其解释中可能被污名的研究。结论：我们得出结论：对参与者和社区的潜在风险不能通过将个人数据匿名化而完全消除，并建议由具有适当利益相关者代表的数据访问委员会或类似的内部监督机构对拟议的二次使用进行明确审查，这应该是任何数据或标本存储库可信治理的必要组成部分。
Background: Recent changes to regulatory guidance in the US and Europe have complicated oversight of secondary research by rendering most uses of de-identified data exempt from human subjects oversight. To identify the implications of such guidelines for harms to participants and communities, this paper explores the secondary uses of one de-identified DNA sample collection with limited oversight: the Human Genome Diversity Project (HGDP)-Centre d'Etude du Polymorphisme Humain, Fondation Jean Dausset (CEPH) Human Genome Diversity Panel.Methods: Using a combination of keyword and cited reference search, we identified English-language scientific articles published between 2002 and 2009 that reported analysis of HGDP Diversity Panel samples and/or data. We then reviewed each article to identify the specific research use to which the samples and/or data was applied. Secondary uses were categorized according to the type and kind of research supported by the collection.Results: A wide variety of secondary uses were identified from 148 peer-reviewed articles. While the vast majority of these uses were consistent with the original intent of the collection, a minority of published reports described research whose primary findings could be regarded as controversial, objectionable, or potentially stigmatizing in their interpretation.Conclusions: We conclude that potential risks to participants and communities cannot be wholly eliminated by anonymization of individual data and suggest that explicit review of proposed secondary uses, by a Data Access Committee or similar internal oversight body with suitable stakeholder representation, should be a required component of the trustworthy governance of any repository of data or specimens.