Ethical Considerations Related to Return of Results from Genomic Medicine Projects: The eMERGE Network (Phase III) Experience
Ethical Considerations Related to Return of Results from Genomic Medicine Projects: The eMERGE Network (Phase III) Experience
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DOI：
10.3390/jpm8010002
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发表时间：
2018-03-01
影响因子：
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通讯作者：
Kullo, Iftikhar J.
中科院分区：
文献类型：
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作者：
Fossey, Robyn;Kochan, David;Kullo, Iftikhar J.
我们检查了电子病历和基因组学（eMERGE）网络中9个学术机构的机构审查委员会（IRB）流程，以确定常见问题和担忧。正在对来自9个研究中心的28，100名参与者进行109种疾病相关基因的测序和14种可操作变体的基因分型。可采取行动的基因中的致病性/可能致病性变体正在返回给研究参与者。我们检查了每个研究中心的研究方案、知情同意材料以及与IRB工作人员的互动。每个研究中心的研究人员完成了关于其IRB互动的问卷调查。为IRB提交准备方案的时间、修订次数和批准时间分别为10-261天、0-11天和11-90天。IRB的建议涉及知情同意材料的可读性、详细说明全部潜在风险、提供接收有限结果或退出的选择、与家庭成员共享信息以及建立回答参与者问题的机制。审查涉及基因组测序结果返回的研究的IRB有各种各样的担忧，预测这些担忧可以帮助研究人员更有效地参与IRB。
We examined the Institutional Review Board (IRB) process at 9 academic institutions in the electronic Medical Records and Genomics (eMERGE) Network, for proposed electronic health record-based genomic medicine studies, to identify common questions and concerns. Sequencing of 109 disease related genes and genotyping of 14 actionable variants is being performed in similar to 28,100 participants from the 9 sites. Pathogenic/likely pathogenic variants in actionable genes are being returned to study participants. We examined each site's research protocols, informed-consent materials, and interactions with IRB staff. Research staff at each site completed questionnaires regarding their IRB interactions. The time to prepare protocols for IRB submission, number of revisions and time to approval ranged from 10-261 days, 0-11, and 11-90 days, respectively. IRB recommendations related to the readability of informed consent materials, specifying the full range of potential risks, providing options for receiving limited results or withdrawal, sharing of information with family members, and establishing the mechanisms to answer participant questions. IRBs reviewing studies that involve the return of results from genomic sequencing have a diverse array of concerns, and anticipating these concerns can help investigators to more effectively engage IRBs.