Disclosing individual genetic results to research participants
Disclosing individual genetic results to research participants
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DOI：
10.1080/15265160600934772
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发表时间：
2006-11-01
影响因子：
13.4
通讯作者：
Wilfond, Benjamin S.
中科院分区：
文献类型：
--
作者：
Ravitsky, Vardit;Wilfond, Benjamin S.
在设计研究时，研究者和机构审查委员会应整合关于适当披露个体遗传结果的计划。仁慈、尊重、互惠和公正的伦理原则为定期向研究参与者提供某些结果提供了正当理由。我们提出了一个结果评估的方法，评估预期的信息和研究的背景下，以决定是否应该提供的结果。根据这种方法，分析的有效性和临床实用性的具体结果决定它是否应该提供常规。因此，即使在同一项研究中，不同的结果也可能需要不同的决定。我们认为，在一项研究中披露一项结果的临床效用阈值应低于同一结果临床使用的阈值。结果的个人意义为评价提供了额外的标准。最后，研究的背景允许通过解决调查人员的适当披露能力，参与者对结果的替代访问以及他们与调查人员的关系进行更细致的分析。这一分析表明，在不同的情况下，同样的结果可能需要不同的决定。
Investigators and institutional review boards should integrate plans about the appropriate disclosure of individual genetic results when designing research studies. The ethical principles of beneficence, respect, reciprocity, and justice provide justification for routinely offering certain results to research participants. We propose a result-evaluation approach that assesses the expected information and the context of the study in order to decide whether results should be offered. According to this approach, the analytic validity and the clinical utility of a specific result determine whether it should be offered routinely. Different results may therefore require different decisions even within the same study. We argue that the threshold of clinical utility for disclosing a result in a research study should be lower than the threshold used for clinical use of the same result. The personal meaning of a result provides additional criteria for evaluation. Finally, the context of the study allows for a more nuanced analysis by addressing the investigators' capabilities for appropriate disclosure, participants' alternative access to the result, and their relationship with the investigators. This analysis shows that the same result may require different decisions in different contexts.