Ethical Considerations for the Return of Incidental Findings in Ophthalmic Genomic Research
Ethical Considerations for the Return of Incidental Findings in Ophthalmic Genomic Research
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DOI：
10.1167/tvst.5.1.3
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发表时间：
2016-01-01
影响因子：
3
通讯作者：
Craig, Jamie E.
中科院分区：
文献类型：
--
作者：
Souzeau, Emmanuelle;Burdon, Kathryn P.;Craig, Jamie E.
全基因组和全外显子组测序技术越来越多地用于研究。然而，他们有可能识别偶然发现（IF），发现不相关的测试的适应症，提出了问题，研究人员的责任，对返回这些信息的参与者。在这项研究中，我们讨论了与IF返回研究参与者相关的伦理考虑，强调研究的类型很重要，并描述了当前的实践标准。目前，研究者没有法律的义务将IF返还给受试者，但一些观点认为，研究者可能有伦理义务将临床有效性和临床实用性的IF返还给受试者，并且这些IF是可诉的。事实上，大多数IF都很难解释，特别是因为它们不是测试的指示。临床效用通常取决于参与者的偏好，这可能具有调解的挑战性，并依赖于参与者的理解。总之，在缺乏明确指导的情况下，研究人员需要有一个明确的计划，以披露或不披露基因组研究中的干扰因素，平衡他们的研究目标和资源与参与者的权利和不伤害的义务。
Whole genome and whole exome sequencing technologies are being increasingly used in research. However, they have the potential to identify incidental findings (IF), findings not related to the indication of the test, raising questions regarding researchers' responsibilities toward the return of this information to participants. In this study we discuss the ethical considerations related to the return of IF to research participants, emphasizing that the type of the study matters and describing the current practice standards. There are currently no legal obligations for researchers to return IF to participants, but some viewpoints consider that researchers might have an ethical one to return IF of clinical validity and clinical utility and that are actionable. The reality is that most IF are complex to interpret, especially since they were not the indication of the test. The clinical utility often depends on the participants' preferences, which can be challenging to conciliate and relies on participants' understanding. In summary, in the context of a lack of clear guidance, researchers need to have a clear plan for the disclosure or nondisclosure of IF from genomic research, balancing their research goals and resources with the participants' rights and their duty not to harm.