Fox Dov, Spencer Emily, Torkamani Ali
J Leg Med. 2018 Apr-Jun;38(2):201-219. doi: 10.1080/01947648.2017.1417934.
This article critically appraises the ethical and legal duties to disclose findings to the family members of research participants. These family members stand to benefit in important ways from discoveries that can inform their own health and reproductive risks. However, careful appreciation of how medical research differs from clinical practice and of the uncertainties at stake in genomic research complicates any warning to relatives. Research laboratories should generally be immune from liability for failing to diagnose or disclose a genetic disorder in time to prevent adverse outcomes for a participant's family members or to return properly interpreted test results for even direct findings under investigation, let alone incidental ones. The only exception is where warning relatives of medical risks is very likely to prevent imminent harm and would not override known participant wishes. Genomic autopsy studies for sudden death satisfy these conditions of life-saving potential for relatives without disrespect to subjects. These are among the rare instances in which we conclude that offering results to family members is not just permissible but obligatory, not just as a moral matter but as a legal one.
本文批判性地评估了向研究参与者家属披露研究结果的伦理和法律责任。这些家属可能会从相关发现中以重要方式受益，这些发现能够告知他们自身的健康和生殖风险。然而，仔细考量医学研究与临床实践的差异以及基因组研究中所涉及的不确定性，会使向亲属发出的任何警示变得复杂。一般来说，研究实验室不应为未能及时诊断或披露基因疾病而承担责任，以防止对参与者家属造成不良后果，或者即使是针对正在调查的直接发现，更不用说偶然发现，也无需返还经过正确解读的检测结果。唯一的例外是，向亲属警示医疗风险极有可能防止即将发生的伤害，且不会违背已知的参与者意愿。针对猝死的基因组尸检研究满足为亲属带来挽救生命潜力且不冒犯受试者的这些条件。在这些罕见的情况下，我们得出结论，向家庭成员提供结果不仅是允许的，而且是义务性的，不仅在道德层面如此，在法律层面也是如此。
