Questioning the need for informed consent: A case study of California's experience with a pilot newborn screening research project
Questioning the need for informed consent: A case study of California's experience with a pilot newborn screening research project
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DOI：
10.1525/jer.2007.2.3.3
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发表时间：
2007-09-01
影响因子：
1.3
通讯作者：
Sciortino, Stan
中科院分区：
文献类型：
--
作者：
Feuchtbaum, Lisa;Cunningham, George;Sciortino, Stan
加州州提供强制性新生儿筛查，如果在生命早期没有发现和治疗，会导致不可逆的严重残疾。不需要父母同意。2001年，遗传病分支处受命对一项新技术进行试点测试，该技术可以利用已经收集的同一血液样本查明许多其他疾病。参与研究需要知情同意，在研究时间范围内获得了47%的分娩。医院无法对所有新生儿执行同意程序，导致拒绝检测和遗漏病例。如果放弃知情同意，所有新生儿都可以接受检测。提出了几个实证问题，每个问题都从社会、父母和新生儿的角度进行了研究。它的结论是，社会的合法需求和新生儿的利益不应被牺牲，以回应少数父母谁不希望他们的婴儿参加研究的自主权利益，并在未来，父母的同意应放弃评估新的筛查技术的项目。
CALIFORNIA PROVIDES MANDATORY newborn screening for disorders that cause irreversible, severe disabilities if not identified and treated early in life. Parental consent is not required. In 2001, the Genetic Disease Branch was mandated to pilot test a new technology that could identify many additional disorders using the same blood specimen already collected. Study participation required informed consent, which was obtained for 47% of births during the study timeframe. The inability of hospitals to carry out the consent procedure for all newborns resulted in denial of testing and missed cases. If informed consent were waived, all newborns could have been tested. Several empirical questions are posed and each is examined from the perspective of society, the parents and the newborn. It is concluded that the legitimate needs of society and the interests of newborns should not be sacrificed to respond to the autonomy interests of the few parents who did not wish their infant to participate in the study, and that in the future, parental consent should be waived for projects evaluating new screening technologies.