State Laws Regarding the Retention and Use of Residual Newborn Screening Blood Samples
State Laws Regarding the Retention and Use of Residual Newborn Screening Blood Samples
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DOI：
10.1542/peds.2010-1468
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发表时间：
2011-04-01
期刊：
影响因子：
8
通讯作者：
Botkin, Jeffrey
中科院分区：
文献类型：
--
作者：
Lewis, Michelle H.;Goldenberg, Aaron;Botkin, Jeffrey
背景：新生儿筛查完成后，许多州保留了残留的新生儿筛查干血样本，用于各种目的，包括计划评估、质量保证和生物医学研究。各州在多大程度上拥有保留剩余干血样(DBS)并将其用于与新生儿筛查无关的目的的法律权力尚不清楚。目的：本研究的目的是评估有关保留和使用DBS的州法律。方法：2008年11月至2009年12月期间，在线获取了所有50个州和哥伦比亚特区与新生儿筛查有关的州法规，并由两名独立审查者审查，以确定DBS的保留和使用问题得到解决的程度。结果：18个州尚未解决DBS的保留和使用问题。在4个州，星展银行成为国家财产。有八个州要求向父母提供有关保留DBS的信息。5个州的父母可以要求销毁孩子的残留样本。在某些情况下，需要父母同意才能释放DBS，以便在6个州进行研究。有一个州禁止将DBS用于研究目的。结论：各州在保留和使用DBS方面的政策有很大的差异。许多州还没有解决关键问题，一些保留星展银行的州的行为可能超出了其法律授权的范围。各州在保留DBS方面缺乏透明度，这可能会破坏公众对州新生儿筛查项目和研究企业的信任。儿科2011；127：703-712
BACKGROUND: After newborn screening has been completed, many states retain residual newborn screening dried blood samples for various purposes, including program evaluation, quality assurance, and biomedical research. The extent to which states possess legal authority to retain residual dried blood samples (DBS) and use them for purposes unrelated to newborn screening is unclear.OBJECTIVE: The purpose of this study was to evaluate state laws regarding the retention and use of DBS.METHODS: State statutes and regulations related to newborn screening of all 50 states plus the District of Columbia were accessed online between November 2008 and December 2009 and reviewed by 2 independent reviewers to determine the extent to which the retention and use of DBS were addressed.RESULTS: The retention or use of DBS has not been addressed in 18 states. In 4 states, DBS becomes state property. Eight states require that parents be provided information regarding the retention of DBS. Parents in 5 states may request the destruction of their child's residual sample. Parental consent is required under certain circumstances to release DBS for research in 6 states. One state prohibits DBS from being used for research purposes.CONCLUSIONS: States have wide variability in their policies regarding the retention and use of DBS. Many states have not addressed key issues, and some states that retain DBS may be acting outside the scope of their legal authority. The lack of transparency on the part of states in retaining DBS may undermine public trust in state newborn screening programs and the research enterprise. Pediatrics 2011;127:703-712