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重新考虑 18 岁时再次同意的必要性。

Reconsidering the Need for Reconsent at 18.

机构信息

Department of Bioethics, National Institutes of Health, Bethesda, Maryland; and

National Human Genome Research Institute, Bethesda, Maryland.

出版信息

Pediatrics. 2018 Aug;142(2). doi: 10.1542/peds.2017-1202. Epub 2018 Jul 6.

DOI:10.1542/peds.2017-1202
PMID:29980586
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6317640/
Abstract

The prevalence of research with biological specimens has led to a debate over what type of consent is needed to obtain biological specimens from minors and store them for future studies. In most cases, parental permission is needed to obtain samples from minors. In addition, almost all commentators and guidelines maintain that researchers need the consent of the donors if they want to continue to store the samples and make them available for future studies after the donors reach the age of majority. In this Ethics Rounds, we argue that this near-consensus view is mistaken on the grounds that the agreement of the parents at the time of obtaining samples provides sufficient permission to store them and use them in research even after the donors turn 18 years old.

摘要

研究生物样本的流行引发了一场争论,即需要什么样的同意才能从小患者身上获取生物样本并将其储存起来用于未来的研究。在大多数情况下,需要父母同意才能从小患者身上获取样本。此外,几乎所有的评论员和准则都认为,如果研究人员希望在供者成年后继续储存样本并将其用于未来的研究,那么他们需要供者的同意。在本次伦理轮盘中,我们认为这种近乎一致的观点是错误的,理由是在获取样本时父母的同意足以提供储存样本并在供者年满 18 岁后将其用于研究的许可。

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Reconsidering the Need for Reconsent at 18.重新考虑 18 岁时再次同意的必要性。
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本文引用的文献

1
Recontacting Pediatric Research Participants for Consent When They Reach the Age of Majority.当儿科研究参与者达到法定年龄时重新联系他们以获取同意。
IRB. 2016 Nov-Dec;38(6):1-9.
2
When Participants in Genomic Research Grow Up: Contact and Consent at the Age of Majority.基因组研究参与者成年后:成年时的联系与同意
J Pediatr. 2016 Jan;168:226-231.e1. doi: 10.1016/j.jpeds.2015.09.020. Epub 2015 Oct 23.
3
Parental Consent for the Use of Residual Newborn Screening Bloodspots: Respecting Individual Liberty vs Ensuring Public Health.使用新生儿筛查剩余血斑的家长同意书:尊重个人自由与确保公众健康
JAMA. 2015 Jul 7;314(1):21-2. doi: 10.1001/jama.2015.6175.
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Practical guidance on informed consent for pediatric participants in a biorepository.生物样本库中儿童参与者知情同意的实用指南。
Mayo Clin Proc. 2014 Nov;89(11):1471-80. doi: 10.1016/j.mayocp.2014.07.006. Epub 2014 Sep 26.
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Eur J Hum Genet. 2013 Jan;21(1):2-7. doi: 10.1038/ejhg.2012.99. Epub 2012 Jun 20.
6
Children, biobanks and the scope of parental consent.儿童、生物银行与父母同意范围
Eur J Hum Genet. 2011 Jul;19(7):735-9. doi: 10.1038/ejhg.2011.29. Epub 2011 Mar 9.
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Research ethics. Children and population biobanks.研究伦理。儿童与人群生物样本库。
Science. 2009 Aug 14;325(5942):818-9. doi: 10.1126/science.1173284.
8
Pediatric biobanks: approaching informed consent for continuing research after children grow up.儿科生物样本库:探讨儿童长大后继续进行研究的知情同意问题。
J Pediatr. 2009 Oct;155(4):578-83. doi: 10.1016/j.jpeds.2009.04.034.
9
Biological sample collections from minors for genetic research: a systematic review of guidelines and position papers.用于基因研究的未成年人生物样本采集:对指南和立场文件的系统评价
Eur J Hum Genet. 2009 Aug;17(8):979-90. doi: 10.1038/ejhg.2009.9.
10
One-time general consent for research on biological samples.对生物样本研究的一次性通用同意书。
BMJ. 2006 Mar 4;332(7540):544-7. doi: 10.1136/bmj.332.7540.544.