Department of Bioethics, National Institutes of Health, Bethesda, Maryland; and
National Human Genome Research Institute, Bethesda, Maryland.
Pediatrics. 2018 Aug;142(2). doi: 10.1542/peds.2017-1202. Epub 2018 Jul 6.
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.
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。