Department of Pediatrics, School of Medicine, University of Louisville, Louisville, Kentucky;
Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, Seattle, Washington; and.
Pediatrics. 2018 Aug;142(2). doi: 10.1542/peds.2017-3038. Epub 2018 Jul 6.
In this issue of , Berkman et al argue that parental permission to obtain samples is sufficient to continue storing them and using them for research after the pediatric participant reaches the age of majority. In this Ethics Rounds, we argue that there are important ethical reasons for obtaining consent from participants when they reach majority. However, these reasons must be balanced with the aim of efficiently and economically conducting research that benefits children. Given current guidance from the relevant regulatory bodies, it remains necessary to obtain consent for the continued use of identified pediatric samples when participants reach the age of majority unless the institutional review board grants a waiver of consent. However, we argue that waivers of consent should more frequently be granted by institutional review boards and used for this purpose.
本期 杂志中,Berkman 等人认为,在儿科参与者达到成年年龄后,只要获得了父母的同意来获取样本,便足以继续存储这些样本并将其用于研究。在本期的伦理讨论中,我们认为,当参与者成年时,从他们那里获得同意有重要的伦理理由。然而,这些理由必须与高效、经济地开展有益于儿童的研究目标相平衡。鉴于相关监管机构的现行指导意见,如果机构审查委员会没有豁免同意,那么在参与者达到成年年龄后,继续使用已识别的儿科样本仍需要获得同意。但是,我们认为机构审查委员会应该更频繁地批准同意豁免,并将其用于此目的。