Crane Stacey, Broome Marion E
Predoctoral Fellow, Indiana University School of Nursing, Indianapolis, IN, USA.
Ruby F. Wilson Distinguished Professor and Dean, Vice-Chancellor for Nursing Affairs, Duke University School of Nursing, Durham, NC, USA.
Worldviews Evid Based Nurs. 2017 Jun;14(3):200-209. doi: 10.1111/wvn.12209. Epub 2017 Feb 16.
The past 20 years have seen distinct shifts in the way the participation of children and adolescents in research is viewed. This has been emphasized by the growing pediatric research enterprise. Additional information on children's and adolescents' experiences during research participation is needed to better inform researchers on the ethical conduct of research with this vulnerable population.
The objective of this analysis was to examine ethical issues in research with children and adolescents from their perspective as participants, including: assent, parental consent, risk perception, impact of research participation, and incentives.
This systematic review was conducted per the Long, Godfrey, Randall, Brettle, and Grant framework by means of an iterative searching process. Using the key words "research ethics" and "child or pediatric or adolescent," PubMed, CINAHL, and EBSCOhost databases were searched to identify articles. Limitations placed on the searches were: English language, year of publication between 2003 and 2014, humans, abstract available, and age birth-18 years.
Twenty-three empiric studies were identified and formed the sample. Included studies represented a diverse range of areas of research, methods, settings, sample demographics, authors, and journals.
Even young children demonstrated the ability to understand essential elements of research, although there is variability in children's level of understanding. Trust was a significant contributing factor to children's and adolescents' participation in research, and also shaped their assessments of risk. Research participation was mainly beneficial for children and adolescents. Incentives were mainly viewed positively, although concerns of possible undue influence were expressed.
在过去20年里，儿童和青少年参与研究的方式发生了显著变化。日益壮大的儿科研究事业凸显了这一点。需要更多关于儿童和青少年参与研究期间经历的信息，以便更好地指导研究人员针对这一弱势群体进行符合伦理的研究。
本分析的目的是从儿童和青少年作为参与者的角度审视研究中的伦理问题，包括：同意、家长同意、风险认知、参与研究的影响以及激励措施。
本系统评价按照朗、戈弗雷、兰德尔、布雷特尔和格兰特框架，通过迭代搜索过程进行。使用关键词“研究伦理”和“儿童或儿科或青少年”，检索了PubMed、CINAHL和EBSCOhost数据库以识别文章。搜索的限制条件为：英文、2003年至2014年发表、人类、有摘要且年龄为出生至18岁。
共识别出23项实证研究并构成样本。纳入的研究涵盖了广泛的研究领域、方法、环境、样本人口统计学、作者和期刊。
即使是幼儿也表现出理解研究基本要素的能力，尽管儿童的理解水平存在差异。信任是儿童和青少年参与研究的一个重要因素，也影响了他们对风险的评估。参与研究对儿童和青少年主要是有益的。激励措施主要被积极看待，尽管有人表达了对可能存在不当影响的担忧。
