Weisleder Pedro
Division of Neurology and Center for Pediatric Bioethics, Nationwide Children's Hospital, The Ohio State University, Columbus, OH, United States.
Front Pediatr. 2020 Feb 7;8:25. doi: 10.3389/fped.2020.00025. eCollection 2020.
For adults, understanding research protocols prior to consenting to participate can be demanding. For children, that challenge is likely amplified. Yet, the participation of minors as research subjects is necessary. Otherwise, the likelihood of improving healthcare for minors now and in the future is hampered. The risk that minors could be harmed by procedures and medicines that are ill-adapted to their age-group or lack adequate scientific basis is real. It is therefore necessary to identify age-appropriate models to help minors understand the concept and process of assent. For this scoping review the concepts of assent and dissent, tools to evaluate the capacity of minors to assent, and six empirically based methods that have been used to help minors understand the process of assent were reviewed. Helping minors become better decision-makers in a manner that is commensurate with their development, supports children's prerogative to participate as human subjects in research.
对于成年人来说,在同意参与之前理解研究方案可能颇具难度。对于儿童而言,这一挑战可能会更大。然而,未成年人作为研究对象参与研究是必要的。否则,改善当前及未来未成年人医疗保健的可能性将会受到阻碍。未成年人因不适合其年龄组或缺乏充分科学依据的程序和药物而受到伤害的风险是切实存在的。因此,有必要确定适合年龄的模式,以帮助未成年人理解同意的概念和过程。在本次范围审查中,对同意和不同意的概念、评估未成年人同意能力的工具,以及六种基于实证的帮助未成年人理解同意过程的方法进行了审查。以与他们的发展相适应的方式帮助未成年人成为更好的决策者,支持了儿童作为人类受试者参与研究的权利。