同意陈述在儿童和青少年中的应用的重要性：一项定性研究。
The importance of applying the statement of assent to children and adolescents: a qualitative study.
机构信息
National Cancer Institute. Rio de Janeiro, RJ, Brazil, Email:
Escola de Enfermagem Aurora de Afonso Costa da Universidade Federal Fluminense. Niterói, RJ, Brazil, Email:
出版信息
Invest Educ Enferm. 2022 Jun;40(2). doi: 10.17533/udea.iee.v40n2e07.
OBJECTIVES
To describe the importance of the Statement of Assent for children and adolescents invited to participate in a clinical study and their main reactions to its explanation.
METHODS
This is an exploratory descriptive qualitative study of 17 children and adolescents, who were invited to participate in a clinical study in the field of oncology in a hospital located in Rio de Janeiro (Brazil). Data were analyzed using thematic analysis.
RESULTS
Two thematic units were generated after data interpretation: signing the statement of assent, in which participants felt their main role when faced with the possibility of expressing their agreement or not to take part in the study; and understanding of the study, when they showed that they understood the steps of the study by asking pertinent questions to clarify their doubts. Children and adolescents understood the steps of the study contained in the Statement of Assent, were interested and asked questions to clarify their doubts about the study.
CONCLUSIONS
The Statement of Assent was important for participants understanding the study and having autonomy over their participation. As the statement strengthened the main role of children and adolescents in the research process, the conclusion was that its use in studies involving the pediatric population should be encouraged.
目的
描述同意声明对于被邀请参与临床研究的儿童和青少年的重要性，以及他们对其解释的主要反应。
方法
这是一项在巴西里约热内卢的一家医院进行的关于肿瘤学领域的临床研究中邀请了 17 名儿童和青少年参与的探索性描述性定性研究。使用主题分析对数据进行分析。
结果
在对数据进行解释后，生成了两个主题单元：签署同意声明，参与者在面临表达同意或不同意参与研究的可能性时，感到自己的主要角色；以及对研究的理解，当他们通过提出相关问题来澄清他们对研究的疑虑，表明他们理解同意声明中包含的研究步骤。儿童和青少年理解了同意声明中研究的步骤，表现出了兴趣，并提出问题澄清了他们对研究的疑虑。
结论
同意声明对参与者理解研究和对其参与的自主权非常重要。由于声明加强了儿童和青少年在研究过程中的主要角色，因此结论是，应鼓励在涉及儿科人群的研究中使用同意声明。
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