Department of Foundational Medical Studies, Oakland University William Beaumont School of Medicine, Rochester, Michigan, USA.
Department of Pediatrics, Oakland University William Beaumont School of Medicine, Royal Oak, Michigan, USA.
AJOB Empir Bioeth. 2024 Oct-Dec;15(4):336-346. doi: 10.1080/23294515.2024.2388517. Epub 2024 Aug 21.
This study assesses how pediatric assent is conceptualized and justified within the therapeutic context. Pediatric ethicists generally agree that children should participate in medical care decisions in developmentally appropriate ways. Much attention has been paid to pediatric assent for research participation, but ambiguities persist in how assent is conceptualized and operationalized in the therapeutic context where countervailing considerations such as the child's best interest and parental permission must also be weighed.
Searches were conducted in 11 databases including PubMed, Embase, Cochrane Library, and Web of Science. Articles published between 2010 and 2020 were screened in COVIDENCE for meeting each of four criteria: (1) focusing on pediatric assent, (2) focusing on clinical care, (3) including normative claims, and (4) containing substantive statements about the meaning of pediatric assent. Full texts were abstracted for (1) operational definitions of assent, (2) discussion of the temporal nature of assent, (3) description of the concept of "understanding," and (4) ethical justifications for soliciting assent. These excerpts were coded and code patterns formed themes presented in the results.
The final analytic data set contained 29 articles. Analysis yielded three key themes. First, valid assent varies by treatment, population (e.g., younger versus older), and geographic/cultural context. Second, assent represents two distinct longitudinal processes: One involves eliciting preferences over a disease course or care episode; the other focuses on children's developmental maturation. Third, ethical justifications for assent draw variously on instrumental and intrinsic reasons, but often remain ambiguous.
There is widespread agreement that assent is morally valuable, but there remain substantial ambiguities or disagreements about its meaning, process, and ethical justification.
本研究评估了儿科同意在治疗背景下的概念化和正当性。儿科伦理学家普遍认为,儿童应以适合其发展的方式参与医疗保健决策。人们对儿童参与研究的同意给予了很多关注,但在治疗背景下,同意的概念化和操作仍然存在模糊性,因为必须权衡儿童的最佳利益和父母许可等反对方针。
在 11 个数据库(包括 PubMed、Embase、Cochrane Library 和 Web of Science)中进行了检索。在 COVIDENCE 中筛选了 2010 年至 2020 年期间发表的文章,以满足以下四个标准中的每一个标准:(1)关注儿科同意,(2)关注临床护理,(3)包含规范性主张,(4)包含关于儿科同意含义的实质性陈述。对(1)同意的操作定义,(2)同意的时间性质讨论,(3)“理解”概念的描述以及(4)征求同意的伦理理由进行了全文摘录。这些摘录进行了编码,并形成了呈现结果的主题模式。
最终的分析数据集包含 29 篇文章。分析产生了三个关键主题。首先,有效的同意因治疗、人群(例如,年龄较大与年龄较小)和地理/文化背景而异。其次,同意代表两个不同的纵向过程:一个涉及对疾病过程或护理事件的偏好;另一个侧重于儿童的发展成熟。第三,同意的伦理理由从工具和内在理由中汲取了不同的理由,但往往仍然存在歧义。
广泛认为同意具有道德价值,但对其含义、过程和伦理理由仍存在相当大的歧义或分歧。