London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.
Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
BMC Med Ethics. 2024 Nov 20;25(1):134. doi: 10.1186/s12910-024-01122-z.
Research in children is essential for them to benefit from the outcomes of research but involvement must be weighed against potential harms. In many countries and circumstances, medical research legally requires parental consent until the age of 18 years, with poorly defined recommendations for assent prior to this. However, there is little research exploring how these decisions are made by families and the ethical implications of this.
To explore key ethical debates in decision-making for participation of children and adolescents in a human papillomavirus (HPV) vaccine trial.
Semi-structured interviews were undertaken with Tanzanian girls (aged 9-16 years) who had participated in an HPV vaccine trial (n = 13), their parents or guardians (n = 12), and girls together with their parents (in paired parent-child interviews) (n = 6). The interviews were analysed using thematic analysis. Interview data came from a qualitative acceptability study undertaken as part of the Dose Reduction Immunobridging and Safety Study of Two Human Papillomavirus (HPV) Vaccines in Tanzanian Girls (DoRIS) trial.
Girls and parents desired collaborative decision-making, with parents ultimately making the decision to consent. However, girls wanted a larger part in decision-making. Decisions to consent involved many people, including extended social networks, the trial team, media outlets and healthcare professionals and this resulted in conflicts to be negotiated. Deciding where to place trust was central in participants and parents considering decisions to consent and overcoming rumours about trial involvement.
Existing models of decision-making help to understand dynamics between parents, adolescents and researchers but neglect the important wider social impacts and the fundamental nature of trust. Children's roles in discussions can be evaluated using the principles of consent: autonomy, freedom and information. Concepts such as relational autonomy help to explain mechanisms families use to negotiate complex consent decisions. Whilst interviewees supported the maintenance of legal parental consent, researchers must design consent processes centring the child to ensure that whole family decision-making processes are supported.
为使儿童受益于研究成果，对其开展研究至关重要，但必须权衡参与研究的潜在风险。在许多国家和情况下，医学研究在 18 岁之前法律上需要获得父母同意，而在此之前的同意则缺乏明确的建议。然而，几乎没有研究探讨家庭如何做出这些决策，以及这其中的伦理含义。
探讨儿童和青少年参与人乳头瘤病毒（HPV）疫苗试验的决策中的关键伦理问题。
对参加 HPV 疫苗试验的坦桑尼亚女孩（9-16 岁）（n=13）、其父母或监护人（n=12）以及女孩与其父母（在配对的亲子访谈中）（n=6）进行半结构化访谈。采用主题分析法分析访谈数据。访谈数据来自于作为坦桑尼亚女孩两种 HPV 疫苗剂量减少免疫桥接和安全性研究（DoRIS）试验的一部分进行的定性可接受性研究。
女孩和父母都希望共同决策，最终由父母做出同意的决定。然而，女孩希望在决策中有更大的参与度。同意的决定涉及到许多人，包括扩大的社交网络、试验团队、媒体和医疗保健专业人员，这导致需要协商解决冲突。参与者和父母在考虑同意决策时，将信任放在何处是核心问题，同时也需要克服有关试验参与的谣言。
现有的决策模型有助于理解父母、青少年和研究人员之间的动态关系，但忽视了重要的更广泛的社会影响和信任的基本性质。可以使用同意的原则来评估儿童在讨论中的作用：自主、自由和信息。关系自主等概念有助于解释家庭用来协商复杂同意决策的机制。虽然受访者支持保留法定父母同意，但研究人员必须设计以儿童为中心的同意程序，以确保整个家庭的决策过程得到支持。
