Aurich Beate, Vermeulen Eric, Elie Valéry, Driessens Mariette H E, Kubiak Christine, Bonifazi Donato, Jacqz-Aigrain Evelyne
Department of Paediatric Clinical Pharmacology and Pharmacogenetics, Robert Debré Hospital, 48 Boulevard Sérurier, Institut National de la Santé et de la Recherche Médicale (INSERM), Paris, France.
Dutch patient association for rare and genetic diseases (VSOP), Soest, The Netherlands.
BMJ Paediatr Open. 2020 Dec 29;4(1):e000847. doi: 10.1136/bmjpo-2020-000847. eCollection 2020.
Obtaining informed consent from parents of critically ill neonates can be challenging. The parental decision-making process is influenced by the severity of the child's condition, the benefit-risk balance, their emotional state and the quality of the relationship with the clinical team. Independent of local legislation, parents may prefer that consent is sought from both. Misconceptions about the absence of risks or unrealistic expectations about benefits should be openly addressed to avoid misunderstandings which may harm the relationship with the clinical team. Continuous consent can be sought where it is unclear whether the free choice of parental consent has been compromised. Obtaining informed consent is a dynamic process building on trusting relationships. It should include open and honest discussions about benefits and risks. Investigators may benefit from training in effective communication. Finally, involving parents in neonatal research including the development of the informed consent form and the process of obtaining consent should be considered standard practice.
从危重新生儿的父母那里获得知情同意可能具有挑战性。父母的决策过程受到孩子病情的严重程度、利弊平衡、他们的情绪状态以及与临床团队关系的质量的影响。无论当地法律如何规定，父母可能更倾向于由双方共同寻求同意。应公开解决关于不存在风险的误解或对益处的不切实际期望，以避免可能损害与临床团队关系的误解。在不清楚父母自由选择同意是否受到损害的情况下，可以寻求持续同意。获得知情同意是一个建立在信任关系基础上的动态过程。它应包括关于益处和风险的开放和诚实的讨论。研究人员可能会从有效的沟通培训中受益。最后，让父母参与新生儿研究，包括知情同意书的制定和获得同意的过程，应被视为标准做法。
