Dahan Sonia, Jung Camille, Dassieu Gilles, Durrmeyer Xavier, Caeymaex Laurence
Neonatal intensive care unit, Centre hospitalier intercommunal de Créteil, Créteil, Ile-de-France, France
Faculté de Médecine, Université Paris Est Créteil Val de Marne, Faculté de Médecine, Créteil, Ile-de-France, France.
J Med Ethics. 2021 Oct;47(10):678-683. doi: 10.1136/medethics-2019-105597. Epub 2020 Feb 20.
This study aimed to describe how parents and physicians experienced the informed consent interview and to investigate the aspects of the relationship that influenced parents' decision during the consent process for a randomised clinical trial in a tertiary neonatal intensive care unit (NICU). The secondary objective was to describe the perspectives of parents and physicians in the specific situation of prenatal informed consent.
Single centre study in NICU of the Centre Hospitalier Intercommunal de Créteil, France, using a convenience period from February to May 2016.
Ancillary study to a randomised clinical trial: Prettineo. Records of interviews for consent.
parents and physicians. Mixed study including qualitative and quantitative interview data about participants' recall and feelings about the consent process. Interviews were reviewed using thematic discourse analysis.
Parents' recall and understanding of the study's main goal and design was good. Parents and physicians had a positive experience, and trust was one of the main reasons for parents to consent. Misunderstanding (bad comprehension) was the main reason for refusal.Before birth, three situations can compromise parents' consent: the mother already consented to participate in other studies, the absence of the father during the interview and the feeling that the baby's birth is not an imminent possibility.
Confronting parents and physicians' perspectives in research can help us reach answers to sensitive issues such as content and timing of information. Each different types of study raises different ethical dilemmas for consent that might be discussed in a more individual way.
本研究旨在描述父母和医生如何体验知情同意访谈，并调查在三级新生儿重症监护病房（NICU）进行的一项随机临床试验的同意过程中，影响父母决策的关系方面。次要目标是描述父母和医生在产前知情同意这一特定情况下的观点。
法国克雷泰伊市立医院中心NICU的单中心研究，采用2016年2月至5月的便利时间段。
一项随机临床试验（Prettineo）的辅助研究：同意访谈记录。
父母和医生。混合研究，包括关于参与者对同意过程的回忆和感受的定性和定量访谈数据。使用主题话语分析对访谈进行审查。
父母对研究的主要目标和设计的回忆和理解良好。父母和医生有积极的体验，信任是父母同意的主要原因之一。误解（理解错误）是拒绝的主要原因。在出生前，三种情况会影响父母的同意：母亲已同意参加其他研究、访谈期间父亲不在场以及感觉婴儿不会很快出生。
在研究中对比父母和医生的观点有助于我们找到诸如信息内容和时机等敏感问题的答案。每种不同类型的研究都会引发不同的同意方面的伦理困境，可能需要以更个性化的方式进行讨论。
