Katheria Anup C, Schmölzer Georg M, Law Brenda, Yoder Bradley A, Clark Erin, El-Naggar Walid, Morales Ana, Dorner Rebecca A, Mooso Benjamin, Rich Wade, Vora Farha, Finer Neil
Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA, USA.
University of Alberta, Edmonton, AB, Canada.
J Perinatol. 2024 Mar;44(3):415-418. doi: 10.1038/s41372-023-01853-8. Epub 2023 Dec 21.
To determine parental perspectives in a trial with waived consent.
Anonymous survey of birth parents with term infants who were randomized using a waiver of consent, administered after infant discharge.
121 (11%) survey responses were collected. Of the 121 responding parents 111 (92%) reported that this form of consent was acceptable and 116 (96%) reported feeling comfortable having another child participate in a similar study. 110 (91%) respondents reported that they both understood the information provided in the consent process and had enough time to consider participation. Four percent had a negative opinion on the study's effect on their child's health.
Most responding parents reported both acceptability of this study design in the neonatal period and that the study had a positive effect on their child's health. Future work should investigate additional ways to involve parents and elicit feedback on varied methods of pediatric consent.
在一项豁免同意的试验中确定父母的观点。
对足月婴儿的亲生父母进行匿名调查，这些婴儿在出院后通过豁免同意的方式被随机分组。
收集到121份（11%）调查问卷回复。在121名回复的父母中，111名（92%）报告称这种同意形式是可以接受的，116名（96%）报告称愿意让另一个孩子参与类似研究。110名（91%）受访者报告称他们既理解了同意过程中提供的信息，又有足够的时间考虑参与。4%的人对该研究对其孩子健康的影响持负面看法。
大多数回复的父母报告称这种研究设计在新生儿期是可接受的，并且该研究对其孩子的健康有积极影响。未来的工作应研究让父母参与的其他方式，并就儿科同意的不同方法征求反馈意见。
