Department of Obstetrics and Gynaecology, The University of Melbourne, Melbourne, Victoria, Australia.
Newborn Research, Royal Women's Hospital, Parkville, Victoria, Australia.
Arch Dis Child Fetal Neonatal Ed. 2021 May;106(3):258-264. doi: 10.1136/archdischild-2020-319974. Epub 2020 Oct 30.
To evaluate the opinions of parents of newborns following their infant's enrolment into a neonatal research study through the process of deferred consent.
Mixed-methods, observational study, interviewing 100 parents recently approached for deferred consent.
Tertiary-level neonatal intensive care unit, Melbourne, Australia.
All 100 parents interviewed had consented to the study/studies using deferred consent; 62% had also experienced a prospective neonatal consent process. Eighty-nine per cent were 'satisfied' with the deferred consent process. The most common reason given for consenting was 'to help future babies'. Negative comments regarding deferred consent mostly related to the timing of the consent approach, and some related to a perceived loss of parental rights. A deferred approach was preferred by 51%, 24% preferred a prospective approach and 25% were unsure. Those who thought prospective consent would not have been preferable cited impaired decision-making, inappropriate timing of an approach before birth and their preference for removal of the decision-making burden via deferred consent. Seventy-seven per cent thought they would have given the same response if approached prospectively; those who would have declined reported that a prospective approach under stressful conditions was unwelcome and too overwhelming.
In our sample, 89% of parents of infants enrolled in neonatal research using deferred consent considered it acceptable and half would not have preferred prospective consent. The ability to make a more considered decision under less stressful circumstances was key to the acceptability of deferred consent.
通过延迟同意的过程，评估新生儿父母对其婴儿参加新生儿研究的意见。
混合方法、观察性研究，对 100 名最近被邀请参加延迟同意的父母进行访谈。
澳大利亚墨尔本的三级新生儿重症监护病房。
所有接受采访的 100 名父母都同意使用延迟同意参加研究/研究；62%的父母也经历了前瞻性新生儿同意过程。89%的父母对延迟同意过程“满意”。同意的最常见原因是“帮助未来的婴儿”。关于延迟同意的负面评论主要与同意的时间有关，一些评论与父母权利的丧失有关。51%的人更喜欢延迟的方法，24%的人更喜欢前瞻性的方法，25%的人不确定。那些认为前瞻性同意不会更好的人提到了决策受损、在出生前的不适当时间提出同意以及他们更喜欢通过延迟同意来免除决策负担。77%的人认为如果前瞻性地接触他们，他们会做出同样的反应；那些会拒绝的人报告说，在压力条件下进行前瞻性的方法不受欢迎，太有压力了。
在我们的样本中，使用延迟同意将婴儿纳入新生儿研究的 89%的父母认为这是可以接受的，而一半的父母不会更喜欢前瞻性同意。在压力较小的情况下做出更慎重决定的能力是延迟同意的可接受性的关键。
