Culbert A, Davis D J
Center for Clinical Education, Teilum, Afsnit 5404, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen O, Denmark.
J Med Ethics. 2005 Dec;31(12):721-6. doi: 10.1136/jme.2004.011247.
Obtaining informed consent for resuscitation research, especially in the newborn, is problematic. This study aimed to evaluate parental preferences for hypothetical consent procedures in neonatal resuscitation research.
Mail-out survey questionnaire.
SETTING/ PARTICIPANTS: Randomly selected parents who had received obstetrical or neonatal care at a tertiary perinatal centre.
Parental levels of comfort (Likert-type scale 1-6) regarding different methods of obtaining consent in hypothetical resuscitation research scenarios.
The response rate was 34%. The respondents were a group of highly educated women with a higher family income than would be expected in the general population. In terms of results, parents valued the impact the research would have on their baby and the importance of a positive interaction with the physicians conducting the research study. Parents felt most comfortable with prospective consent in the setting of prenatal classes or prenatal visits with a physician, but they were somewhat uncomfortable with prospective consent upon admission to hospital after labour had begun. Parents were uncomfortable with waived consent, deferred consent, and opting out, no matter when during the pregnancy consent was requested.
This pilot study reports parental preferences for prenatal information and consent for such research trials of neonatal resuscitation. A low response rate and potentially skewed demographics of the respondents prevent generalisability of this result. Interview studies should be performed to better determine parental preferences for informed consent in a more representative population.
获取关于复苏研究的知情同意书，尤其是在新生儿中，存在问题。本研究旨在评估父母对于新生儿复苏研究中假设同意程序的偏好。
邮寄调查问卷。
地点/参与者：在一家三级围产期中心接受过产科或新生儿护理的随机选择的父母。
在假设的复苏研究场景中，父母对于不同获取同意方法的舒适度水平（李克特量表1 - 6）。
回复率为34%。受访者是一群受过高等教育的女性，家庭收入高于一般人群预期。就结果而言，父母重视研究对其婴儿的影响以及与进行研究的医生积极互动的重要性。父母在产前课程或与医生进行产前检查时对前瞻性同意最感到舒适，但在分娩开始后入院时对前瞻性同意有些不舒服。无论在孕期何时请求同意，父母对豁免同意、延迟同意和选择退出都感到不舒服。
这项试点研究报告了父母对于新生儿复苏此类研究试验的产前信息和同意的偏好。低回复率和受访者潜在的人口统计学偏差妨碍了该结果的普遍性。应进行访谈研究，以在更具代表性的人群中更好地确定父母对知情同意的偏好。
