University of Washington, Seattle, WA, USA.
Seattle Children's Hospital, Seattle, WA, USA.
J Perinatol. 2018 Jul;38(7):865-872. doi: 10.1038/s41372-018-0119-6. Epub 2018 May 25.
There is a variability regarding timing of consent and personnel used in patient recruitment for neonatal research. We explored the associations between the study personnel and timing of consent with parents' decisional conflict and ultimately their decision to enroll.
This was a multi-site, cross-sectional survey conducted between August 2015 and October 2017. Participants were parents approached to enroll their 24-28-week infant in a clinical trial. Parents completed an interviewer-administered 61-item questionnaire.
Overall, 163 surveys were completed; 105 by parents of enrolled infants and 58 by parents of non-enrolled infants (54.5% participation rate). Neither the individual requesting nor timing of consent was associated with parents' knowledge score, decisional conflict, or decision to enroll. Parents preferred to be approached prenatally and by their infant's doctor.
Study designers and IRBs may allow flexibility in personnel and timing of consent as it is respectful of parents and may enhance trial enrollment.
新生儿研究中，患者招募时的同意书签署时间和参与人员存在差异。本研究旨在探讨研究人员和同意书签署时间与父母决策冲突的关系，以及最终对其入组决策的影响。
这是一项于 2015 年 8 月至 2017 年 10 月进行的多中心、横断面调查。研究对象为其 24-28 周婴儿即将参与临床试验的父母。父母完成了由调查员管理的 61 项问卷调查。
共有 163 份调查问卷完成，其中 105 份来自已入组婴儿的父母，58 份来自未入组婴儿的父母（54.5%的参与率）。无论是请求同意的个人还是同意书签署时间，均与父母的知识得分、决策冲突或入组决策无关。父母更倾向于在产前由婴儿的医生来接触并获得同意。
研究设计者和机构审查委员会（IRB）可能会允许在人员和同意书签署时间方面具有一定的灵活性，这是对父母的尊重，并且可能会提高试验的入组率。
