Weiss Elliott Mark, Wilfond Benjamin S, Kraft Stephanie A
Treuman Katz Center for Pediatric Bioethics and Palliative Care, Seattle Children's Research Institute, Seattle, WA, USA; Department of Pediatrics, University of Washington School of Medicine, Seattle, WA, USA.
Treuman Katz Center for Pediatric Bioethics and Palliative Care, Seattle Children's Research Institute, Seattle, WA, USA; Department of Pediatrics, University of Washington School of Medicine, Seattle, WA, USA.
Semin Perinatol. 2025 Apr;49(3):152055. doi: 10.1016/j.semperi.2025.152055. Epub 2025 May 21.
Whether to participate in clinical research is a special type of decision for parents with infants in the neonatal intensive care unit (NICU). Parents often report negative experiences being approached for NICU research and researchers struggle to enroll a representative sample. We consider how enrollment decision-making might be better supported by integrating learnings from clinical decision-making.
Approaches to supporting decision-making about clinical research, though distinct from those for clinical decision-making, share many similarities. We consider ways researchers may incorporate advances in knowledge about clinical decision-making to: (a) improve documents used for regulatory purposes (e.g., consent forms), and (b) better support relationship building between researchers and parents considering research enrollment.
Researchers may benefit from considering approaches to enrollment decision-making that draw on clinical decision-making methods. Future work should assess the impact of such approaches on parental experiences of recruitment; enrollment and retention rates; and representative inclusion of NICU populations.
对于新生儿重症监护病房（NICU）中有婴儿的父母来说，是否参与临床研究是一种特殊类型的决策。父母经常报告在被邀请参与NICU研究时有着负面经历，并且研究人员难以招募到具有代表性的样本。我们思考如何通过整合临床决策的经验教训来更好地支持入组决策。
支持临床研究决策的方法虽然与临床决策方法不同，但有许多相似之处。我们思考研究人员可以如何将临床决策知识的进展纳入其中，以：（a）改进用于监管目的的文件（如同意书）；以及（b）更好地支持研究人员与考虑参与研究入组的父母之间建立关系。
研究人员可能会从考虑借鉴临床决策方法的入组决策方法中受益。未来的工作应评估此类方法对父母招募体验、入组率和留存率以及NICU人群代表性纳入的影响。
