Treuman Katz Center for Pediatric Bioethics, Seattle Children's Hospital and Research Institute, Seattle, WA, USA.
Department of Pediatrics, University of Washington School of Medicine, Seattle, WA, USA.
Genet Med. 2020 Jun;22(6):1094-1101. doi: 10.1038/s41436-020-0763-z. Epub 2020 Feb 24.
This study describes challenges faced while incorporating sometimes conflicting stakeholder feedback into study design and development of patient-facing materials for a translational genomics study aiming to reduce health disparities among diverse populations.
We conducted an ethnographic analysis of study documents including summaries of patient advisory committee meetings and interviews, reflective field notes written by study team members, and correspondence with our institutional review board (IRB). Through this analysis, we identified cross-cutting challenges for incorporating stakeholder feedback into development of our recruitment, risk assessment, and informed consent processes and materials.
Our analysis revealed three key challenges: (1) balancing precision and simplicity in the design of study materials, (2) providing clinical care within the research context, and (3) emphasizing potential study benefits versus risks and limitations.
While involving patient stakeholders in study design and materials development can increase inclusivity and responsiveness to patient needs, patient feedback may conflict with that of content area experts on the research team and IRBs who are tasked with overseeing the research. Our analysis highlights the need for further empirical research about ethical challenges when incorporating patient feedback into study design, and for dialogue with genomic researchers and IRB representatives about these issues.
本研究描述了在将有时相互冲突的利益相关者反馈纳入旨在减少不同人群健康差异的转化基因组学研究的研究设计和患者导向材料开发过程中所面临的挑战。
我们对研究文件进行了人种学分析，包括患者顾问委员会会议和访谈的总结、研究团队成员撰写的反思性实地笔记，以及与我们的机构审查委员会（IRB）的通信。通过这种分析，我们确定了将利益相关者反馈纳入我们的招募、风险评估和知情同意过程和材料开发的跨领域挑战。
我们的分析揭示了三个关键挑战：（1）在研究材料的设计中平衡精确性和简洁性，（2）在研究背景下提供临床护理，以及（3）强调潜在的研究益处与风险和局限性。
虽然让患者利益相关者参与研究设计和材料开发可以提高包容性和对患者需求的响应性，但患者反馈可能与研究团队中内容领域专家和负责监督研究的 IRB 的反馈相冲突。我们的分析强调了在将患者反馈纳入研究设计时需要进一步进行有关伦理挑战的实证研究，以及与基因组学研究人员和 IRB 代表就这些问题进行对话的必要性。
