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Integrating stakeholder feedback in translational genomics research: an ethnographic analysis of a study protocol's evolution.
Genetics in Medicine ( IF 8.8 ) Pub Date : 2020-02-24 , DOI: 10.1038/s41436-020-0763-z
Stephanie A Kraft 1, 2 , Carmit McMullen 3 , Nangel M Lindberg 3 , David Bui 3 , Kelly Shipman 1 , Katherine Anderson 4 , Galen Joseph 5 , Devan M Duenas 1 , Kathryn M Porter 1 , Tia L Kauffman 3 , Alyssa Koomas 6 , Chelese L Ransom 7 , Paige Jackson 7 , Katrina A B Goddard 3 , Benjamin S Wilfond 1, 2 , Sandra Soo-Jin Lee 8
Affiliation  

PURPOSE 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. METHODS 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. RESULTS 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. CONCLUSIONS 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.

中文翻译:

将利益相关者的反馈整合到转化基因组学研究中:研究方案演变的人种学分析。

目的本研究描述了将有时相互矛盾的利益相关者反馈纳入研究设计和开发面向患者的转化基因组学研究材料时所面临的挑战,旨在减少不同人群之间的健康差异。方法 我们对研究文件进行了人种学分析,包括患者咨询委员会会议和访谈的摘要、研究团队成员撰写的反思性现场笔记以及与我们的机构审查委员会 (IRB) 的通信。通过这一分析,我们确定了将利益相关者反馈纳入我们的招聘、风险评估以及知情同意流程和材料开发中的跨领域挑战。结果我们的分析揭示了三个关键挑战:(1)平衡研究材料设计的精确性和简单性,(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。结论 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能力,但患者的反馈可能与研究团队和负责监督研究的 IRB 的内容领域专家的反馈发生冲突。我们的分析强调,在将患者反馈纳入研究设计时,需要对伦理挑战进行进一步的实证研究,并与基因组研究人员和 IRB 代表就这些问题进行对话。
更新日期:2020-02-24
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