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研究人员对将多组学数据结果反馈给研究参与者的看法:来自身体活动分子传感器联盟(MoTrPAC)研究的见解

Researcher views on returning results from multi-omics data to research participants: insights from The Molecular Transducers of Physical Activity Consortium (MoTrPAC) Study.

作者信息

Ormond Kelly E, Stanclift Caroline, Reuter Chloe M, Carter Jennefer N, Murphy Kathleen E, Lindholm Malene E, Wheeler Matthew T

机构信息

Department of Genetics, Stanford University School of Medicine, Stanford, CA, USA.

Stanford Center for Biomedical Ethics, Stanford University School of Medicine, Stanford, CA, USA.

出版信息

BMC Med Ethics. 2025 Feb 7;26(1):22. doi: 10.1186/s12910-025-01174-9.

Abstract

BACKGROUND

There is growing consensus in favor of returning individual specific research results that are clinically actionable, valid, and reliable. However, deciding what and how research results should be returned remains a challenge. Researchers are key stakeholders in return of results decision-making and implementation. Multi-omics data contains medically relevant findings that could be considered for return. We sought to understand researchers' views regarding the potential for return of results for multi-omics data from a large, national consortium generating multi-omics data.

METHODS

Researchers from the Molecular Transducers of Physical Activity Consortium (MoTrPAC) were recruited for in-depth semi-structured interviews. To assess understanding of potential clinical utility for types of data collected and attitudes towards return of results in multi-omic clinical studies, we devised an interview guide focusing on types of results generated in the study for hypothetical return based on review of the literature and professional expertise of team members. The semi-structured interviews were recorded, transcribed verbatim and co-coded. Thematic trends were identified for reporting.

RESULTS

We interviewed a total of 16 individuals representative of 11 sites and 6 research roles across MoTrPAC. Many respondents expressed positive attitudes regarding hypothetical multi-omics results return, citing participant rights to their data and perception of minimal harm. Ethical and logistical concerns around the return of multi-omics results were raised, and they often mirrored those in the published literature for genomic return of results including: uncertain clinical validity, a lack of expertise to communicate results, and an unclear obligation regarding whether to return multi-omics results. With the exception of privacy concerns, respondents were able to give examples within multi-omics of how each point was relevant. Further, researchers called for more guidance from funding agencies and increased researcher education regarding return of results.

CONCLUSION

Overall, researchers expressed positive attitudes toward multi-omic return of results in principle, particularly if medically actionable. However, competing ethical considerations, logistical constraints, and need for more external guidance were raised as key implementation concerns. Future studies should consider views and experiences of other relevant stakeholders, specifically clinical genomics professionals and study participants, regarding the clinical utility of multi-omics information and multi-omics results return.

摘要

背景

对于返回具有临床可操作性、有效且可靠的个体特定研究结果,人们的共识日益增加。然而,决定应返回哪些研究结果以及如何返回仍然是一项挑战。研究人员是结果返回决策和实施中的关键利益相关者。多组学数据包含可考虑返回的医学相关发现。我们试图了解研究人员对于从一个生成多组学数据的大型国家联盟返回多组学数据结果的可能性的看法。

方法

招募了来自身体活动分子传感器联盟(MoTrPAC)的研究人员进行深入的半结构化访谈。为了评估对所收集数据类型的潜在临床效用的理解以及对多组学临床研究中结果返回的态度,我们根据文献综述和团队成员的专业知识,设计了一份访谈指南,重点关注基于假设返回的研究中产生的结果类型。半结构化访谈进行了录音、逐字转录并共同编码。确定了主题趋势以进行报告。

结果

我们总共采访了16名代表MoTrPAC中11个站点和6种研究角色的人员。许多受访者对假设的多组学结果返回表达了积极态度,提及参与者对其数据的权利以及认为危害极小。围绕多组学结果返回提出了伦理和后勤方面的担忧,这些担忧常常反映了已发表文献中关于基因组结果返回的担忧,包括:临床有效性不确定、缺乏传达结果的专业知识以及关于是否返回多组学结果的义务不明确。除了隐私担忧外,受访者能够在多组学范围内举例说明每个要点的相关性。此外,研究人员呼吁资助机构提供更多指导,并加强研究人员关于结果返回的教育。

结论

总体而言,研究人员原则上对多组学结果返回表达了积极态度,特别是如果具有医学可操作性。然而,相互竞争的伦理考量、后勤限制以及对更多外部指导的需求被提出作为关键的实施问题。未来的研究应考虑其他相关利益相关者,特别是临床基因组学专业人员和研究参与者,对于多组学信息的临床效用和多组学结果返回的观点和经验。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2423/11804059/ae42a2fb5ef8/12910_2025_1174_Fig1_HTML.jpg

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