PDF(Pubmed)
Abstract：
Over the last decade, the return of results (ROR) in precision medicine research (PMR) has become increasingly routine. Calls for individual rights to research results have extended the \"duty to report\" from clinically useful genetic information to traits and ancestry results. ROR has thus been reframed as inherently beneficial to research participants, without a needed focus on who benefits and how. This paper addresses this gap, particularly in the context of PMR aimed at increasing participant diversity, by providing investigator and researcher perspectives on and questions about the assumed value of ROR in PMR.
Semi-structured interviews with a purposive sample of investigators and researchers across federally funded PMR studies in three national consortia, as well as observations of study activities, focused on how PM researchers conceptualize diversity and implement inclusive practices across research stages, including navigating ROR.
Interviewees (1) validated the value of ROR as a benefit of PMR, while others (2) questioned the benefit of clinically actionable results to individuals in the absence of sufficient resources for translating findings into health care for diverse and disadvantaged populations; (3) expressed uncertainties in applying the presumed value of ROR as a benefit for non-clinical results; and (4) and debated when the promise of the value of ROR may undermine trust in PMR, and divert efforts to return value beyond ROR.
Conceptualizations of diversity and inclusion among PM researchers and investigators raise unique ethical questions where unexamined assumptions of the value of ROR inform study recruitment efforts to enroll minoritized and under-represented populations. A lack of consideration for resources and infrastructure necessary to translate ROR into actionable information may hinder trustworthy community-research relationships. Thus, we argue for a more intentional interrogation of ROR practices as an offer of benefit and for whom.
Semi-structured interviews with a purposive sample of investigators and researchers across federally funded PMR studies in three national consortia, as well as observations of study activities, focused on how PM researchers conceptualize diversity and implement inclusive practices across research stages, including navigating ROR.
Interviewees (1) validated the value of ROR as a benefit of PMR, while others (2) questioned the benefit of clinically actionable results to individuals in the absence of sufficient resources for translating findings into health care for diverse and disadvantaged populations; (3) expressed uncertainties in applying the presumed value of ROR as a benefit for non-clinical results; and (4) and debated when the promise of the value of ROR may undermine trust in PMR, and divert efforts to return value beyond ROR.
Conceptualizations of diversity and inclusion among PM researchers and investigators raise unique ethical questions where unexamined assumptions of the value of ROR inform study recruitment efforts to enroll minoritized and under-represented populations. A lack of consideration for resources and infrastructure necessary to translate ROR into actionable information may hinder trustworthy community-research relationships. Thus, we argue for a more intentional interrogation of ROR practices as an offer of benefit and for whom.
摘要：
■在过去的十年里，精准医学研究（PMR）中的结果返回（ROR）已变得越来越常规。对研究结果的个人权利的呼吁已将“报告义务”从临床上有用的遗传信息扩展到了特征和血统结果。因此，ROR被重新定义为对研究参与者固有的好处，没有必要关注谁受益以及如何受益。本文解决了这一差距，特别是在PMR旨在增加参与者多样性的背景下，通过提供研究者和研究者对PMR中ROR的假定值的观点和问题。
■对三个国家财团中联邦资助的PMR研究的研究者和研究人员的有目的样本进行半结构化访谈，以及对研究活动的观察，专注于PM研究人员如何概念化多样性，并在研究阶段实施包容性实践，包括导航ROR。
■受访者（1）验证了ROR的价值是PMR的好处，而其他人（2）质疑在缺乏足够的资源将研究结果转化为针对不同和处境不利人群的医疗保健的情况下，临床可操作结果对个人的益处；（3）在将ROR的假定值用作非临床结果的益处方面表示不确定性；（4）当ROR的价值承诺可能破坏对PMR的信任时，进行了辩论，并转移努力以超越ROR返回价值。
■PM研究人员和调查人员之间的多样性和包容性的概念化提出了独特的道德问题，其中对ROR价值的未经审查的假设为研究招募工作提供了信息，以招募人数较少的人群。缺乏对将ROR转换为可操作信息所必需的资源和基础设施的考虑可能会阻碍值得信赖的社区研究关系。因此，我们主张对ROR实践进行更有意的询问，以提供利益和为谁提供利益。
■对三个国家财团中联邦资助的PMR研究的研究者和研究人员的有目的样本进行半结构化访谈，以及对研究活动的观察，专注于PM研究人员如何概念化多样性，并在研究阶段实施包容性实践，包括导航ROR。
■受访者（1）验证了ROR的价值是PMR的好处，而其他人（2）质疑在缺乏足够的资源将研究结果转化为针对不同和处境不利人群的医疗保健的情况下，临床可操作结果对个人的益处；（3）在将ROR的假定值用作非临床结果的益处方面表示不确定性；（4）当ROR的价值承诺可能破坏对PMR的信任时，进行了辩论，并转移努力以超越ROR返回价值。
■PM研究人员和调查人员之间的多样性和包容性的概念化提出了独特的道德问题，其中对ROR价值的未经审查的假设为研究招募工作提供了信息，以招募人数较少的人群。缺乏对将ROR转换为可操作信息所必需的资源和基础设施的考虑可能会阻碍值得信赖的社区研究关系。因此，我们主张对ROR实践进行更有意的询问，以提供利益和为谁提供利益。
