Exploring Understanding of "Understanding": The Paradigm Case of Biobank Consent Comprehension
Exploring Understanding of "Understanding": The Paradigm Case of Biobank Consent Comprehension
复制标题
DOI：
10.1080/15265161.2019.1587031
复制
发表时间：
2019-01-01
影响因子：
13.4
通讯作者：
Weinfurt, Kevin P.
中科院分区：
文献类型：
--
作者：
Beskow, Laura M.;Weinfurt, Kevin P.
记录研究参与者之间的理解差的数据和大规模研究中评估理解的实时努力正在将新的注意力集中在知情同意的理解上。在生物库同意的背景下，我们之前召集了一个多学科小组，就必须了解哪些信息才能将潜在参与者的同意视为有效达成共识。随后，我们向他们展示了另一项研究的数据，这些数据显示，许多美国成年人无法理解专家组认为必不可少的信息。当被要求再次评估信息的重要性时，小组成员的意见发生了戏剧性的转变，要求更少的信息被理解。后续访谈表明，在确定理解的阈值以及当潜在参与者无法掌握关键信息时应该发生什么方面存在重大不确定性。这些发现对迫切需要讨论的同意理解是一种伦理要求还是一种伦理愿望具有重要意义。
Data documenting poor understanding among research participants and real-time efforts to assess comprehension in large-scale studies are focusing new attention on informed consent comprehension. Within the context of biobanking consent, we previously convened a multidisciplinary panel to reach consensus about what information must be understood for a prospective participant's consent to be considered valid. Subsequently, we presented them with data from another study showing that many U.S. adults would fail to comprehend the information the panel had deemed essential. When asked to evaluate the importance of the information again, panelists' opinions shifted dramatically in the direction of requiring that less information be understood. Follow-up interviews indicated significant uncertainty about defining a threshold of understanding and what should happen when prospective participants are unable to grasp key information. These findings have important implications for urgently needed discussion of whether consent comprehension is an ethical requirement or an ethical aspiration.