Center for Bioethics, Indiana University School of Medicine, Indianapolis, Indiana, USA.
Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.
AJOB Empir Bioeth. 2021 Apr-Jun;12(2):113-122. doi: 10.1080/23294515.2020.1851313. Epub 2020 Dec 4.
Biobank participants often do not understand much of the information they are provided as part of the informed consent process, despite numerous attempts at simplifying consent forms and improving their readability. We report the first assessment of biobank enrollees' comprehension under an "integrated consent" process, where patients were asked to enroll in a research biobank as part of their normal healthcare experience. A number of healthcare systems have implemented similar integrated consent processes for biobanking, but it is unknown how much patients understand after enrolling under these conditions. We recruited patients who enrolled in a biobank while in a healthcare setting when receiving ordinary care. We assessed knowledge of consent materials using 11 true/false questions drawn from a well-known biobank knowledge test. After reviewing the results from 114 participants, we revised the consent form and repeated the knowledge assessment with 144 different participants. Participants scored poorly on the knowledge test in both rounds, with no significant differences in overall scores or individual items between the rounds. In Phase 1, participants answered 53% of the questions correctly, 25% incorrectly, and 22% "I don't know." In Phase 2, participants answered 53% of questions correctly, 24% incorrectly, and 23% "I don't know." Participants scored particularly poorly on questions about data sharing and accessing medical records. Enrollees under an integrated consent model had significant misunderstandings that persisted despite an attempt to improve information specifically about those topics in a consent form. These results raise challenges for current approaches that attribute misunderstanding to overly complex consent forms. They also suggest that the pressures of the clinic may compound other problems with patient understanding of biobank consent. As health systems increasingly blend research and care, they may need to rethink their approach to educating patients about participation in a biobank.
生物库参与者在知情同意过程中经常对所提供的信息了解甚少，尽管人们多次尝试简化同意书并提高其可读性。我们报告了首例在“综合同意”过程下对生物库参与者理解能力的评估，在此过程中，患者被要求在正常医疗保健体验中加入研究生物库。许多医疗保健系统已经实施了类似的生物库综合同意程序，但尚不清楚在这些条件下登记后患者理解了多少。我们招募了在医疗保健环境中接受普通护理时加入生物库的患者。我们使用从著名的生物库知识测试中抽取的 11 个真假问题来评估对同意书材料的了解程度。在对 114 名参与者的结果进行审查后，我们修改了同意书并对 144 名不同的参与者重复了知识评估。参与者在两轮知识测试中的得分都很差，两轮之间的总分或个别项目均无显着差异。在第 1 阶段，参与者答对了 53%的问题，答错了 25%，不知道的占 22%。在第 2 阶段，参与者答对了 53%的问题，答错了 24%，不知道的占 23%。参与者在数据共享和访问病历方面的问题上得分特别低。在综合同意模式下登记的参与者存在重大误解，尽管试图改进同意书中关于这些主题的信息，但这些误解仍然存在。这些结果对目前归因于过于复杂的同意书而导致误解的方法提出了挑战。它们还表明，诊所的压力可能会使患者对生物库同意的理解问题更加复杂。随着健康系统越来越多地将研究和护理融合在一起，他们可能需要重新考虑向患者传授参与生物库的方法。
