Center for Ethics and Humanities in the Life Sciences, Michigan State University, East Lansing, MI, USA.
Center for Bioethics and Social Sciences in Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.
Eur J Hum Genet. 2018 Feb;26(2):176-185. doi: 10.1038/s41431-017-0063-5. Epub 2018 Jan 18.
In this study, we evaluate the effect of education and deliberation on the willingness of members of the public to donate tissue to biobank research and on their attitudes regarding various biobank consent policies. Participants were randomly assigned to a democratic deliberation (DD) group, an education group that received only written materials, and a control group. Participants completed a survey before the deliberation and two surveys post-deliberation: one on (or just after) the deliberation day, and one 4 weeks later. Subjects were asked to rate 5 biobank consent policies as acceptable (or not) and to identify the best and worst policies. Analyses compared acceptability of different policy options and changes in attitudes across the three groups. After deliberation, subjects in the DD group were less likely to find broad consent (defined here as consent for the use of donations in an unspecified range of future research studies, subject to content and process restrictions) and study-by-study consent acceptable. The DD group was also significantly less likely to endorse broad consent as the best policy (OR = 0.34), and more likely to prefer alternative consent options. These results raise ethical challenges to the current widespread reliance on broad consent in biobank research, but do not support study-by-study consent.
在这项研究中，我们评估了教育和讨论对公众成员向生物库研究捐赠组织的意愿以及他们对各种生物库同意政策的态度的影响。参与者被随机分配到民主审议（DD）组、仅接受书面材料的教育组和对照组。参与者在审议前完成了一项调查，并在审议后完成了两项调查：一项是在审议当天或之后进行的，另一项是在 4 周后进行的。要求受试者对 5 项生物库同意政策进行可接受性（或不可接受性）评估，并确定最佳和最差政策。分析比较了三组之间不同政策选择的可接受性和态度的变化。审议后，DD 组的受试者不太可能认为广泛同意（在这里定义为同意将捐赠用于未来研究研究的未指定范围，受内容和程序限制）和逐个研究同意可以接受。DD 组也不太可能将广泛同意视为最佳政策（OR=0.34），并且更倾向于选择其他同意选项。这些结果对当前生物库研究中广泛依赖广泛同意的做法提出了伦理挑战，但不支持逐个研究的同意。
