【2h】

Forward-Thinking in U.S. Biobanking

机译:美国生物银行中的前瞻性思维

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摘要

>Aims: Do biobanks enact policies and plans that allow them to anticipate and respond to potential challenges? If a biobank has one such policy or plan, is it likely to have more? Using survey data from 456 U.S. biobanks, we assess four possible indicators of such “forward-thinking.”>Methods: We present response frequencies and cross-tabulations regarding policies for return of results and ownership of specimens, and for having a formal business plan and a plan for what happens to specimens if the biobank closes. We analyze the relationships among these indicators, using chi-square for tests of statistical significance.>Results: Policies—Sixty-two percent of biobanks have a policy about returning individual research results; 70% have a policy designating ownership of specimens and/or technology. Having these two policies is significantly related (p < 0.001). Plans—34% of biobanks have a formal business plan; 26% have a written plan for what will happen to the specimens if the biobank closes. Having these two plans is significantly related (p < 0.001). Relationships among indicators—only 7% of biobanks are forward-thinking across all four indicators; 12% are forward-thinking across none.>Discussion: The two policies we examined tend to occur together, as do the two plans. These policies and plans seem to tap different aspects of accountability and responsiveness. Specifically, the policies reflect issues most commonly raised in the ethical and legal literature on biobanking, while the plans are indicators of sustainability, a separate area of concern in biobanking.
机译:>目标:生物库是否制定了政策和计划,使它们能够预测和应对潜在挑战?如果一个生物库有一个这样的政策或计划,它可能会有更多的政策或计划吗?使用来自美国456个生物库的调查数据,我们评估了这种“前瞻性思维”的四个可能指标。>方法:我们介绍了有关结果归还和标本所有权政策的响应频率和交叉列表,以及制定正式的商业计划,以及生物样本库关闭后对标本的处理计划。我们使用卡方检验来分析这些指标之间的关系,以进行统计显着性检验。>结果:政策-62%的生物库制定了退还个人研究结果的政策; 70%的人有指定标本和/或技术所有权的政策。拥有这两个策略有着显着的相关性(p <0.001)。计划-34%的生物库有正式的商业计划;有26%的人有书面计划,说明如果关闭生物库,样品会发生什么情况。拥有这两个计划是显着相关的(p <0.001)。指标之间的关系-在所有四个指标中,只有7%的生物库具有前瞻性; 12%的人具有远见卓识。>讨论:我们研究的两个政策往往会同时出现,这两个计划也是如此。这些政策和计划似乎利用了问责制和响应能力的不同方面。具体而言,这些政策反映了有关生物银行的伦理和法律文献中最常提出的问题,而计划则是可持续性的指标,而可持续性是生物银行中一个单独的关注领域。

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