Funding considerations for the disclosure of genetic incidental findings in biobank research.
Funding considerations for the disclosure of genetic incidental findings in biobank research.
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DOI：
10.1111/cge.12190
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发表时间：
2013-11-01
影响因子：
3.5
通讯作者：
Sauvageau, G
中科院分区：
文献类型：
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作者：
Black, L;Avard, D;Sauvageau, G
近年来，生物库在生物医学研究中的使用大幅增长。由于对生物库中储存的组织样本的分析越来越多，除了研究目标之外，偶然发现（IF）的可能性也有所增加。我们从国际、区域和国家组织中确定了23项法律、政策和指南，这些法律、政策和指南为研究参与者提供了指导或确定了披露IF的必要性。我们分析了这些工具，以确定他们的设想的资金考虑的披露IF，检查他们的指导谁披露和研究人员的责任范围。我们发现，现有的规范性文件几乎没有为研究人员和生物库提供如何解决与IF披露相关的成本和资金问题的指导。因此，研究界和政策界必须认真考虑将披露综合框架的道德责任强加于财务方面的影响。政策制定者、伦理学家、研究人员、临床医生和研究机构应共同努力，制定详细的资助建议，可能具有普遍适用性，以帮助披露IF，我们就可以采取的步骤提供建议，以确保充分考虑这些问题。
The use of biobanks in biomedical research has grown considerably in recent years. As a result of the increasing analysis of tissue samples stored in biobanks, there has also been an increase in the probability of discovering-in addition to the research target-incidental findings (IF). We identified 23 laws, policies and guidelines from international, regional and national organizations that provide guidance or identify the need for the disclosure of IF to research participants. We analyzed these instruments to determine their contemplation of the funding considerations for the disclosure of IF, examining their guidance for who discloses and the extent of researcher responsibilities. We found that the available normative documents provide little guidance to researchers and biobanks for how they should address cost and funding concerns associated with IF disclosure. It is therefore essential that the research and policy communities think through the financial implications of imposing an ethical responsibility to disclose IF. Concerted efforts should be made by policymakers, ethicists, researchers, clinicians and research institutions to develop detailed funding recommendations, potentially universal in application, to aid in the disclosure of IF, and we provide recommendations on steps that can be taken to ensure full consideration of these issues.