Biobanking and the Abandonment of Informed Consent: An Ethical Imperative
Biobanking and the Abandonment of Informed Consent: An Ethical Imperative
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DOI：
10.1093/phe/phw001
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发表时间：
2016-11-01
影响因子：
2.1
通讯作者：
Cargill, Stephanie Solomon
中科院分区：
文献类型：
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作者：
Cargill, Stephanie Solomon
研究伦理文献中围绕生物样本库知情同意的适当形式进行了广泛的讨论，无论是采用适当的内容，还是采用广泛或分层同意等适当的形式。这些讨论的前提是可以从一开始就披露足够的信息，以促进明智的选择向生物库捐赠。我认为无法实现知情同意，因为在生物样本库背景下，我们要么同意不是研究的企业（因此披露的信息应该完全不同），要么同意未来的研究（因此披露的信息尚不存在）。放弃知情同意在道德上要求披露一定量的最少量信息以做出知情选择这一观点的解决方案也不是通过误导性地将广泛的、全面的甚至分层的同意视为“知情”同意的形式。相反，我们应该放弃研究的知情同意可以适应生物样本库的工作类型的想法，并理解开发替代方案的目标，而不是作为知情同意的替代形式，而是知情同意的替代方案。
There has been extensive discussion in research ethics literature surrounding the appropriate form of informed consent for biobanking, whether with adapted content, or adapted forms such as broad or tiered consent. These discussions presuppose that it is possible to disclose adequate information at the outset to facilitate an informed choice to donate to a biobank. I will argue that informed consent cannot be achieved because in the biobanking context, we are either consenting to an enterprise that is not research (so the information disclosed should be radically different) or to future research (so the information disclosed does not exist yet). Nor is the solution to abandon the idea that informed consent ethically requires the disclosure of a certain minimal amount of information to make an informed choice by misleadingly identifying broad, blanket or even tiered consent as forms of 'informed' consent. Rather, we should abandon the idea that informed consent for research can be adapted to the type of endeavor that biobanking is, and understand the goal as to develop alternatives not as alternative forms of informed consent, but rather alternatives to informed consent.