Potential harms, anonymization, and the right to withdraw consent to biobank research
Potential harms, anonymization, and the right to withdraw consent to biobank research
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DOI：
10.1038/sj.ejhg.5201458
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发表时间：
2005-09-01
影响因子：
5.2
通讯作者：
Helgesson, G
中科院分区：
文献类型：
--
作者：
Eriksson, S;Helgesson, G
本文讨论了生物库研究中涉及的潜在危害，以及如何根据这些危害处理伦理审查、知情同意、样品撤回和匿名化。生物库研究比人类研究涉及的风险更小；因此，应该区别对待。我们认为，匿名化不应成为对撤回请求的自动允许的答复。撤回请求也不一定会停止对可识别样本的研究。除了不太适合保护个人利益外，样本匿名化对研究也有负面影响。我们建议，在生物库研究的背景下，放弃目前由《赫尔辛基宣言》和随后的伦理准则支持的关于退出研究的观点，取而代之的是以《纽伦堡守则》为灵感的方法。这种方法要求那些希望从研究中撤回样本的人提出充分的理由这样做。我们对“充分理由”的解释包括所有那些涉及真正的、深切感受到的担忧，而不是基于误解的担忧。尽管如此，这突显了一个事实，即我们都对健康研究负有责任，任何人都不应对退出生物库研究掉以轻心。
This paper discusses the potential harms involved in biobank research and how ethical review, informed consent, withdrawals, and anonymization of samples should be handled in the light of these harms. There is less risk involved in biobank research than in human subject research; it should therefore be treated differently. In our view, anonymization should not be an automatically permissible response to requests for withdrawal. Nor should a request for withdrawal necessarily stop research on identifiable samples. Apart from not being particularly appropriate for protecting the interests of individuals, anonymization of samples has a negative impact on research. We suggest that the current view on withdrawal from research, supported by the Declaration of Helsinki and subsequent ethical guidelines, be abandoned in the context of biobank research and be replaced by an approach inspired by the Nuremberg Code. This approach requires those wishing to withdraw their samples from research to present sufficient reason for doing so. Our interpretation of 'sufficient reason' includes all those involving genuine, deeply felt concerns that are not based on misconceptions. Still, this underlines the fact that we all share a responsibility for health research and that no one should take withdrawal from biobank research lightly.