Meta-consent in research on decisional capacity: a "Catch-22"?
Meta-consent in research on decisional capacity: a "Catch-22"?
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决策能力研究中的元同意：“第 22 条军规”？
DOI：
10.1093/schbul/sbj017
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发表时间：
2006
期刊：
影响因子：
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通讯作者：
Palmer,BartonW
中科院分区：
文献类型：
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作者：
Saks,ElynR;Dunn,LauraB;Palmer,BartonW
近年来，对伦理问题的实证研究在数量和范围上都有所增加，但它本身可能会同时引发实践和伦理问题。这类问题的一个例子是，谁可以合法地参加决策能力研究；是否所有同意能力研究的参与者都必须具有同意能力？这个问题可能会引起“第二十二条军规”：例如，如果某项关于同意能力的研究的某些参与者被某一特定标准视为无能力表示同意。在权衡同意能力研究的风险和收益时，评价者应该如何考虑寻求参与者同意的实际试验和假设试验的背景？在这里，我们以“主动同意”的概念为中心，通过描述问题的各个方面和可能的解决办法来探讨这些“元同意”问题(要求明确了解研究的目的及其自愿性质，以及表示选择参加)。
Empirical studies of ethical issues, which have increased in number and scope in recent years, may themselves raise both practical and ethical issues. One example of such an issue is the question of who may be legitimately enrolled in studies of decision-making capacity; must all participants in studies of consent capacity have capacity to consent? This question may pose a “Catch-22”: For example, if some of the participants in a study of consent capacity are deemed by a particular standard to be incapable of consent. In weighing the risks and benefits of studies of consent capacity, how should reviewers consider the context of actual versus hypothetical trials for which the participant's consent is being sought? Here, we explore these “meta-consent” issues by describing the dimensions of the issue and potential solutions, centering around the concept of “active assent” (requiring expressed understanding of the purpose of the study and its voluntary nature, as well as expression of a choice to participate).