Segal Aaron Eli, Wendler David S
Department of Bioethics, Clinical Center, National Institutes of Health, Bethesda, MD 20892 USA.
Ethical Theory Moral Pract. 2024;27(4):555-570. doi: 10.1007/s10677-024-10441-4. Epub 2024 May 22.
Research regulations around the world do not impose any limits on the risks to which consenting adults may be exposed. Nonetheless, most review committees regard some risks as too high, even for consenting adults. To justify this practice, commentators have appealed to a range of considerations which are external to informed consent and the risks themselves. Most prominently, some argue that exposing consenting adults to very high risks has the potential to undermine public trust in research. This justification assumes that it is not the magnitude of the risks themselves which raises concern, but the way in which the public might respond to them. This justification thus depends on the possibility that the public will find out about the risks and respond to them in the specified way. Like the other proposed external justifications, it thereby fails to offer a reason to think that exposing consenting adults to very high risks is problematic in itself. In the present paper, we describe and endorse a different justification. Rather than appealing to external factors, we argue that limits on risks for consenting adults trace to internal limits on informed consent, to limits on the things consent can and cannot make ethically permissible. In doing so, we aim to provide a firmer conceptual basis for the view that some research risks are unacceptably high, no matter how the research is conducted.
世界各地的研究法规并未对自愿参与研究的成年人可能面临的风险设定任何限制。尽管如此，大多数审查委员会认为某些风险过高，即使对于自愿参与的成年人也是如此。为了证明这种做法的合理性，评论家们诉诸于一系列知情同意和风险本身之外的考量因素。最突出的是，一些人认为让自愿参与的成年人面临极高风险有可能破坏公众对研究的信任。这种理由假设引起关注的并非风险本身的大小，而是公众可能对这些风险作出反应的方式。因此，这种理由取决于公众会发现这些风险并以特定方式作出反应的可能性。与其他提出的外部理由一样，它因此未能提供理由来认为让自愿参与的成年人面临极高风险本身存在问题。在本文中，我们描述并支持一种不同的理由。我们不是诉诸外部因素，而是认为对自愿参与的成年人的风险限制源于知情同意的内在限制，源于对同意可以和不能在伦理上允许之事的限制。这样做时，我们旨在为以下观点提供更坚实的概念基础，即无论研究如何进行，某些研究风险都高得不可接受。
