Wendler David, Wertheimer Alan
NIH Clinical Center, Bethesda, Maryland, USA.
J Med Philos. 2017 Apr 1;42(2):114-131. doi: 10.1093/jmp/jhw064.
The Standard View in research ethics maintains that, under certain conditions, investigators may deceive subjects and may enroll subjects without their consent. In contrast, it is always impermissible to coerce subjects to enroll, even when the same conditions are satisfied. This view raises a question that, as far as we are aware, has received no attention in the literature. Why is it always impermissible to undermine the validity of subjects' consent through coercion, but it can be permissible to undermine the validity of subjects' consent through deception, and it can be permissible to enroll subjects without any consent at all? The present analysis suggests that the answer traces to the conditions on the appropriate treatment of subjects. This conclusion suggests that some requirements for human subjects research, and for valid consent more generally, trace not to the protection of subjects per se but to the proper behavior of agents.
研究伦理中的标准观点认为，在某些情况下，研究者可以欺骗受试者，也可以在未经受试者同意的情况下招募他们。相比之下，即使满足相同条件，胁迫受试者参与研究始终是不允许的。据我们所知，这一观点引发了一个在文献中未受到关注的问题。为什么通过胁迫破坏受试者同意的有效性总是不允许的，而通过欺骗破坏受试者同意的有效性却可能是允许的，甚至在完全未经同意的情况下招募受试者也可能是允许的？目前的分析表明，答案可追溯到对待受试者的适当条件。这一结论表明，人类受试者研究以及更普遍意义上有效同意的一些要求，并非源于对受试者本身的保护，而是源于研究者的适当行为。
