Julius Center for Health Sciences and Primary Care, Utrecht University Medical Center, Huispost Str. 6.131, PO Box 85500, 3508 GA Utrecht, The Netherlands.
Drug Discov Today. 2011 Sep;16(17-18):751-4. doi: 10.1016/j.drudis.2011.06.007. Epub 2011 Jun 29.
This article addresses the question about whether informed consent (IC) can be waived in Phase IV randomized observational drug studies (P4RODSs). To do this, it was first necessary to establish that the term P4RODS is a contradiction precisely because randomization necessarily makes a study 'interventional', hence P4RIDS. Once this was established we argued that, based on the right and the harm principles, universally waiving IC in P4RIDS is ethically unjustifiable. Looking into public health and the nature of equipotent and bioequivalent drugs were also insufficient rationale to justify circumstantial waiving of IC. We conclude that IC can never be waived in P4RIDS, although an opt-out procedure in minimal risk studies could be ethically acceptable.
本文探讨了在 IV 期随机观察性药物研究（P4RODS）中是否可以放弃知情同意（IC）的问题。为此，首先需要确定 P4RODS 一词本身就是一个矛盾，因为随机化必然使研究具有“干预性”，因此应该称为 P4RIDS。一旦确定了这一点，我们就认为，基于权利和伤害原则，在 P4RIDS 中普遍放弃 IC 在伦理上是不合理的。考虑到公共卫生和等效药物的性质，也没有充分的理由来证明在特殊情况下放弃 IC 是合理的。我们的结论是，在 P4RIDS 中永远不能放弃 IC，尽管在低风险研究中采用默认同意程序在伦理上是可以接受的。
