Curr Med Res Opin. 2011 Mar;27(3):513-8. doi: 10.1185/03007995.2010.546393. Epub 2011 Jan 6.
Most of the literature on informed consent in pharmaceutical drug research works on the assumption that informed consent is something that is homogeneous and thus can be rendered procedurally universal. This may be justifiable to a certain extent owing to the fact these are all drug trials anyway. Nevertheless, in spite of this general similarity, we also know that the clinical drug development phases are characteristically different, and that phase IV is very different from the other phases because, owing to its postmarketing nature, it is much more varied in scope and in type. Thus, it is worthwhile looking into the ethical nuances relevant to the informed consent process in phase IV non-interventional drug research. We shall deal with the issues on the necessity of informed consent for this type of research and then discuss the possibilities for an opt-out system. We conclude that informed consent is necessary for non-interventional studies, and thus any form of waiving of rights of participants to informed consent must have a valid substantial justification. The distinct character of phase IV accounts for the difference in content of the informed consent document compared to that of earlier phases, and both opt-in and opt-out procedures are ethically justifiable as long as the participant's participation remains informed and voluntary.
大多数关于药物研究中知情同意的文献都基于这样一种假设，即知情同意是同质的，因此可以通过程序实现普遍化。由于这些都是药物试验，这在一定程度上是合理的。然而，尽管存在这种普遍的相似性，我们也知道临床药物开发阶段的特点是不同的，第四阶段与其他阶段非常不同，因为由于其上市后的性质，它在范围和类型上更加多样化。因此，值得研究第四阶段非干预性药物研究中与知情同意过程相关的伦理细微差别。我们将处理关于此类研究进行知情同意的必要性的问题，然后讨论选择退出系统的可能性。我们的结论是，非干预性研究需要知情同意，因此，参与者放弃知情同意权利的任何形式都必须有有效的实质性理由。第四阶段的独特性质解释了知情同意文件的内容与早期阶段的不同，只要参与者的参与仍然是知情和自愿的，选择加入和选择退出程序在伦理上都是合理的。
