Lie Reidar K, Chan Francis K L, Grady Christine, Ng Vincent H, Wendler David
Department of Philosophy, University of Bergen, Sydnesplassen 12, 5020, Bergen, Norway.
Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong Special Administration Region, People's Republic of China.
BMC Med Ethics. 2017 Jun 19;18(1):42. doi: 10.1186/s12910-017-0202-0.
Ethical issues related to comparative effectiveness research, or research that compares existing standards of care, have recently received considerable attention. In this paper we focus on how Ethics Review Committees (ERCs) should evaluate the risks of comparative effectiveness research.
We discuss what has been a prominent focus in the debate about comparative effectiveness research, namely that it is justified when "nothing is known" about the comparative effectiveness of the available alternatives. We argue that this focus may be misleading. Rather, we should focus on the fact that some experts believe that the evidence points in favor of one intervention, whereas other experts believe that the evidence favors the alternative(s). We will then introduce a case that illustrates this point, and based on that, discuss how ERCs should deal with such cases of expert disagreement.
We argue that ERCs have a duty to assess the range of expert opinions and based on that assessment arrive at a risk judgment about the study under consideration. We also argue that assessment of expert disagreement is important for the assignment of risk level to a clinical trial: what is the basis for expert opinions, how strong is the evidence appealed to by various experts, and how can clinical trial monitoring affect the possible increased risk of clinical trial participation.
与比较效果研究相关的伦理问题，即比较现有护理标准的研究，最近受到了广泛关注。在本文中，我们重点探讨伦理审查委员会（ERC）应如何评估比较效果研究的风险。
我们讨论了比较效果研究辩论中的一个突出焦点，即在对现有替代方案的比较效果“一无所知”时，该研究是合理的。我们认为这种焦点可能会产生误导。相反，我们应该关注这样一个事实，即一些专家认为证据支持一种干预措施，而另一些专家则认为证据支持其他替代措施。然后，我们将介绍一个说明这一点的案例，并在此基础上讨论伦理审查委员会应如何处理此类专家意见分歧的情况。
我们认为伦理审查委员会有责任评估专家意见的范围，并基于该评估对正在考虑的研究做出风险判断。我们还认为，评估专家意见分歧对于确定临床试验的风险水平很重要：专家意见的依据是什么，不同专家所援引的证据有多强，以及临床试验监测如何影响临床试验参与可能增加的风险。
