Public titles of clinical trials should have ethics review.
Public titles of clinical trials should have ethics review.
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临床试验公开名称应当进行伦理审查。
DOI：
10.1016/j.jclinepi.2014.05.016
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发表时间：
2015
影响因子：
7.2
通讯作者：
Tisdale,JohnF
中科院分区：
文献类型：
--
作者：
Saenz,Carla;Reveiz,Ludovic;Tisdale,JohnF
保证人类受试者研究符合伦理道德的一个关键方面被忽视了。伦理审查委员会投入大量精力审查研究方案的知情同意文件，以确保潜在的参与者能够有效地提供同意，并且不会被误导认为他们可能签署的实验干预已经知道是治疗性的。然而，如果向潜在参与者介绍研究的标题逃避了伦理审查，这些避免所谓的"治疗误解"的努力可能是徒劳的。研究参与者可能会被标题为"新疗法"的临床试验所欺骗，而试验的目的恰恰是为了找出所涉及的干预措施是否具有治疗作用。向潜在的研究参与者提供这种误导性信息会妨碍他们做出明智决定的能力。如果临床试验的注册（为之选择公共名称）构成独立于伦理审查的过程，则伦理审查委员会对同意书进行的既定审查是有限的。在这篇文章中，我们研究这个问题，评估最近的措施，以整合临床试验注册与伦理审查过程，并提供具体的建议，以解决这个问题，并最终提高问责制，透明度和伦理的研究与人类受试者。
A key aspect to guarantee that research with human subjects is ethical is being overlooked. Ethics review committees invest great effort examining the informed consent documents of research protocols to ensure that potential participants can provide consent validly and are not deluded into thinking that the experimental intervention they may sign up for is already known to be therapeutic. However, these efforts to avoid what is called the “therapeutic misconception” might be in vain if the title with which the studies are being introduced to the potential participants escapes ethics review. Research participants might be deceived by clinical trials entitled “novel therapy” when the point of the trial is precisely to find out whether the intervention at stake is therapeutic or not. Providing potential research participants with such misleading information hampers their ability to make informed decisions. The well-established scrutiny that ethics review committees exercise with regard to consent forms is limited if the registration of clinical trials, for which a public title is chosen, constitutes a process that is independent from the ethics review. In this article, we examine this problem, assess recent measures to integrate clinical trial registration with ethics review processes, and provide specific recommendations to solve the problem and ultimately enhance the accountability, transparency, and ethics of research with human subjects.
影响因子：
4.1
作者：
Wertheimer, A.;Miller, F. G.
通讯作者：
Miller, F. G.
当听起来积极的缩写词研究结果是消极的试验时。
影响因子：
3.5
作者：
T. Cheng
通讯作者：
T. Cheng