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首页> 外文期刊>Journal of empirical research on human research ethics : >Of Parachutes and Participant Protection: Moving Beyond Quality to Advance Effective Research Ethics Oversight
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Of Parachutes and Participant Protection: Moving Beyond Quality to Advance Effective Research Ethics Oversight

机译：降落伞和参与者保护：超越质量，推进有效的研究道德监督

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There are several reasons to believe that Institutional Review Boards (IRBs) and Human Research Protection Programs (HRPPs) contribute to ethical research and the protection of research participants, but there are also important reasons to interrogate this belief. Determining whether IRBs and HRPPs "work" requires empirical evaluation of whether and how well they actually achieve what they were designed to do. In other words, it is critical to examine their outcomes and not only their procedures and structures. In this response to Tsan, we argue that the concept of IRB and HRPP quality entails three dimensions: (1) effectiveness, (2) procedures and structures likely to promote effectiveness, and (3) features unrelated to effectiveness but nonetheless essential, such as efficiency, fairness, and proportionality. Because not all types of quality necessarily guarantee or entail effectiveness, we suggest that broad quality assessments, including such features as regulatory compliance and other procedural measures suggested by Tsan, are unhelpful as the first step in evaluating IRBs and HRPPs. Instead, we must start with outcomes relevant to effectiveness. To do this, we launched the Consortium to Advance Effective Research Ethics Oversight (AEREO), with a mission to define and specify ways to measure relevant outcomes for research ethics oversight, empirically evaluate whether those outcomes are achieved, test new approaches to achieving them, and ultimately, develop and implement empirically-based policy and practice to advance IRB and HRPP effectiveness. We describe several anticipated AEREO projects and call for collaboration between various stakeholders to more meaningfully evaluate IRB and HRPPs.
机译：有几个理由相信机构审查委员会（IRB）和人类研究保护计划（HRPPS）有助于道德研究和研究参与者的保护，但也有重要的原因询问这种信念。确定IRB和HRPPS的“工作”是否需要实证评估是否实际实现它们所设计的内容。换句话说，检查他们的结果并不仅仅是他们的程序和结构至关重要。在对Tsan的这种反应中，我们认为IRB和HRPP质量的概念需要三个维度：（1）有效性，（2）可能促进有效性的程序和结构，以及（3）与有效性无关的功能，但仍然是必要的，如效率，公平和比例。由于并非所有类型的质量都必须保证或征收有效性，我们建议广泛的质量评估，包括TSAN建议的监管合规性和其他程序措施等特征，这是评估IRB和HRPPS的第一步。相反，我们必须从与有效性相关的结果开始。为此，我们推出了联盟，以推进有效的研究道德监督（Aereo），有一个使命来定义和指定衡量研究道德监督的相关结果的方法，明确评估是否达到了这些结果，测试了实现这些结果的新方法，最终，制定和实施基于经验的政策和实践，以推进IRB和HRPP的效果。我们描述了几个预期的Aereo项目，并呼吁各利益相关者之间的合作，以更有意义地评估IRB和HRPP。

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