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首页> 外文期刊>Journal of empirical research on human research ethics : >IRB Oversight of Patient-Centered Outcomes Research: A National Survey of IRB Chairpersons
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IRB Oversight of Patient-Centered Outcomes Research: A National Survey of IRB Chairpersons

机译：IRB监督患者以患者为中心的结果研究：对IRB主席的国家调查

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摘要

Patient-centered outcomes research (PCOR) is becoming increasingly common. However, there is little evidence regarding what novel ethical challenges, if any, are posed by PCOR with relevance to institutional review board (IRB) oversight and human subjects protections. This article reports the results of a national survey of all IRB chairpersons from research-intensive institutions in the United States. Findings address the responsibilities of IRBs and the challenges associated with PCOR review and oversight. IRB chairpersons varied in their judgment of PCOR's overall value to the scientific enterprise and to research at their institution. Furthermore, 27% of respondents considered patients serving in nontraditional roles to be research subjects even when they are not enrolled in research. There was also variation in the training and safeguards their IRBs require for patient partners. Our results suggest that guidance should be developed around ethical and regulatory issues associated with PCOR oversight.
机译：以患者为中心的结果研究（PCOR）变得越来越普遍。但是，如果有的话说，如果有的话，如果有的话，如果有的话，如果有的话，如果有的话，如果有的话，具有与机构审查委员会（IRB）监督和人类受试者保护有关。本文报告了美国研究密集型机构对所有IRB主席的国家调查结果。调查结果涉及IRB的职责以及与PCOR审查和监督相关的挑战。 IRB主席在他们对科学企业的总体价值的判断中变化，并在其机构研究。此外，27％的受访者认为，即使在没有参加研究时，也认为患有非传统角色的患者是研究科目。培训也有变异，并保障他们的患者伴侣的IRB。我们的结果表明，应围绕与PCOR监督相关的道德和监管问题制定指导。

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