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首页> 外文期刊>Journal of women’s health >Filling the Regulatory Gap: Potential Role of Institutional Review Boards in Promoting Consideration of Sex as a Biological Variable
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Filling the Regulatory Gap: Potential Role of Institutional Review Boards in Promoting Consideration of Sex as a Biological Variable

机译：填补监管差距：机构审查委员会在促进思考作为生物变量时的潜在作用

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摘要

Consideration of sex differences in biomedical research is crucial to ensure the safety and effectiveness of drugs and devices for both sexes and to improve the rigor and reproducibility of scientific discoveries. Historically, women were underrepresented in clinical research and sex differences typically were not considered. The U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have played a role in improving the representation of women in clinical trials and in encouraging the consideration of sex differences. As it is not appropriate for all studies to be reviewed by the FDA nor do all studies have NIH funding, this results in a regulatory gap. We propose that local institutional review boards (IRBs) and institutional animal care and use committees (IACUCs) provide greater oversight by encouraging researchers to consider sex as a biological variable (SABV) during protocol review. In this perspective article, we review how FDA and NIH policies have fostered change and highlight how IRBs and IACUCs could encourage investigators to consider SABV.
机译：对生物医学研究的性别差异的思考至关重要，以确保为两性的药物和设备的安全性和有效性以及改善科学发现的严谨性和再现性。从历史上看，妇女在临床研究中经历了代表性，并且通常不考虑性别差异。美国食品和药物管理局（FDA）和国家卫生研究院（NIH）在改善临床试验中的妇女代表中发挥了作用，并鼓励对性差异的审议。由于不适合由FDA审查的所有研究，也不是所有研究都有NIH资金，这导致监管差距。我们建议当地的机构审查委员会（IRB）和机构动物护理和使用委员会（IACUCS）通过鼓励研究人员在议定书审查期间认为作为生物学变量（SABV）进行性行为提供更大的监督。在这篇透视文章中，我们审查了FDA和NIH政策如何促进变革，并强调IRBS和IACUCS如何鼓励调查人员考虑SABV。

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