Department of Psychiatry, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, Colorado.
Office of Human Research Affairs, United HealthGroup, Boston, Massachusetts.
J Womens Health (Larchmt). 2020 Jun;29(6):868-875. doi: 10.1089/jwh.2019.8084. Epub 2020 Apr 8.
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.
考虑生物医学研究中的性别差异对于确保男女两性的药物和器械的安全性和有效性至关重要，并且有助于提高科学发现的严谨性和可重复性。从历史上看，女性在临床研究中的代表性不足，而且通常不考虑性别差异。美国食品和药物管理局（FDA）和美国国立卫生研究院（NIH）在增加临床试验中女性的代表性以及鼓励考虑性别差异方面发挥了作用。由于并非所有研究都适合由 FDA 进行审查，并且并非所有研究都有 NIH 资助，因此这导致了监管空白。我们建议地方机构审查委员会（IRB）和机构动物护理和使用委员会（IACUC）通过在协议审查期间鼓励研究人员将性别视为生物学变量（SABV）来提供更多的监督。在本文观点中，我们回顾了 FDA 和 NIH 政策如何促进变革，并强调了 IRB 和 IACUC 如何鼓励研究人员考虑 SABV。
