Addressing Sex as a Biological Variable in Preclinical Pharmacology and Neuroscience Research: Accounting for Neglected Factors and Applying Practical Solutions to Enhance Rigor and Reproducibility

将性别作为临床前药理学和神经科学研究中的生物变量：考虑被忽视的因素并应用实用的解决方案来提高严谨性和可重复性

• 批准号: 10197959
• 负责人: Chantelle Ferland-Beckham
• 金额: $ 1.43万
• 依托单位: COHEN VETERANS BIOSCIENCE, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-29 至 2022-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10197959
• 关键词: Academia; Accounting; Accreditation; Address; Advertising; Aging; Animal Housing; Animals; Behavior; Biological; Biological Assay; Biological Sciences; Data; Drug Kinetics; Ensure; Equilibrium; Equipment; Estrus; European; Evaluation; Female; Funding; Goals; Grant; Guidelines; Hormones; Human Resources; Industry; Institutes; Institution; Journals; Knowledge; Left; Link; Logistics; Monitor; National Institute of General Medical Sciences; Neurons; Neurosciences; Neurosciences Research; Newsletter; Pharmaceutical Preparations; Pharmacology; Policies; Principal Investigator; Publishing; Reporting; Reproducibility; Research; Research Design; Research Personnel; Resources; Rodent; Scientist; Series; Sex Differences; Societies; Statistical Data Interpretation; System; Testing; Training; Training Activity; United States National Institutes of Health; Veterans; Work; brain behavior; career; college; education research; male; meetings; neglect; neuropsychopharmacology; pre-clinical; pre-clinical research; programs; sex; social media; success; web site

Application ID: 339139 Addressing Sex as a Biological Variable in Preclinical Pharmacology and Neuroscience Research: Accounting for Neglected Factors and Applying Practical Solutions to Enhance Rigor and Reproducibility ! The National Institutes of Health (NIH) recently instituted a requirement to consider sex as a biological variable in animal studies in an effort to ensure that preclinical research is applicable to both males and females. This policy, however, has raised many questions about how researchers should design studies that include both male and female rodents. Although some resources provide guidance on this new requirement, most of these guidelines focus on why sex is a critical biological variable rather than how to practically implement these considerations into preclinical research design, analyses, and reporting. We propose to develop a series of open-access online training modules that provide preclinical researchers with the practical knowledge and guidance they need to conduct rigorous and reproducible research that is applicable to both sexes. We aim to create three modules, respectively entitled “Sex Differences and Study Design”, Sex Differences in the Brain and Behavior”, and “Sex Differences and Pharmacology”. Each module will consist of engaging short videos (“episodes”) that cover a single topic in the form of a didactic presentation and case comparisons. The principal investigator and key personnel will work with subject-matter experts to develop the modules. Furthermore, internal evaluators will systematically monitor the program and perform a formative and summative evaluation of its success on an ongoing basis. The evaluators will gather data to determine whether the program is meeting its specific objectives and goals and whether the training videos are helpful to preclinical researchers across all career stages to understand how to address sex as a biological variable. We will make these training modules freely available on YouTube by the second year of the funding period, and post links to these modules across the Cohen Veterans Bioscience, European College of Neuropsychopharmacology Preclinical Data Forum Network, Society for Neuroscience, National Institute of General Medical Sciences, and Journal of Neuroscience Research, and Partnership for Assessment and Accreditation of Scientific Practice websites. Our goal is that the training modules will not only guide preclinical scientists to meet the NIH grant requirement, but also to empower researchers to include both sexes in their studies. PI: Patricia Kabitzke Institution: Cohen Veterans Bioscience

申请编号：339139 在临床前药理学和神经科学研究中将性别作为一个生物变量： 被忽视的因素和应用实用的解决方案，以提高严谨性和重现性 ! 美国国立卫生研究院（NIH）最近制定了一项要求， 作为动物研究中的生物学变量，以确保临床前研究 适用于男性和女性。然而，这一政策引起了许多问题， 关于研究人员应该如何设计包括雄性和雌性啮齿动物的研究。 尽管一些资源提供了关于这一新要求的指导，但其中大多数 指导方针的重点是为什么性是一个关键的生物变量，而不是如何实际 在临床前研究设计、分析和报告中考虑这些因素。 我们建议开发一系列开放式在线培训模块， 临床前研究人员的实际知识和指导，他们需要进行 对两性都适用的严谨和可重复的研究。我们的目标是创造 三个模块，分别题为“性别差异和研究设计”， 在大脑和行为”，和“性别差异和药理学”。每个模块将 由引人入胜的短视频（“剧集”）组成，以 教学演示和案例比较。主要研究者和关键人员 将与专题专家合作开发这些单元。此外，内部 评估人员将系统地监测该计划，并进行形成性和 持续对其成功进行总结性评价。评估人员将收集数据 确定该计划是否符合其具体目标和目的， 培训视频是否对所有职业阶段的临床前研究人员都有帮助 来理解如何将性别作为一个生物学变量。我们将使这些训练 在资助期的第二年之前，在YouTube上免费提供模块， 链接到这些模块在科恩退伍军人生物科学，欧洲学院 神经精神药理学临床前数据论坛网络，神经科学学会， 国家普通医学科学研究所和神经科学研究杂志， 和科学实践评估和认证伙伴关系网站。我们 目标是，培训模块不仅将指导临床前科学家，以满足国家卫生研究院 这不仅是一项赠款要求，而且也使研究人员能够在其研究中包括两性。 PI：Patricia Kabitzke 机构：科恩退伍军人生物科学