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
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 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 left many researchers unclear about how to appropriately design studies that include both male and female rodents. We propose to develop a series of open-access online training modules that provide preclinical researchers across career stages with the practical knowledge and guidance they need to conduct rigorous and reproducible research on both sexes. ! PI: Patricia Kabitzke Institution: Cohen Veterans Bioscience
