title: Recommendations concerning the new U.S. National Institutes of Health initiative to balance the sex of cells and animals in preclinical research.
abstract: The U.S. National Institutes of Health (NIH) announced last May that steps will be taken to address the over-reliance on male cells and animals in preclinical research. To further address this announcement, in September 2014, scientists with varying perspectives came together at Georgetown University to discuss the following questions. (1) What metrics should the NIH use to assess tangible progress on policy changes designed to address the over-reliance on male cells and animals in preclinical research? (2) How effective can education be in reducing the over-reliance on male cells and animals in preclinical research and what educational initiatives sponsored by the NIH would most likely effect change? (3) What criteria should the NIH use to determine rigorously defined exceptions to the future proposal requirement of a balance of male and female cells and animals in preclinical studies? (4) What additional strategies in addition to proposal requirements should NIH use to reduce the overreliance of male cells and animals in preclinical research? The resulting consensus presented herein includes input from researchers not only from diverse disciplines of basic and translational science including biology, cell and molecular biology, biochemistry, physiology, pharmacology, neuroscience, cardiology, endocrinology, nephrology, psychiatry, and obstetrics and gynecology, but also from recognized experts in publishing, industry, advocacy, science policy, clinical medicine, and population health. We offer our recommendations to aid the NIH as it selects, implements, monitors, and optimizes strategies to correct the over-reliance on male cells and animals in preclinical research.
authors.affiliation: *Center for the Study of Sex Differences in Health, Aging and Disease and Division of Nephrology and Hypertension, Department of Medicine, and Division of Endocrinology and Metabolism, Department of Medicine, Georgetown University, Washington, DC, USA; Georgetown-Howard Universities Center for Clinical and Translational Science, Washington, DC, USA; and MedStar Health Research Institute, Hyattsville, Maryland, USA sandberg@georgetown.edu.
authors.forename: Kathryn
authors.initials: K
authors.lastname: Sandberg
authors.affiliation: *Center for the Study of Sex Differences in Health, Aging and Disease and Division of Nephrology and Hypertension, Department of Medicine, and Division of Endocrinology and Metabolism, Department of Medicine, Georgetown University, Washington, DC, USA; Georgetown-Howard Universities Center for Clinical and Translational Science, Washington, DC, USA; and MedStar Health Research Institute, Hyattsville, Maryland, USA.
authors.forename: Jason G
authors.initials: JG
authors.lastname: Umans
mesh_terms: D032761:Animal Experimentation / Q000592:standards*; D000818:Animals; D004195:Disease Models, Animal; D005260:Female; D017408:Guidelines as Topic; D006801:Humans; D008297:Male; D009316:National Institutes of Health (U.S.); D012107:Research Design / Q000592:standards*; D035842:Research Subjects; D012727:Sex Characteristics; D012737:Sex Factors; D057170:Translational Research, Biomedical / Q000592:standards*; D014481:United States
keywords: gender; over-reliance; sex bias; sex differences; sexual dimorphism