title: Sex and the Lab: An Alcohol-Focused Commentary on the NIH Initiative to Balance Sex in Cell and Animal Studies.
abstract: In May 2014, Dr. Francis Collins, the director of U.S. National Institutes of Health (NIH), and Dr. Janine Clayton, the director of the U.S. National Institutes of Health Office of Research on Women's Health, published a commentary in the journal Nature announcing new policies to ensure that preclinical research funded by the NIH considers both males and females. While these policies are still developing, they have already generated great interest by the scientific community and triggered both criticism and applause. This review provides a description and interpretation of the NIH guidelines, and it traces the history that led to their implementation. As expected, this NIH initiative generated some anxiety in the scientific community. The use of female animals in the investigation of basic mechanisms is perceived to increase variability in the results, and the use of both sexes has been claimed to slow the pace of scientific discoveries and to increase the cost at a time characterized by declining research support. This review discusses issues related to the study of sex as a biological variable (SABV) in alcohol studies and provides examples of how researchers have successfully addressed some of them. A practical strategy is provided to include both sexes in biomedical research while maintaining control of the research direction. The inclusion of sex as an important biological variable in experimental design, analysis, and reporting of preclinical alcohol research is likely to lead to a better understanding of alcohol pharmacology and the development of alcohol use disorder, may promote drug discovery for new pharmacotherapies by increasing scientific rigor, and may provide clinical benefit to women's health. This review aims to promote the understanding of the NIH's SABV guidelines and to provide alcohol researchers with a theoretical and practical framework for working with both sexes in preclinical research.
authors.affiliation: Department of Behavioral Neuroscience, Oregon Health & Science University, VA Portland Health Care System, Portland, Oregon.
authors.forename: Marina
authors.initials: M
authors.lastname: Guizzetti
authors.affiliation: Department of Clinical Pharmacy, University of Southern California, Los Angeles, California.
authors.forename: Daryl L
authors.initials: DL
authors.lastname: Davies
authors.affiliation: Division of Neuroscience and Behavior, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, Maryland.
authors.forename: Mark
authors.initials: M
authors.lastname: Egli
authors.affiliation: Department of Behavioral Neuroscience, Oregon Health & Science University, VA Portland Health Care System, Portland, Oregon.
authors.forename: Deborah A
authors.initials: DA
authors.lastname: Finn
authors.affiliation: Department of Physiology and Alcohol and Drug Abuse Center of Excellence , Louisiana State University, New Orleans, Louisiana.
authors.forename: Patricia
authors.initials: P
authors.lastname: Molina
authors.affiliation: Division of Neuroscience and Behavior, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, Maryland.
authors.forename: Soundar
authors.initials: S
authors.lastname: Regunathan
authors.affiliation: Bowles Center for Alcohol Studies and Department of Psychiatry , University of North Carolina, Chapel Hill, North Carolina.
authors.forename: Donita L
authors.initials: DL
authors.lastname: Robinson
authors.affiliation: Department of Neuroscience and Experimental Therapeutics , Texas A&M, Bryan, Texas.
authors.forename: Farida
authors.initials: F
authors.lastname: Sohrabji
mesh_terms: D000818:Animals; D009316:National Institutes of Health (U.S.) / Q000592:standards*; D057766:Policy; D012107:Research Design / Q000592:standards*; D012737:Sex Factors; D014481:United States; D016387:Women's Health
keywords: Cell and Animal Studies; Ethanol; Gender; Policy; Preclinical Research