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Sex now needs to be included as a biological variable in NIH-funded research, but how?


Credit: Mary Ann Liebert, Inc., publishers

New Rochelle, NY, July 5, 2017–The National Institutes of Health (NIH) instituted a policy that now expects sex to be considered as a variable, much like a subject's age or weight, in the biomedical research it funds, but researchers appear unclear what this should entail. How to take into consideration the potential influence of sex and how to ensure that it is a critical element of study design and results interpretation are the focus of an article published in Gender and the Genome, a peer-reviewed publication from Mary Ann Liebert, Inc., publishers. The article is available free on the journal website until August 4, 2017.

In the article "Considering Sex as a Biological Variable in Biomedical Research," coauthors Terri Lynn Cornelison, MD, PhD and Janine Austin Clayton, MD, National Institutes of Health, Bethesda, MD, provide specific recommendations for how biomedical researchers can incorporate sex into their experimental design, data analysis, and publication of findings. Among their recommendations, the authors advise investigators to consider the influence of sex when developing research questions, design studies that include both male and female subjects, and take care to generalize research findings appropriately.

"This paper answers many of the questions investigators have about implementing the NIH mandate to include both sexes in biomedical research protocols. These clear guidelines are very helpful. One of the most important points is that the increased cost of studying both sexes is insufficient justification for not doing so," says Gender and the Genome Editor-in-Chief Marianne J. Legato, MD, PhD (hon. c.), FACP, Emerita Professor of Clinical Medicine, Columbia University, Adjunct Professor of Medicine, Johns Hopkins University, and Founder and Director of the Foundation for Gender-Specific Medicine.


About the Journal

The new journal, Gender and the Genome, the official journal of The Foundation for Gender-Specific Medicine, fills a unique niche in medical publishing. Led by Editor-in-Chief Marianne J. Legato, MD, PhD (hon.c.), FACP Emerita Professor of Clinical Medicine, Columbia University, Adjunct Professor of Medicine, Johns Hopkins University, and Founder and Director of the Foundation for Gender-Specific Medicine, the journal has a specific, well-defined mission: to explore the impact of sex/gender on the data and concepts generated as a result of utilizing state-of-the-art methods and new capabilities. The Journal is designed to acknowledge the consequences of the profound change in our ability to explore, augment–and to transform–the nature of created life and to manufacture entirely novel species, both biological and mechanical

About the Publisher

Mary Ann Liebert, Inc., publishers is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in many promising areas of science and biomedical research, including Human Gene Therapy, Stem Cells and Development, DNA and Cell Biology. Its biotechnology trade magazine, GEN (Genetic Engineering & Biotechnology News) was the first in its field and is today the industry's most widely read publication worldwide. A complete list of the firm's 80 journals, books, and newsmagazines is available on the Mary Ann Liebert, Inc., publishers website.

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