Newswise — Washington, DC—To advance scientific understanding of how hormone disorders can affect men and women differently, the Endocrine Society has introduced policies to improve reporting of the sex of research subjects in its journals.
Authors submitting original research papers to the Society’s scholarly journals are now required to disclose the sex of human and animal research subjects. In cases where researchers are studying human cells, authors will be asked to indicate the sex of the cell lines.
“Science shows us that biological differences between men and women can affect how they respond to illnesses and treatments,” said Endocrine Society President Richard J. Santen, MD. “With its new policies, the Endocrine Society is leading the way in encouraging scientists to more fully explore the implications of sex differences in health and biomedical research.”
The policies apply to all original research journals published by the Society:• The Journal of Clinical Endocrinology & Metabolism (JCEM) is the world's leading peer-reviewed journal of clinical practice and applied clinical research.• Endocrinology publishes 6,000 pages annually of the highest quality original work, including subcellular mechanisms and whole animal physiology.• Molecular Endocrinology publishes research devoted to describing molecular mechanisms by which hormones and related compounds regulate function.• Hormones and Cancer is a multidisciplinary translational journal that features basic scientific, epidemiological, pre-clinical and clinical research papers in the field of hormones and cancer.
As part of the journals’ submission process, scientists will be asked whether sex differences were considered as part of the analysis. The new policies build on requirements Endocrinology implemented in 2012.
Many preclinical research studies fail to appropriately incorporate information on the sex of cell lines and research subjects, with potentially harmful consequences for patients. For instance, the Food and Drug Administration halved the recommended dose of the sleep drug Ambien for women in 2013. Science revealed that women metabolized the drug differently than men and could be at risk for impaired driving because their bodies eliminated the drug more slowly.
The Society has advocated for federal initiatives to balance the use of male and female cells and animals in preclinical research examining conditions that affect both sexes. Addressing the issue earlier in the research pipeline could lead to improvements in the design of clinical studies that provide evidence for hormone disorder treatments. In September, the National Institutes of Health (NIH) announced it had invested an additional $10.1 million in supplemental funding for 82 grantees to explore the effects of sex in preclinical and clinical research.
“We are pleased to see progress being made in this arena,” Santen said. “Sex is an important variable that needs to be considered in basic science as well as clinical research.”
The Society publishes five major peer-reviewed journals about endocrinology and metabolism. Journal access is available at http://press.endocrine.org.
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Founded in 1916, the Endocrine Society is the world’s oldest, largest and most active organization devoted to research on hormones and the clinical practice of endocrinology. Today, the Endocrine Society’s membership consists of over 18,000 scientists, physicians, educators, nurses and students in more than 122 countries. Society members represent all basic, applied and clinical interests in endocrinology. The Endocrine Society is based in Washington, DC. To learn more about the Society and the field of endocrinology, visit our site at www.endocrine.org. Follow us on Twitter at https://twitter.com/#!/EndoMedia.
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