Considering sex as a biological variable in preclinical research

Leah R Miller; Cheryl Marks; Jill B Becker; Patricia D Hurn; Wei-Jung Chen; Teresa Woodruff; Margaret M McCarthy; Farida Sohrabji; Londa Schiebinger; Cora Lee Wetherington; Susan Makris; Arthur P Arnold; Gillian Einstein; Virginia M Miller; Kathryn Sandberg; Susan Maier; Terri L Cornelison; Janine A Clayton

doi:10.1096/fj.201600781R

Considering sex as a biological variable in preclinical research

FASEB J. 2017 Jan;31(1):29-34. doi: 10.1096/fj.201600781R. Epub 2016 Sep 28.

Authors

Leah R Miller¹, Cheryl Marks², Jill B Becker³, Patricia D Hurn⁴, Wei-Jung Chen⁵, Teresa Woodruff⁶, Margaret M McCarthy⁷, Farida Sohrabji⁵, Londa Schiebinger⁸, Cora Lee Wetherington⁹, Susan Makris¹⁰, Arthur P Arnold^{11

12}, Gillian Einstein^{13

14

15}, Virginia M Miller^{16

17}, Kathryn Sandberg^{18

19}, Susan Maier²⁰, Terri L Cornelison²⁰, Janine A Clayton²⁰

Affiliations

¹ Office of Research on Women's Health, National Institutes of Health, Bethesda, Maryland, USA; leah.miller@nih.gov.
² Division of Cancer Biology, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
³ Molecular and Behavioral Neuroscience Institute, University of Michigan, Ann Arbor, Michigan, USA.
⁴ School of Nursing, University of Michigan, Ann Arbor, Michigan, USA.
⁵ Department of Neuroscience and Experimental Therapeutics, Texas A&M Health Science Center, Bryan, Texas, USA.
⁶ Women's Health Research Institute, Northwestern University, Chicago, Illinois, USA.
⁷ Department of Pharmacology, University of Maryland, Baltimore, Maryland, USA.
⁸ History of Science, Stanford University, Stanford, California, USA.
⁹ National Institute on Drug Abuse, National Institutes of Health, Bethesda, Maryland, USA.
¹⁰ Office of Research and Development, National Center for Environmental Assessment, U.S. Environmental Protection Agency, Washington, D.C., USA.
¹¹ Department of Integrative Biology and Physiology, University of California, Los Angeles, Los Angeles, California, USA.
¹² Laboratory of Neuroendocrinology of the Brain Research Institute, University of California, Los Angeles, Los Angeles, California, USA.
¹³ Department of Psychology, University of Toronto, Toronto, Ontario, Canada.
¹⁴ The Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.
¹⁵ Women's College Research Institute, Toronto, Ontario, Canada.
¹⁶ Department of Surgery and Physiology, Mayo Clinic, Rochester, Minnesota, USA.
¹⁷ Department of Biomedical Engineering, Mayo Clinic, Rochester, Minnesota, USA.
¹⁸ Department of Medicine, Georgetown University Medical Center, Washington, D.C., USA.
¹⁹ Center for the Study of Sex Differences in Health, Aging and Disease, Georgetown University Medical Center, Washington, D.C., USA.
²⁰ Office of Research on Women's Health, National Institutes of Health, Bethesda, Maryland, USA.

Abstract

In June 2015, the National Institutes of Health (NIH) released a Guide notice (NOT-OD-15-102) that highlighted the expectation of the NIH that the possible role of sex as a biologic variable be factored into research design, analyses, and reporting of vertebrate animal and human studies. Anticipating these guidelines, the NIH Office of Research on Women's Health, in October 2014, convened key stakeholders to discuss methods and techniques for integrating sex as a biologic variable in preclinical research. The workshop focused on practical methods, experimental design, and approaches to statistical analyses in the use of both male and female animals, cells, and tissues in preclinical research. Workshop participants also considered gender as a modifier of biology. This article builds on the workshop and is meant as a guide to preclinical investigators as they consider methods and techniques for inclusion of both sexes in preclinical research and is not intended to prescribe exhaustive/specific approaches for compliance with the new NIH policy.-Miller, L. R., Marks, C., Becker, J. B., Hurn, P. D., Chen, W.-J., Woodruff, T., McCarthy, M. M., Sohrabji, F., Schiebinger, L., Wetherington, C. L., Makris, S., Arnold, A. P., Einstein, G., Miller, V. M., Sandberg, K., Maier, S., Cornelison, T. L., Clayton, J. A. Considering sex as a biological variable in preclinical research.

Keywords: gender; methods; sex differences; sex influences.

Publication types

Review

MeSH terms

Biomedical Research / standards*
Drug Evaluation, Preclinical*
Female
Humans
Male
National Institutes of Health (U.S.) / standards*
Sex Factors
United States

Abstract

Publication types

MeSH terms

Grants and funding