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Editorial policies for sex and gender analysis

2016; Elsevier BV; Volume: 388; Issue: 10062 Linguagem: Inglês

10.1016/s0140-6736(16)32392-3

1474-547X

Londa Schiebinger, Seth S. Leopold, Virginia M. Miller,

Science, Research, and Medicine

Sex and gender are basic variables in preclinical and clinical scientific research. 1 Curno MJ Heidari S Absence of evidence is not evidence of absence: encouraging gender analyses in scholarly publications. Eur Sci Editing. 2011; 37: 104-105 Google Scholar , 2 Klein SL Schiebinger L Stefanick ML et al. Opinion: sex inclusion in basic research drives discovery. Proc Natl Acad Sci USA. 2015; 112: 5257-5258 Crossref PubMed Scopus (149) Google Scholar , 3 National Institutes of HealthConsideration of sex as a biological variable in NIH-funded research. Notice NOT-OD-15–102, 2015. National Institutes of Health, Bethesda, MD2015 Google Scholar , 4 Clayton JA Studying both sexes: a guiding principle for biomedicine. FASEB J. 2016; 30: 519-524 Crossref PubMed Scopus (191) Google Scholar Data show that physiology differs between male and female humans and animals beyond reproductive function to encompass all systems, including differences in cardiovascular, respiratory, musculoskeletal, immunological, gastrointestinal, neurological, and renal function. 5 Oertelt-Prigione S Regitz-Zagrosek V Sex and gender aspects in clinical medicine. Springer Verlag, London2012 Crossref Scopus (61) Google Scholar , 6 Schenk-Gustafsson K DeCola PR Pfaff SW Plsetsky D Handbook of clinical gender medicine. Karger Publishers, Basel2012 Crossref Google Scholar , 7 Regitz-Zagrosek V Sex and gender differences in pharmacology. Springer Verlag, London2012 Crossref Google Scholar Failure to account for sex and gender may result in the inability to reproduce scientific findings, and often translates into less than adequate care of, or even harm to, men and women. 8 Legato MJ Johnson PA Manson JE Consideration of sex differences in medicine to improve health care and patient outcomes. JAMA. 2016; 316: 1865-1886 Crossref PubMed Scopus (93) Google Scholar For example, many drugs fail because sex and gender are not examined as variables in preclinical and translation research: between 1997 and 2000, ten drugs were withdrawn from the US market because of life-threatening health effects; eight of which posed greater health risks for women than for men. 9 Heinrich J Gahart MT Rowe EJ Bradley L Drug safety: most drugs withdrawn in recent years had greater health risks for women. A letter to The Honorable Tom Harkin, The Honorable Olympia J Snowe, The Honorable Barbara A Mikulski, United States Senate, The Honorable Henry Waxman, House of Representatives. United States General Accounting Office, Washington, DC2001 Google Scholar Funding agency mechanisms to increase sex and gender analysisWe applaud Londa Schiebinger and colleagues' (Dec 10, p 2841)1 commitment to promote editorial policies for sex and gender analysis.2 One concern voiced by journal editors is how to handle papers that do not include both sexes, in cases for which insufficient funding was provided by research funding agencies to study equal numbers of male and female participants. Research funding agencies are taking this mandate seriously.3–5 We describe four structural mechanisms used by the Canadian Institutes of Health Research across various funding opportunities to build capacity for improvement of sex and gender integration in health research. Full-Text PDF