Abstract
In 2016, to address the historical overrepresentation of male subjects in biomedical research, the US National Institutes of Health implemented a policy requiring investigators to consider sex as a biological variable. In order to assess the impact of this policy, we conducted a bibliometric analysis across nine biological disciplines for papers published in 34 journals in 2019, and compared our results with those of a similar study carried out by Beery and Zucker in 2009. There was a significant increase in the proportion of studies that included both sexes across all nine disciplines, but in eight of the disciplines there was no change in the proportion studies that included data analyzed by sex. The majority of studies failed to provide rationale for single-sex studies or the lack of sex-based analyses, and those that did relied on misconceptions surrounding the hormonal variability of females. Together, these data demonstrate that while sex-inclusive research practices are more commonplace, there are still gaps in analyses and reporting of data by sex in many biological disciplines.
Highlights
Studies of both males and females are essential to the advancement of human health, and the influences of sex on the prevalence, presentation, and progression of many disease states is profound
There have been numerous calls to address this issue through sex-inclusive research practices and policies (Kim et al, 2010; Klein et al, 2015; Mazure and Jones, 2015; Woodruff, 2014), culminating in 2016 when the National Institutes of Health (NIH) in the United States implemented a policy requiring investigators to consider sex as a biological variable (Clayton and Collins, 2014)
We provide an updated perspective on the state of sex-inclusive research within the biological sciences, and highlight areas of improvement alongside shortcomings in the decade since Beery and Zucker conducted their original study
Summary
Studies of both males and females are essential to the advancement of human health, and the influences of sex on the prevalence, presentation, and progression of many disease states is profound. Within the biological sciences, it has been a common and preferential practice to utilize male research subjects in basic and preclinical research (Beery and Zucker, 2011; Kong et al, 2016; Sugimoto et al, 2019; Yoon et al, 2014) This male bias stems from the misconception that female animals increase experimental variability due to cyclical fluctuating hormones and the historical belief that no major differences exist between the sexes outside of reproductive functions (Institute of Medicine, 2001). These biases are not limited to the basic sciences, but extend into clinical research as well (Geller et al, 2018; Mansukhani et al, 2016; Prakash et al, 2018; Scott et al, 2018).
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