Sex as a biological variable
Sex as a biological variable (SABV) is a research policy recognizing sex as an important variable to consider when designing studies and assessing results. Research including SABV has strengthened the rigor and reproducibility of findings. Public research institutions including the European Commission, Canadian Institutes of Health Research, and the U.S. National Institutes of Health have instituted SABV policies. Editorial policies were established by various scientific journals recognizing the importance and requiring research to consider SABV.
Background
Public research institutions
In 1999, the
In 2003, the European Commission (EC) began influencing investigators to include sex and gender in their research methodologies. The Canadian Institutes of Health Research (CIHR) requires four approaches: sex and gender integration in research proposals, sex and gender expertise among research teams, sex and gender platform in large consortiums, and starting in September 2015, the completion of sex and gender online training programs.[1]
In May 2014, the NIH announced the formation of SABV policy.[4] The policy came into effect in 2015 which specified that "SABV is frequently ignored in animal study designs and analyses, leading to an incomplete understanding of potential sex-based differences in basic biological function, disease processes, and treatment response. NIH expects that sex as a biological variable will be factored into research designs, analyses, and reporting in vertebrate animal and human studies. Strong justification from the scientific literature, preliminary data or other relevant considerations must be provided for applications proposing to study only one sex."[2][1] The review criteria should assess the extent to which the sex of participants has been incorporated into the research plan.[5]
Scientific journals
In 2010, the National Centre for the Replacement, Refinement and Reduction of Animals in Research published the ARRIVE guidelines which promotes incorporating SABV in animal studies.[6] In 2012, the American Physiological Society (APS) journals began requiring sex and gender to be reported in studies involving cells, tissues, animals, and humans.[7] This APS editorial policy was not widely accepted by reviewers and researchers.[8]
The European Association of Science Editors established the gender policy committee (GPC) in 2012. The GPC published Sex and Gender Equity in Research (SAGER) guidelines in 2016.[9] In January 2017, the Journal of Neuroscience Research began requiring the consideration of SABV.[10] The December 2017 ICMJE recommendations encouraged the use of SABV by researchers.[1]
Impact
Research incorporating sex as a biological variable increases the rigor and reproducibility of results.[11][12] After publishing the NIH published SABV policy, there were increases in the percentage of scientists understanding and recognizing its importance.[13] Some investigators were critical of the NIH SABV policy, saying it would increase cost and labor requirements.[14][15] Including SABV in basic research and preclinical studies can reduce costs and time requirements to test sex differences in clinical trials.[16][17]
Historically, there were concerns among researchers of the female reproductive system impacting findings in animal studies.[18] Other studies using mice models found that despite the estrous cycle, variability was the same among sexes.[19] Studies following SABV policies can identify potential hormonal variability in earlier phases of biomedical research.[20]
In 2020, the NIH
References
- ^ PMID 29429452.
- ^ a b "NOT-OD-15-102 Guidance: Consideration of Sex as a Biological Variable in NIH-funded Research" (PDF). National Institutes of Health. 2015. Retrieved 2021-02-26. This article incorporates text from this source, which is in the public domain.
- ^ "NIH Policy on Sex as a Biological Variable | Office of Research on Women's Health". orwh.od.nih.gov. Retrieved 2021-02-26.
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- Office of Research on Women's Health. Retrieved 2021-02-26. This article incorporates text from this source, which is in the public domain.
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