Interest in sex and gender in research—and resources to help investigators—is growing. In the 5 years since NIH enacted its pioneering Policy on Sex as a Biological Variable (SABV) (see our progress report here), there has been a lot of activity, including increased attention on sex differences and influences and many questions and requests for assistance. I’m pleased to announce the NIH Office of Research on Women’s Health (ORWH) has issued two new courses, Sex as a Biological Variable: A Primer and Bench to Bedside: Integrating Sex and Gender to Improve Human Health, to our suite of free e-learning offerings.
In part three of our series on rigor and transparency in research grant and career development award applications, we focus on consideration of relevant biological variables. Updated instructions for the Approach section of the Research Strategy ask the applicant to: ….
In 2014, NIH announced plans for policy changes to ensure that NIH-supported investigators consider relevant measures, including sex as a biological variable (SABV), in preclinical research. NIH solicited feedback through a request for information, and we invited the research community to participate in workshops and resource development. These activities led to new guidelines for addressing SABV as an aspect of rigor and reproducibility in NIH research project grant applications and mentored career development award applications due January 25, 2016, and beyond. As you prepare applications and think about addressing the new instructions we wanted to offer some reminders about the policy’s origin, and about the application and review information. In particular, we wanted to point out what including SABV does not mean. ….
One year ago, NIH announced a plan to adopt a new policy requiring a deliberate approach to the consideration of sex as a biological variable (SABV) in preclinical research. (Read the article, co-authored by Janine Clayton and NIH Director Francis Collins, here.) Since that moment, we have been working diligently and collaboratively inside and outside NIH to craft meaningful policy that promotes the best science. ….
We as a scientific community have made major progress toward balancing the number of men and women who volunteer as participants in biomedical research studies; in fact, women now account for roughly half of the participants in NIH-funded clinical trials. However, we haven’t seen a similar pattern in the pre-clinical research involving animals and cells. …. Thus, as announced in May, NIH intends to develop and implement policies requiring NIH applicants to consider sex as a variable in biomedical research involving animals and cells. …. today we announced a formal request for information (RFI) to get input from the research community, and others. As described in the RFI, we want to hear your thoughts on several topics – for example, whether consideration of sex as a biological variable is an issue affecting the reproducibility of research findings ….
You likely saw the recent Nature policy article, in which NIH Director Francis Collins and NIH Office of Research on Women’s Health Director Janine Clayton discussed ways that NIH is addressing sex differences in research. As our understanding of science evolves, so do our policies that govern research. This commentary cites several studies that highlight the need to further consider sex differences in preclinical research and describes how NIH will enact new policies to expand the consideration of sex differences in research studies using animal models and cells. The article generated quite a buzz in the community, and I wanted to take this opportunity to explain the roll out of our implementation plan. ….