The Integration of Sex and Gender Considerations into Biomedical Research: Lessons from International Funding Agencies.

To improve the outcomes of research and medicine, government-based international research funding agencies have implemented various types of policies and mechanisms with respect to sex as a biological variable and gender as a sociocultural factor. After the 1990s, the US National Institutes of Health (NIH), the Canadian Institute for Health Research (CIHR), and the European Commission (EC) began 1) requesting that applicants address sex and gender considerations in grant proposals and 2) offering resources to help the scientific community integrate sex and gender into biomedical research. Although, it is too early to analyze data on the success of all of the policies and mechanisms implemented, here we review the use of both carrots (incentives) and sticks (requirements) developed to motivate researchers and the entire scientific research enterprise to consider sex and gender influences on health and in science. The NIH focused on sex as a biological variable (SABV) aligned with an initiative to enhance reproducibility through rigor and transparency; CIHR instituted a sex- and gender-based analysis (SGBA) policy; and the EC required the integration of the "gender dimension", which incorporates sex, gender, and intersectional analysis into research and innovation. Other global efforts are briefly summarized. Although we are still learning what works, we share lessons learned to improve the integration of sex and gender considerations into research. In conjunction with refining and expanding the policies of funding agencies and mechanisms, private funders/philanthropic groups, editors of peer-reviewed journals, academic institutions, professional organizations, ethics boards, healthcare systems, and industry also need to make concerted efforts to integrate sex and gender into research, and we all must bridge across silos to promote system-wide solutions throughout the biomedical enterprise. For example, policies that encourage researchers to disaggregate data by sex and gender, the development of tools to better measure gender effects, or policies similar to SABV and/or SGBA adopted by private funders would accelerate progress. Uptake, accountability for, and a critical appraisal of sex and gender throughout the biomedical enterprise will be crucial to achieving the goal of relevant, reproducible, replicable, and responsible science that will lead to better evidence-based personalized care for all, but especially for women. Published by Oxford University Press on behalf of the Endocrine Society 2021.