NIH awards $10.1 million in supplemental funding to study effects of sex in preclinical, clinical studies

Investment sets the stage for a transformative shift in science

The National Institutes of Health has awarded $10.1 million in supplemental funding to bolster the research of 82 grantees to explore the effects of sex in preclinical and clinical studies.

This investment encourages researchers to study females and males, and is a catalyst for considering sex as a fundamental variable in research. The current overreliance on male subjects in preclinical research can obscure key findings related to sex that could guide later human studies. This progressive approach will result in greater awareness of the need to study both sexes, demonstrate how research can incorporate sex, and reinforce the value of taking it into account as these studies yield results.

"This funding strategy demonstrates our commitment to moving the needle toward better health for all Americans, while helping grow our knowledge base for both sexes and building research infrastructure to aid future studies," said Janine Austin Clayton, M.D., NIH associate director for women's health research. "The scientists receiving these awards have approached their research questions with fresh thinking, and are looking for innovation and discovery through a new lens."

The projects span a wide array of science, including basic immunology, cardiovascular physiology, neural circuitry, and behavioral health. The projects will contribute to the body of sex-based knowledge, informing the understanding of health by adding one of the following elements to the original project:

• Addition of animals, tissues, or cells of the opposite sex to allow sex-based comparisons
• Addition of more subjects of either sex to a sample that already includes males and females to allow analysis for a sex/gender difference
• Analysis of existing datasets containing information from males and females

NIH launched the supplement program in fiscal year 2013 under leadership from the Office of Research on Women's Health, funding close to 50 supplements at $4.6 million total. Most institutes and centers at NIH have funded supplements since the program began.

The new awards include 18 supplements to existing grants from the NIH Common Fund, which identifies and funds areas of biomedical science to create new fields of research and to develop large-scale public resources that benefit the research community. In keeping with the trans-NIH scope of the Common Fund, knowledge gained from these supplements is expected to affect research across a variety of scientific disciplines. This year's investment brings total support for the program to $14.7 million.

"By making strategic investments that incorporate sex into existing funded studies, we are paving the way for researchers to better understand when sex matters in their research," said James M. Anderson, M.D., Ph.D., director of the Division of Program Coordination, Planning, and Strategic Initiatives, which oversees the NIH Common Fund.