Inclusion of sex and gender in biomedical research: survey of clinical research proposed at the University of Pennsylvania.

Background: The 2015 National Institutes of Health (NIH) policy that sex be considered as a biological variable (SABV) is now a critical part of the peer-review process for NIH funding as well as publication in several high-impact scientific journals. We sought to determine the degree to which biomedical researchers at the University of Pennsylvania already consider SABV or gender in their research.

Methods: We reviewed 240 research protocols approved by the University of Pennsylvania Investigational Review Board (IRB) consecutively submitted between January and July 2016.