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

Review of a subset of IRB protocols submitted at a major research institution suggests that very few investigators are considering sex or gender as important variables in their clinical research at the stage of protocol development. IRBs are in an excellent position to encourage investigators to consider SABV and gender in order to enhance the rigor of research design, maximize the importance of the resulting knowledge, and ensure that subject selection is equitable. These findings serve as the basis for developing an intervention at the level of IRB protocol development and submission that will promote consideration of SABV and/or gender, factors with critical import to patient safety and efficacy of interventions.