The Role of Institutional Review Boards in Improving the Inclusion of Sex and Gender as Variables in Clinical Research

In orthopaedic clinical research, as in other fields, sex and gender-specific analyses are not consistently performed, despite evidence of sex differences in outcomes. Both institutional review boards (IRBs) and journal editors have a role in impacting the rate at which such analyses are performed and reported. The authority, responsibilities, and potential actions of IRBs are discussed herein, with the aim of setting investigator expectations and propelling changes to the study plan before the research is initiated.