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

Author:

Bierer Barbara E.123ORCID

Affiliation:

1. Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard, Boston, Massachusetts

2. Division of Global Health Equity, Department of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts

3. Department of Medicine, Harvard Medical School, Boston, Massachusetts

Abstract

Abstract 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.

Publisher

Ovid Technologies (Wolters Kluwer Health)

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