Abstract
Historically, women, including those who are pregnant or lactating, have traditionally been excluded from research, resulting in a lack of available data on health, disease, and treatment outcomes. This document provides a historical overview of issues surrounding the inclusion of women in research trials. It also provides an ethical framework and discussion for increasing inclusivity for people who identify as women and people who are pregnant, who could have become pregnant, or who are lactating, specifically through the lenses of justice, informed consent, contraception requirements, nongestational parent consent, pregnant individuals as participants in research, and fetal outcomes in research trials.
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