Sex and Gender in Clinical Research

The roles of sex, gender, and sexual orientation in clinical research are important but underexplored. Discussion at the Bioethics Collaborative focused on two types of ethical issues related to sex, gender, and sexual orientation in clinical research. First, while sexual orientation and gender identity (SOGI) are social constructs, disease risk, manifestation, and/or response to treatment may vary by SOGI characteristics.

It is important to understand that any variation in disease risk, manifestation, or response, if it exists, is likely related to other underlying differences (e.g., hormonal status). Nevertheless, collecting and analyzing data on sex, gender, and sexual orientation may point to differences that need to be understood biologically to provide safe and effective interventions across diverse populations. Second, research should be respectful and inclusive of individuals of diverse sexes, genders, and sexual orientations. The principles of respect for persons and justice must be considered in addition to that of biologic relevance.

Deliverables