Research Ethics in Pregnancy: The Maternal-Fetal Dyad

Abstract

Pregnant persons and their physicians often make decisions for health care without clinical evidence to guide their choices. Years of exclusionary practices in research, dominated by fears of fetal harm, have resulted in limited evidence on therapies for pregnancy-specific conditions. It has also eroded pregnant persons’ rights as autonomous individuals capable of weighing risks and benefits to make choices for themselves and their infants based on sound evidence. A paradigm shift from “routine exclusion” to “fair inclusion” of pregnant persons in clinical trials is needed to ensure that ethical principles are upheld when undertaking research in this population. This article will provide a brief review of the historical aspects of clinical research ethics for pregnant persons, focus on some key concepts within the context of the maternal-fetal dyad, and include a recent example from the coronavirus disease 2019 (COVID-19) pandemic to understand how society has interpreted tensions among the ethical principles of justice, beneficence, nonmaleficence, and autonomy. Note: This review uses the term “pregnant person(s)” to include women and people who are pregnant and do not identify themselves as women.