Ethical research when abortion access is legally restricted

Abstract

The legal landscape surrounding ABORTION in the United States has shifted dramatically since the Supreme Court’s June 2022 decision in Dobbs v. Jackson Women’s Health Organization eliminated a nationwide right to abortion. In the year since, roughly half of US states have expanded abortion restrictions. Some consequences of heightened restrictions—including increased maternal morbidity and mortality and deepening socioeconomic and racial inequities—have quickly come into view. However, little attention has focused on the ethical, legal, and practical implications that such restrictions have for research involving people who could become pregnant during research and research staff. Notably, limited access to abortion can pose risks to clinical research participants and potentially compromise the scientific and social value of some research. As a result, assessments of potential research risks and benefits may be altered. We outline points for various stakeholders [such as sponsors, investigators, research sites, and institutional review boards (IRBs)] to consider in addressing these issues.Stakeholders involved in research with participants who could become pregnant should explicitly consider the points outlined here, both to minimize the risks to participants and staff and to help safeguard the scientific and social value of research. If on careful examination it seems implausible to safely conduct the proposed research at a particular site, consideration should be given to conducting the research elsewhere. Nevertheless, lessons learned about efficient processes for the safe design and implementation of research with people who can become pregnant in the face of restricted abortion access should be described and disseminated widely as a means of helping generate best practices. Doing so would be facilitated by collecting and analyzing systematic data regarding how often challenges due to abortion restrictions are encountered in research as well as how they are managed. In the meantime, education of researchers, IRBs, institutional officials and state and local policy-makers is crucial. Last, those contemplating the development and implementation of policies pertaining to abortion should also consider the potential negative impact on the ability of researchers to advance science that can improve the health and well-being of those who are or may become pregnant and their fetuses.