In the year since the Supreme Court’s decision in Dobbs eliminated the nationwide right to abortion, consequences of heightened restrictions — including increased maternal morbidity and mortality and deepening socioeconomic and racial inequities — have quickly come into view. Less apparent have been the ethical, legal, and practical implications these restrictions have for research involving people who could become pregnant during research and research staff.
In the paper, “Ethical research when abortion access is legally restricted,” published today in Science, a group of researchers led by Dr. Jeremy Sugarman, MD, of the Johns Hopkins Berman Institute of Bioethics say limited access to abortion can pose risks to clinical research participants, potentially compromising the scientific and social value of some research.
“Ambiguous abortion laws and fear of criminal prosecution raise profound concerns and could deter those who might become pregnant from participating in clinical research,” said Sugarman, the Harvey M. Meyerhoff Professor of Bioethics and Medicine at the Berman Institute and Johns Hopkins School of Medicine.
“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.”
The paper outlines a number of implications for clinical research arising from new laws restricting abortion passed in almost half of U.S. states since the Dobbs ruling. For example, participants might be unable to legally obtain an abortion to mitigate harms resulting from research. Alternatively, a pregnancy test required for participation might document an early pregnancy, placing the participant at risk of legal action if the pregnancy results in an early miscarriage and would otherwise have gone unnoticed.
Clinical research staff also might face legal risks, such as prosecution for referring a participant to an abortion provider out of state. And research could be compromised, both by people hesitating to enroll and by leaving researchers hesitant to obtain rigorous data on pregnancy.
The paper also includes points to consider for researchers as they plan clinical studies in the post-Dobbs environment. In research site selection and management, this includes making provisions for legal abortion access for participants. In study design and implementation, points include safeguarding participant confidentiality, obtaining informed consent that includes risks involved with legal restrictions on abortion, and ensuring that institutional review boards have made determinations related to risks or issues associated with legal abortion.
“Stakeholders involved in research with participants who could become pregnant should explicitly consider the points in the paper, both to minimize the risks to participants and staff and to help safeguard the scientific and social value of research,” said Sugarman. “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.”