In this Policy Forum, Jeremy Sugarman and colleagues describe the risks that increasingly limited access to abortion may pose to clinical research participants and staff, one year after the U.S. Supreme Court's decision in Dobbs v. Jackson Woman's Health Organization.
People who may become pregnant are already an understudied population in clinical research. The authors suggest that new laws restricting abortion access may lead to ethical, legal and practical problems that make the risk of conducting research with this population unreasonable compared to the potential benefits.
Among the challenges noted by Sugarman et al.: Clinical trials may expose some participants to threats to their health or life or a fetus if they become pregnant, but restrictive laws could prevent a safe and timely abortion in this case. Participants in some studies are required to get regular pregnancy tests, which could detect and document miscarriages that could raise concerns in some places that an illegal abortion was obtained. The risks of restricting abortion may make some participants less likely to participate in clinical research, and researchers themselves might be less likely to collect information on pregnancy, compromising the scientific and social value of the research.
Sugarman et al. note that researchers may need to make provisions for safe and legal abortion access for study participants, while identifying and protecting against legal risk to research staff. Researchers should also make study participants aware of the status of abortion restrictions and how they might relate to the research in explicit informed consent documents, they say. "Finally, those contemplating the development and implementation of policies pertaining to abortion should also consider their potential negative impact on the ability of researchers to advance science that can improve the health and well-being of those who are pregnant and their fetuses," the Policy Forum authors write.
Source:
Journal reference:
Sugarman, J., et al. (2023) Ethical research when abortion access is legally restricted. Science. doi.org/10.1126/science.adh3104.