In light of a history of categorical exclusion, it is critical that pregnant people are included in research to help improve the knowledge base and interventions needed to address public health. Yet the volatile legal landscape around reproductive rights in the United States threatens to undue recent progress made toward the greater inclusion of pregnant people in research. We offer ethical and practical guidance for researchers, sponsors, and institutional review boards to take specific steps to minimize legal risks and ensure the ethical conduct of research with pregnant people in an evolving legal environment.

Federal law often avoids setting minimum standards for women’s health and reproductive rights issues, leaving legislative and regulatory gaps for the states to fill as they see fit. This has mixed results. It can lead to state innovation that improves state-level health outcomes, informs federal health reform, and provides data on best practices for other states. On the other hand, some states may use the absence of a federal floor to impose draconian policies that pose risks to women’s and maternal health. Health reforms at the federal level must trod carefully to enable state innovation, while imposing foundational safeguards for promoting women’s health nationwide.

Mobile devices with health apps, direct-to-consumer genetic testing, crowd-sourced information, and other data sources have enabled research by new classes of researchers. Independent researchers, citizen scientists, patient-directed researchers, self-experimenters, and others are not covered by federal research regulations because they are not recipients of federal financial assistance or conducting research in anticipation of a submission to the FDA for approval of a new drug or medical device. This article addresses the difficult policy challenge of promoting the welfare and interests of research participants, as well as the public, in the absence of regulatory requirements and without discouraging independent, innovative scientific inquiry. The article recommends a series of measures, including education, consultation, transparency, self-governance, and regulation to strike the appropriate balance.

Assisted reproductive technology (ART) is a multibillion dollar market in the United States (U.S.), generating a continual demand for oocyte donors whose gametes contributed to 12.6% of all ART cycles in 2012. Oocyte donation is a variant of in vitro fertilization (IVF) that is typically used when an intended mother cannot produce healthy oocytes of her own and instead uses oocytes provided by a third party in an attempt to produce one or more children. When oocyte donation was first developed, oocyte donors were selected among family and friend groups but, increasingly, active solicitation of anonymous donors and brokering the relationship between donor and recipient has become part of the services offered by fertility clinics. In addition, recipients may choose to work with an independent donor agency to find a suitable donor before completing the IVF procedure at a fertility clinic.