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.

Revisions to the Common Rule and NIH policy require the use of a single Institutional Review Board (sIRB) for the review of most federally funded, multisite research, with the intent of streamlining the review process. However, since initial implementation in 2018, many IRBs and institutions continue to struggle with the logistics of implementing this requirement. In this paper, we report the findings of a workshop held in 2022 to examine why sIRB review remains problematic and propose possible solutions. Workshop participants identified several issues as major barriers, including new responsibilities for study teams, persistent duplicative review processes, the lack of harmonization of policies and practices across institutions, the absence of additional guidance from federal agencies, and the need for greater flexibility in policy requirements. Addressing these problems will require providing additional resources and training to research teams, the commitment of institutional leaders to harmonize practice, and policymakers to critically evaluate the requirement and provide flexibility in applicability.

Research on opioid use in pregnancy is critically important to understand how the opioid epidemic has affected a generation of children, but also raises significant ethical and legal challenges. Embedded ethicists can help to fill the gaps in ethics oversight for such research, but further guidance is needed to help strike the balance between integration and independence.

Youth are an understudied population requiring additional safeguards when participating in research. Their input is necessary to facilitate participation and interest in studies. To address this, Mayo Clinic established one of the first pediatric advisory boards (PAB) comprised of 18 diverse youth aged 11–17. The PAB members participated in quarterly meetings (in person and then by video conference with the advent of COVID-19) where they provided feedback to researchers on recruitment strategies, study materials, and procedures. The PAB meetings fostered bidirectional conversations with researchers on several health research topics, including mental health. Youth advisory boards can promote engagement in pediatric research.

M.H. Pappworth's 1967 book, Human guinea pigs, was a major catalyst for change in the ethics and regulation of human research in the 1970s. Many of Pappworth's ethical concerns about the threats posed to human subjects are still valid today, yet the source of those threats has shifted from universities to industry sponsors.