Research with Pregnant and Lactating Persons: Mitigating Risk and Liability: Proceedings of a Workshop—in Brief

Excerpt

Pregnant and lactating persons are frequently excluded from clinical research, and often have to make treatment decisions without an adequate understanding of the benefits and risks to themselves and their developing fetus or newborn baby. The National Academies Committee on Developing a Framework to Address Legal, Ethical, Regulatory, and Policy Issues for Research Specific to Pregnant and Lactating Persons held a workshop in March 2023 as part of a consensus study to discuss how institutions and organizations make risk-benefit decisions regarding the inclusion and exclusion of pregnant and lactating persons in clinical research, and the role of real and perceived liability considerations, health equity, risk management, and trial insurance in those decisions. The workshop reviewed existing approaches to manage and mitigate risks relevant to the inclusion of pregnant and lactating persons in clinical research. This Proceedings of a Workshop—in Brief summarizes the discussions held during the workshop.