Health and Medicine Division
Board on Health Sciences Policy
Committee on Developing a Framework to Address Legal, Ethical, Regulatory, and Policy Issues for Research Specific to Pregnant and Lactating Persons
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Congressional Briefings
Wednesday, April 3, 2024 – 1:00 p.m.
and
Tuesday, May 28, 2024 – 10:00 a.m.
via Zoom
on
Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks
Requested by Congress in P.L. 117-103, the Consolidated Appropriations Act of 2022, this National Academies of Sciences, Engineering, and Medicine report, examines the real and perceived risks of liability arising from research conducted with pregnant and lactating women. The resulting report, Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks, explores and finds limited evidence of legal liability for inclusion of pregnant and lactating women in clinical research, contradicting perceptions of heightened liability. The committee also makes recommendations that could lead to a more robust evidence base about the safety and efficacy of medications for pregnant and lactating women that would facilitate more informed decision-making regarding care while mitigating liability.
These briefings were for members of Congress and congressional staff only. The report was publicly released on April 10, 2024 and can be found, in its entirety, on the Web site of the National Academies Press.