Advancing clinical research with pregnant and lactating populations overcoming real and perceived liability risks

Congress called on the National Academies to convene a committee to examine 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 Liab...

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Bibliographic Details
Corporate Author: National Academies of Sciences, Engineering, and Medicine (U.S.) Committee on Developing a Framework to Address Legal, Ethical, Regulatory, and Policy Issues for Research Specific to Pregnant and Lactating Persons
Other Authors: Riley, Margaret Foster (Editor), Helman, Alex (Editor), March, Andrew (Editor)
Format: eBook
Language:English
Published: Washington, DC National Academies Press 2024, [2024]
Series:Consensus study report
Online Access:
Collection: National Center for Biotechnology Information - Collection details see MPG.ReNa
Description
Summary:Congress called on the National Academies to convene a committee to examine 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
Physical Description:1 PDF file (xvii, 287 pages) illustrations
ISBN:0309716888
9780309716888