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241009 r ||| eng |
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|a 0309716888
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|a 9780309716888
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|a Riley, Margaret Foster
|e [editor]
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|a Advancing clinical research with pregnant and lactating populations
|h Elektronische Ressource
|b overcoming real and perceived liability risks
|c Margaret Foster Riley, Alex Helman, and Andrew March, editors ; Committee on Developing a Framework to Address Legal, Ethical, Regulatory, and Policy Issues for Research Specific to Pregnant and Lactating Persons, Board on Health Sciences Policy, Health and Medicine Division
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| 260 |
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|a Washington, DC
|b National Academies Press
|c 2024, [2024]
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| 300 |
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|a 1 PDF file (xvii, 287 pages)
|b illustrations
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|a Includes bibliographical references
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|a Helman, Alex
|e [editor]
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|a March, Andrew
|e [editor]
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|a National Academies of Sciences, Engineering, and Medicine (U.S.)
|b 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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|a eng
|2 ISO 639-2
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| 989 |
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|b NCBI
|a National Center for Biotechnology Information
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|a Consensus study report
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|u https://www.ncbi.nlm.nih.gov/books/NBK603025
|3 Volltext
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|a 340
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|a 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
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