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Advancing clinical research with pregnant and lactating populations : overcoming real and perceived liability risks
- Author(s):
- Riley, Margaret Foster, 1959-, editor
- Helman, Alex, editor
- March, Andrew, (Associate program officer), editor
- National Academies of Sciences Engineering and Medicine (US) Committee on Developing a Framework to Address Legal Ethical Regulatory and Policy Issues for Research Specific to Pregnant and Lactating Persons, sponsoring body
- Title(s):
- Advancing clinical research with pregnant and lactating populations : overcoming real and perceived liability risks / 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.
- Series:
- Consensus study report
- Country of Publication:
- United States
- Publisher:
- Washington, DC : National Academies Press, [2024]
- Description:
- 1 online resource (1 PDF file (xvii, 287 pages)) : illustrations.
-
Language:
- English
- ISBN:
- 9780309716888
0309716888
- Electronic Links:
- https://www.ncbi.nlm.nih.gov/books/NBK603025/
- 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.
- MeSH:
- Biomedical Research/legislation & jurisprudence
Breast Feeding
Liability, Legal
Patient Selection
Pregnant Women*
United States
- Notes:
- Includes bibliographical references.
Issued also in print.
This activity was supported by contracts between the National Academy of Sciences and the National Institutes of Health (HHSN263201800029I/75N98022F00010). Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.
- Other ID:
- (OCoLC)1438672531
- NLM ID:
- 9918879465706676 [Electronic Resource]