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Pocket
Advancing Clinical Research with Pregnant and Lactating Populations
Engineering National Academies Of Sciences And Medicine • Health And Medicine Division • Board On Health Sciences Policy • Regulatory Committee On Developing A Framework To Address Legal • Ethical And Policy Issues For • Andrew March
669:-
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. Table of Contents Front Matter Summary 1 Introduction 2 Legal Liability 3 Strategies to Reduce Harm Through Clinical Research 4 Mitigating Liability Associated with Clinical Research 5 Dissuasive and Persuasive Factors for the Inclusion of Pregnant and Lactating Women in Clinical Research 6 Recommendations Appendix A: Public Meeting Agendas Appendix B: Scope of Liability Related to Pharmaceuticals Dispensed to Pregnant and Lactating Women Appendix C: Commissioned Paper: State Statutes Regarding Fetal Research, Fetal Personhood, Fetal Homicide and Child Abuse/Neglect & Substance Abuse Appendix D: Assessing U.S. Food and Drug Administration Authorities, Guidance, and Policies for Prescription Drug, Biological Product, and Medical Device Development and Commercialization for Use by Pregnant and Lactating Women Appendix E: The Impact of Dobbs v. Jackson Women's Health Organization on Clinical Research with Pregnant and Lactating Persons
- Format: Pocket/Paperback
- ISBN: 9780309716888
- Språk: Engelska
- Antal sidor: 306
- Utgivningsdatum: 2025-01-10
- Förlag: National Academies Press