Advancing Clinical Research with Pregnant and Lactating Populations

Overcoming Real and Perceived Liability Risks

Engineering National Academies of Sciences and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Ethical Committee on Developing a Framework to Address Legal Regulatory and Policy Issues for Research Specific to Pregnant and Lactating Persons (Autoren)

Buch | Softcover

306 Seiten

2024
National Academies Press (Verlag)
978-0-309-71688-8 (ISBN)

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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

Erscheinungsdatum	22.08.2024
Verlagsort	Washington
Sprache	englisch
Maße	152 x 229 mm
Themenwelt	Medizin / Pharmazie
ISBN-10	0-309-71688-8 / 0309716888
ISBN-13	978-0-309-71688-8 / 9780309716888
Zustand	Neuware