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 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 ContentsFront MatterSummary1 Introduction2 Legal Liability3 Strategies to Reduce Harm Through Clinical Research4 Mitigating Liability Associated with Clinical Research5 Dissuasive and Persuasive Factors for the Inclusion of Pregnant and Lactating Women in Clinical Research6 RecommendationsAppendix A: Public Meeting AgendasAppendix B: Scope of Liability Related to Pharmaceuticals Dispensed to Pregnant and Lactating Women