Advancing Clinical Research with Pregnant and Lactating Populations

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