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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
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Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

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 Consensus Study Report A02260_Advancing_Clinical_Research_FM.indd 1 5/13/24 12:44 PM

NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001 This activity was supported by contracts between the National Academy of Sciences and the National Institutes of Health (HHSN2632018000029I/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. International Standard Book Number-13: 978-0-309-71688-8 International Standard Book Number-10: 0-309-71688-8 Digital Object Identifier: https://doi.org/10.17226/27595 Library of Congress Control Number: 2024937619 This publication is available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu. Copyright 2024 by the National Academy of Sciences. National Academies of Sciences, Engineering, and Medicine and National Academies Press and the graphical logos for each are all trademarks of the National Academy of Sciences. All rights reserved. Printed in the United States of America. Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2024. Advancing clinical research with pregnant and lactating populations: Overcoming real and perceived liability risks. Washington, DC: The National Academies Press. https://doi.org/10.17226/27595. A02260_Advancing_Clinical_Research_FM.indd 2 5/13/24 12:44 PM

The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Marcia McNutt is president. The National Academy of Engineering was established in 1964 under the charter of the National Academy of Sciences to bring the practices of engineering to advising the nation. Members are elected by their peers for extraordinary contributions to engineering. Dr. John L. Anderson is president. The National Academy of Medicine (formerly the Institute of Medicine) was established in 1970 under the charter of the National Academy of Sciences to advise the nation on medical and health issues. Members are elected by their peers for distinguished contributions to medicine and health. Dr. Victor J. Dzau is president. The three Academies work together as the National Academies of Sciences, Engineering, and Medicine to provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. The National Academies also encourage education and research, recognize outstanding contributions to knowledge, and increase public understanding in matters of science, engineering, and medicine. Learn more about the National Academies of Sciences, Engineering, and Medicine at www.nationalacademies.org. A02260_Advancing_Clinical_Research_FM.indd 3 5/13/24 12:44 PM

Consensus Study Reports published by the National Academies of Sciences, Engineering, and Medicine document the evidence-based consensus on the study’s statement of task by an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and the committee’s deliberations. Each report has been subjected to a rigorous and independent peer-review process, and it represents the position of the National Academies on the statement of task. Proceedings published by the National Academies of Sciences, Engineering, and Medicine chronicle the presentations and discussions at a workshop, symposium, or other event convened by the National Academies. The statements and opinions contained in proceedings are those of the participants and are not endorsed by other participants, the planning committee, or the National Academies. Rapid Expert Consultations published by the National Academies of Sciences, Engineering, and Medicine are authored by subject-matter experts on narrowly focused topics that can be supported by a body of evidence. The discussions contained in rapid expert consultations are considered those of the authors and do not contain policy recommendations. Rapid expert consultations are reviewed by the institution before release. For information about other products and activities of the National Academies, please visit www.nationalacademies.org/about/whatwedo. A02260_Advancing_Clinical_Research_FM.indd 4 5/13/24 12:44 PM

COMMITTEE ON DEVELOPING A FRAMEWORK TO ADDRESS LEGAL, ETHICAL, REGULATORY, AND POLICY ISSUES FOR RESEARCH SPECIFIC TO PREGNANT AND LACTATING PERSONS MARGARET FOSTER RILEY (Chair), Professor of Law, Dorothy Danforth Compton Chair, Miller Center, University of Virginia IFEYINWA ASIODU, Associate Professor of Family Health Care Nursing, University of California, San Francisco PAUL BENINGER, Professor of Public Health and Community Medicine, Tufts University ALEXANDER M. CAPRON, University Professor Emeritus, Scott H. Bice Chair Emeritus in Healthcare Law, Policy and Ethics; Professor Emeritus of Law and Medicine, University of Southern California PATRICIA DANZON (resigned from committee September 2023), Celia Moh Professor Emeritus of Healthcare Management, University of Pennsylvania AHIZECHUKWU EKE, Director of Research, Division of Maternal-Fetal Medicine, Johns Hopkins University MARY F. HEBERT, Professor of Pharmacy, Adjunct Professor of Obstetrics and Gynecology, University of Washington LESLIE MELTZER HENRY, Professor of Law, University of Maryland Carey School of Law; Core Faculty, Johns Hopkins Berman Institute of Bioethics PATRICIA A. KING, Professor Emerita of Law, Georgetown University BRUCE KUHLIK, Executive Vice President and General Counsel, Merck & Co., Inc. (Retired) ANNE CC LEE, Associate Professor of Pediatrics, Harvard School of Medicine; Director of Global Newborn Health, Brigham and Women’s Hospital, Harvard Medical School ANNA C. MASTROIANNI, Research Professor in Bioethics and Law, Johns Hopkins Berman Institute of Bioethics; Charles I Stone Professor of Law Emeritus, University of Washington JONELL EFANTIS POTTER, Professor, Clinical Obstetrics, Gynecology and Reproductive Sciences, University of Miami ENRIQUE SCHISTERMAN, Chair of Biostatistics, Epidemiology and Informatics, University of Pennsylvania BROWNSYNE TUCKER EDMONDS, Professor of Obstetrics and Gynecology; Associate Dean for Health Equity Research, Indiana University School of Medicine v A02260_Advancing_Clinical_Research_FM.indd 5 5/13/24 12:44 PM

Study Staff ALEX HELMAN, Study Codirector and Senior Program Officer ANDREW MARCH, Study Codirector and Program Officer CAROLYN SHORE, Senior Program Officer EMILY MCDOWELL, Research Associate RAYANE SILVA-CURRAN, Senior Program Assistant (from August 14, 2023) EDEN NELEMAN, Senior Program Assistant (July 1, 2023–August 11, 2023) MELVIN JOPPY, Senior Program Assistant (until June 30, 2023) REBECCA MORGAN, Senior Research Librarian CLARE STROUD, Senior Board Director, Board on Health Sciences Policy Consultants KAVITA SHAH ARORA, Greenwall Fellow in Bioethics, National Academy of Medicine CHERYL M. KILLION, Distinguished Nurse Scholar-in-Residence, National Academy of Medicine ALLISON M. WHELAN, Assistant Professor, Georgia State University College of Law MARY JO LAMBERTI, Research Associate Professor, Tufts University TALEENA N. NADKARNI, Research Assistant, University of Virginia School of Law AMELIA NELL, Research Assistant, University of Virginia School of Law ERIN HAMMERS FORSTAG, Science Writer vi A02260_Advancing_Clinical_Research_FM.indd 6 5/13/24 12:44 PM

Reviewers This Consensus Study Report was reviewed in draft form by indi- viduals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical com- ments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published report as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We thank the following individuals for their review of this report: FLORENCE T. BOURGEOIS, Harvard Medical School MELINDA J.B. BUNTIN, Johns Hopkins University CHRISTINA CHAMBERS, University of California, San Diego R. ALTA CHARO, University of Wisconsin–Madison LINDA COLEMAN, Yale University RENA M. CONTI, Boston University WILLIAM COOPER, Vanderbilt University NORA FREEMAN ENGSTROM, Stanford Law School RUTH FADEN, Johns Hopkins Berman Institute of Bioethics SANDRA L. KWEDER, Greenleaf Health, Inc. ANNE DRAPKIN LYERLY, University of North Carolina at Chapel Hill vii A02260_Advancing_Clinical_Research_FM.indd 7 5/13/24 12:44 PM

viii REVIEWERS CATHERINE Y. SPONG, University of Texas Southwestern Medical Center ALISON M. STUEBE, University of North Carolina JILL WADLUND, Berkley Life Sciences (Retired ) KIRKE D. WEAVER, Organon Although the reviewers listed above provided many constructive com- ments and suggestions, they were not asked to endorse the conclusions or recommendations of this report nor did they see the final draft before its release. The review of this report was overseen by BRUCE N. CALONGE, University of Colorado School of Medicine, and ELLEN W. CLAYTON, Vanderbilt University Medical Center. They were responsible for making certain that an independent examination of this report was carried out in accordance with the standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the authoring committee and the National Academies. A02260_Advancing_Clinical_Research_FM.indd 8 5/13/24 12:44 PM

Acknowledgments To begin, the committee would like to thank the sponsor of this study. Funds for the committee’s work were provided by the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institutes of Health. Numerous individuals and organizations made important contri- butions to the study process and this report. The committee wishes to express its gratitude for each of these contributions, although space does not permit identifying them all here. The committee wishes to express special thanks to Hogan Lovells US LLP and Goodwin Procter LLP for their significant pro bono contri- butions to this report. At Hogan Lovells, the committee thanks Lauren S. Colton, Katherine Kramer, Megan Dorsh, and Phil Katz for rapidly producing a comprehensive analysis of the case law (Appendix B). The committee appreciates the contributions of Taleena Nadkarni and Amelia Nell for their synthesis and analysis of state statutes with implications for research including pregnant and lactating women (Appendix C available online at https://nap.nationalacademies.org/catalog/27595). The commit- tee thanks Sarah Wicks, Julie Tibbets, Elizabeth Caruso, Emily Tribulski, and Elizabeth Mulkey of Goodwin Procter LLP for their detailed, critical analysis of the U.S. Food and Drug Administration rules, regulations, and guidance pertaining to pregnant and lactating women (Appendix D available online at https://nap.nationalacademies.org/catalog/27595). The committee appreciates the contributions of Allison Whelan for her analy- sis on the impacts of Dobbs v. Jackson Women’s Health Organization on ix A02260_Advancing_Clinical_Research_FM.indd 9 5/13/24 12:44 PM

x ACKNOWLEDGMENTS clinical research with pregnant and lactating women (Appendix E avail- able online at https://nap.nationalacademies.org/catalog/27595). The committee would also like to thank the two National Academy of Medicine fellows, Drs. Kavita Shah Aurora and Cheryl M. Killion, for their contributions throughout its work. The committee would also like to acknowledge Erin Hammers Forstag for her writing contributions. A02260_Advancing_Clinical_Research_FM.indd 10 5/13/24 12:44 PM

Contents PREFACE xv SUMMARY 1 1 I NTRODUCTION 17 The Human Costs of Inadequate Data, 18 Circumstances That Have Led to Inadequate Data to Guide Medical Decision Making, 25 The Social Value of Clinical Research, 27 Study Background, 30 Committee Task and Approach, 31 References, 41 2 LEGAL LIABILITY 49 A Survey of Reported Legal Liability Risk, 52 Perceived Liability, 61 Law and Liability in Clinical Research, 63 Conclusions, 76 References, 76 3 STRATEGIES TO REDUCE HARM THROUGH CLINICAL RESEARCH 81 Introduction to the Medical Product Development Pathway, 83 Reducing Harm Through FDA Regulations and Guidance, 89 xi A02260_Advancing_Clinical_Research_FM.indd 11 5/13/24 12:44 PM

xii CONTENTS Reducing Harm Through Federal Protections for Human Subjects, 104 Reducing Harm Through Research Design, 109 Conclusions, 116 References, 117 4 MITIGATING LIABILITY ASSOCIATED WITH CLINICAL RESEARCH 123 Mitigating Liability for Industry Sponsors, 124 Mitigating Liability for Institutions, IRBs, and Investigators, 127 Mitigating Liability for Sponsors, Research Institutions, and Investigators, 133 Mitigating Criminal and Civil Liability for Pregnant Research Participants, 139 Conclusions, 143 References, 143 5  DISSUASIVE AND PERSUASIVE FACTORS FOR THE INCLUSION OF PREGNANT AND LACTATING WOMEN IN CLINICAL RESEARCH 149 Factors That Dissuade Sponsors and Investigators from Including Pregnant and Lactating Women in Research, 150 Factors That Incentivize the Inclusion of Pregnant and Lactating Women, 160 Conclusions, 171 References, 172 6 RECOMMENDATIONS 179 Provide Greater Regulatory Clarity, 180 Provide Incentives, Funding, and Accountability for Research, 187 Improve Existing Data and Safety Monitoring, 198 Protect Research Participants’ Privacy, 201 References, 203 APPENDIXES A Public Meetings Agendas 207 B Commissioned Paper: Scope of Liability Related to Pharmaceuticals Dispensed to Pregnant and Lactating Women 217 A02260_Advancing_Clinical_Research_FM.indd 12 5/13/24 12:44 PM

Boxes, Figure, and Tables BOXES 1-1 Common Conditions and Treatments in Pregnancy, 21 1-2 Physiological Changes and the Implications for Use of Medications, 22 1-3 Global Efforts for Broader Inclusion of Pregnant and Lactating Women in Research, 27 1-4 Statement of Task, 32 1-5 Medical Product Development for Conditions Specific to Pregnancy and Lactation, 34 1-6 Relevant Stakeholders and Their Roles, 37 2-1 The Long Shadow of Thalidomide and DES, 60 2-2 Theories of Liability: Terms and Definitions, 64 3-1 Data Safety Monitoring Boards, 91 3-2 FDA’s PDUFA VII Commitments, 105 3-3 Successes of HIV Research in Pregnant and Lactating Women, 110 4-1 National Vaccine Injury Compensation Fund, 135 5-1 NIH Initiatives in Pregnancy and Lactation Research, 161 5-2 Best Pharmaceuticals for Children Act and Pediatric Research Equity Act, 167 xiii A02260_Advancing_Clinical_Research_FM.indd 13 5/13/24 12:44 PM

xiv BOXES, FIGURE, AND TABLES FIGURE 3-1 Phase 1: Dose escalation, 86 TABLES 3-1 Developmental and Reproductive Toxicology (DART) Studies, 85 3-2 Common Parameters of Studies Conducted During Clinical Development, 87 A02260_Advancing_Clinical_Research_FM.indd 14 5/13/24 12:44 PM

Preface My three children were born between 1990 and 2000. I was extremely fortunate that my overall health was good and that I had few health issues during my pregnancies and later when nursing my children. Even as a healthy pregnant and lactating woman, I had so many questions for my doctors. I wanted to know how certain medications might affect me or my fetus and later my infant. I was frustrated when my doctors could not answer my questions with confidence. I worried. Between the time my first child was born in 1990 and the third was born in 2000, the clinical research landscape changed dramatically. In 1990, most research participants in the United States were White men. By 2000, the human subjects research laws and regulations were changed to encourage the participation of women, including women of childbear- ing potential, and efforts had been made to improve the ethnic diversity of research participants. Soon after, legislation was passed to promote clinical research with pediatric populations to study medications that were used by children. There is still much work to be done to improve the diversity of our research populations, but as a society, we have made progress gathering and acknowledging the value of collecting evidence about how medical treatments may affect women, children, and people of different races and ethnicities. One thing has not changed: there is still a dearth of data about the appropriate dosage, efficacy, and safety of most medical interventions used by pregnant and lactating women. This stood out during our experi- ence with the COVID-19 pandemic. Despite broad liability protections for xv A02260_Advancing_Clinical_Research_FM.indd 15 5/13/24 12:44 PM

xvi PREFACE medical product manufacturers, health care providers, and others, preg- nant and lactating women were not included in the preauthorization clini- cal trials for vaccines. Although their exclusion from research has since been remedied, for months these populations were without evidence of their safety and efficacy and ultimately reducing vaccine uptake in these populations. If my daughter were to become pregnant now, she would likely have the same kind of unanswered questions for her doctors that I had when I was pregnant with her. Despite a national and international consensus that avoiding research involving pregnant and lactating women is causing real harm, concerns about potential liability continue to thwart efforts to expand that research. No one has deeply studied the assumptions and realities behind those concerns about liability. This committee has done a thorough examination of the forces—legal, financial, and cultural—that disincentivize research with pregnant and lactating women. The committee provides evidence that conducting clinical studies with pregnant and lactating populations is not currently fraught with liability and how such research can—and must—be done safely and well. Our committee is indebted to the work of the U.S. Department of Health and Human Services Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC Task Force), which provided foundational knowledge for this committee to build from and which recommended that such a committee as ours be established. I am also grateful to the many experts who shared their knowledge of the complex legal and clinical landscapes in our public meetings and to the outstand- ing people who created our four commissioned papers. I am particularly grateful to the National Academies of Sciences, Engineering, and Medi- cine staff, led by Alex Helman and Andrew March, who provided guid- ance and expertise as well as thousands of hours of supporting research and editing. Finally, I am grateful to have worked with an amazing group of committed experts on this consensus committee, many of whom have devoted their entire careers to improving health for pregnant and lactat- ing women. Everyone generously volunteered countless hours and gave up more than one holiday to create a report that aims to finally answer these concerns about liability. In the process, we had hours of robust con- versation and had friendly but probing disagreements. We taught each other concepts of regulatory science, medicine, business, law, and ethics. And in the end, we found agreement and solutions, all in a mission to support the millions of pregnant and lactating women who, in a very real sense, represent the future of this country. Many of the people on this committee and those who have supported its work have been waiting for decades to see pregnant and lactating A02260_Advancing_Clinical_Research_FM.indd 16 5/13/24 12:44 PM

PREFACE xvii women appropriately supported through clinical research. The United States’ current record on maternal and newborn health is weak and unworthy of a country that is capable of scientific and medical wonders. It is my hope that as you read the report, you will sense the urgency of its key messages and find a way to act on them, whatever your role may be in the clinical research enterprise. Our recommendations are compre- hensive, but they are far from daunting. I hope that in the coming decade, if my children and their partners choose to join the millions of pregnant and lactating women each year in the United States, that they will do so with confidence that the medical treatments they may need are as safe and effective as possible. Margaret Foster Riley, Chair Committee on Developing a Framework to Address Legal, Ethical, Regulatory, and Policy Issues for Research Specific to Pregnant and Lactating Persons A02260_Advancing_Clinical_Research_FM.indd 17 5/13/24 12:44 PM

A02260_Advancing_Clinical_Research_FM.indd 18 5/13/24 12:44 PM

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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.

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