About

Anna Mastroianni, JD, MPH, joined the Johns Hopkins Berman Institute of Bioethics in 2022 as a Research Professor in Bioethics and Law. Her scholarly work is widely published and examines complex issues at the intersection of law, bioethics, public health, and health policy, with special emphasis on the legal and ethical challenges arising in research in pregnancy, the use of genetic technologies in public health, reproductive rights, and family building through assisted reproductive technologies. She is the executive producer (with Jeffrey Kahn) of the bioethics podcast 'playing god?' and co-investigator of the Berman Institute’s oral history project, 'Moral Histories: Voices of the Founders of Bioethics.' Professor Mastroianni is also a Charles I. Stone Emerita Professor of Law at the University of Washington, where she served as associate director of the Institute for Public Health Genetics and held faculty appointments in the School of Public Health and the School of Medicine. Her background includes practicing law and serving in legal and governmental policy positions in Washington, D.C., such as Staff Director of the White House Advisory Committee on Human Radiation Experiments and Study Director for the National Academy of Medicine. She is an elected Fellow of The Hastings Center and the American Association for the Advancement of Science, recognized for her contributions to health policy, law, and bioethics. Her education includes a BA in Spanish and Portuguese, a BS in Economics, and a JD from the University of Pennsylvania, as well as an MPH from the University of Washington.

Research topics

• Medicine
• Biology
• Social Science
• Political Science
• Sociology
• Engineering ethics
• Intensive care medicine
• Psychology
• Medical education
• Virology
• Pathology
• Engineering
• Public relations
• Family medicine
• Law

Selected publications

• Advancing maternal and perinatal health through clinical trials: key insights from a WHO global consultation

  The Lancet Global Health · 2025-03-28 · 15 citations

  reviewOpen access

  Pregnant and lactating women have long been excluded from participation in clinical research. This exclusion has resulted in the absence of high-quality evidence on the effectiveness and safety of medical products (medicines, vaccines, and other biological or biomedical products) during pregnancy and lactation, and fragmented health policies and practice recommendations. Based on the discussions at the inaugural WHO Global Clinical Trials Forum in November, 2023, a rapid review of key global, regional, or national ethical and regulatory documents, and previous expert consultations, this paper aims to summarise obstacles and suggest opportunities for appropriate inclusion of pregnant and lactating women in clinical trials. The main challenges identified relate to issues of: trial design; inconsistent interpretation and implementation of ethical, regulatory, and legal guidance; high costs of trials and low return on investments; insufficient research capacity and funding opportunities; misinformation; and insufficient community engagement. Appropriate inclusion is necessary and possible through: multi-stakeholder coordination; alignment with governance bodies to streamline ethical, regulatory, and legal processes for trial conduct; advocacy to prioritise investments in research; stronger focus on capacity strengthening; and good participatory practice that includes women and communities. A paradigm shift towards more inclusive and integrated research methodologies is urgently needed. This shift extends beyond pregnancy to transform the overall trial ecosystem and prioritise the health and wellbeing of all women and their infants everywhere, to truly achieve equitable access to health and innovations and leave no one behind.

  PublisherDOI

• Bright‐Line Policy and the Future of the Fourteen‐Day Rule

  The Hastings Center Report · 2025-09-01

  articleOpen access1st authorCorresponding

  As global science leaders revisit the fourteen-day rule for human embryo research, this commentary explores why its clarity, stability, and the public trust it has fostered have made it a notable success in science policy-and why any change must be approached with care.

  PublisherOA PDFDOI

• Opportunities to Advance Maternal Immunization Research

  The Pediatric Infectious Disease Journal · 2025-02-01

  review1st authorCorresponding

  In the last decade, there has been a notable surge in efforts to address longstanding obstacles to the conduct of clinical trials during pregnancy. This brief report draws attention to recent initiatives in vaccine and pregnancy-related research and highlights opportunities for researchers and clinicians to advance maternal immunization research, benefiting the health of pregnant women, fetuses and neonates.

  PublisherDOI

• Blurring Boundaries: A Proposed Research Agenda for Ethical, Legal, Social, and Historical Studies at the Intersection of Infectious and Genetic Disease.

  UNC Libraries · 2024-10-31

  articleOpen accessSenior author

  Contemporary understanding of the mechanisms of disease increasingly points to examples of "genetic diseases" with an infectious component and of "infectious diseases" with a genetic component. Such blurred boundaries generate ethical, legal, and social issues and highlight historical contexts that must be examined when incorporating host genomic information into the prevention, outbreak control, and treatment of infectious diseases.

  PublisherDOI

• Blurring Boundaries: A Proposed Research Agenda for Ethical, Legal, Social, and Historical Studies at the Intersection of Infectious and Genetic Disease

  The Journal of Law Medicine & Ethics · 2024-01-01

  articleOpen access

  Contemporary understanding of the mechanisms of disease increasingly points to examples of "genetic diseases" with an infectious component and of "infectious diseases" with a genetic component. Such blurred boundaries generate ethical, legal, and social issues and highlight historical contexts that must be examined when incorporating host genomic information into the prevention, outbreak control, and treatment of infectious diseases.

  PublisherOA PDFDOI

• The Ethics of Repurposing Previously Collected Research Biospecimens in an Infectious Disease Pandemic

  2021-01-01

  article

  In the early days of a pandemic, repurposing bio-specimens from established research projects could prove to be extraordinarily useful in achieving substantial and timely public health benefits. Nonetheless, there are potential ethical and regulatory uncertainties that may impede access to those valuable bio-specimens. In this article, we argue that there should be a presumption in favor of using previously collected identifiable research bio-specimens without reconsent to directly address an infectious disease pandemic, assuming certain conditions are met. This argument fills a unique yet critical gap in decision‐making where the specific consent accompanying the identifiable bio-specimens would not otherwise permit repurposing. Further, it suggests that even if gaining reconsent is feasible, doing so in a fast‐moving crisis is not necessary. This analysis also attempts to address the ethical concerns of public health authorities who already may have the power to use such specimens but are reluctant to do so.

• The Ethics of Repurposing Previously Collected Research Biospecimens in an Infectious Disease Pandemic

  Ethics & Human Research · 2021 · 7 citations

  • Political Science
  • Political Science
  • Engineering ethics

  In the early days of a pandemic, repurposing biospecimens from established research projects could prove to be extraordinarily useful in achieving substantial and timely public health benefits. Nonetheless, there are potential ethical and regulatory uncertainties that may impede access to those valuable biospecimens. In this article, we argue that there should be a presumption in favor of using previously collected identifiable research biospecimens without reconsent to directly address an infectious disease pandemic, assuming certain conditions are met. This argument fills a unique yet critical gap in decision-making where the specific consent accompanying the identifiable biospecimens would not otherwise permit repurposing. Further, it suggests that even if gaining reconsent is feasible, doing so in a fast-moving crisis is not necessary. This analysis also attempts to address the ethical concerns of public health authorities who already may have the power to use such specimens but are reluctant to do so.

  PublisherOA PDFDOI

• Epidemiology and Informed Consent

  2021-08-05

  book-chapter1st authorCorresponding

  Abstract This chapter focuses on informed consent, which is a central concept and practice in the protection of the rights and interests of both patients receiving clinical care and individuals participating in research. It addresses the commitment to the ethical principles underlying informed consent that dates back to the early twentieth century, as reflected in many countries' laws governing the physician–patient relationship. It also recounts how informed consent was codified into national policies and international guidelines and standards for research on human subjects. The chapter explores the parallel origins of informed consent and its applications, which are based on distinctions between clinical practice and research and do not naturally apply to or readily translate to epidemiology. It outlines the requirements for consent that have been and are treated differently in epidemiology depending on the type of activity and sometimes the practicability of seeking consent from participants.

  PublisherDOI

• Public Health Ethics

  Oxford University Press eBooks · 2020-03-01

  book-chapter

  This chapter, which grew out of a Greenwall Foundation–funded working group of a dozen or so ethicists, lawyers, and public health practitioners, provides a rough conceptual map of the terrain of public health ethics. It examines the nature of public health and public health interventions, and it identifies a number of general moral considerations (principles) relevant to public health policy and practice and often, especially as articulated in basic human rights, promotive of public health. Because these moral considerations are general and broad, they require specification and weighting. In cases of conflict, five “justificatory conditions” need to be met: effectiveness, proportionality, necessity, least infringement, and public justification. These conditions help to determine whether protecting or promoting public health warrants overriding individual liberty in particular situations.

  PublisherDOI

• The Pathway Forward: Insights on Factors that Facilitate Research with Pregnant Women

  Ethics & Human Research · 2020 · 6 citations

  1st authorCorresponding
  • Sociology
  • Social Science
  • Medicine

  The near-routine exclusion of pregnant women from clinical research has resulted in evidence gaps that endanger the health of pregnant women and their future offspring. Although existing literature documents numerous obstacles along the clinical trial pathway that can stymie research involving pregnant women, there is little guidance on how to facilitate such research. This qualitative study aims to fill that void by examining the experiences of individuals involved in conducting, approving, or overseeing research involving pregnant women at one academic institution. The study identifies factors throughout the clinical pathway-from protocol development, to IRB review, and ultimately trial execution-that likely contribute to the successful conduct of research with pregnant women. Attention to those factors, coupled with agreement among stakeholders that research with pregnant women should and can be done ethically and legally, is critical to shifting the narrative from "why we cannot" do such research to "how we can."

  PublisherDOI

Frequent coauthors

• Ruth Faden

  Johns Hopkins University

  66 shared

• Jeffrey Kahn

  53 shared

• Leslie Meltzer Henry

  University of Maryland, Baltimore

  43 shared

• Margaret Olivia Little

  28 shared

• Kristen Sullivan

  26 shared

• R. Jean Cadigan

  26 shared

• Emily Namey

  Family Health International 360

  26 shared

• Daniel D. Federman

  26 shared

Awards & honors

• Fellow of The Hastings Center
• Fellow of the American Association for the Advancement of Sc…