About

Ruth R. Faden, PhD, MPH, is the founder of the Johns Hopkins Berman Institute of Bioethics and served as its director from 1995 until 2016. She is the inaugural Philip Franklin Wagley Professor of Biomedical Ethics and was the inaugural Andreas C. Dracopoulos Director from 2014 to 2016. Under her leadership, the Berman Institute transformed from an informal faculty interest group into one of the world’s premier bioethics programs, with over 35 faculty, 30 staff, and more than 100 alumni. She secured a significant endowment, including six endowed professorships and an endowed directorship, and established the Institute as a university-wide unit reporting to the Provost. Her scholarly work focuses on bioethics, with key contributions in social justice, informed consent, structural injustice, and public health policy. Her current research emphasizes structural justice theory, global health challenges, learning health systems, women’s health, and the rights of pregnant women. She has authored and edited numerous books and articles, including her latest book, 'Structural Injustice: Power, Advantage, and Human Rights,' forthcoming in early 2024. Dr. Faden is an elected member of the National Academy of Medicine, a Fellow of the Hastings Center and the American Psychological Association, and has served on various national advisory committees, including chairing President Clinton’s Advisory Committee on Human Radiation Experiments. She co-launched the Global Food Ethics and Policy Program, co-founded the Hinxton Group on stem cell ethics, and the Second Wave initiative to promote fair representation of pregnant women’s health interests in biomedical research.

Research topics

• Medicine
• Political Science
• Law
• Internal medicine
• Marketing
• Biology
• Public relations
• Obstetrics
• Psychology
• Nursing
• Virology
• Business
• Economics

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

• Testing an experimental vaccine during a public health emergency: Lessons from a Peruvian case

  Vaccine · 2025-04-24 · 1 citations

  articleOpen access

  The Peruvian Government searched for a vaccine as a response to COVID-19. A clinical trial evaluating an inactivated SARS-CoV-2 vaccine was approved. A national news program revealed that Peru's president had received the vaccine outside the clinical trial, generating a national protest. The Peruvian National Academy of Medicine created a commission to identify improper procedures and provide guidance on how to prevent a similar case in the future. Commission members reviewed all publicly available documents and information sources and generated a final report. There were 6 ethical principles violations: 1) 3200 vaccine doses were used to vaccinate individuals outside the clinical trial; 2) prominent individuals were vaccinated outside of the clinical trial; 3) study conduct was monitored by a contract research organization with a conflict of interest; 4) an additional study was conducted with the vaccine without an approved protocol; 5) the placebo-controlled trial was continued when an approved vaccine was available; and 6) results of the clinical trial were not released. There were 5 regulatory procedures ignored: 1) no clinical trial supervision by a high-quality clinical monitoring agency outside Peru; 2) a university acting as a sponsor of a vaccine produced by a foreign company; 3) expedited reviews and approvals; 4) lack of adequate supervision by local regulatory bodies and the study contract research organization (CRO); and 5) no input from the Data Safety Monitoring Board. The COVID-19 health emergency created an environment where existing regulatory and ethical principles were circumvented under political pressure. Regulatory bodies and agencies should inform countries of the dangers of conducting clinical trials during a public health emergency and proper ethical and regulatory procedures should be followed. • Testing an experimental SARS-CoV-2 vaccine, as a response to the COVID-19 in Peru, included vaccinating individuals not participating in the vaccine trial. • The Peruvian Academy of Medicine created a commission to identify what was not done properly and recommend how to prevent a similar case in the future. • Six ethical principles were violated, and 5 regulatory procedures were not done properly. • Testing an experimental vaccine during a sanitary emergency, under high political pressure, creates and environment where existing regulatory procedures and ethical principles can be circumvented.

  PublisherDOI

• The need for inclusion of pregnant women in COVID-19 vaccine trials

  UNC Libraries · 2025-05-16

  articleOpen access
  PublisherDOI

• Under-Funded and Under-Pressure: State Epidemiologists During the COVID-19 Response

  Disaster Medicine and Public Health Preparedness · 2025-01-01

  articleOpen access

  OBJECTIVES: We conducted interviews with state epidemiologists involved in the state-level COVID-19 response to understand the challenges and opportunities that state epidemiologists and state health departments faced during COVID-19 and consider the implications for future pandemic responses. METHODS: As part of a broader study on policymaking during COVID-19, we analyzed 12 qualitative interviews with state-epidemiologists from 11 US states regarding the challenges and opportunities they experienced during the COVID-19 response. RESULTS: Interviewees described the unprecedented demands COVID-19 placed on them, including increased workloads as well as political and public scrutiny. Decades of under-funding and constraints posed particular challenges for meeting these demands and compromised state responses. Emergency funding contributed to ameliorating some challenges. However, state health departments were unable to absorb the funds quickly, which created added pressure for employees. The emergency funding also did not resolve longstanding resource deficits. CONCLUSIONS: State health departments were not equipped to meet the demands of a comprehensive COVID-19 response, and increased funding failed to address shortfalls. Effective future pandemic responses will require sustained investment and adequate support to manage on-going and surge capacity needs. Increased public interest and skepticism complicated the COVID-19 response, and additional measures are needed to address these factors.

  PublisherOA PDFDOI

• Global disparities in public health guidance for the use of COVID-19 vaccines in pregnancy

  UNC Libraries · 2025-04-24

  articleOpen access

  INTRODUCTION: Gaps in information about the safety and efficacy of COVID-19 vaccines in pregnancy have led to substantial global variation in public health guidance regarding the use of COVID-19 vaccines in pregnancy over the course of the pandemic. METHODS: We conducted systematic screenings of public health authorities' websites across 224 countries and territories every 3 weeks to track the development of policies on COVID-19 vaccine use in pregnancy. Policies were categorised using a 1-5 permissiveness scale, with 1 indicating policies that recommended use, and 5 indicating policies that recommended against use. RESULTS: As of 30 September 2021, 176 countries/territories had issued explicit guidance on COVID-19 vaccine use in pregnancy, with 38% recommending use, 28% permitting use, 15% permitting use with qualifications, 2% not recommending but with exceptions, and 17% not recommending use whatsoever. This represented a significant shift from May 2021, when only 6% of countries/territories with such policies recommended the use of COVID-19 vaccines in pregnancy (p<0.001). However, no policy positions could be found for 21% of all countries and territories, the vast majority being low and middle income. Policy positions also varied widely by vaccine product, with Pfizer/BioNTech and Moderna vaccines being most commonly recommended or permitted. CONCLUSION: Our study highlights the evolution of policies regarding COVID-19 vaccine use in pregnancy over a 5-month period in 2021, the role of pregnancy-specific data in shaping these policies and how inequities in access for pregnant people persist, both within countries and globally.

  PublisherDOI

• Women’s views about contraception requirements for biomedical research participation

  UNC Libraries · 2025-07-23

  articleOpen access

  The scientific and ethical importance of including women of reproductive age in biomedical research is widely acknowledged. Concerns about preventing fetal exposure to research interventions have motivated requirements for contraception among reproductive aged women in biomedical studies-often irrespective of risks and benefits or a woman's actual potential for pregnancy, raising important questions about when such requirements are appropriate. The perspectives of women themselves on these issues are largely unexplored. We conducted 140 interviews, 70 in the U.S. and 70 in Malawi, with women either living with or at-risk for HIV, exploring their views about the practice of requiring contraception in clinical trials. A majority of women interviewed from both countries indicated overall support for the practice, with seven themes characterizing advantages and disadvantages raised: reproductive control, health effects, prevention of fetal harm, burden on women, deferral to authority, autonomy regarding enrollment and birth control method, and relationship concerns. While women in the US frequently raised prevention of fetal harm as a key advantage, many other positives noted by women in both countries were related to contraception use in general, not specific to a trial context. With regard to disadvantages, U.S. women tended to focus on biomedical risks such as side effects and impact on fertility, whereas Malawian women focused on the social risks of contraception requirements, including violations of trust in marital relations and suspicions of potential infidelity. Given the potential benefits and burdens highlighted, contraception in research should be sensitive to actual fetal risk assessments; directed where justified at optimizing effective pregnancy prevention; responsive to women's reproductive preferences; and made available as an ancillary benefit even where risk thresholds do not justify requirement-in order to facilitate trials that are both ethical and robustly oriented around the interests and lives of women who will participate in them.

  PublisherDOI

• Views From State-Level Policy Actors About the US Federal Government COVID-19 Response

  Health Security · 2025-02-01 · 1 citations

  articleOpen accessSenior author

  The United States takes a federalist approach to pandemic responses while the bulk of pandemic powers sits at the state level. Thus, comprehensive accounts of how state health officials managed the crisis and how the federal government affected those efforts are needed to better understand the governmental response to the COVID-19 pandemic. This article reports the results of semistructured interviews with 29 state-level policy actors from 16 US states. Interviewees discussed multiple aspects of the US federal COVID-19 response that affected the response in their states, including communications with the public, intergovernmental communications, and federal actions regarding various aspects of health service preparedness including emergency funding, procurement, testing capacity, vaccine development and distribution, and data systems. This research enriches the discussion about US pandemic preparedness and response, and indicates that alignment of public communications across government levels, enhanced intergovernmental communication, inclusion of rural perspectives, and federal investment in and sustainment of health service preparedness are key factors that can improve future US pandemic responses.

  PublisherDOI

• Gender equity and COVID-19 vaccine policies for pregnant people: a global analysis

  International Journal for Equity in Health · 2025-05-07 · 3 citations

  articleOpen accessSenior author

  BACKGROUND: Despite increasing vaccine availability and evidence and expert recommendations to support administration, some countries maintained restrictive policies regarding COVID-19 vaccination in pregnancy throughout the pandemic. This global analysis explores the role of gender equity, country income level, and vaccine availability in predicting national policies on COVID-19 vaccine administration in pregnancy. METHODS: Policies were collected from May 2021 to January 2023 from 224 countries/territories using publicly available information posted on national public health authority web pages. Policies were categorized into 6 types, representing different levels of permissiveness, from recommended for some or all to not recommended, and changes in national policies were captured over time. Outcomes were defined as: 1) prevalence of restrictive policies at a specific time point; 2) country-level change from restrictive policy/no position at an earlier time point to a permissive policy at a later timepoint. Simple and multivariable logistic regressions were performed to explore the association between the outcomes and potential policy predictors, including income level, mRNA vaccine availability, and the Global Gender Gap Index (GGGI). RESULTS: Complete cross-sectional data were available for 114 countries as of June 2021, 137 countries as of October 2021, and 142 countries as of March 2022. The number of maternal immunization policies increased and became steadily more permissive between 2021 and 2022. Availability of mRNA vaccines and higher income level were associated with reduced odds of a restrictive policy at the 2021 timepoints, and higher GGGI scores were associated with reduced odds of restrictive policies at all timepoints. After adjusting for income level and mRNA vaccine availability, higher GGGI scores reduced the relative odds of a restrictive COVID-19 vaccine policy by 10% (aOR: 0.90, 95CI: 0.81, 0.99) in October 2021 and 14% (aOR: 0.86, 95%CI: 0.76, 0.97) in March 2021. Higher GGGI scores were also associated with increased odds of a policy switch from restrictive/no position in June 2021 to permissive in October 2021 (aOR: 1.12, 95%CI: 1.00, 1.24). CONCLUSIONS: Gender inequity was associated with greater odds of a restrictive policy for use of COVID-19 vaccines in pregnancy, suggesting that gender biases may influence fair policymaking for pregnant people in pandemic preparedness and response.

  PublisherOA PDFDOI

• Prioritization of pregnant individuals in state plans for coronavirus disease 2019 vaccination

  UNC Libraries · 2025-06-10

  articleOpen accessSenior author
  PublisherDOI

• ‘Staying in the lane’ of public health? Boundary‐work in the roles of state health officials and experts in COVID‐19 policymaking

  Sociology of Health & Illness · 2024-01-17 · 6 citations

  articleOpen access

  The state-level COVID-19 response in the United States necessitated collaboration between governor' offices, health departments and numerous other departments and outside experts. To gain insight into how health officials and experts contributed to advising on COVID-19 policies, we conducted semi-structured interviews with 25 individuals with a health specialisation who were involved in COVID-19 policymaking, taking place between February and December 2022. We found two diverging understandings of the role of health officials and experts in COVID-19 policymaking: the role of 'staying in the lane' of public health in terms of the information that they collected, their advocacy for policies and their area of expertise and the role of engaging in the balancing of multiple considerations, such as public health, feasibility and competing objectives (such as the economy) in the crafting of pandemic policy. We draw on the concept of boundary-work to examine how these roles were constructed. We conclude by considering the appropriateness as well as the ethical implications of these two approaches to public health policymaking.

  PublisherOA PDFDOI

Recent grants

• NIH Grant R01HD024816

  NIH · $902k · 1993

• NIH Grant R01HG001086

  NIH · $986k · 2000

Frequent coauthors

• Jeremy Sugarman

  156 shared

• Christine Grady

  National Institutes of Health Clinical Center

  102 shared

• Dale E. Hammerschmidt

  University of Minnesota Medical Center

  102 shared

• Lisa Eckenwiler

  102 shared

• Carol Levine

  United Hospital Fund

  102 shared

• Nancy E. Kass

  Johns Hopkins University

  101 shared

• Carleigh Krubiner

  Wellcome Trust

  69 shared

• Anna C. Mastroianni

  Johns Hopkins University

  66 shared

Awards & honors

• Lifetime Achievement Awards from the American Society for Bi…