About

Nancy E. Kass, ScD, is the Phoebe R. Berman Professor of Bioethics and Public Health at Johns Hopkins University. She serves as the Deputy Director for Public Health at the Johns Hopkins Berman Institute of Bioethics and is also a Professor of Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health. Her research focuses on empirical work in bioethics and health policy, with publications primarily in U.S. and international research ethics, HIV/AIDS ethics policy, public health ethics—including ethics related to obesity prevention and public health preparedness—and ethics within the learning healthcare system. Dr. Kass has held roles such as Vice-Provost for Graduate Education at Johns Hopkins and has served as a consultant to various national and international bodies, including the President’s Advisory Committee on Human Radiation Experiments, the National Bioethics Advisory Commission, and the National Academy of Sciences. She is also involved in developing ethical guidance for infectious disease outbreaks and improving informed consent in human research. Her academic background includes a BA from Stanford University, a ScD from Johns Hopkins Bloomberg School of Public Health, and post-doctoral training at the Kennedy Institute of Ethics, Georgetown University. Dr. Kass is an elected member of the Institute of Medicine (now National Academy of Medicine) and a Fellow of the Hastings Center.

Research topics

• Political Science
• Medicine
• Virology
• Business
• Law
• Nursing
• Environmental health
• Public relations
• Pathology
• Risk analysis (engineering)

Selected publications

• Health Research Ethics in Southern Africa: Building Capacity and Cultivating Excellence

  Journal of Empirical Research on Human Research Ethics · 2025-06-30 · 2 citations

  articleOpen access

  The health research landscape in southern Africa is becoming increasingly complex as research efforts intensify to address the region's significant disease burden. The increasing volume and complexity of health research in low- and middle-income countries (LMICs) highlights the ongoing need for enhanced research ethics capacity. To supplement a review published in 2014, this paper provides an overview of research ethics capacity-building initiatives supported through substantive long-term competitive awards from the Fogarty International Center of the US National Institutes of Health between 2014 and 2024. These programs aimed to enhance the capabilities of research ethics committees (RECs) and strengthen research ethics capacity throughout Southern Africa, with broader benefits to the African continent and globally as collaborative health research increases. The programs have successfully developed and delivered comprehensive research ethics curricula tailored to research ethics concerns in the region. Trainees and graduates include clinicians, researchers, REC members, REC administrators, lawyers, and ethicists, with focused efforts to ensure gender parity. This increased representivity of scholars has improved the membership on RECs and in skilled research ethics leadership in the region. For the benefit of future planning, this paper also describes some of the many challenges faced in delivering on program goals - including COVID-19. We also describe innovative solutions developed to address these challenges and meet the needs of students, faculty and institutions, while cultivating excellence in health research ethics. The paper concludes by highlighting areas for future research, underscoring the importance of continued diverse global investment in research ethics capacity to protect research participants and maintain and improve ethical standards and practice in health research within the region and globally. This will enable the development of innovative evidence-based global health solutions based on ethical research.

  PublisherDOI

• Experiences of participants in ETEC controlled human infection model studies

  PLoS ONE · 2025-12-22

  articleOpen access

  BACKGROUND: Controlled human infection model (CHIM) studies raise ethical issues due to intentional exposure of healthy volunteers to a pathogen. In this study we examine the experiences of participants who have chosen to participate in enterotoxigenic Escherichia coli (ETEC) CHIM studies in a single research center. METHODS: An interviewer-administered paper-based survey was conducted with participants in an ETEC CHIM study at the Center for Immunization Research (CIR) from 2009-2020. We analyzed participant characteristics, study experiences, and perceived risks before and after study participation. RESULTS: 48 participants in ETEC studies were interviewed. 81.3% of participants identified as Black or African American, 43.8% completed at most high school, and 39.6% of interviewees had incomes of less than $18,500 in the last year. Most respondents enjoyed participating and were glad they joined. Participants most frequently identified interactions with research staff, compensation, and food quality as the most positive aspects of their experiences. There was a significant reduction in the perceived risk of the ETEC study after completing participation compared to perceived risk before joining. CONCLUSIONS: Despite the expected side effects of ETEC CHIM studies, most participants believe the benefits outweigh the risks and would participate again.

  PublisherDOI

• Health Research Ethics in Southern Africa: Building Capacity and Cultivating Excellence.

  UNC Libraries · 2025-07-10

  articleOpen access

  The health research landscape in southern Africa is becoming increasingly complex as research efforts intensify to address the region's significant disease burden. The increasing volume and complexity of health research in low- and middle-income countries (LMICs) highlights the ongoing need for enhanced research ethics capacity. To supplement a review published in 2014, this paper provides an overview of research ethics capacity-building initiatives supported through substantive long-term competitive awards from the Fogarty International Center of the US National Institutes of Health between 2014 and 2024. These programs aimed to enhance the capabilities of research ethics committees (RECs) and strengthen research ethics capacity throughout Southern Africa, with broader benefits to the African continent and globally as collaborative health research increases. The programs have successfully developed and delivered comprehensive research ethics curricula tailored to research ethics concerns in the region. Trainees and graduates include clinicians, researchers, REC members, REC administrators, lawyers, and ethicists, with focused efforts to ensure gender parity. This increased representivity of scholars has improved the membership on RECs and in skilled research ethics leadership in the region. For the benefit of future planning, this paper also describes some of the many challenges faced in delivering on program goals - including COVID-19. We also describe innovative solutions developed to address these challenges and meet the needs of students, faculty and institutions, while cultivating excellence in health research ethics. The paper concludes by highlighting areas for future research, underscoring the importance of continued diverse global investment in research ethics capacity to protect research participants and maintain and improve ethical standards and practice in health research within the region and globally. This will enable the development of innovative evidence-based global health solutions based on ethical research.

  PublisherDOI

• Optimizing Informed Consent—A Call to Action

  JAMA Health Forum · 2025-05-02 · 3 citations

  articleOpen access1st authorCorresponding

  This Viewpoint discusses the US Food and Drug Administration’s proposal for a collaborative approach toward clarifying the informed consent process for potential clinical trial participants.

  PublisherDOI

• Advancing Doctoral and Postdoctoral International Bioethics Training Programs Supported by the D43 National Institutes of Health (NIH) Fogarty Mechanism

  Journal of Empirical Research on Human Research Ethics · 2025-06-26 · 2 citations

  articleOpen access

  Advancing doctoral and postdoctoral international bioethics training in low-and-middle income countries (LMICs) is essential to address the emerging and reemerging healthcare needs of local populations. The COVID-19 pandemic underscored the need for sustenance of global collaboration and rapid adaptability in the future to further prioritize research frameworks to benefit LMICs. Thus, the purpose of the manuscript is to share the successes, challenges, and future considerations of building bioethics research capacity in seven federally funded training programs supported by the Fogarty International Center of the National Institutes of Health D43 mechanism. We advocate for continued investment in training programs recognizing that it requires committed time and effort, specialized funding opportunities, cultural sensitivity, and interdisciplinary faculty support both domestically and internationally. This investment supports cross-disciplinary collaboration, enhances the ethical conduct of research and recognizes the importance of context-sensitive research that generates evidence-based data for global solutions.

  PublisherDOI

• Modernizing the Data Infrastructure for Clinical Research to Meet Evolving Demands for Evidence

  JAMA · 2024-08-05 · 24 citations

  article

  Importance: The ways in which we access, acquire, and use data in clinical trials have evolved very little over time, resulting in a fragmented and inefficient system that limits the amount and quality of evidence that can be generated. Observations: Clinical trial design has advanced steadily over several decades. Yet the infrastructure for clinical trial data collection remains expensive and labor intensive and limits the amount of evidence that can be collected to inform whether and how interventions work for different patient populations. Meanwhile, there is increasing demand for evidence from randomized clinical trials to inform regulatory decisions, payment decisions, and clinical care. Although substantial public and industry investment in advancing electronic health record interoperability, data standardization, and the technology systems used for data capture have resulted in significant progress on various aspects of data generation, there is now a need to combine the results of these efforts and apply them more directly to the clinical trial data infrastructure. Conclusions and Relevance: We describe a vision for a modernized infrastructure that is centered around 2 related concepts. First, allowing the collection and rigorous evaluation of multiple data sources and types and, second, enabling the possibility to reuse health data for multiple purposes. We address the need for multidisciplinary collaboration and suggest ways to measure progress toward this goal.

  PublisherDOI

• Ethical issues in implementation science: perspectives from a National Heart, Lung, and Blood Institute workshop

  Implementation Science · 2024-11-19 · 4 citations

  articleOpen access

  Ethical issues arise in the context of implementation science that may differ from those encountered in other research settings. This report, developed out of a workshop convened by the Center for Translation Research and Implementation Science within the United States National Heart, Lung, and Blood Institute, identifies six key themes that are important to the assessment of ethical dimensions of implementation science. First, addressing ethical challenges in implementation science does not require new ethical principles, commitments, or regulations. However, it does require understanding of the specific contexts arising in implementation research related to both study design and the intervention being implemented. Second, implementation research involves many different types of people in research, including patients, clinicians, administrators, the social networks of any of these, and the general population. These individuals play different roles that may entail different ethical considerations, obligations, and vulnerabilities. Third, the appropriateness of and need for informed consent in implementation research is connected to the role of the subject/participant, the nature of the intervention, and the design of the study. Even where traditional "full" consent processes are unnecessary or inappropriate, communication and engagement are critical. Similarly, even when research is exempt and informed consent unnecessary, Data Safety and Monitoring Board oversight of implementation studies may be advisable to ensure quality, address unexpected consequences, and identify overwhelming evidence of benefit. Fourth, implementation science is often explicitly designed to encourage specific behaviors and discourage others. There is a need for clarity regarding when efforts at behavioral change enhance or threaten autonomy and how to protect participants whose autonomy is threatened. Fifth, there is significant overlap between implementation science and quality improvement, and the ideal regulatory oversight structure for implementation science remains unclear. It is critical to encourage learning and growth while assuring appropriate protections. Sixth, implementation research takes place across a range of social and cultural contexts. Engagement and collaboration with stakeholders in designing and executing implementation trials and studies- especially when vulnerabilities exist- is essential. Attention to these themes will help ensure that implementation science fulfills its goal of advancing the practice of health care within a sound ethical framework.

  PublisherOA PDFDOI

• The Integration of Clinical Trials With the Practice of Medicine

  JAMA · 2024-06-03 · 64 citations

  articleOpen access

  Importance: Optimal health care delivery, both now and in the future, requires a continuous loop of knowledge generation, dissemination, and uptake on how best to provide care, not just determining what interventions work but also how best to ensure they are provided to those who need them. The randomized clinical trial (RCT) is the most rigorous instrument to determine what works in health care. However, major issues with both the clinical trials enterprise and the lack of integration of clinical trials with health care delivery compromise medicine's ability to best serve society. Observations: In most resource-rich countries, the clinical trials and health care delivery enterprises function as separate entities, with siloed goals, infrastructure, and incentives. Consequently, RCTs are often poorly relevant and responsive to the needs of patients and those responsible for care delivery. At the same time, health care delivery systems are often disengaged from clinical trials and fail to rapidly incorporate knowledge generated from RCTs into practice. Though longstanding, these issues are more pressing given the lessons learned from the COVID-19 pandemic, heightened awareness of the disproportionate impact of poor access to optimal care on vulnerable populations, and the unprecedented opportunity for improvement offered by the digital revolution in health care. Four major areas must be improved. First, especially in the US, greater clarity is required to ensure appropriate regulation and oversight of implementation science, quality improvement, embedded clinical trials, and learning health systems. Second, greater adoption is required of study designs that improve statistical and logistical efficiency and lower the burden on participants and clinicians, allowing trials to be smarter, safer, and faster. Third, RCTs could be considerably more responsive and efficient if they were better integrated with electronic health records. However, this advance first requires greater adoption of standards and processes designed to ensure health data are adequately reliable and accurate and capable of being transferred responsibly and efficiently across platforms and organizations. Fourth, tackling the problems described above requires alignment of stakeholders in the clinical trials and health care delivery enterprises through financial and nonfinancial incentives, which could be enabled by new legislation. Solutions exist for each of these problems, and there are examples of success for each, but there is a failure to implement at adequate scale. Conclusions and Relevance: The gulf between current care and that which could be delivered has arguably never been wider. A key contributor is that the 2 limbs of knowledge generation and implementation-the clinical trials and health care delivery enterprises-operate as a house divided. Better integration of these 2 worlds is key to accelerated improvement in health care delivery.

  PublisherOA PDFDOI

• Making the Ethical Oversight of All Clinical Trials Fit for Purpose

  JAMA · 2024-10-19 · 19 citations

  article1st authorCorresponding

  Importance: With the increase in trials assessing comparative effectiveness of approved products and alternative care strategies, guidance is needed to ensure ethical oversight is fit for purpose for the risks, burdens, and constraints on choice this research presents. Observations: US regulations governing human research emerged in response to horrific research abuses, reinforcing the view that research holds greater risks, uncertainties, and potential for abuse than clinical care, and thus protections and oversight are required for research, but not for care. The research oversight system established by these regulations has been effective, with most clinical research reviewed in advance for possible risk and burdens and for threats to autonomy and justice. For clinical research, however, it has become too much of a one-size-fits-all mechanism. As more comparative effectiveness and other research on widely used clinical interventions are conducted, research oversight should be fit for purpose for these kinds of trials, with the degree of oversight based on 2 morally relevant features of a trial. The first of these features is the degree to which risks and burdens increase or change when research is integrated into clinical care compared with what patient-participants would have experienced in care absent the research. The second is whether the activity restricts meaningful patient decision-making about care in morally important ways: (1) does the research restrict a choice or decision that patients ordinarily are or should be involved in and (2) does research participation remove from patients the ability to make a decision that may be meaningful to them, one based, at least in part, on their values, priorities, logistical or practical considerations, and the like? Whether clinical trials add risk or burden to what patients would otherwise have experienced, and whether studies restrict meaningful decisions patients would or should have had the opportunity to make, should help to determine whether clinical studies are designated as greater than vs minimal risk. Further, it is recommended that investigators and oversight bodies consider streamlined consent procedures for research presenting minimal additional risk or burden and that does not constrain meaningful patient decisions, rather than assuming that waiving all consent requirements is the only alternative. Conclusions and Relevance: Ethical oversight of clinical research must be fit for purpose-with greater oversight for studies with greater risks, uncertainties, and impacts on meaningful patient decisions-and more streamlined oversight for other types of research.

  PublisherDOI

• Ethics of Adaptive Designs for Randomized Controlled Trials

  Ethics & Human Research · 2023-09-01 · 12 citations

  articleOpen accessSenior author

  Over recent decades, adaptive trial designs have been used more and more often for clinical trials, including randomized controlled trials (RCTs). This rise in the use of adaptive RCTs has been accompanied by debates about whether such trials offer ethical and methodological advantages over traditional, fixed RCTs. This study examined how experts on clinical trial methods and ethics believe that adaptive RCTs, compared to fixed ones, affect the ethical character of clinical research. We conducted in-depth interviews with 17 researchers from bioethics, epidemiology, biostatistics, and/or medical backgrounds. While about half believed that adaptive trials are more complex and may thus threaten autonomy, these respondents also expressed that this challenge is not insurmountable. Most respondents expressed that efficiency and potential for participant benefit were the main justifications for adaptive trials. There was tension about whether adaptive randomization in response to increasing information disrupts clinical equipoise, with some respondents insisting that uncertainty still exists and therefore clinical equipoise is not disrupted. These findings suggest that further discussion is needed to increase the awareness and utility of these study designs.

  PublisherOA PDFDOI

Recent grants

• NIH Grant R01AI042574

  NIH · $1.2M · 2001

• The Addis Ababa University-Johns Hopkins University Research Ethics Training Program in Ethiopia (AAU-JHU RETP)

  NIH · $6.2M · 2000–2030

• NIH Grant R21AI074005

  NIH · $582k · 2012

• NIH Grant R25ES012085

  NIH · $837k · 2007

• NIH Grant R03HS006108

  NIH · $21k · 1989

Frequent coauthors

• Ruth Faden

  Johns Hopkins University

  101 shared

• Jeremy Sugarman

  70 shared

• Joseph Ali

  Johns Hopkins University

  52 shared

• Adnan A. Hyder

  Milken Institute

  47 shared

• Peter J. Pronovost

  43 shared

• Nanette M. Schwann

  University of South Florida

  42 shared

• Marc S. Kanchuger

  NYU Langone Health

  42 shared

• Holly A. Taylor

  36 shared

Awards & honors

• Elected Member of the Institute of Medicine (now National Ac…
• Fellow of the Hastings Center
• Chair of the NIH Precision Medicine Initiative Central IRB