About

Stephanie Morain, PhD, MPH, is a faculty member at the Berman Institute of Bioethics and an Associate Professor in the Department of Health Policy and Management at the Bloomberg School of Public Health. She conducts both empirical and normative research into issues at the intersection of clinical research, public health, and health policy. Her work focuses on ethical and practical challenges presented by the integration of research and care, such as in pragmatic clinical trials and comparative effectiveness, as well as issues related to women’s reproductive health. Dr. Morain’s research interests include the ethics and politics of public health policy, challenges associated with transitioning to learning health care systems, and public and stakeholder attitudes towards health policies. She has a background that includes a BA from Lafayette College with a dual major in Biology and History, Government, & Law, an MPH from Columbia University’s Mailman School of Public Health, and a PhD from Harvard University’s Interfaculty Initiative in Health Policy.

Research topics

• Medicine
• Computer Science
• Social Science
• Sociology
• Environmental health
• Nursing
• Demography
• Immunology
• Gender studies
• Social psychology
• Medical education
• Obstetrics
• Pediatrics
• Risk analysis (engineering)
• Internal medicine
• Virology
• Psychology
• Family medicine

Selected publications

• Navigating "Wicked" Disagreement in Public Health.

  PubMed · 2026-04-01

  articleOpen access

  2026;116(4):544-551. https://doi.org/10.2105/AJPH.2025.308350).

  PublisherOA PDFDOI

• Empirical research related to the ethics of pragmatic clinical trials: A scoping review

  Learning Health Systems · 2025-10-04

  articleOpen access

  Background: Pragmatic clinical trials (PCTs) offer insights into real-world intervention effectiveness, but they may involve challenging ethical issues. Empirical ethics research may inform deliberations about them. Methods: We conducted a scoping review of empirical ethics research related to PCTs. This involved searching in PubMed and Embase, charting findings, and analyzing themes to identify trends and gaps. Results: Eighty-two publications were included, which examined a vast number of issues encompassing 22 themes. The five most prominent were: consent/disclosure; risk assessment; trust and transparency; burdens, barriers, and costs; and engagement. Written consent is often impractical, prompting interest in opt-out or general notification approaches. Challenges in risk assessment include variability in defining minimal risk, thereby complicating regulatory determinations for the appropriateness of particular participant protections and communicating research risks. Trust-building practices, such as result-sharing and data-use disclosure, can foster confidence. Stakeholder engagement can address logistical barriers, improve recruitment, and align research with participant needs. Time, financial, and regulatory burdens are significant obstacles to implementing PCTs. Conclusion: There has been progress in understanding many ethical issues encountered in PCTs, including appropriately navigating alternatives to obtaining written informed consent, trust-building, and the operational role of stakeholder engagement. However, critical gaps remain, with research concentrated in Western contexts and reliant on surveys and hypothetical scenarios, limiting generalizability and real-world insights. Addressing these gaps with geographically inclusive studies, innovative methods, and nested empirical work will be important for more comprehensively understanding the ethical issues in PCTs and developing appropriate approaches to mitigating them.

  PublisherOA PDFDOI

• A framework for health systems to assess and prioritize participation in pragmatic clinical trials

  Learning Health Systems · 2025-05-14 · 1 citations

  articleOpen access1st authorCorresponding

  Introduction: Pragmatic clinical trials (PCTs) are frequently embedded within settings in which patients receive their routine clinical care. The health care institutions that deliver routine clinical care must therefore decide how they prioritize PCTs in comparison to other institutional priorities. Yet no formal guidance yet exists to support health care institutions' assessment and prioritization of PCTs. Methods: Drawing on a critical review and synthesis of published literature and experience in PCTs, we developed a framework by which health care institutions can assess the appropriateness and feasibility of a given PCT within their system. Results: We propose healthcare institutions assess the appropriateness of a given PCT through three lines of inquiry: (1) importance and timeliness of the research question, (2) feasibility of the study within the respective institution, and (3) institutional willingness to act on the study results. Conclusion: The proposed framework may support decision-making about whether to initiate a given PCT and also how to do so in a way that supports both research and operational priorities.

  PublisherOA PDFDOI

• Monitoring in pragmatic trials lessons from the NIH pragmatic trials collaboratory

  Contemporary Clinical Trials · 2025-02-25 · 2 citations

  articleOpen access
  PublisherOA PDFDOI

• Patient notification about pragmatic clinical trials conducted with a waiver of consent: A qualitative study

  Clinical Trials · 2025-10-16

  article1st authorCorresponding

  BACKGROUND: Some scholars have proposed that investigators and health systems should notify patients about their enrollment in pragmatic clinical trials conducted with a waiver of consent. However, others argue that decision-making about notification requires judgment, and reports suggest considerable heterogeneity about whether, when, and how individuals enrolled in pragmatic clinical trials with a waiver of consent are notified about that enrollment. Empirical data can inform this decision-making. METHODS: We conducted semi-structured interviews with knowledgeable stakeholders involved in conducting and/or overseeing pragmatic clinical trials conducted with waivers of consent, including investigators, those charged with the oversight of human subjects research, and operational leadership. Interviews were conducted via video conference from September to December 2024 and were audio-recorded and professionally transcribed. Data were qualitatively analyzed using an integrated approach, including both a priori codes drawn from the interview guide and emergent, inductive codes. RESULTS: Twenty-three of 28 experts invited to participate completed interviews. Respondents described rationales both for and against notification. Rationales for notification included both appeals to moral values (respect for persons, respect for autonomy, and transparency), as well as instrumental goals (promoting understanding of and/or support for research, avoiding downstream surprise, and supporting buy-in). Rationales against notification included preserving scientific validity, perceiving notification to lack value, and concerns that notification might be burdensome for patient-subjects or undermine trust and/or clinical or public health goals. Decision-making about notification was context-specific and reflected features related to the study design, the health system setting, the patient population, the clinical condition, and the intervention(s) being evaluated. While some factors were consistently described as weighing against notification, including scientific validity or decisions for which a patient would not be offered a choice outside the research context, other factors resulted in divergent decisions across different pragmatic clinical trials (or even across different sites for the same trial). CONCLUSIONS: While several rationales support notification about enrollment in pragmatic clinical trials conducted with waivers of consent, the relative value and practicability of notification is context-dependent. Some features, such as the need to preserve scientific validity, may appropriately weigh in favor of forgoing notification. However, evidence of divergent decision-making for similar trials suggests the need for a framework to guide future notification decisions. These data can be an important input to inform future framework development.

  PublisherDOI

• Exception from Informed Consent and Waiver of Informed Consent for Comparative Effectiveness Trials in Emergency Care Research

  Ethics & Human Research · 2025-12-31 · 1 citations

  articleOpen accessSenior author

  For many of the decisions made in the clinical care setting, clinicians lack evidence to inform which treatment would result in the best patient outcomes. This problem is particularly common in emergency care, a field in which the condition of the patient and the urgent nature of the treatment often preclude research conducted using prospective informed consent. Large-scale comparative effectiveness clinical trials could address the evidence gaps in clinical medicine and improve patient outcomes but are hindered by the lack of a clear regulatory framework in the United States for low-to-minimal risk trials comparing commonly used treatments. In this paper, we summarize a presentation and discussion that took place at a workshop held by the National Institutes of Health that focused on the issue of informed consent and the appropriate regulatory pathway for comparative effectiveness trials conducted in the emergency care setting. A key insight of this workshop is that generating the comparative effectiveness data needed to improve clinical care will require revising ethical and regulatory oversight practices and related guidance to support the conduct of this socially valuable research.

  PublisherOA PDFDOI

• Overdue: Delayed Revision of Institutional Review Board Policies Characterizing Pregnant Women After the Revised Common Rule

  Annals of Internal Medicine · 2025-11-03

  editorialSenior author
  PublisherDOI

• The Importance of Including Underserved Populations in Research

  Pharmaceutical Medicine · 2025-03-01 · 11 citations

  reviewOpen access
  PublisherOA PDFDOI

• Reflections on a Principal of Research Ethics: Tom Beauchamp, Moral Specification, and Waivers of Informed Consent

  The American Journal of Bioethics · 2025-10-16 · 6 citations

  article1st authorCorresponding

  Tom Beauchamp's work is deeply woven into the field of bioethics. In this article, we honor Professor Beauchamp's pioneering contributions to research ethics, focusing on his seminal work articulating the key ethical principles that have become central to our understanding of research ethics scholarship and practice. We then examine how Professor Beauchamp's analytical framework of shared moral principles for research ethics can inform a contemporary ethics challenge: when can the requirements of informed consent permissibly be relaxed for research studies embedded into clinical care? We use this example both to illustrate how conceptual analysis and moral specification can inform the work of investigators, institutional review boards, and others charged with ensuring the ethical conduct of human subjects research, and to highlight where further conceptual work and practical guidance are needed.

  PublisherDOI

• Optimizing Informed Consent—A Call to Action

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

  articleOpen access

  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

Frequent coauthors

• Jeremy Sugarman

  63 shared

• Nancy E. Kass

  Johns Hopkins University

  29 shared

• Juli Bollinger

  Johns Hopkins University

  28 shared

• Gail Geller

  Johns Hopkins Medicine

  25 shared

• Debra Mathews

  25 shared

• Kevin P. Weinfurt

  Duke University

  22 shared

• Elizabeth May

  18 shared

• Joseph Ali

  Johns Hopkins University

  17 shared

Education

• Hecht-Levi Postdoctoral Fellow

  Johns Hopkins University Berman Institute of Bioethics

  2015

• PhD, Interfaculty Initiative in Health Policy

  Harvard University

  2014

• MPH, Sociomedical Studies

  Columbia University Mailman School of Public Health

  2009

Awards & honors

• Hecht-Levi Postdoctoral Fellow at the Berman Institute