MEHP Online
Penn Bioethics Seminar Series (PBS)
Research Ethics and Policy Series (REPS)

Research Ethics and Policy Series (REPS)

OCTOBER 4, 2021

What just happened? The strange tale of the FDA’s approval of aducanumab for the treatment of Alzheimer’s disease

On the morning of June 7, 2021, the idea of using a positron emission tomography (PET) measure of beta-amyloid as a surrogate for the care of patients with Alzheimer disease was an important hypothesis in need of more research. By the evening of June 7, it was clinical practice. 

This revolution in care was the aftermath of not a scientific breakthrough but the imperious decision of a divided Food and Drug Administration (FDA). The FDA had approved Biogen’s drug aducanumab for the treatment of Alzheimer disease. The agency argued that the drug’s ability to reduce beta-amyloid is an adequate surrogate for clinical benefit. Jason Karlawish will discuss why this controversial decision continues to reverberate throughout the American health care system. It has exposed enduring controversies in developing treatments for brain diseases, the steady breakdown in processes at FDA, the need to revisit why we even have an FDA, and how, in America, a disease does not fully exist until it has a business model.


Research Ethics and Policy Series (REPS): Jason Karlawish, MD

Jason Karlawish, MD
Professor of Medicine, Medical Ethics and Health Policy, and Neurology, and Co-Director, Penn Memory Center, Perelman School of Medicine, University of Pennsylvania


June 7, 2021

The Abramson Cancer Center’s Strategies to Increase Accrual of
Black Participants to Cancer Clinical Trials

Dr. Carmen Guerra is the Ruth C. and Raymond G. Perelman Associate Professor of Medicine and the Associate Director of Diversity and Outreach at the Abramson Cancer Center.  Dr. Guerra leads the Abramson Cancer Center’s community engaged efforts to increase participation by underrepresented minorities in cancer clinical trials. In this talk, Dr. Guerra will review the underrepresentation of Black patients on cancer clinical trials, the barriers to participation and how the Abramson Cancer Center has increased participation by Black patients in cancer treatment trials.

Carmen Guerra, M.D., M.S.C.E., F.A.C.P.
Ruth C. and Raymond G. Perelman Associate Professor
Vice Chair of Diversity and Inclusion, Department of Medicine
Associate Director of Diversity and Outreach, Abramson Cancer Center
Advisory Dean, Dr. Helen O. Dickens House, PSOM


Research Ethics and Policy Series (REPS): Carmen Guerra, MD, MSCE, FACP

Dr. Haresh Kirpalani is Emeritus Professor on the pediatrics faculty at CHOP and McMaster University in Canada. He has been pursuing randomized trial evaluation of common therapies in newborn and pediatric ICU medicine, including a trial completed out of the University of Pennsylvania as the lead site—the Sustained Aeration of the Infant Lung (SAIL) RCT (Kirpalani H, JAMA 2019; 321:1165-1175). This trial addressed emergent management of the preterm infant who fails to transition to an extrauterine environment at birth. As a delivery room trial of an emergent therapy it faced special challenges of parent information and informed consent. Internationally the climate for the practice of deferred consent for research involving in sick preterm newborns in the delivery room varies a great deal. In the SAIL trial, the data safety and monitoring board (DSMB) noted an unexpected complication of early death within 48 hours of delivery in the experimental arm. The trial was therefore stopped early (426 instead of 600 as planned). Dr. Kirpalani will discuss the SAIL trial, its results, and the discussions that followed. Dr. Chris Feudtner will then comment on the ethical importance of clinical trials of common therapies and the ethics of deferred consent in clinical research.



Research Ethics and Policy Series (REPS): Haresh Kirpalani, MD, MSc and Chris Feudtner, MD, PhD, MPH

Haresh Kirpalani, MD, MSc
Emeritus Professor CE of Pediatrics, Perelman School of Medicine

Commentary by Chris Feudtner, MD, PhD, MPH
Director of Research, Pediatric Advanced Care Team, CHOP

SAIL paper: 

Dr. David Fajgenbaum will share his groundbreaking work to advance precision medicine for Castleman disease, a condition that he is battling as a physician, researcher, advocate, and patient. Combining -omic technologies with machine learning and other bioinformatic tools, Dr. Fajgenbaum has discovered novel predictive biomarkers of treatment response and novel treatment approaches, including one that is saving his life and others. In this REPS lecture, Dr. Fajgenbaum will discuss the ethics of self-experimentation, fairness of resource allocation across rare diseases, and other ethics and policy issues, reflecting on his own personal journey and research.

David C. Fajgenbaum, MD, MBA, MSc
Assistant Professor of Medicine, Perelman School of Medicine


Nudges are subtle changes to the choice environment that can have an outsized impact on our decisions and behaviors.  Electronic health records have been rapidly adopted by health systems and clinicians, however there exist hidden nudges which are often misaligned with clinician and patient goals. The Penn Medicine Nudge Unit is the world’s first behavioral design team embedded within the operations of a health system and focuses on working with health system leadership and frontline clinicians and staff to design, test, and implement nudges to improve the delivery of health care. This presentation will provide a background on the Penn Medicine Nudge Unit and provide examples of past project and their ethical implications.

Mitesh S. Patel, MD, MBA
Ralph Muller Presidential Associate Professor, Perelman School of Medicine


Dr. Meyer is Associate Professor of Medicine and directs the Center for Translational Lung Biology at Penn. A translational scientist, she and her team pivoted their ongoing sepsis cohort study to enroll moderately and severely ill patients hospitalized with COVID-19 into an observational molecular study that is yielding insights into the varied host immune response incited by SARS-CoV2. She is also involved in several clinical trials for COVID-19 subjects. This lecture will highlight policy decisions and ethical concerns that arose both early in the pandemic, while clinical care was highly uncertain, and issues that persist as the pandemic evolves. Dr. Meyer will attempt to balance the clinician’s perspective as a critical care doctor, the researcher’s desire to maximize and disseminate knowledge, and the administrator’s concerns about justice, transparency, and safety.

Nuala J. Meyer, MD, MS
Associate Professor of Medicine at the Hospital of the University of Pennsylvania

In recent years, an increasing number of intraoperative neuroscience studies have been supported by the NIH through the BRAIN initiative. Some of these studies take advantage of intraoperative situations—such as Parkinson’s disease patients undergoing deep brain stimulation surgery—to advance basic neuroscience knowledge. However, the use of neurosurgical patients as human research subjects raises important ethical considerations, particularly regarding informed consent and undue influence, as well as subjects’ motivations for participation. In this talk, I will present results from a recent empirical study that examined these considerations and assessed informed consent recall in Parkinson’s disease patients who participated in an intraoperative neuroscience study at the University of Pennsylvania.

Anna Wexler, PhD
Assistant Professor of Medical Ethics and Health Policy, Perelman School of Medicine

The Family Smoking Prevention and Tobacco Control Act, signed into law on June 22, 2009, gives the United States Food and Drug Administration authority to regulate the manufacture, distribution, and marketing of tobacco products. Regulation occurs with a goal of improving the nation’s health, and must be supported by the best and most current scientific evidence and research. In September 2018, the NIH and FDA funded a second round of Tobacco Centers of Regulatory Science (TCORS). Dr. Andrew Strasser is Principal Investigator of the UPenn TCORS, and with colleagues across Penn, Rutgers, Georgetown and Wake Forest Universities, conducts tobacco policy focused research on the advertising, marketing, labeling, use and exposure of combustible tobacco products. He will present his research on nicotine product standards, tobacco advertising, and packaging warning labels that inform tobacco control and regulatory science. 

Andrew A. Strasser, PhD
Research Professor of Psychiatry, Perelman School of Medicine  

Using laboratory studies to inform tobacco control and policy

Research funding bodies in Europe and North America increasingly encourage or require grantees to engage patients not simply as research participants but as partners in all phases of research from topic generation to the dissemination of study results. Patient engagement has been said to improve the relevance, quality, and impact of research, but evidence of these benefits remains limited. This presentation will explore some of the challenges of evaluating the effects of patient engagement in research and also consider the argument that patient engagement in research is intrinsically justified regardless of its effects.

Matthew McCoy, PhD
Assistant Professor, Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania


060120 REPS Matt McCoy

The most common way for people in the United States to get access to investigational medical products is by participating in clinical trials. For patients who are unable to participate in clinical trials but who wish to try an experimental drug, device, vaccine, or other medical product, there are two pathways that permit non-trial access to products that are still in clinical development and not approved for any use. These are Expanded Access, which has existed for several decades, and Right to Try, which is much newer. Alison Bateman-House will compare and contrast the two pathways and explain why Expanded Access is preferable to Right to Try, both for patients and for the companies whose investigational products will be involved in such “compassionate use” attempts. She will underscore that the existence of such regulatory pathways are necessary but far from sufficient for patients to be able to use experimental medical products outside of clinical trials and highlight what other obstacles, real and perceived, reasonable and unreasonable exist.

Alison Bateman-House, PhD, MPH, MA
Assistant Professor, Division of Medical Ethics
New York University Langone Medical Center

Commentary by Robert Vonderheide, MD, DPhil
John H. Glick Abramson Cancer Center Professor, Perelman School of Medicine

The challenges of balancing scientific rigor and ethical concerns in community-engaged research are unique and complex. Ethical issues can arise in terms of methodology, research implementation, and practical aspects of community-based research. This talk will introduce ethical issues related to communities/stakeholders, research participants, and professional relationships with illustrations from case studies and an introduction to useful resources.

Karen Glanz, PhD, MPH
George A. Weiss University Professor
Perelman School of Medicine and School of Nursing


Supplemental readings and commentary:

Sarah Tishkoff, PhD
David and Lyn Silfen University Professor,
Departments of Genetics & Biology, Perelman School of Medicine

Commentary by Kellie Owens, PhD
Fellow, Medical Ethics & Health Policy, Perelman School of Medicine


Do you think institutional review boards (IRBs) “work”? What does that mean and how would we know? It turns out that evaluating IRB quality and effectiveness beyond superficial measurements related to compliance and efficiency is remarkably challenging. Nonetheless, it is essential to determining whether the system’s overall benefits outweigh its burdens, as well as what adjustments might be in order. In this lecture, Holly Fernandez Lynch describes the problem and introduces several novel approaches currently being pursued by the Consortium to Advance Effective Research Ethics Oversight (AEREO).

Holly Fernandez Lynch, JD, MBe
John Russell Dickson, MD Presidential Assistant
Professor of Medical Ethics, Medical Ethics & Health Policy, Perelman School of Medicine


October 7, 2019 

Gene editing and geopolitics

The controversy about the gene edited babies in China happens to have coincided with increasing tensions between the US and China and intensified competition in the life sciences, including legal action against some Chinese scientists based in the US. In this talk I sketch out the background geopolitical issues that have received little attention but that provide context for the regulation of CRISPR and related technologies.

Jonathan D. Moreno, PhD
David and Lyn Silfen University Professor of Ethics,
Medical Ethics and Health Policy, Perelman School of Medicine


Informed consent for clinical research in the context of acute and emergent illness is widely recognized as challenging and is often not possible. There is, however, a wide spectrum of acute and emergent conditions and a similarly wide range of potential for patients and surrogates to engage in decisions about research enrollment. Dr. Dickert will focus on research designed to understand and integrate patients’ and surrogates’ perspectives on consent for clinical trials in the context of acute myocardial infarction and stroke. He will argue that involving patients and surrogates in enrollment decisions in many emergency situations is not pointless despite important limitations that must be recognized.

Neal Dickert, MD, PhD, FACC
Assistant Professor, Emory University School of Medicine
Department of Medicine, Division of Cardiology, ECCRI
Emory University Rollins School of Public Health,
Department of Epidemiology, Emory Center for Ethics


Commentary by Benjamin S. Abella, MD, MPhil, FAHA
Professor and Vice Chair for Research
Director, Center for Resuscitation Science
Department of Emergency Medicine
Perelman School of Medicine

MEHP Online

School closure and reopening in light of the COVID-19 pandemic raises critical questions about decision-making in the face of uncertainty, how best to meet the needs of children, how to keep communities safe, and how to generate evidence on each of these issues. In this panel, we’ll hear from leading experts in epidemiology, education, and policy. What do we know about the epidemiology of school opening and closure and what are the most relevant factors to consider? What are the educational impacts of school closure and remote learning and how can negative impacts be minimized? What are the challenges of advising school districts on their responses to the pandemic? Watch this discussion of the ethical implications of each of these questions with Kristen A. Feemster, MD, MPH, MSHPR, FAAP; Jonathan A. Supovitz, EdD, MA; Meredith Matone, DrPH, MHS; and moderated by Holly Fernandez Lynch, JD, MBe. Learn more at

School Openings and COVID-19: Medical, Educational, and Policy Considerations

Penn Bioethics Seminar Series (PBS)

In this presentation, Dr. George Yancy argues that whiteness is both an opaque and systemic structure. In short, to be white, to be embodied as white, raises the question not only of white privilege, but the question of white racism and how it is that racism is an insidious phenomenon that is replicated in the lives of white people. We can all agree that white racism is unethical. But what if it is not possible to make a clean exit, as it were, from the bind of whiteness? What if to be white means that one's ethical state, as Peggy McIntosh has suggested, is not completely dependent upon one's ethical will? This raises not only the theme of the unethical structure of whiteness, but the way in which white people (consciously or unconsciously) perpetuate racialized injustice and thereby are unethical.  

George D. Yancy, PhD
Samuel Candler Dobbs Professor of Philosophy, Department of Philosophy, Emory College of Arts and Sciences

100620 George Yancy


DISCLAIMER: The presentations are not to be reproduced or distributed to the public or press. Please do not cite contents of presentations without the consent of the presenter and the participants. This presentation is also subject to the University of Pennsylvania's Computing Copyright Policy, found here.

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