Videos

Social and behavioral genomics (SBG) uses molecular, genome-wide data, to examine whether and how genetic differences between individuals shape differences in characteristics and outcomes such as same-sex sexual behavior and educational attainment. The field is the ongoing subject of polarizing debate and controversy. While claims regarding genetic differences in behavior have long been used to justify social inequalities, misguided and harmful genetic myths continue today – wielded by White supremacists, academic researchers, and high-profile public figures who cite recent genomic studies as evidence to support their beliefs. Meanwhile, social and behavioral genomic data are increasingly available to consumers via direct-to-consumer genetic testing and polygenic embryo selection. This talk argues that the ethical and socially responsible conduct and translation of social and behavioral genomics calls for a full accounting of ‘the acid we inherit’: a dual inheritance process through which DNA and harmful myths about DNA get passed down from one generation to the next.

Daphne O. Martschenko, PhD
Assistant Professor
Stanford University Center for Biomedical Ethics

In 2021, the National Institutes of Health asked the National Academies to conduct a study to review and assess existing methodologies, benefits, and challenges in using race, ethnicity, ancestry, and other population descriptors in genomics research. To accomplish this task, the National Academies empaneled a committee of 17 members with expertise in various genetics fields, anthropology, sociology, social epidemiology, demography, and population statistics, as well as historical, ethical, legal, and social implications research, including Penn professor Dorothy Roberts. Professor Roberts will discuss the committee’s consensus report, issued in March 2023, which examines the current use of population descriptors in genomics research, presents a set of guiding principles and overarching approaches, and recommends best practices.

Dorothy E. Roberts, JD
George A. Weiss University Professor of Law & Sociology;
Raymond Pace & Sadie Tanner Mossell Alexander Professor of Civil Rights and Professor of Africana Studies
Director, Program on Race, Science and Society

Improving the quality of patient care is a top priority for all health care systems and performing quality improvement (QI) work is an essential ingredient for success. In academic medical centers, many individuals and teams who lead QI work also wish to rigorously evaluate and disseminate their findings which can sometimes lead to ethical dilemmas related to oversight.  In this session, Drs. Shivan Mehta and Jennifer Myers, PSOM faculty and Penn Medicine physicians who lead and advise others in QI work, will share the story behind how Penn’s QI IRB pathway came to fruition and the process for how to utilize it. Using lessons learned and case studies, they will discuss the ethical considerations and tensions that still exist in the field and moderate a discussion with the audience.  

Jennifer Myers, MD
Professor of Clinical Medicine (Hospital Medicine)
Director, Center for Health Care Improvement and Patient Safety
Perelman School of Medicine, University of Pennsylvania

Shivan Mehta, MD, MBA, MSHP
Associate Professor of Medicine (Gastroenterology)
Hospital of the University of Pennsylvania
Veterans Administration Medical Center

Early phase trials and innovative care protocols draw their support from basic science, preclinical studies and clinical research. Because these forms of evidence vary and address different questions, methods for synthesizing evidence and assessing scientific and ethical merit, like meta-analysis, are inapt. In what follows, I offer a structured approach, PATH (Preclinical Assessment of Translation to Humans) for presenting a comprehensive, accurate and transparent scientific justification for early phase trials and innovative care.

PATH is grounded on the premise that the case for administering novel strategies to patients requires connecting the dots between nine mechanistic steps supporting a clinical hypothesis. Further applications of PATH, including its potential use in health technology assessment, research planning and risk assessment will be discussed briefly.

Jonathan Kimmelman, PhD
Director of Biomedical Ethics Unit
Department of Equity, Ethics and Policy
McGill University | Montreal, QC

Against a historical backdrop of distrust of researchers stemming from perceived lack of benefit, transparency, and engagement, efforts are underway to develop better models for genetic and genomic research with Indigenous Peoples. To increase engagement, there is a need to identify and address factors that impact collaborations between researchers and communities as well as understand federal and Tribal Nation policies governing research. This talk will describe perspectives, pathways, and policies by first describing results from qualitative
research with Indigenous leaders, health professionals and policy makers to identify barriers and facilitators to participation in genetic and genomic research and end with a discussion of the CARE Principles for Indigenous Data Governance as a tool to address gaps in existing policies, research codes, and formal guidance. Addressing the concerns and gaps may better enable researchers to build trust, transparency, and respect for culture to facilitate more equitable and reciprocal research partnerships.

Nanibaa' Garrison, PhD
Associate Professor
Institute for Society & Genetics Institute
for Precision Health | UCLA

Recently, the U.S. Food and Drug Administration (FDA) has been placing greater emphasis and implementing reforms focused on improving health equity. The focus of the reforms has been largely on increasing representation in clinical trials, enhancing transparency and access to available data on the effect of medical products on minority populations, and promoting health and safety communication to these populations.  Concurrently, FDA continues to increasingly adopt regulatory flexibility in their review process, accepting less rigorous evidence as the basis of approval of novel medical products. In the case of accelerated approval, the agency allows for residual uncertainty at the time of approval, but then requires sponsors to complete additional studies that confirm clinical benefit in a timely manner; should these not be completed or if the studies yield negative results, FDA can withdraw these drugs from the market. However, the expanded and more flexible use of this pathway by the FDA has raised questions about which communities will bear the burden of such uncertainty and whether this may in fact exacerbate health disparities.

In this presentation, Dr. Ramachandran will discuss trends in FDA’s adoption of regulatory flexibility in the approval of novel medical predicts, the implication of such policies, and proposals to center health equity in regulatory decision-making.

Reshma Ramachandran, MD, MPP, MHS
Assistant Professor of Medicine
Yale School of Medicine

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 improvinghealthcare.net/