The Promise and Perils of FDA’s New ‘Plausible Mechanism’ Pathway With Holly Fernandez Lynch, JD, MBe

The Science of Being Counted With David Dutwin, PhD

In this episode of PRIM&R’s podcast, "Research Ethics Reimagined," we explore the methodology, ethics, and future of public opinion research with David Dutwin, PhD, Executive Director and Senior Vice President of AmeriSpeak at NORC at the University of Chicago. Dr. Dutwin is a senior fellow with the program for opinion research and election studies at the University of Pennsylvania. He is a nationally recognized survey methodologist. For more than 20 years, he has taught courses in survey research and design, political polling, research methods, rhetorical theory, media effects, and other courses as an adjunct professor at the University of Pennsylvania, the University of Arizona, and West Chester University. He discusses how probability-based sampling underpins scientifically valid survey research, the safeguards that protect participants in sensitive surveys, and how artificial intelligence is reshaping the field.

Disability, Inclusion, and Research Ethics With Nancy Olson, JD

In this episode of PRIM&R's podcast, "Research Ethics Reimagined," we explore the inclusion of individuals with disabilities in research with Nancy Olson, JD, IRB. Olson serves as an analyst at the University of Nebraska Medical Center and is the recipient of PRIM&R's 2024 Service Award. Drawing on more than two decades of experience in human research protections and her own lived experience as a person who became deaf, Olson discusses how assumptions about disability shape — and often limit — who gets to participate in research. She examines the responsibilities of both researchers and IRBs in designing accessible studies and calls for a shift from compliance-focused thinking to genuine participant-centered preparation.

Scientific Research for the Common Good with Alex John London, PhD

In this episode of PRIM&R's podcast, "Research Ethics Reimagined," we explore the philosophical foundations of research ethics and the challenges of deploying artificial intelligence in medicine with Alex John London, K&L Gates Professor of Ethics and Computational Technologies at Carnegie Mellon University, where he directs the Center for Ethics and Policy. Professor London discusses his book “For the Common Good,” which argues that justice should be the foundational principle of research ethics. Professor London also offers his assessment of AI's promise and limitations in healthcare.

The Promise and Perils of FDA’s New ‘Plausible Mechanism’ Pathway With Holly Fernandez Lynch, JD, MBe

In this episode of PRIM&R's podcast, "Research Ethics Reimagined," we explore FDA's plausible mechanism pathway for ultra-rare genetic disorders with Holly Fernandez Lynch, Associate Professor of Medical Ethics at the University of Pennsylvania's Perelman School of Medicine. She discusses how this pathway enables personalized gene therapies for N-of-one or N-of-few diseases while raising important questions about regulatory process, evidence standards, and equitable access. Professor Fernandez Lynch also examines the remarkable case of baby KJ, who received a gene editor to treat his urea cycle disorder, and considers both the transformative potential and the procedural concerns surrounding FDA's approach.

Ethical Challenges in Suicide Research With Matthew Nock, PhD

In this episode of PRIM&R's podcast, "Research Ethics Reimagined," we explore the ethical and methodological complexities of suicide and self-harm research with Matthew Nock, PhD, the Edgar Pierce Professor of Psychology at Harvard University and former chair of the Harvard IRB. Dr. Nock discusses how research demonstrates that asking about suicide does not increase risk, the importance of IRB-researcher collaboration, and the challenges of real-time monitoring and intervention with high-risk participants. He shares insights from developing consensus guidelines on ethical conduct of suicide research and emphasizes the critical need for advancing this often-stigmatized field of study.