Research Ethics Reimagined

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.

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.

In this episode of PRIM&R's podcast, "Research Ethics Reimagined," we explore the unprecedented wave of federally funded research terminations affecting tens of thousands of study participants. Brandon Brown, MPH, PhD, is a Professor of Medicine at UC Riverside School of Medicine’s Department of Social Medicine, Population and Public Health and a Hastings Center Fellow. Dr. Brown discusses the ethical and practical challenges researchers and IRBs face when studies end suddenly due to funding cuts. He examines how IRBs and researchers can collaborate to develop guidance to ensure communication and transparency for impacted researchers and participants.

In this episode of PRIM&R's podcast, "Research Ethics Reimagined," we celebrate PRIMR25 Award recipients Lisa Chuba and Alison Pohl from UConn Health, along with the first-ever Outstanding Student Poster Award recipient, Leah Huff, from the University of Virginia. Chuba and Pohl discuss transforming their IACUC's relationship with researchers from adversarial to collaborative through creative outreach programs. Huff shares her research on reimagining consent as an ongoing educational process that adapts to different learning styles, drawing connections between effective teaching and participant understanding.

In this episode of PRIM&R's podcast, "Research Ethics Reimagined," we speak with Dr. Josh Fessel about trust in science, translational medicine, and the challenges facing federal research. Dr. Fessel is a physician scientist who most recently served as chief medical officer and director of the Office of Translational Medicine in the National Center for Advancing Translational Sciences at NIH. He discusses lessons from the COVID-19 pandemic, ethical considerations in AI implementation, and his decision to leave federal service when directives conflicted with his values as a physician and researcher.