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.

In this episode of PRIM&R's podcast, "Research Ethics Reimagined," we explore the intersection of artificial intelligence, trust, and bioethics with Dr. Vardit Ravitsky, President and CEO of the Hastings Center for Bioethics. Dr. Ravitsky discusses the rapid implementation of AI in healthcare and biomedical research, strategies for combating misinformation, and maintaining organizational values during challenging political times. She also shares practical advice for emerging professionals in bioethics and biomedical research.

In this episode of "Research Ethics Reimagined," we explore human challenge studies for shigellosis, examining their role in vaccine development and the ethical considerations surrounding intentional infection of healthy volunteers. Our guests are Dr. Wilbur H. Chen, the Frank M. Calia, MD Endowed Professor and Chief of the Division of Geographic Medicine at the University of Maryland School of Medicine, and Jake Eberts of 1Day Sooner, who is a former participant in a Shigella challenge trial.

In this episode of PRIM&R's podcast, "Research Ethics Reimagined," we explore groundbreaking cancer vaccine research for dogs with potential implications for human cancer treatment. Our guest is Dr. Mark Mamula, Professor at the Yale School of Medicine and leading researcher in immunology and innovative vaccine development. 

In this episode of "Research Ethics Reimagined," Mark Barnes, JD, LLM, a partner in the healthcare and life sciences practice at Ropes and Gray LLP in Boston shares his thoughts on the first 100 days of the new administration and identifies the ongoing legal challenges that affect the research oversight community. 

In this episode of "Research Ethics Reimagined," we explore community-engaged research and its role in advancing health equity, particularly in cancer care. Our guest is Monica L. Albertie, Director of Research Operations for Community Outreach and Engagement at the Mayo Clinic Comprehensive Cancer Center. She provides operational leadership for cancer-focused community outreach and community-engaged research aimed at reducing the cancer burden. In addition to her leadership role, Monica also serves as an Assistant Professor of Health Care Administration at the Mayo Clinic College of Medicine and Science.