Tag: IRBs

In this conversation, Daniel Belkin and Mitch Belkin interview Simon Whitney, MD, JD, about his book From Oversight to Overkill. They discuss the history of Institutional Review Boards (IRBs), including ethically questionable experiments such as Chester Southam’s cancer cell injections, the Willowbrook experiment, as well as the US Public Health Service Syphilis Study (AKA Tuskegee experiment). They then discuss Peter Buxton, Henry Beecher, James Shannon, and the congressional oversight of federally funded research. Finally, they touch on the ISIS-2 study, Pronovost’s checklist, OHRP’s crackdown in the late 1990s, and discuss whether research is too safe, IRB infallibility, autonomy in the Belmont Report, and the risks and benefits of restricting research in the name of safety.

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Who is Simon Whitney?

Simon Whitney, MD, JD, is a family medicine physician and ethicist. He previously taught at Baylor College of Medicine for 22 years. He is currently retired from the practice of medicine but continues to publish and teach medical ethics. He is the author of the book “From Oversight to Overkill: Inside the Broken System That Blocks Medical Breakthroughs—And How We Can Fix It.”

References:

• Simon Whitney’s website
• Simon Whitney’s book: From Oversight to Overkill
• ISIS-2 trial
• Pronovost’s Study on catheter-related infections
• Scott Alexander’s Review of the Book

If you enjoyed this episode, be sure to check out our episode with Carl Schneider.

In this colorful conversation, Daniel Belkin and Mitch Belkin speak with Carl Schneider, JD about informed consent and the problematic nature of IRBs. We discuss the difficulties of patient education and whether patients actually want medical knowledge in order to guide their decision-making. We discuss the onerousness of IRB regulation, event licensing, the costs of inhibiting knowledge generation, as well as the paternalism of IRBs. We cover how “protections” for vulnerable groups counterintuitively harms these groups by preventing both the generation of knowledge and the development of treatments. Professor Schneider argues that IRBs should be abolished and the system of informed consent ought to be reconsidered.

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Who is Carl Schneider?

Professor Carl Schneider is a lawyer and bioethicist. He is a Professor of Ethics, Morality, and the Practice of Law at University of Michigan. After attending University of Michigan Law School, he served as law clerk to Justice Potter Stewart of the United States Supreme Court. Schneider has authored several books, including The Censor’s Hand: The Misregulation of Human-Subject Research and The Practice of Autonomy: Patients, Doctors, and Medical Decisions.

References

• Carl Schneider – University of Michigan Law School Bio
• The Practice of Autonomy: Patients, Doctors, and Medical Decisions
• The Censor’s Hand: The Misregulation of Human-Subject Research
• Mentalist Derren Brown’s – The Push (Trailer)
• Stanley Milgram’s Experiments
• Daniel & Mitch’s Sensible Medicine Substack – Signaling in Med Ed
• Tuskegee Syphillis Study

If you enjoyed this episode, be sure to check out our episode with Simon Whitney.