PurposeThis Commentary examines whether current ethics approval systems for medical research, grounded in the Belmont Report's principles of respect for persons, beneficence, and justice, paradoxically result in preventable deaths by delaying patient access to experimental therapies and proposes a framework for democratizing ethics oversight while maintaining safety.FindingsPeer-reviewed evidence demonstrates that ethics delays impose mortality costs that vastly exceed the harms they prevent, particularly for terminal illnesses. Bayesian decision analysis confirms current statistical thresholds are substantially more conservative than optimal for fatal diseases. COVID-19 pandemic responses proved that regulatory timelines can be dramatically compressed through organizational innovation, including accelerated vaccine development and distributed open-source manufacturing, without sacrificing safety.ConclusionsA five-part framework can enable patient autonomy in research ethics while preserving robust safeguards against exploitation: tiered consent based on disease severity, adaptive trial designs with patient governance, mandatory open-source transparency, post-market surveillance, and independent safety monitoring with patient representation.
Joshua M. Pearce (Tue,) studied this question.