Which event brought increased public attention to the problems with the IRB system?

The event that brought increased public attention to the problems with the Institutional Review Board (IRB) system was the death of Jesse Gelsinger. This incident highlighted significant ethical and regulatory issues within the clinical research framework. Gelsinger was a participant in a gene therapy clinical trial at the University of Pennsylvania for a rare genetic disorder when he suffered a severe adverse reaction that ultimately led to his death.

This event was notable not only because of the tragic outcome but also due to the subsequent investigations that revealed lapses in safety protocols, informed consent processes, and oversight by the IRB. Gelsinger’s case became a catalyst for public discourse on the responsibility of researchers and institutions in protecting human subjects. It spurred calls for reform in the oversight of clinical trials and brought to light the need for more stringent ethical standards in research involving human participants.

Consequently, the Gelsinger case played a crucial role in the evolution of regulations surrounding IRBs and contributed to legislative and procedural changes designed to enhance the protection of individuals involved in research studies. Other listed events, while significant, did not generate the same level of public scrutiny or immediate calls for systemic change within the IRB framework as this tragic event did.