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

The death of research subject Jesse Gelsinger in 1999 is a pivotal event that brought significant public attention to the Institutional Review Board (IRB) system. Gelsinger was a participant in a gene therapy trial that went tragically wrong, leading to his death. This incident raised serious concerns about the oversight and ethical standards upheld by IRBs in clinical research.

Gelsinger's case highlighted issues related to informed consent, the potential risks of research, and the responsibilities of both researchers and IRBs in protecting human subjects. As details about the circumstances surrounding the trial emerged, including prior safety concerns that had not been adequately addressed, it sparked widespread media coverage and led to a public outcry. This case ultimately resulted in a reevaluation of IRB practices and the regulatory framework governing research involving human subjects.

The explosion of public interest prompted government agencies, including the Office for Human Research Protections (OHRP), to strengthen the IRB system and foster a greater emphasis on ethical oversight in biomedical research.