The event that brought increased public attention to the problems with the Institutional Review Board (IRB) system was the death of research subject Jesse Gelsinger in 1999 during a gene therapy trial. His death exposed serious ethical concerns such as inadequate informed consent, conflicts of interest, and insufficient oversight by the IRB, leading to heightened scrutiny and calls for reform of the IRB system. Other notable contributors that drew public attention include:
- The HHS Inspector General Report of 1998 , which highlighted significant issues within the IRB system.
- The 1983 Presidential Commission Report , addressing ethical concerns and IRB effectiveness.
- "Shut Downs" by the Office for Human Research Protections (OHRP) , which underscored the consequences of IRB non-compliance with federal regulations.
- High-profile cases like the death of Ellen Roche and research shutdowns at major institutions such as Duke University.
However, Jesse Gelsinger's case remains the most pivotal incident leading to widespread public awareness of the IRB system’s problems.