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

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

A. Death of Research Subject (Jesse Gelsinger)

B. HHS Inspector General Report of 1998

C. 1983 Presidential Commission Report”

D. Shut Downs” by OHRP

Answer: A. Death of Research Subject (Jesse Gelsinger)

Answer: The tragic death of Jesse Gelsinger in a gene therapy clinical trial at the University of Pennsylvania in 1999 directed immense public concern about the flaws inherent in the Institutional Review Board (IRB). This tragic event revealed huge gaps in research supervision, obtaining subjects’ consent, as well as how conflicts of interest are addressed. Gelsinger suffered from a metabolic disease and died from multiple organ dysfunction after a risky treatment. The case demonstrated that, in some instances, authors refrained from reporting pertinent agenda and past deleterious animal experiences to the IRB members as well as research subjects. It generated substantial public interest, and congressional and media attention and fed a federal investigation that produced a major set of changes in the protection of human research subjects. It was instrumental in enhancing the guidelines of IRBs, enhancing the clarity of clinical trials, and stressing the significance of Ethics in human research.