Jesse Gelsinger was diagnosed with partial OTC deficiency when he was a young child. He was found to have a unique mutation that formed spontaneously. Some of his cells had a defective OTC gene with a large deletion, whereas others had a normal gene. This type of condition is known as mosaicism. Jesse Gelsinger lived in Tucson, Arizona. He was the 18th and final subject in the study, and at age 18, he was the youngest person enrolled. He had learned about the trial in 1998 from his physician, and was only allowed into the study because another subject had dropped out. His father was stated in saying that he “was doing this for other people.”1 Jesse Gelsinger set aside his personal life to participate in the study, and took an unpaid leave from his job. On September 13, 1999, Gelsinger became the second subject to receive the highest dose of the adenovirus. In the other study participants, including the first to receive the highest dose, the adverse effects were only temporary muscle aches and fever. These side effects were not life threatening.1 About 18 hours after the infusion of the adenovirus vector, Gelsinger started to develop an altered mental status and jaundice. He then developed a systemic inflammatory response to the virus, …show more content…
In their attempt to help patients with a life-threatening disease, researchers at one of the leading academic medical centers in the United States lost their focus. They overlooked warning signs that the experimental intervention was not safe, which caused a fatal consequence. The case underscores the responsibilities of investigators to obtain informed consent properly, to disclose all the risks of research clearly, to adhere to the research protocol, to keep good records, and to communicate promptly and completely with IRBs and regulatory agencies. It also underscores the obligations of the IRB and regulatory agencies to provide effective supervision of the