Question

Jesse Gelsinger was a clinical trial participant in one of the first clinical trials on an investigational gene therapy approached that was testing adenovirus as a vector to introduce a functional gene. He died as a result of a massive immune response to the AAV. What is not a GCP violation that the investigators involved were found to have committed?

Investigator was not present to personally supervise the trial
-Investigators ignored previous reports of serious adverse reaction in two other patients
-Inadequate informed consent documentation regarding deaths in monkeys
-Jesse had a health condition that should have excluded him from participating in the trial
-"There were conflict of interests, i.e., scientists and the hospital were getting research funding from the company sponsoring the trial"

Answer 1

The presence of conflicts of interest - where researchers are funded by the company sponsoring the trial - is not in itself a GCP violation, unlike the other infractions in Jesse Gelsinger's case.

Step-by-step explanation:

The question relates to the case of Jesse Gelsinger who died due to a massive immune response during a clinical trial for gene therapy. Among the violations of Good Clinical Practice (GCP) that the investigators were found to have committed, the one action that is not a GCP violation is the presence of conflicts of interest, such as the hospital and scientists receiving research funding from the company sponsoring the trial.

While conflicts of interest can affect the judgment of researchers, they do not inherently violate GCP unless they lead to conduct that breaches ethical guidelines or regulations. Other infractions included the investigator not being present to supervise the trial, ignoring previous serious adverse reactions, inadequate informed consent concerning deaths in monkeys, and Jesse's health condition that should have disqualified him from participation.