Examining the Basic Principles of the Belmont Report in Relevance to the Clinical Trial Involving Human Subject, Jesse Gelsinger. Sara Schultze BTC6
1223 Words5 Pages
In the United States, the basis for ethical protection for human research subjects in clinical research trials are outlined by the Belmont Report developed in the late 1970’s. This document, published by the Nation Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, highlights three important basic principles that are to be considered when any clinical trial will involve human research subjects. They are; respect for persons, beneficence, and justice. (Chadwick & Gunn, 2004)
Over 20 years after the proclamation of these specific ethical guidelines, we are introduced to the University of Pennsylvania’s Institute for Human Gene Therapy’s study on a delivery mechanism for gene therapy that resulted in the death of an 18 year old research subject Jesse Gelsinger. Gelsinger suffered from partial OTC (ornithine transcarbamylase) deficiency caused by a defective single gene (Obasogie, 2009).
Upon first examination of the Jesse Gelsinger case, it may seem as if his death was merely an unforeseeable result after all protocol and considerations were distinctly followed. In the weeks proceeding his death, investigations into the study would find vital flaws with the clinical study design protocol and ethical judgment. The facts uncovered after Jesse Gelsinger’s death would raise questions into how our seemingly advanced regulatory structure could fail this patient.
We can cross examine each principle outlined within the Belmont Report to specific sequences of events to determine in which ways these principles were skewed or ignored, perhaps understanding the way in which the regulatory protocols can be incorrectly carried out or enforced, despite the fact the United States has set such p...
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...Restricted After Gene Therapy Death. The New York Times - Breaking News, World News & Multimedia. Retrieved September 22, 2011, from http://partners.nytimes.com/library/national/science/health/052500hth-gene-therapy.html?scp=9&sq=FDA%20jesse%20gelsinger&st=cse
STOLBERG, S. G. (n.d.). F.D.A. Officials Fault Penn Team in Gene Therapy Death - New York Times. The New York Times - Breaking News, World News & Multimedia. Retrieved September 21, 2011, from http://www.nytimes.com/1999/12/09/us/fda-officials-fault-penn-team-in-gene-therapy-death.html?ref=jessegelsinger
STOLBERG, S. G. (n.d.). U.S. Panel Moves to Force Disclosure in Gene Testing - New York Times. The New York Times - Breaking News, World News & Multimedia. Retrieved September 22, 2011, from http://www.nytimes.com/1999/10/30/us/us-panel-moves-to-force-disclosure-in-gene-testing.html?ref=jessegelsingerhttp://