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 protections in place.
Respect for Persons
The Belmont Report outlines the respect for persons to include protections for an individual’s right to know and understand the details of the clinical trial in which they are to become a subject. One aspect of this principle explains the importance in the protection of autonomy for individuals, to ensure they are not being subjected to research against their will. It also outlines provisions for individuals that are deemed ‘vulnerable populations’ to be recognized and given special considerations. Vulnerable populations generally include children, mentally incapacitated and prisoners that may not be capable of providing true consent due to cognitive abilities or personal freedoms. (Chadwick & Gunn pg.30).
In this aspect of the Respect for Persons principle, we know that Jesse Gelsinger was protected. As a legal adult, it was documented and reported by his family that he was excited about the prospective outcome of the gene therapy trial. He recognized that he would not benefit from the study, but looked forward to being able to help advance medical knowledge so that others like him, with debilitating or potentially fatal single gene deficiencies, could be saved in the...