Ethical Issues In Clinical Research

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

The Gelsinger family was unaware of the resultant death of two test rhesus monkeys receiving the same treatment that Jesse would undergo, and both the family and the governmental agencies were not given notice to the adverse events that had occurred in previous research subjects in the same study. Moreover, investigation into the study has declared that Jesse Gelsinger was ineligible to be a participant, as his liver (into which the gene therapy adenovirus was injected) was not functioning well enough to participate in the first place. The last aspect that was undisclosed was the fact that the individual overseeing the study had a monetary interest in achieving a successful result. Dr. John Wilson, owned a considerable stake in the private corporation that was providing funding. (Stolberg) The lack of the comprehensive disclosure required in obtaining an informed consent had been argued and found to be insufficient, with restrictions placed on Dr. Wilson’s operation and ability to conduct future clinical trials. (Stolberg). We are unable to know if the Gelsinger family would have changed their minds had they been given such information, completely and correctly, but we do know that Jesse Gelsinger was failed by the study investigators in the ability to give the informed consent as outlined by the Respect for Persons

(n.d.). The New York Times - Breaking News, World News & Multimedia. Retrieved September 24, 2011, from http://www.nytimes.com/2000/11/04/us/penn-settles-suit-on-genetic-test.html?ref=jessegelsinger

STOLBERG, S. G. (n.d.). Institute 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