Ethical Conduct of Research
We will conduct our research with integrity and intellectual honesty, and show the greatest care for human or animal subjects-
This means that each member of the campus community to whom this standard applies
- Demonstrates appropriate regard for human and animal subjects
Perspective: A Real World Illustration
A February 2005 Associated Press newspaper article reported on a legal settlement in which a public university located in Pennsylvania and another non-profit organization agreed to pay the government a total of $1 million to settle fraud allegations related to the death of an Arizona teenager during a gene therapy experiment.
The 18-year-old patient died on his fourth day of involvement in the study in 1999. The teen had suffered from an inherited disorder that blocks the body from properly processing nitrogen. Researchers had hoped to cure him by injecting him with a modified virus carrying a gene that could replace the medications and special diet that had been controlling his condition. The Food and Drug Administration concluded that the injection killed him. After the death, the teen's family said he had been misled about the experiment's potential risks.
Federal prosecutors alleged in a civil complaint that researchers should have realized that the experiment had unacceptable side effects. They also alleged that researchers had submitted reports to government entities misrepresenting the study's clinical findings. The two institutions maintain that the teen's death was unforeseen and that he was properly enrolled in the study based on the best scientific information available at the time. Neither the university nor the non-profit is required to acknowledge any wrongdoing as part of the settlement.
Under the agreement, the university will pay the government $517,496 and the non-profit will pay $514,622, amounts equivalent to the federal funding the institutions received to conduct the clinical trial that led to the teen's death.
University officials said in a written statement that in the five years since the teen's death, they had overhauled their rules for clinical research on human subjects. "Out of this tragedy has come a renewed national effort to protect the safety of those who help to advance new treatments and cures through clinical research," the statement said.
The teen's family attorney said the family was "extremely disappointed." He said they had wanted all documents in the case made public "so real changes could be made in the way human research is conducted in this country."
The settlement will allow the three researchers involved in the experiment to continue their research, although all three will have restrictions placed on their future work.
Last Revised 5/23/2006