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Penn and U.S. Settle Over Research Death

Penn and U.S. Settle Over Research Death
February 10, 2005

The University of Pennsylvania agreed Wednesday to pay more than a half-million dollars to settle a U.S. Justice Department investigation into the 1999 death of an 18-year-old patient in a gene therapy study. As part of the accord, three researchers have agreed to significant limitations on their involvement in studies involving human subjects.

Under its settlement with the Justice Department, Penn will pay the government $517,496, although it did not admit to any culpability in its treatment of Jesse Gelsinger, who died at Penn's hospital soon after receiving an injection of therapeutic genes aimed at treating a rare liver disease. The government accused Penn of providing false statements and data in grant applications and reports to the Food and Drug Administration.

The settlement agreement notes that Penn made numerous changes to its research policies in the wake of Gelsinger's death, including upgrading the institutional review board that approves research studies and improving its training of clinical scientists. The National Children's Medical Center in Washington, where one of the researchers involved in the gene therapy study works, agreed to pay $514,000.

The lead researcher in the case, James Wilson of Penn, agreed in his personal settlement with the government to severe restrictions on his participation in research studies, although he too denied wrongdoing. He may not participate in human subjects research for at least five years, and only then if he completes a series of educational requirements and has his work closely overseen by a "medical monitor" for three years, "to gain practical experience."

Two other scientists, Steven Raper of Penn and Mark Batshaw of the National Children's Medical Center, will face restrictions on their research activities for three years.

"Perhaps most significant is the impact that these settlements will have on the way clinical research on human participants is conducted throughout the country," Patrick L. Meehan, the U.S. Attorney in Philadelphia, said in a prepared statement. "This action covers two major research centers which have instituted important changes in the conduct and monitoring of clinical research on human participants. We hope that these settlements will now serve as a model for similar research nationwide."

 

 

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