UPennClinicalResearch.pdf;JSESSIONIDVISTA=h8CXTnyGGw25W2TG0phyvjsZCYCKHxsycvCGV9nvccTpshnyFbt2!-2853

UPennClinicalResearch.pdf;JSESSIONIDVISTA=h8CXTnyGGw25W2TG0phyvjsZCYCKHxsycvCGV9nvccTpshnyFbt2!-2853

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U. of Pennsylvania to Pay $500,000 to Settle Federal Accusations Over Gene- Therapy Death From The Chronicle of Higher Education, February 11, 2005 By JEFFREY BRAINARD The University of Pennsylvania has agreed to pay the federal government $517,496 to settle allegations that Penn researchers misled regulators and failed to protect patients during a 1999 gene-therapy study that led to the death of an 18-year-old research volunteer, Jesse Gelsinger. The civil settlement, announced on Wednesday by the U.S. Justice Department, also restricted future clinical research by three scientists involved, including the principal investigator, James M. Wilson. Dr. Wilson remains a faculty member at Penn, but the Food and Drug Administration barred his research group from studying human subjects shortly after Mr. Gelsinger's death. Under the settlement, Dr. Wilson is prohibited from leading clinical research involving human subjects until 2010. He may resume participation in studies involving human subjects before then if he undergoes additional training in such research and his work is independently monitored. Neither Dr. Wilson nor Penn admitted liability in the death, and they have contended that their conduct was at all times lawful and appropriate. Penn has strengthened its oversight of clinical
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This note was uploaded on 01/01/2012 for the course PHAR 6010 taught by Professor Mullis during the Spring '11 term at University of Georgia Athens.

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UPennClinicalResearch.pdf;JSESSIONIDVISTA=h8CXTnyGGw25W2TG0phyvjsZCYCKHxsycvCGV9nvccTpshnyFbt2!-2853

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