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Moffitt Cancer Center discovers patient consent was falsified for study

St. Petersburg Times, August 26, 2010

The H. Lee Moffitt Cancer Center on Wednesday revealed that it is investigating whether hundreds of patient signatures were falsified on documents enrolling them in the hospital's largest cancer research study. William Dalton, MD, Moffitt's president and CEO, said that an employee admitted falsifying a patient signature on a consent form, sparking an investigation that uncovered 492 questionable signatures. Dalton said the breach did not affect patient care. The study is an observational trial called Total Cancer Care, which tracks thousands of cancer patients over time but does not involve the treatment they receive. But because proper patient consent is so vital to the research process — and patients' trust in it — the discovery of an improper signature on July 29 led to an immediate audit of the employee's work.