TAMPA — 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.
Dr. William Dalton, 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.
"We're asking patients' permission to study them,'' said Dalton, who came to the St. Petersburg Times editorial board Wednesday to reveal what had happened. "Patients have to believe you're going to take this very seriously."
The patients whose signatures are in question are being notified, and Moffitt plans to change its procedures to help ensure such a breach does not happen again.
"I was nauseated. I was incredulous, also," Dalton said of his initial reaction to the breach. "I have never seen this before in my life."
Dalton would not identify the employee, who was fired July 30, only saying he worked for Moffitt for about 2½ years as a clinic consenter. These technicians give patients information about the study and collect their signatures on a consent form if they agree to participate. Consenters are hired at a salary range of $27,664 to $34,736.
Dalton said there are no incentives or quotas that might influence a consenter to gather more signatures. He said he didn't know the fired employee's motive, only speculating laziness might have been the issue.
On July 29, another consenter discovered that a patient who had supposedly signed a consent form wasn't even aware of the study. That consenter went to a supervisor, who confronted the initial consenter. He admitted falsifying the signature but said it was the only time he had done that, Dalton said.
The hospital immediately began an investigation, bringing in the auditing firm Ernst & Young. A handwriting expert analyzed the 6,464 consent signatures that the employee had gathered.
Letters were sent this week to each of the 492 patients informing them of an audit, and Moffitt officials on Wednesday began calling to ask whether they actually signed the forms.
As part of the investigation, Moffitt officials also interviewed the six other consenters and checked a random sample of the signatures they collected. Dalton said he is confident the breach is limited to the one employee.
Moffitt has since initiated more intensive training of consenters and supervisors. It also plans to revise its consent process for additional assurance of accuracy. Dalton said that could include simply following up with the patient to ask "Did you sign this form?"
Dalton said Moffitt has also contacted officials with the Institutional Review Board office at the University of South Florida, the federal Office for Human Research Protections and the federal National Institutes of Health and National Cancer Institute, all of whom work to ensure the safety of patients involved in research and trials. Each group was made aware of the breach and the corrective steps Moffitt is taking, Dalton said.
Moffitt officials have also contacted law enforcement authorities, though Dalton said he wasn't sure if laws had been broken.
Dalton didn't know of other consequences the breach could have on Moffitt, such as a loss of grant funding.
A spokesman with the National Cancer Institute contacted Wednesday said the group does not comment on ongoing investigations. Officials with the Institutional Review Board and USF did not return calls seeking comment.
Moffitt intends to write about its experience and publish it in a professional journal so others may learn from it.
Dalton said it's possible that news of the breach could make patients less willing to participate in the study, which has enrolled almost 60,000 patients since it began four years ago.
Patients in the study allow researchers to track the care they receive through their lifetimes. They also donate tumor samples, which are stored and may be analyzed by researchers seeking to advance the treatment and prevention of cancer. The doctors may contact patients at any time if information is discovered that could help them.
Among the participants is Dr. James Omel of Grand Island, Neb., a 62-year-old retired family physician who has multiple myeloma, an incurable blood and bone marrow cancer. He said that such studies are extremely important and that it would be unfortunate if the "inappropriate actions of one person" have any lasting effect on the study.
"Patients are excited about the work that Moffitt is doing," Omel said. "We're happy for any chance to contribute to their understanding of various cancers."
Richard Martin can be reached at [email protected] or (727) 893-8330.