On July 29, the H. Lee Moffitt Cancer Center discovered that hundreds of patient consent forms had been falsified by one of its employees, inaccurately enrolling them in a cancer research study. The act is still under investigation.
“Another consenter discovered an irregularity with one of the forms obtained for that study,” said Michelle Foley, manager of community relations and public affairs at Moffitt. “After further investigation, we found that one of our consenters falsified the signature, and they admitted to that. But they said they had only forged one signature.”
Foley said this knowledge led immediately to an internal investigation that included an external team of handwriting experts.
The results found that the employee had been responsible for approximately 6,464 signatures over the last three years – 90 percent of which were genuine. However, about 490 were questionable.
“The study (patients were enrolled in) is called Total Cancer Care, and it’s an observational study. It involves patients, doctors and researchers whose goal, of course, is to improve all aspects of cancer prevention and care,” said Dr. Robert Wenham, principal investigator for the Moffitt Total Cancer Care protocol. “I think that it was kind of a shock because it was just something that was really unanticipated and it didn’t make a lot of sense. There is no incentive to getting a certain number of patients, so it may have been just trying to get out of work.”
Foley said Moffitt is now in the process of reaching out to patients whose signatures were questionable to determine whether they would like to continue their enrollment in the study or if they had never signed up.
Wenham said the employee under scrutiny was immediately terminated and steps are being taken to prevent similar incidents. “We’ve worked on initiating intensive training for our consenters and supervisors and we’re contacting the patients,” he said. “So moving forward, we’re working on regular auditing, developing a follow-up procedure for patients to confirm their participation in the study and looking into the processes and technologies that other institutions use to avoid these incidents.”
Wenham said the study did not at any time put the patients’ treatment or health at risk.
“Now that we have been able to wrap our heads around it, this appears to have been a very isolated issue relating back to one consenter,” he said. “I think patients have been able to kind of see it for what it is, and most people have appreciated the fact that we have been very transparent about it.”