While skimming through the case summaries to select one to cover for this assignment, it seems that all of the violations I read about were related to data falsification or fabrication. The resulting investigations led to retractions of papers based on false data and a probation period and/or specific sanctions to ensure that future publications were based on non-falsified data. Scientists found to have committed repeated violations were barred from contracting with the federal government for future research, usually for a set number of years.
Of these case summaries, one stood out to me because of the severity of the penalties and the serious negative consequences of data falsification:
According to the Office of Research Integrity (1), Paul Kornak, a former researcher at a Veterans Affairs medical center, was indicted on 48 criminal charges stemming from several serious infractions. He pled guilty to 3 of these charges as part of a plea deal, admitting that he had lied about a previous conviction and probation on his job application. He also admitted that while employed at the research center, he falsified information on potential study participants and including people in studies who did not meet inclusion criteria. A 2005 popular press article on the case further elaborated that Mr. Kornak “admitted to doctoring records for at least 27 patients from 1999 to 2002 as coordinator for clinical trials” (2). This falsified paperwork led to the death of one person, who was included in a study of chemotherapy drugs despite previous test results showing “impaired kidney and liver function,” which should have prevented their inclusion in the study (1).
As a result, Mr. Kornak was permanently barred from working with the federal government, sentenced to almost 6 years in prison, and ordered to pay $639,000 back to his former employer and the pharmaceutical companies that he had defrauded as part of his activities.
Given that his actions led to the death of a study participant, I’m surprised that the penalties were not more severe, although the prison sentence was apparently the maximum allowed length for criminally negligent homicide (2). I’m curious as to whether whether there was any additional civil legal action related to these ethics violations.
As someone who is relatively unfamiliar with the medical research field, I found the fact that researchers would intentionally falsify data during medical studies particularly disturbing, given the potential effects on human health and wellbeing. While I understand that the “publish or perish” attitude prevalent in academia and research creates a lot of pressure for scientists to get results and present them, I don’t see how any publication could be worth falsifying data to get the results that you want, especially knowing that your work is likely to influence the medical care of countless unknown people later on.