Misconduct in clinical research

According to a paper recently published in The Proceedings of the National Academy of Sciences, scientific misconduct is the leading cause of retractions. Misconduct means fabrication, falsification and/or plagiarism during any phase of the research, from proposal to publication. Misconduct in clinical research often takes the form of falsifying participant records or conducting human subjects research without proper approval.

Looking at a total of 2047 retractions from 1977 to the present that were found in the PubMed database, Dr. Ferric C. Fang and colleagues found that just over 20% could be attributed to mistakes. More than two thirds were due to fraud or suspected fraud. Unsurprisingly, journals with higher impact factors (a relative measure of a publication’s importance) had higher rates of retractions.

Misconduct in clinical research is particularly troubling because of its potential to cause harm to research participants, future patients and the public at large. Notable examples include Merck’s voluntary withdrawal of rofecoxib from the world market in the face of allegations of misconduct, and the now-discredited research of Andrew Wakefield, which influenced many parents to forgo immunization of their children and has been described as “the most damaging medical hoax of the last 100 years”. Less tangible societal harms stem from public mistrust of the research enterprise and poor stewardship of taxpayer dollars.

Investigators and research team members need to understand that research misconduct is likely to be a career-ending move if it is discovered, even in the absence of demonstrable harm to others. In addition to loss of employment, the range of possible consequences includes debarment by FDA, loss of professional licensure or certification, civil or criminal penalties – even jail time. Institutions may face severe penalties as well.

The good news is that retractions account for less than one tenth of one percent of the papers in the PubMed database, suggesting that scientific fraud is relatively rare. Still, the frequency of retractions is increasing, perhaps because it’s so much more difficult to cover one’s tracks in the digital age.

Suggestions for further reading:

  • Funding agencies such as the National Institutes of Health and the National Science Foundation provide extensive information on their websites to help investigators and institutions understand their obligations to conduct scientifically and ethically sound research.
  • The HHS Office of Research Integrity oversees investigations of misconduct in federally funded research and provides education on the responsible conduct of research.
  • The blog Retraction Watch highlights notable retractions of scientific papers.

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