Data integrity, reliability and fraud in medical research.

BACKGROUND

Data reliability in original research requires collective trust from the academic community. Standards exist to ensure data integrity, but these safeguards are applied non-uniformly so errors or even fraud may still exist in the literature.

OBJECTIVE

To examine the prevalence and consequences of data errors, data reliability safeguards and fraudulent data among medical academics.

METHODOLOGY

Corresponding authors of every fourth primary research paper published in the Journal of the American Medical Association (2001-2003), Canadian Medical Association Journal (2001-2003), British Medical Journal (1998-2000), and Lancet (1998-2000) were surveyed electronically. Questions focused on each author's personal experience with data reliability, data errors and data interpretation.

RESULTS

Sixty-five percent (127/195) of corresponding authors responded. Ninety-four percent of respondents accepted full responsibility for the integrity of the last manuscript on which they were listed as co-author; however, 21% had discovered incorrect data after publication in previous manuscripts they had co-authored. Fraudulent data was discovered by 4% of respondents in their previous work. Four percent also noted 'smudged' data. Eighty-seven percent of respondents used data reliability safeguards in their last published manuscript, typically data review by multiple authors or double data entry. Twenty-one percent were involved in a paper that was submitted despite disagreement about the interpretation of the results, although the disagreeing author commonly withdrew from authorship.

CONCLUSIONS

Data reliability remains a difficult issue in medical literature. A significant proportion of respondents did not use data reliability safeguards. Research fraud does exist in academia; however, it was not reported to be highly prevalent.