Original article Data integrity, reliability and fraud in medical research Mark Otto Baerlocher a, ⁎, Jeremy O'Brien b , Marshall Newton c , Tina Gautam d , Jason Noble e a University of Toronto Radiology Residency Program, Toronto, Ontario, 13 Marshview Drive; Sackville, New Brunswick, Canada E4L 3B2 b McGill University Radiology Residency Program, Montreal, Quebec, #205–3827 boul Saint-Laurent, Montreal, Quebec, Canada H2W1X9 c University of Western Ontario, London, Canada d University of Toronto, Toronto, Canada e Dept. of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Canada abstract article info Article history: Received 30 August 2009 Received in revised form 8 November 2009 Accepted 11 November 2009 Available online 26 November 2009 Keywords: Data integrity Academia Data reliability Academic fraud 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. © 2009 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved. 1. Introduction Despite a rigorous manuscript external review process, involving both Journal Editors as well as independent ‘experts’, the reader of scientific literature is often forced to trust manuscript authors that the presented data are accurate. The reader cannot know if there are errors in the presented data, save for a suspicion developing if the end result does not make sense to him. In the example of a new medication, or new intervention, it may be particularly difficult for the reader to have a pre-conceived sense of the expected outcome prior to reading the manuscript. In many cases, inaccuracies and errors may be revealed through time. We cannot know how errors were missed. In essence, we must trust that the investigators have eliminated, or at least minimized, human error through data reliability safeguards and thus only true values were recorded, analyzed, and presented. Data checks may include double data entry, multiple investigators independently interpreting the data/statistics, duplicate statistical analyses, tests of inter-observer variability, duplicate data abstraction, and hard copies of electronic data sent from the lab or data acquisition source. In addition to formal statements of authorship contribution from each author, many Journals also require a formal assumption of responsibility for the integrity of the entire work, from “inception to published article” (e.g. JAMA: http://jama.ama-assn.org/ifora_current. dtl Accessed on January 3, 2005) by one or all of the authors, and an assumption of responsibility for the integrity of at least some of the work by all authors. Generally, all authors must agree to provide the data or to fully cooperate in obtaining and providing the data on which the manuscript is based if requested for examination by the Editors of the respective Journal. All authors must sign this form. However, most Journals do not require a statement which details the European Journal of Internal Medicine 21 (2010) 40–45 ⁎ Corresponding author. E-mail addresses: mark.baerlocher@utoronto.ca (M.O. Baerlocher), obrien.jeremy@gmail.com (J. O'Brien), mnewton4@uwo.ca (M. Newton), tina.gautam@utoronto.ca (T. Gautam), jason.noble@utoronto.ca (J. Noble). 0953-6205/$ – see front matter © 2009 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved. doi:10.1016/j.ejim.2009.11.002 Contents lists available at ScienceDirect European Journal of Internal Medicine journal homepage: www.elsevier.com/locate/ejim