Background Papers retracted for fraud (data fabrication or data falsification) may represent a deliberate effort to deceive, a motivation fundamentally different from papers retracted for error. It is hypothesised that fraudulent authors target journals with a high impact factor (IF), have other fraudulent publications, diffuse responsibility across many co-authors, delay retracting fraudulent papers and publish from countries with a weak research infrastructure. Methods All 788 English language research papers retracted from the PubMed database between 2000 and 2010 were evaluated. Data (...) pertinent to each retracted paper were abstracted from the paper and the reasons for retraction were derived from the retraction notice and dichotomised as fraud or error. Data for each retracted article were entered in an Excel spreadsheet for analysis. Results Journal IF was higher for fraudulent papers (p<0.001). Roughly 53% of fraudulent papers were written by a first author who had written other retracted papers (‘repeat offender’), whereas only 18% of erroneous papers were written by a repeat offender (χ=88.40; p<0.0001). Fraudulent papers had more authors (p<0.001) and were retracted more slowly than erroneous papers (p<0.005). Surprisingly, there was significantly more fraud than error among retracted papers from the USA (χ2=8.71; p<0.05) compared with the rest of the world. Conclusions This study reports evidence consistent with the ‘deliberate fraud’ hypothesis. The results suggest that papers retracted because of data fabrication or falsification represent a calculated effort to deceive. It is inferred that such behaviour is neither naïve, feckless nor inadvertent. (shrink)

Background Clinical papers so flawed that they are eventually retracted may put patients at risk. Patient risk could arise in a retracted primary study or in any secondary study that draws ideas or inspiration from a primary study. Methods To determine how many patients were put at risk, we evaluated 788 retracted English-language papers published from 2000 to 2010, describing new research with humans or freshly derived human material. These primary papers—together with all secondary studies citing them—were evaluated using ISI (...) Web of Knowledge. Excluded from study were 468 basic science papers not studying fresh human material; 88 reviews presenting older data; 22 case reports; 7 papers retracted for journal error and 23 papers unavailable on Web of Knowledge. Overall, 180 retracted primary papers (22.8%) met the inclusion criteria. Subjects enrolled and patients treated in 180 primary studies and 851 secondary studies were combined. Results Retracted papers were cited over 5000 times, with 93% of citations being research related, suggesting that ideas promulgated in retracted papers can influence subsequent research. Over 28 000 subjects were enrolled—and 9189 patients were treated—in 180 retracted primary studies. Over 400 000 subjects were enrolled—and 70 501 patients were treated—in 851 secondary studies which cited a retracted paper. Papers retracted for fraud (n=70) treated more patients per study (p<0.01) than papers retracted for error (n=110). Conclusions Many patients are put at risk by retracted studies. These are conservative estimates, as only patients enrolled in published clinical studies were tallied. (shrink)

Aims and background: Little is known about how participants perceive prevention trials, particularly trials designed to prevent mental illness. This study examined participants’ motives for participating in a trial and their views of randomisation and the ability to withdraw from a randomised controlled trial for prevention of depression. Methods: Participants were older adults reporting elevated depression symptoms living in urban and regional locations in Australia who had consented to participate in an RCT of interventions to prevent depression. Participants rated their (...) agreement with various statements describing motivations for enrolment in the trial and opinions regarding randomisation and withdrawal. Results: The majority of participants expressed a triad of altruistic motivation for participation, relative lack of concern about randomisation and commitment to the trial. Certain subgroups of participants, such as women and those with higher depression scores, reported higher levels of concern about specific issues. Conclusions: The findings suggest that participants enrolled in prevention trials for mental illness are likely to hold positive attitudes towards research trials. The identification of relationships between key person factors and trial-related attitudes enabled profiling of participant groups, which can inform recruitment strategies and interactions of participants and research projects in future prevention trials. (shrink)