Fraud and Deceit in Medical Research

Deceit and fraud in medical research – Publish or perish culture is to blame

Questionable research practices are common and probably do more damage to science than the “big three” of fabrication, falsification, and plagiarism, said Nick Steneck, consultant to the US Office of...

In February 1991 the Royal College of Physicians produced a report entitled ‘Fraud and Misconduct in Medical Research’. Most of the cases documented have come from the United States but by the end of 1988 five cases had been formally reported in Britain. One of these was a financial fraud perpetrated by a psychiatrist who worked in a district general hospital in the Northern Region and who forged data for a drug company. He was subsequently reported to the General Medical Council by the Association of the British Pharmaceutical Industry and had his name removed from the medical register. Informal investigations, however, suggest that fraudulent research might be more widespread and as a result the Royal College of Physicians established a working party to look at this issue in detail. They recommended that a twin track approach of prevention and thorough management of complaints of misconduct be adopted. The report was kindly forwarded to the Research Committee of the Royal College of Psychiatrists which felt that a summary of these recommendations should be widely published among researchers in psychiatry.

Prevalence of research misconduct, questionable research practices (QRPs) and their associations with a range of explanatory factors has not been studied sufficiently among academic researchers. The National Survey on Research Integrity targeted all disciplinary fields and academic ranks in the Netherlands. It included questions about engagement in fabrication, falsification and 11 QRPs over the previous three years, and 12 explanatory factor scales. We ensured strict identity protection and used the randomized response method for questions on research misconduct. 6,813 respondents completed the survey. Prevalence of fabrication was 4.3% (95% CI: 2.9, 5.7) and of falsification 4.2% (95% CI: 2.8, 5.6). Prevalence of QRPs ranged from 0.6% (95% CI: 0.5, 0.9) to 17.5% (95% CI: 16.4, 18.7) with 51.3% (95% CI: 50.1, 52.5) of respondents engaging frequently in at least one QRP. Being a PhD candidate or junior researcher increased the odds of frequently engaging in at least one QRP, as did being male. Scientific norm subscription (odds ratio (OR) 0.79; 95% CI: 0.63, 1.00) and perceived likelihood of detection by reviewers (OR 0.62, 95% CI: 0.44, 0.88) were associated with engaging in less research misconduct. Publication pressure was associated with more often engaging in one or more QRPs frequently (OR 1.22, 95% CI: 1.14, 1.30). We found higher prevalence of misconduct than earlier surveys. Our results suggest that greater emphasis on scientific norm subscription, strengthening reviewers in their role as gatekeepers of research quality and curbing the “publish or perish” incentive system promotes research integrity.

Information for authors and editorial policies

Fraud in medical publishing has risen to the national spotlight as manufactured and suspect data have led to retractions of papers in prominent journals. Moral turpitude in medical research has led to the loss of National Institute of Health (NIH) grants, directly affected patient care, and has led to severe legal ramifications for some authors. While there are multiple checks and balances in medical research to prevent fraud, the final enforcement lies with journal editors and publishers. There is an ethical and legal obligation to make careful and critical examinations of the medical research published in their journals. Failure to follow the highest standards in medical publishing can lead to legal liability and destroy a journal’s integrity. More significant, however, is the protection of the medical profession’s trust with their colleagues and the public they serve. This article discusses various techniques and tools available to editors and publishers that can help curtail fraud in medical publishing.

This paper explores how cultural understandings of the autonomy and responsibility of science in modern society are manifested in two contemporary science novels about research misconduct in biomedical research. In doing so, it looks at several facets of the societal impact of and on public and private biomedical research, especially with respect to changing authority relations and their epistemic and institutional consequences. The analysis focuses on the multi-layered ways in which social and epistemic interests are treated in Allegra Goodman’s Intuition and Jennifer Rohn’s The Honest Look. Goodman’s novel demonstrates how, intensified by the economization of science, internal cultural and institutional aspects of the scientific field enable social configurations that, among others, encourage scientific malpractice and lead to the delay of research projects epistemically and socially worth pursuing. In contrast, Rohn’s novel exemplifies the corrosion of the ideal scientific ethos by profit-driven practices in private-sector biomedical sciences. The concluding discussion juxtaposes these findings with pertinent contemporary phenomena in modern science systems to provide a more substantial understanding of the interpenetration between science and other social spheres.

Fraud and other misconduct in biomedical research

Authorship.

Ethical problems were a major distraction during my editorship of Neurology (1987–1996). Resolving an ethical issue is usually more time-consuming than deciding whether to accept (and then edit), or reject, a manuscript, and the stakes are higher. A mistakenly rejected paper will certainly be published elsewhere, and a mistakenly published error-ridden paper will generate critical Correspondence. By contrast, mistakenly jeopardizing a colleague’s reputation and academic career may never be adequately remediated, and must scrupulously be avoided. We only needed to retract one article1 and one abstract2 while I served as Editor. But, in so doing, I became a “poster editor” for the Office of Research Integrity (ORI), the investigative agency for the NIH and other Public Health Service entities. My popularity related to other editors being reluctant to retract articles. Indeed, I attended an ORI meeting where the editor of a major journal espoused the position that only the author, and not the editor, can retract a paper, despite documented falsification or fabrication. Serious scientific journals now adhere to the guidelines of the International Committee of Medical Journal Editors (ICMJE),3 and most editors seem to follow the rules. When Robert Griggs succeeded me as Editor in 1997, he sought my advice about ethical issues. This led to my appointment as the journal’s first Scientific Integrity Advisor, in 2004. We developed policies to deal with scientific misconduct and breach of publication ethics, which we explained in an Editorial4 and our Information for Authors. “Misconduct” includes “fabrication, falsification, and plagiarism,” with “intent to deceive.” Fabrication is making up data; falsification is falsely reporting data or methodology; …

Bhutta and Crane debate whether research fraud should be a crime.1 In the United States, the Office for Human Research Protections (OHRP) of the Department of Health and Human Services...

This cross-sectional study evaluates the knowledge, attitudes, experiences, and behavior of final year medical students, PhD students, and supervisors at the School of Medicine of the University of Zagreb in relation to research misconduct, questionable research practices, and the research environment. The overall response rate was 36.4% (68%-100% for the paper survey and 8%-15% for the online surveys). The analysis reveals statistically significant differences in attitude scores between PhD students and supervisors, the latter having attitudes more in concordance with accepted norms. The results overall show a nonnegligible incidence of self-reported misconduct and questionable research practices, as well as some problematic attitudes towards misconduct and questionable research practices. The incidence of problematic authorship practices was particularly high. The research environment was evaluated as being mostly supportive of research integrity.

Letter to the editor: A clinician's perspective of the ‘unfortunate experiment’

This paper describes the role of the Office of Research Integrity (ORI), a component of the Public Health Service (PHS), in defining scientific misconduct in research supported with PHS funds and in establishing standards for responding to allegations of misconduct. The principal methods by which ORI exercises its responsibilities in this area are defining what types of behaviors undertaken by research investigators constitute misconduct, overseeing institutional efforts to investigate and report misconduct, and recommending to the Assistant Secretary for Health (ASH) PHS administrative actions when misconduct is identified. ORI also takes affirmative steps to promote research integrity through education, training, and other initiatives. The role of the research institution in responding to misconduct and promoting research integrity is complementary and overlapping with ORI's efforts but, as the employer of research investigators and front-line manager of the research, the institution has a greater opportunity to promote the highest standards of integrity in the day-to-day conduct of research. Finally, legal precedent established through civil litigation has played an important role in defining the standards that apply in determining when a breach of research integrity has occurred.

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