The Division of Investigative Oversight within the U.S. Office of Research Integrity (ORI) is responsible for conducting oversight review of institutional inquiries and investigations of possible research misconduct. It is also responsible for determining whether Public Health Service findings of research misconduct are warranted. Although ORI findings rely primarily on the scope and quality of the institution’s analyses and determinations, ORI often has been able to strengthen the original findings by employing a variety of analytical methods, often computer based. Although (...) ORI does not conduct inquiries or investigations, it has broad authority to provide assistance to institutions at all stages of their reviews of allegations. This assistance can range from providing advice on best practices, to legal assistance, to suggestions for how best to investigate specific allegations. When asked, ORI can also conduct certain forensic analyses, such as a statistical examination of questioned digits or a simple examination of a questioned figure in Photoshop. ORI will not provide opinions or render judgment on such analyses while the institution is still conducting its investigation. Such analyses can be done without knowing much else about the case. (shrink)

Objective—To determine the prevalence of, and attitudes towards, observed and personal research misconduct among newly appointed medical consultants. Design—Questionnaire study.Setting—Mersey region, United Kingdom.Participants—Medical consultants appointed between Jan 1995 and Jan 2000 in seven different hospital trusts (from lists provided by each hospital's personnel department). Main outcome measures—Reported observed misconduct, reported past personal misconduct and reported possible future misconduct.Results—One hundred and ninety-four replies were received (a response rate of 63.6%); 55.7% of respondents had observed some form of research misconduct; 5.7% of (...) respondents admitted to past personal misconduct; 18% of respondents were either willing to commit or unsure about possible future research misconduct. Only 17% of the respondents reported having received any training in research ethics. Anaesthetists reported a lower incidence of observed research misconduct (33.3%) than the rest of the respondents (61.5%) (p<0.05). Conclusion—There is a higher prevalence of observed and possible future misconduct among newly appointed consultants in the UK than in the comparable study of biomedical trainees in California. Although there is a need for more extensive studies, this survey suggests that there is a real and potential problem of research misconduct in the UK. (shrink)

Objective: To report results from a national survey of coordinators and managers of clinical research studies in the US on their perceptions of and experiences with scientific misconduct.Methods: Data were collected using the Scientific Misconduct Questionnaire-Revised. Eligible responses were received from 1645 of 5302 surveys sent to members of the Association of Clinical Research Professionals and to subscribers of Research Practitioner, published by the Center for Clinical Research Practice, between February 2004 and January 2005.Findings: Overall, the perceived frequency of misconduct (...) was low. Differences were noted between workplaces with regard to perceived pressures on investigators and research coordinators, and on the effectiveness of the regulatory environment in reducing misconduct. First-hand experience with an incident of misconduct was reported by 18% of respondents. Those with first-hand knowledge of misconduct were more likely to report working in an academic medical setting, and to report that a typical research coordinator would probably do nothing if aware that a principal investigator or research staff member was involved in an incident of misconduct.Conclusion: These findings expand the knowledge on scientific misconduct by adding new information from the perspective of research coordinators. The findings provide some data supporting the influence of workplace climate on misconduct and also on the perceived effectiveness of institutional policies to reduce scientific misconduct. (shrink)

The issue of how to best minimize scientific misconduct remains a controversial topic among bioethicists, professors, policymakers, and attorneys. This paper suggests that harsher criminal sanctions against misconduct, better protections for whistleblowers, and the creation of due process standards for misconduct investigations are urgently needed. Although the causes of misconduct and estimates of problem remain varied, the literature suggests that scientific misconduct—fraud, fabrication, and plagiarism of scientific research—continues to damage public health and trust in science. Providing stricter criminal statutes against (...) misconduct is necessary to motivate whistleblowers and deter wrongdoers, and the provision of basic due process protections is necessary for ensuring a fair and balanced misconduct investigation. (shrink)

There has been relatively little empirical research into the causes of research misconduct. To begin to address this void, the authors collected data from closed case files of the Office of Research Integrity (ORI). These data were in the form of statements extracted from ORI file documents including transcripts, investigative reports, witness statements, and correspondence. Researchers assigned these statements to 44 different concepts. These concepts were then analyzed using multidimensional scaling and cluster analysis. The authors chose a solution consisting of (...) seven clusters: (1) personal and professional stressors, (2) organizational climate, (3) job insecurities, (4) rationalizations A, (5) personal inhibitions, (6) rationalizations B and, (7) personality factors. The authors discuss the implications of their findings for policy and for future research. (shrink)