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At least 127 records · Page 7Linked to original sources

The effect of scientific misconduct on the results of clinical trials: a Delphi survey.

OBJECTIVES: To discover what types of scientific misconduct are most likely to influence the results of a clinical trial. DESIGN: Delphi survey of expert opinion with three rounds of consultation. SETTING: Non-industry clinical trial "community". PARTICIPANTS: Experts identified from invitees to a previous MRC consultation on clinical trials. 32 out of the 40 experts approached agreed to participate. RESULTS: We identified thirteen forms of scientific misconduct for which there was majority agreement (>50%) that they would be likely or very likely to distort the results and majority agreement (>50%) that they would be likely or very likely to occur. Of these, the over-interpretation of 'significant' findings in small trials, selective reporting and inappropriate subgroup analyses were the main themes. CONCLUSIONS: According to this expert group, the most important forms of scientific misconduct in clinical trials are selective reporting and the opportunistic use of the play of chance. Data fabrication and falsification were not rated highly because it was considered that these were unlikely to occur. Registration and publication of detailed clinical trial protocols could make an important contribution to preventing scientific misconduct.

Bias↗

Scientific misconduct as a dilemma for nursing.

Scientific misconduct--fabrication, falsification, plagiarism or other deviations from ethical standards--is not new or unique to any discipline. Although nurses have not been included in publicized cases of misconduct, nursing is not immune. Circumstances that may be related to misconduct such as pressures to publish and to earn tenure, inadequate supervision of young scientists, limitations of the peer review system, and excessive numbers of publications by an individual are present or could develop within the profession. Careful socialization of young scientists, modifications in tenure and promotion guidelines, and replication studies are suggested as ways to prevent misconduct within nursing.

Biomedical Research↗

Using criminalization and due process to reduce scientific misconduct.

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.

Crime↗

The Scientific Misconduct Questionnaire--Revised (SMQ-R): validation and psychometric testing.

PURPOSE: The overall purposes of this article are to report the development of a survey instrument, Scientific Misconduct Questionnaire-Revised (SMQ-R) that elicits the perceptions of research coordinators managing clinical trials about the various aspects of scientific misconduct and to present psychometric analyses for the SMQ-R. METHODS: A panel of five researchers and research coordinators reviewed the original SMQ (Rankin and Esteeves, 1997) and suggested an additional 42 items based on the review of the literature and their own experiences in research. The SMQ-Revised (SMQ-R) consists of 68 closed-choice items in six sections and one section with 12 open-ended questions. The SMQ-R was sent to 5302 persons who were members of the Association for Clinical Research Professionals (ACRP) or subscribers to Research Practitioner, published by the Center for Clinical Research Practice (CCRP). FINDINGS: Internal consistency of subscales was assessed with Cronbach's alpha and ranged from .83 to .84. Confirmatory factor analysis was used to test construct validity of the instrument subscales. The factor structure was assessed with the principal factors method, using the squared multiple correlations as initial communality estimates followed by varimax (orthogonal) or biquartimax (oblique) rotations. Analyses revealed five distinct factors among three subscales. Construct validity for the SMQ-R was also assessed by testing hypothesized relationships using the known groups approach. CONCLUSION: The current effort demonstrated the usefulness of the SMQ-R in obtaining information from a national sample of experienced research coordinators about their perceptions of the prevalence of different types of scientific misconduct and of factors that influence the occurrence of misconduct. The psychometric evaluation of the SMQ-R suggests good internal consistency for most subscales and suggests adequate construct validity of the instrument as a whole. The analyses also suggest that further refinement of the instrument for future studies is warranted.

Attitude↗

From Baltimore to Bell Labs: reflections on two decades of debate about scientific misconduct.

This essay proposes a new definition of scientific "misconduct," which is broader than the definition recently adopted by the U.S. government. According to the proposed definition, misconduct is a serious and intentional violation of accepted scientific practices, commonsense ethical norms, or research regulations in proposing, designing, conducting, reviewing, or reporting research. Punishable misconduct includes fabrication of data or experiments, falsification of data, plagiarism, or interference with a misconduct investigation. Misconduct does not include honest errors, differences of opinion, or ethically questionable research practices.

Biomedical Research↗

What should the standard of proof be in scientific misconduct proceedings relating to public health service-funded research?

This article discusses the nature and purposes behind the three standards of proof commonly used in the United States. It summarizes the analytical constructs or standards of review courts commonly use to determine the constitutional validity of standards of proof (as well as other procedural protections) in physician disciplinary proceedings. It applies these constructs to the context of scientific misconduct and an illustrative case, and shows that sound policy and morals as well as procedural due process and equal protection provisions of the United States and some state constitutions require the use of the clear and convincing evidence standard of proof in scientific misconduct proceedings. That standard is necessary to protect scientists from misuse of scientific misconduct charges and proceedings, entailing, as they do, vast discretion in bureaucratic officials as well as staggering costs. The imminent rule making proceedings at the federal level will provide a special opportunity to right a wrong that long has been long visited upon academic scientists throughout the United States.

Employee Discipline↗

Responding to allegations of scientific misconduct: the procedure at the French National Medical and Health Research Institute.

Institutions in France are not yet well prepared to respond to allegations of scientific misconduct. Following a serious allegation in late 1997, INSERM, the primary organization for medical and health-related research in France, began to reflect on this subject, aided by scientists and jurists. The conclusions have resulted in establishing a procedure to be followed in cases of alleged misconduct, and also in reinforcing the application of good laboratory practices within each laboratory. Guidelines for authorship practices and scientific assessment must also be considered. Even though each institution must remain responsible for responding to allegations of scientific misconduct within its doors, INSERM would like to see national, European, and international co-ordination about the methods of such response.

Academies and Institutes↗

Scientific misconduct and findings against graduate and medical students.

Allegations of scientific misconduct against graduate students appear to have unique attributes in the detection, investigation, processes used and sanctions imposed vis-à-vis other populations against which misconduct is alleged and found. An examination of the cases closed by the Department of Health and Human Services' Office of Research Integrity and the National Science Foundation reveals that most of the allegations made against graduate and medical students are for falsification and fabrication. Further, additional processes are used in these cases, e.g., student judicial processes, more students are "set up" and more students admit misconduct. Finally, the sanctions imposed when a finding is made typically involve separation from the institution and the federal sanction ranges from none to debarment. Drawing upon the teachings and circumstances of cases involving graduate student peers is a good vehicle for illustrating the concepts and perils of misconduct to graduate students.

Academies and Institutes↗

A new perspective on scientific misconduct.

The level of social concern about any form of deviance reveals much about the society that disapproves of the behavior. In that light, why has scientific misconduct recently received so much public attention and opprobrium? Inquiring into this and related areas raises questions about the changing relationship between science and society. Rising concern about scientific misconduct may indicate that the state and other powerful actors see the value of science clearly, a perception perhaps intensified by a growing reliance upon science, the value of science as a resource for power, and the resulting desire of powerful social groups to control science. An important factor is the increased importance science has acquired within organizations (such as universities and businesses), requiring scientists to engage in more intense interactions with the professionals who work there, including lawyers, accountants, public relations specialists, and administrators. In itself, this tighter coupling of science to other social and organizational purposes would be expected to increase scrutiny and the likelihood of interventions. Also, this more frequent contact makes competition for dominance between professions more likely. Policies might be devised to renegotiate the relationship between science and society in a way that might alleviate the "pathogenic pressures" in the present environment. Specifically, the author suggests eight changes, including reducing and redistributing the financial rewards immediately available to scientists, their companies, and their universities by installing a form of "escrow" account to hold profits for a fixed period of time; decoupling graduate student and postdoctoral support from research grants; and resisting the trend to replace intrinsic rewards and controls with extrinsic ones.

Attitude↗

[Scientific misconduct and medical research in Norway].

To evaluate the occurrence of scientific misconduct in medical research in Norway, 274 randomly selected Norwegian scientists were asked to complete a questionnaire on their knowledge and experience of deviations from the Medical Research Council's professional standard. Altogether 215 (80%) completed the questionnaire. Knowledge of severe misconduct was reported by 22% while 3% reported occurrence of falsification or fabrication of data within their own research group. Ten percent of the respondents knew of plagiarism, while 58% confirmed experience of less severe misconduct, most frequently misleading authorship. Nine percent had themselves contributed to one or more incidents of misconduct. Occurrence of misconduct was not related to area of research. The gap between admitting own misconduct and knowledge of misconduct by others was striking. According to 54% of the respondents, organized ethical education for young scientists would be an effective way of preventing misconduct. Altogether, the present data show that efforts are needed to prevent misconduct in medical research.

Humans↗

Ethics and fraud in science: a review of scientific misconduct and applications to craniofacial research.

The purpose of this article is to review and discuss the occurrence of fraud in biomedical research and analyze the definition, origin, and various forms of scientific misconduct. Fraud in research most often involves reporting data for which no records of experiment or population are present; manipulating research materials, equipment, or procedures to arrive at the desirable result; adding, changing, or omitting results, which positively or negatively relate to the hypothesis that the research intends to test; and incorporating ideas, statements, procedures of others' work without permission and appropriate credit to the source. The etiologic factors contributing to this deviant behavior, and measures taken by relevant bodies to eliminate this phenomenon are discussed. Ethical and integrity aspects of craniofacial research are explored and a set of criteria to facilitate rigorous assessment of the integrity of clinical and basic research protocols is proposed. These include (1) an integrity-focused training of researchers to adhere to specific laboratory procedure and tactics which discourage fraud; (2) appointment of external reviewers to detect unusual and suspicious experimental process or data patterns; and (3) encouragement of multicenter trials. Although it is widely recognized that the sole determinant of scientific misconduct is the individual investigator's integrity, a number of precautions may effectively reduce the prevalence of this event, which may affect the status and trends of biomedical research in general.

Bioethical Issues↗

Evaluating the oversight of scientific misconduct.

The Office of Research Integrity has proposed a new definition of scientific misconduct that will substantively reduce the federal government's role of oversight of scientific practices. The standard is being changed despite the lack of evidence about the effects of current policies or understanding of why research misconduct occurs, how it can be detected and prevented, and the nature and effectiveness of sanctions. Given this lack of knowledge and the perception that the integrity of science is falling, we believe it would be unwise for the academic and scientific community to adopt this new standard.

Biomedical Research↗

[Scandinavian cooperation in scientific misconduct].

During recent years the scientific world has addressed the problem of scientific fraud, with a view to setting up a system to alert the scientific community in the event of more serious instances, such as occurred recently in the USA, but also to function in a preventive capacity with regard to fraud and accusations of fraud in research. The scientific communities in the Nordic countries have recently begun to cooperate in this field.

Humans↗

The Medical Research Council's approach to allegations of scientific misconduct.

The UK's Medical Research Council (MRC) introduced a specific policy and procedure for inquiring into allegations of scientific misconduct in December 1997; previously cases had been considered under normal disciplinary procedures. The policy formally covers staff employed in MRC units, but those in receipt of MRC grants in universities and elsewhere are expected to operate under similar policies. The MRC's approach is stepwise: preliminary action; assessment to establish prima facie evidence of misconduct; formal investigation; sanctions; and appeal. Strict time limits apply at all stages. The procedure will be evaluated after two years. The indications so far are that the procedure is robust, and its clarity and transparency have been an asset to all parties. The MRC is also convinced that it is equally important to achieve a working culture that fosters integrity. Thus education and training in good research practices are fundamental to the prevention of research misconduct.

Biomedical Research↗

Scientific misconduct. How prevalent is fraud? That's a million-dollar question.

How often does scientific misconduct occur? There seems to be no consensus on the answer, although a range of estimates were presented at a conference called last month by a key federal watchdog agency to announce a $1 million grants program to investigate the prevalence of fraud, data fabrication, plagiarism, and other questionable practices in science. The 8-year-old Office of Research Integrity hopes to support studies gauging the frequency of misconduct and assessing efforts to raise ethical standards.

Behavioral Research↗

Scientific misconduct.

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Scientific Misconduct↗