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PubMed2006

Scientific misconduct and science ethics: a case study based approach.

The Schön misconduct case has been widely publicized in the media and has sparked intense discussions within and outside the scientific community about general issues of science ethics. This paper analyses the Report of the official Committee charged with the investigation in order to show that what at first seems to be a quite uncontroversial case, turns out to be an accumulation of many interesting and non-trivial questions (of both ethical and philosophical interest). In particular, the paper intends to show that daily scientific practices are structurally permeated by chronic problems; this has serious consequences for how practicing scientists assess their work in general, and scientific misconduct in particular. A philosophical approach is proposed that sees scientific method and scientific ethics as inextricably interwoven. Furthermore, the paper intends to show that the definition of co-authorship that the members of the Committee use, although perhaps clear in theory, proves highly problematic in practice and raises more questions that it answers. A final plea is made for a more self-reflecting attitude of scientists as far as the moral and methodological profile of science is concerned as a key element for improving not only their scientific achievements, but also their assessment of problematic cases.

Authorship↗
PubMed2000

Scientific misconduct and research integrity for the bench scientist.

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.

Academic Medical Centers↗
PubMed1989

The role of data audits in detecting scientific misconduct. Results of the FDA program.

To evaluate the extent of the problem of scientific misconduct in investigational drug trials, we reviewed data from 1955 routine audits conducted by the US Food and Drug Administration (FDA) from June 1977 to April 1988. Serious deficiencies were detected in 12% of audits prior to October 1985, but in only 7% since that date. At the same time, there was no evidence of a decline over time in the rate of detection of many categories of deficiencies, and some investigators were able to continue to participate in drug trials after flagrant violations of recognized norms of research. The data auditing program should be continued, but additional measures are needed to regulate misconduct. These must be tailored to the variety of causes of misconduct, ranging from negligence to fraud. Possible additional approaches could include certifying the competence of potential investigators; peer-reviewed, competitive application for the opportunity to conduct FDA-authorized clinical trials; limiting an investigator's level of participation in clinical trials; penalizing manufacturers who fail to detect their investigators' misconduct; and permitting the FDA to suspend investigators prior to a hearing. Measures taken should maximize public utility at the least economic cost to society and should be evaluated thoroughly.

Biomedical Research↗
PubMed2002

Research ethics and scientific misconduct in biomedical research.

Scientists have the responsibility of judging what is best for the patient and the optimal conditions for the conduct of the study. All physicians should ensure that research they participate in is ethically conducted. Every clinician should learn and receive training in the responsible conduct of research and publication, and each project must be reviewed by an institutional review committee. Scientific misconduct is defined as any practice that deviates from those accepted by the scientific community and ultimately damages the integrity of the research process. "Sloppy Research" and "Scientific Fraud" include activities which can violate science, records and publication. Sloppy research is due to absence of appropriate training in research discipline and methodologies. In contrast, scientific fraud is defined as deliberate action during application, performance of research, and publication. It includes piracy, plagiarism and fraud. Research institutions should adopt rules and regulations to respond to allegations, start investigational operations and perform appropriate sanctions.

Clinical Trials as Topic↗
PubMed1990

Underreporting research is scientific misconduct.

Substantial numbers of clinical trials are never reported in print, and among those that are, many are not reported in sufficient detail to enable judgments to be made about the validity of their results. Failure to publish an adequate account of a well-designed clinical trial is a form of scientific misconduct that can lead those caring for patients to make inappropriate treatment decisions. Investigators, research ethics committees, funding bodies, and scientific editors all have responsibilities to reduce underreporting of clinical trials. An extended use of prospective registration of trials at inception, as well as benefiting clinical research in other ways, could help people to play their respective roles in reducing underreporting of clinical trials.

Biomedical Research↗
PubMedDate not supplied

Scientific misconduct and unethical human experimentation: historic parallels and moral implications.

Although a great deal of human experimentation has been performed to elucidate information otherwise not obtainable, there are many recorded instances of unethical human experimentation. There is also a history of crimes that were committed and disguised as human experiments, best exemplified by the activities of some physicians in Nazi Germany from 1933 until 1945. As a direct result of these activities, a war-crimes trial after World War II resulted in the creation of the Nuremberg Code, to guide future human experimentation. Despite this, unethical experiments were conducted at major academic institutions in the United States in the years after World War II by otherwise normal physicians who did not feel that the Nuremberg Code applied to them personally. There are several possible explanations for such activities, but the desire for personal advancement is prominent among these. Episodes of scientific misconduct such as falsification of experimental data or of personal qualifications seem to be more commonly reported recently and have also been described in the popular press. This activity may also be motivated by desire for personal advancement, giving it a parallel to the conduct of unethical human experimentation. Education may be the best way to prevent these activities that may have similar motivating factors.

Codes of Ethics↗
PubMed2002

[Reporting of scientific misconduct in health care research].

The incidence of scientific dishonesty in the Netherlands is not known, yet experiences at both the NWO (the Netherlands Organization for Scientific Research) and Nederlands Tijdschrift voor Geneeskunde (Dutch Journal of Medicine) indicate that there must be several cases per year. For scientific fraud to be prevented students and researchers should receive thorough teaching, and in research laboratories an emphasis should be placed upon integrity. The Academic Medical Centre in Amsterdam has published a research protocol which is perfect for internal use. The Royal Netherlands Academy of Arts and Sciences publishes brochures on good research practice for researchers, teachers and students. The NWO and the Vereniging van Universiteiten (Dutch Association of Universities) have set up a committee for scientific integrity to function as a fallback mechanism and to assess the institutional procedures or to repeat the inquiries. As healthcare research institutions other than universities are involved since authorities are not always objective, an independent committee has been established to assess complaints about scientific dishonesty, the Scientific Integrity Health Research. Like the Committee on Publication Ethics it will publish its cases anonymously on an annual basis. Its judgments will be communicated to the people involved and the proper authorities.

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