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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

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

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