CSE's White Paper on Promoting Integrity in Scientific Journal Publications
3.0 IDENTIFICATION OF RESEARCH MISCONDUCT AND GUIDELINES FOR ACTION
3.1 Description of Research Misconduct
Although no standard definition of research misconduct exists, and new variations are, unfortunately, likely to arise as scientific methods progress, research misconduct generally falls into one of the following areas:
- Unethical treatment of research subjects
- Fabrication of data
- Falsification of data
- Plagiarism
As a general guide, the term "research misconduct" applies to any action that involves mistreatment of research subjects or purposeful manipulation of the scientific record such that it no longer reflects observed truth. A Joint Consensus Conference on Misconduct in Biomedical Research in October 1999 led to the following broad definition of misconduct: "Behaviour by a researcher, intentional or not, that falls short of good ethical and scientific standard."92 This section attempts to objectively define research practices that do not meet these subjective standards.
The concepts of negligence and deceit are central to the definition of research misconduct. Not every instance of harm to a research subject is necessarily the result of research misconduct. However, editors and others should consider research misconduct in circumstances in which the harm occurs in the setting of, or as a direct result of, research practices that do not meet ethical norms or as a direct result of irresponsible behavior of the investigator. Similarly, not all inaccurate reports of data are the result of misconduct. For example, the Wellcome Trust, Britain's largest biomedical charity, specifically states that research misconduct does not include honest error or honest differences in the design, execution, interpretation, or judgment in evaluating research methods or results.93 Poor-quality research is not misconduct unless the investigators used poor-quality methods with the intention to deceive or without regard to the harm that might befall subjects.
3.1.1 Mistreatment of Research Subjects
Researchers have an obligation to the subjects they study. These obligations apply whether the subjects are humans or animals and whether the entire organism is being studied or specimens are being taken. When research involves human subjects or their specimens, failure to adhere to the principles in the Declaration of Helsinki94 and to seek approval from and adhere to the ethical standards of the appropriate institutional or national committee on human experimentation is a serious form of scientific misconduct. For researchers who study animals, failure to follow institutional or national recommendations for the care and use of laboratory animals is also a serious type of research misconduct.
The following are examples of actions that constitute mistreatment of research subjects:41
- Failure to obtain approval from an ethical review board before starting the study
- Failure to follow the approved protocol during the conduct of the study
- Absent or inadequate informed consent of human subjects
- Maltreatment of laboratory animals
- Exposure of subjects to physical or psychological harm without informing them of the potential for harm
- Exposure of subjects (or the environment) to harm because research practices or protocols do not meet accepted and/or specified standards
- Failure to maintain confidentiality of human data without specific consent from the subject
Click here for examples of editorial letters related to this topic (refer to letters 10-12 and 14-17).
The International Committee of Medical Journal Editors (ICMJE) addresses this last issue in the Uniform Requirements:95
Patients have a right to privacy that should not be infringed without informed consent. Identifying information, including patients' names, initials, or hospital numbers, should not be published in written descriptions, photographs, and pedigrees unless the information is essential for scientific purposes and the patient (or parent or guardian) gives written informed consent for publication. Informed consent for this purpose requires that a patient who is identifiable be shown the manuscript to be published.
3.1.2 Falsification and Fabrication of Data
Perhaps the most blatant and easy to define (although not always easy to detect) form of research misconduct is investigators' fabrication or falsification of data. Fabrication refers to the invention, recording, or reporting of data. Falsification refers to the alteration of research materials, equipment, protocols, data, or results. Fabrication and falsification are 2 points along a spectrum, but both are serious forms of misconduct because they result in a scientific record that does not accurately reflect observed truth.44,45 Click here for examples of editorial letters related to this topic (refer to letters 4, 5, and 14-17).
Piracy is defined as the appropriation of ideas, data, or methods from others without adequate permission or acknowledgment. Again, deceit plays a central role in this form of misconduct. The intent of the perpetrator is the untruthful portrayal of the ideas or methods as his or her own.42,43
Plagiarism is a form of piracy that involves the use of text or other items (figures, images, tables) without permission or acknowledgment of the source of these materials. Plagiarism generally involves the use of materials from others, but can apply to researchers' duplication of their own previously published reports without acknowledgment (this is sometimes called self-plagiarism or duplicate publication).39,40 Click here for examples of editorial letters related to this topic (refer to letters 1-3 and 14-17).
(Authorship: Christine Laine took the lead in writing this section of the white paper on behalf of the CSE Editorial Policy Committee. Christine Laine revised this section for the 2009 Update. Members of the Editorial Policy Committee and the CSE Board of Directors reviewed and commented on it. This section was formally approved by the CSE Board of Directors on March 29, 2009.)
3.1.4 Resources and Case Studies
Joint consensus conference on misconduct in biomedical research: 28th and 29th October 1999: consensus statement. The COPE Report 2000. Available at: http://publicationethics.org/static/2000/2000pdf5.pdf (Accessed January 20, 2011).
International Committee of Medical Journal Editors (ICMJE). Uniform requirements for manuscripts submitted to biomedical journals. Available at: http://www.icmje.org (Accessed January 20, 2011).
Return to the Promoting Integrity in Scientific Journals table of contents page.
- Joint consensus conference on misconduct in biomedical research: 28th and 29th October 1999: Consensus statement. The COPE Report 2000. Available at: http://publicationethics.org/static/2000/2000pdf5.pdf (Accessed January 20, 2011).
- Fraud and misconduct in medical research: causes, investigation and prevention: a report of the Royal College of Physicians. J R Coll Physicians Lond. 1991;25:89-94.
- World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2000;284:3043-3045.
- International Committee of Medical Journal Editors (ICMJE). Uniform requirements for manuscripts submitted to biomedical journals. II.E. Privacy and confidentiality. II.E.1. Patients and study participants. Available at: http://www.icmje.org/#privacy (Accessed January 20, 2011).