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_Lecture notes_misconduct

_Lecture notes_misconduct - Fraud and Misconductin Clinical...

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Fraud and Misconductin Clinical Research: Definitions, Examples, Prevention, Detection Scientific misconduct can range from comparatively minor (for example, disputes over priority on articles and appropriate credit) to serious fraud that threatens the integrity of the entire process (falsification of data or experiments). Clinical research is not immune to misconduct. But it may cause more problems than basic science: 1. Most basic science findings are replicated independently a number of times, but many clinical trials are one-time. 2. Clinical trial findings often make immediate changes in treatment practice. 3. Clinical trial problems can generate a great deal of publicity. What is misconduct? National Academy of Science distinguishes three categories: 1. Misconduct in science: data fabrication or falsification, plagiarism. 2. Questionable research practices: failing to retain important data long enough inadequate research records refusing to allow reasonable access to data using inappropriate statistical methods to enhance significance of data exploiting or inadequately supervising research subordinates naming authors without regard to significant contributions 3. Other misconduct sexual and other harassment misuse of funds vandalism conflict of interest Public Health Service: a more vague definition that has been applied to inaccurate progress reports, naming authors on publications without their knowledge, selective reporting of primary data, false reporting of patient status, use of improper and faulty statistical methods. This covers research funded by FDA, CDC, NIH. NSF has a short list: fabrication, falsification or deviation from accepted practices; retaliation against whistleblowers who act in good faith. Misconduct is not common but it gets a lot of press when it happens. The Office of Research Integrity (PHS) is responsible for oversight of research. Several universities have had research shut down completely for problems with clinical research. These have included Johns Hopkins, University of Illinois at Chicago, Rush.
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