LECTURE 15 2011

LECTURE 15 2011 - Misconduct in Research Big Sins(Fraud...

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Big Sins (Fraud), Little Sins (Negligence) and Others Types of Bad Behavior Misconduct in Research
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Suggested Readings 1. Committee on the Conduct of Science. National Academy of Sciences. On Being a Scientist, 3 rd Edition, 2009 (see www.nap.edu/catalog.php?record_id=12192 (can read online) 2. Committee on the Responsible Conduct of Research of the Institute of Medicine. The Responsible Conduct of Research in the Health Sciences. National Academy Press. Washington, DC, 1989. 3. Woodward J, Goodstein D. Conduct, Misconduct and the Structure of Science. Amer Scientists 1996; 479-90. 3. Conduct in Science. Science 1995; 268:1705-18. 4. Buyse M et. al. The role of biostatistics in the prevention, detection and treatment of fraud in clinical trials. Stat Med 18:3435-51, 1999. 5. Horton R. The clinical trial: deceitful, disputable, unbelievable, unhelpful, and shameful – what next? Cont Clin Trials 22:593-604, 2001. 6. Martinson BC et al. Scientists behaving badly. Nature 435:737-738, 2005. 7. Lo B, Field MJ. Conflict of interest in medical research, education, and practice. Washington DC, National Academies Press, 2009. 8. Fleming TR. Clinical trials: discerning hype from substance. Ann Intern Med 153:400-406, 2010.
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Definition: Misconduct in Science according to a National Academy of Science Report Misconduct in science is defined as fabrication, falsification, or plagiarism, in preparing, performing, or reporting research. Misconduct in science does not include errors of judgment; errors in the recording, selection or analysis of data; differences in opinions involving the interpretation of data; or misconduct unrelated to the research process. “Intent-to-Cheat”
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More Recently - Research Misconduct as Defined in Federal Register, May 17,2005 42 C.F.R § 50 and 93 (U.S. Office of Science and Technology Policy) Research misconduct means fabrication, falsification, or plagiarism in proposing or reviewing research, or in reporting research results - Fabrication is making up data or results and recording or reporting of them. - Falsification is manipulating research materials, equipment , or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. - Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit. - Does not include honest error or differences of opinion.
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Three Conditions For Misconduct According to Federal Policy A significant departure from accepted practices in the scientific community. Be committed intentionally, or knowingly in reckless disregard for accepted practices. Allegation must be proven by a preponderance of evidence.
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Definition of Research Misconduct Proposed by a British Consensus Panel (1999) "Behaviour by a researcher, intentional or not, that falls short of good ethical and scientific standards."
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Spectrum of Scientific Misconduct Data Collection Data fabrication Data alteration
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This note was uploaded on 11/21/2011 for the course PUBH 7420 taught by Professor Ph7420 during the Spring '07 term at Minnesota.

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LECTURE 15 2011 - Misconduct in Research Big Sins(Fraud...

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