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1. Title Title of document Truth in research labelling
 
2. Creator Author's name, affiliation, country John H Noble Jr; State University of New York at Buffalo, 508 Rio Grande Loop, Georgetown, Texas 78633-4786, USA.
 
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4. Description Abstract This report describes the background and context of a currently circulating petition to the US Congress that seeks amendment of Section 801 of the Public Health Services Act (42 U.S.C. 282) to close a loophole in existing law which makes possible post hoc adjustment of randomised controlled trial (RCT) results reported to the Food and Drug Administration that differ from those reported to ClinicalTrials.gov and to medical journals. The report describes the petition's rationale, underlying assumptions, and support for its proposed remedy in deontological, consequentialist, and casuist philosophical ethics theories. It addresses the several reservations of the World Association of Medical Editors (WAME) with citations of evidence for the petition's assertions. The report suggests that some medical journals are not unknowing victims but rather complicit enablers of the post hoc adjusted RCT results that they publish. Its closing remarks dwell on the negative impact that embrace of a neoliberal, anti-regulatory philosophy of government will likely have on any regulatory reform to promote the integrity of biomedical science and the future of evidence-based medicine.
 
5. Publisher Organizing agency, location Forum for Medical Ethics Society
 
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7. Date (YYYY-MM-DD) 2016-12-28
 
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9. Format File format HTML , PDF
 
10. Identifier Uniform Resource Identifier https://ijme.in/articles/truth-in-research-labelling/
 
11. Source Title; vol., no. (year) Indian Journal of Medical Ethics;: Is regulation serving the intended purpose?
 
12. Language English=en en
 
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