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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. |
3. | Subject | Discipline(s) | |
3. | Subject | Keyword(s) | |
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 |
6. | Contributor | Sponsor(s) | |
7. | Date | (YYYY-MM-DD) | 2016-12-28 |
8. | Type | Status & genre | |
8. | Type | Type | |
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 |
13. | Relation | Supp. Files | |
14. | Coverage | Geo-spatial location, chronological period, research sample (gender, age, etc.) | |
15. | Rights | Copyright and permissions | All articles published in IJME are available on its website free of charge. The copyright for published material belongs to IJME/FMES. IJME freely permits the reprint (or reproduction on a website) of articles from the journal, as long as this is for non-commercial use and appropriate credit is given to the author and the journal and publication details are mentioned. The commercial use of our content can be made only after obtaining permission from and on payment to IJME. This is intended to support production of the journal. |