Document Detail


Ethics and methods in surgical trials.
MedLine Citation:
PMID:  19717699     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
This paper focuses on invasive therapeutic procedures, defined as procedures requiring the introduction of hands, instruments, or devices into the body via incisions or punctures of the skin or mucous membranes performed with the intent of changing the natural history of a human disease or condition for the better. Ethical and methodological concerns have been expressed about studies designed to evaluate the effects of invasive therapeutic procedures. Can such studies meet the same standards demanded of those, for example, evaluating pharmaceutical agents? This paper describes a research project aimed at examining the interplay and sometimes apparent conflict between ethical standards for human research and standards for methodological rigor in trials of invasive procedures. The paper discusses how the authors plan to develop a set of consensus standards that, if met, would result in substantial and much-needed improvements in the methodological and ethical quality of such trials.
Authors:
C M Ashton; N P Wray; A F Jarman; J M Kolman; D M Wenner; B A Brody
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of medical ethics     Volume:  35     ISSN:  1473-4257     ISO Abbreviation:  J Med Ethics     Publication Date:  2009 Sep 
Date Detail:
Created Date:  2009-08-31     Completed Date:  2010-01-29     Revised Date:  2014-09-13    
Medline Journal Info:
Nlm Unique ID:  7513619     Medline TA:  J Med Ethics     Country:  England    
Other Details:
Languages:  eng     Pagination:  579-83     Citation Subset:  E; IM    
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MeSH Terms
Descriptor/Qualifier:
Humans
Randomized Controlled Trials as Topic / ethics*,  methods,  standards
Research Design / standards*
Stroke / prevention & control
Surgical Procedures, Operative / ethics*,  methods,  standards
Grant Support
ID/Acronym/Agency:
R01 CA134995/CA/NCI NIH HHS; R01 CA134995-01/CA/NCI NIH HHS
Comments/Corrections

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