Document Detail

Guidelines on the ethics of clinical research in anaesthesia.
MedLine Citation:
PMID:  16534337     Owner:  NLM     Status:  PubMed-not-MEDLINE    
PURPOSE OF REVIEW: This review will identify ethical issues arising from conflicts of interest in sponsored clinical trials, and the need for compliance with recent privacy legislation. It will guide investigators facing ethical dilemmas that compromise the integrity of their research because of conflicts of interest or a flawed consent process. Authors will learn about changes in journal editorial policies that will require registration of clinical trials and consent for publication of case reports. RECENT FINDINGS: Recently, ethics review committees and clinical investigators have violated research ethical guidelines and authors have ignored journal policies on disclosure of data in multicentre clinical trials. Published reports show selective reporting of data from clinical trials that biases the body of evidence available for clinical decision-making. Privacy laws legislate that patient consent for the use of their health information, other than for their clinical care, must be obtained explicitly. SUMMARY: Clinical trial registration and the need for consent for publication of case reports aim to restore and improve the integrity of biomedical publication. Journal policies that incorporate these changes may be persuasive in interpreting privacy laws, in a practical way, to protect patients from harm. It is difficult to eliminate all ethical problems with sponsored trials and government regulatory drug-approval processes may require review.
Joan C Bevan
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Current opinion in anaesthesiology     Volume:  18     ISSN:  0952-7907     ISO Abbreviation:  Curr Opin Anaesthesiol     Publication Date:  2005 Apr 
Date Detail:
Created Date:  2006-03-14     Completed Date:  2006-04-24     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8813436     Medline TA:  Curr Opin Anaesthesiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  189-94     Citation Subset:  -    
University of Toronto, Toronto, Canada.
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