Document Detail


Standards for research ethics committees: purpose, problems and the possibilities of other approaches.
MedLine Citation:
PMID:  19482984     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Criticism of ethical review of research continues and research ethics committees (RECs) need to demonstrate that they are "fit for purpose" by meeting acknowledged standards of process, debate and outcome. This paper reports a workshop in Warsaw in April 2008, organised by the European Forum for Good Clinical Practice, on the problems of setting standards for RECs in the European Union. Representatives from 27 countries were invited; 16 were represented. Problems identified were the limited and variable resources, difficulties of setting standards for ethical debate and its outcomes and that REC members, as volunteers, may resent the imposition of standards. Other ways to set standards were discussed, including analysis of current multicentre review, collecting REC member reports for review, learning from appeals and feedback from applicants, and use of other regional and national meetings. The place of a central, national board or ethics committee was debated as was the need for collaborating with partners in other fields.
Authors:
H Davies; F Wells; M Czarkowski
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Publication Detail:
Type:  Congresses    
Journal Detail:
Title:  Journal of medical ethics     Volume:  35     ISSN:  1473-4257     ISO Abbreviation:  J Med Ethics     Publication Date:  2009 Jun 
Date Detail:
Created Date:  2009-06-01     Completed Date:  2009-11-02     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7513619     Medline TA:  J Med Ethics     Country:  England    
Other Details:
Languages:  eng     Pagination:  382-3     Citation Subset:  E; IM    
Affiliation:
H Davies, National Research Ethics Service, 4-8 Maple Street, London W1T 5HD, UK. Hugh.davies@nres.npsa.nhs.uk
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MeSH Terms
Descriptor/Qualifier:
Clinical Protocols / standards*
Ethical Review / standards*
Ethics Committees, Research / standards*,  trends
European Union
Humans
Poland

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