Research ethics committees in Europe: implementing the directive, respecting diversity.
With the recent Clinical Trials Directive, a degree of harmonisation into research ethics committees (RECs) across Europe, including the time taken to assess a trial proposal and the kinds of issues a committee should take into account, has been introduced by the European Union (EU). How four different member states-Hungary, Portugal, Sweden and the UK-have chosen to implement the directive is shown. Although this has resulted in four very different ways of structuring RECs, similar themes are present in all four cases, such as centralisation of control over RECs within member states, harmonisation of REC procedures across the EU and increased role of political decision making with regard to such committees.
Hedgecoe
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Department of Sociology, School of Social Sciences, University of Sussex, Falmer, Brighton BN1 9QN, UK. a.m.hedgecoe@sussex.ac.uk
Carvalho
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Lobmayer
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Raka
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F
D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000592:standards*; D028744:Ethics Committees, Research / Q000331:legislation & jurisprudence / Q000592:standards*; D005062:European Union; D006079:Government Publications as Topic; D006801:Humans; D006814:Hungary; D007391:International Cooperation / Q000331:legislation & jurisprudence; D011057:Politics; D011174:Portugal; D013548:Sweden; D013997:Time Factors; D006113:United Kingdom