RESEARCH ETHICS

Research ethics committees in Europe: implementing the directive, respecting diversity

A Hedgecoe, F Carvalho, P Lobmayer and F Raka

Department of Sociology, School of Social Sciences, University of Sussex, Falmer, Brighton, UK

Correspondence to:
Correspondence to:
Adam Hedgecoe
Department of Sociology, School of Social Sciences, University of Sussex, Falmer, Brighton BN1 9QN, UK; a.m.hedgecoe{at}sussex.ac.uk

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.

Abbreviations: CES, Comissões de Ética para Saúde; CEIC, Comissão de Ética para a Investigação Clinica; EU, European Union; GYAB, Committee for Application of remedies; IKEB, Institutional Ethics Committee; KEOB, Research Ethics Medical Committee; KFAB, Clinico-Pharmacology Subcommittee; KFEB, Clinico-Pharmacological Ethics Committee; MFR, Swedish Medical Research Council; OGYI, National Institute of Pharmacology; REC, research ethics committee; UKECA, UK Ethics Committee Authority

CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

This article has been cited by other articles:

• Hedgecoe, A. (2008). Research Ethics Review and the Sociological Research Relationship. Sociology 42: 873-886 [Abstract]  
• Porcu, L, Poli, D, Torri, V, Rulli, E, Di Tullio, M C, Cinquini, M, Bajetta, E, Labianca, R, Di Costanzo, F, Nitti, D, Floriani, I (2008). Impact of recent legislative bills regarding clinical research on Italian ethics committee activity. J. Med. Ethics 34: 747-750 [Abstract] [Full Text]  
• McGuinness, S (2008). Research ethics committees: the role of ethics in a regulatory authority. J. Med. Ethics 34: 695-700 [Abstract] [Full Text]