Research Ethics Committees in Europe: Implementing the Directive, Respecting Diversity
Journal of Medical Ethics 2006 August; 32(8): 483-486
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.
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Multicentre Trials Review Process by Research Ethics Committees in Spain: Where Do They Stand Before Implementing the New European Regulation? Dal-Re, R.; Ortega, R.; Morejon, E. (2005-06)OBJECTIVES: To review the performance of research ethics committees (RECs) in Spain in assessing multicentre clinical trial (MCT) drug protocols, and to evaluate if they would comply with the requirements of the new EU ...