Switch to: Citations

Add references

You must login to add references.
  1. Multicentre Trials Review Process by Research Ethics Committees in Spain: Where Do They Stand Before Implementing the New European Regulation?R. Dal-Re - 2005 - Journal of Medical Ethics 31 (6):344-350.
    Objectives: To review the performance of research ethics committees in Spain in assessing multicentre clinical trial drug protocols, and to evaluate if they would comply with the requirements of the new EU Directive to be implemented by May 2004.Design and setting: Prospective study of applications of MCT submitted to RECs.Main measurements: Protocol related features and evaluation process dynamics.Results: 187 applications to be performed in 114 centres, were reviewed by 62 RECs. RECs had a median number of 14 members, of which (...)
    Download  
     
    Export citation  
     
    Bookmark   2 citations  
  • New Governance Arrangements for Research Ethics Committees: Is Facilitating Research Achieved at the Cost of Participants’ Interest. E. Cave & S. Holm - 2002 - Journal of Medical Ethics 28 (5):318-321.
    This paper examines the UK’s response to a recent European Clinical Trials Directive, namely the Department of Health, Central Office for Research Ethics Committee guidance, Governance Arrangements for NHS Research Ethics Committees. The revisions have been long awaited by researchers and research ethics committee members alike. They substantially reform the ethical review system in the UK. We examine the new arrangements and argue that though they go a long way toward addressing the uncertainty surrounding ethics committee function, the system favours (...)
    Download  
     
    Export citation  
     
    Bookmark   9 citations