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Division and discord in the Clinical Trials Regulation
  1. David Shaw1,2,
  2. David Townend1
  1. 1Department of Health, Ethics and Society, CAPHRI Research School, Maastricht University, Maastricht, the Netherlands
  2. 2Institute for Biomedical Ethics, University of Basel, Basel, Switzerland
  1. Correspondence to Dr David Shaw, Department of Health, Ethics and Society, Maastricht University, Maastricht, 6200 MD, the Netherlands; Postbus 616; d.shaw{at}maastrichtuniversity.nl

Abstract

The Clinical Trials Regulation is intended to harmonise and streamline the review and conduct of clinical trials in the European Union. In this paper, we identify and analyse several serious issues concerning the division imposed by the Regulation between scientific review and ethical review. We conclude that these problems may compromise the objectives of the Regulation.

  • Clinical trials
  • Ethics Committees/Consultation
  • Policy Guidelines/Inst. Review Boards/Review Cttes.

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