The European Union Directive on Clinical Research: present status of implementation in EU member states’ legislations with regard to the incompetent patient

@article{Lemaire2005TheEU,
  title={The European Union Directive on Clinical Research: present status of implementation in EU member states’ legislations with regard to the incompetent patient},
  author={François Lemaire and Julian Bion and Jose Daniel Molina Blanco and Pierre Damas and Christiane Druml and Konrad Falke and Jozef Kesecioglu and Anette Larsson and Jordi Mancebo and Dimitrios Matamis and Antonio Pesenti and J Couto Pimentel and Marco V. Ranieri},
  journal={Intensive Care Medicine},
  year={2005},
  volume={31},
  pages={476-479}
}
A new law or an amendment to existing law has already been incorporated in national statutes or is in the process of approval in The Netherlands, France, Belgium, Italy, Denmark, Germany, Austria, and Spain (Table 1). In other countries discussions and proposals are still not complete. In some countries the proposals are limited to drug research (as was intended by the Directive); in others (Belgium, France, The Netherlands, the United Kingdom) its scope has been broadened to include all types… CONTINUE READING

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Insuring international clinical trials ; an Academic viewpoint

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