Intensive Care Medicine

, Volume 31, Issue 3, pp 476–479 | Cite as

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

  • ESICM Task Force on Legislation Affecting Clinical Research in the Critically Ill Patient
  • F. Lemaire
  • J. Bion
  • J. Blanco
  • P. Damas
  • C. Druml
  • K. Falke
  • J. Kesecioglu
  • A. Larsson
  • J. Mancebo
  • D. Matamis
  • A. Pesenti
  • J. Pimentel
  • M. Ranieri
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References

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    European Parliament (2001) Directive 2001/20/EC of the European Parliament and Council of 4 April 2001. Official J L121:34–44Google Scholar
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    Dijk Y, PHJ van, van der Voort, MA Kuiper, J Kesecioglu (2003) Research on subjects incapable of giving informed consent: the situation in Dutch intensive care departments. Intensive Care Med 29:2100–2101CrossRefPubMedGoogle Scholar
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    Druml C, EA Singer (2004) The European Directive: a further blow to science in intensive care medicine in Austria. Intensive Care Med 30:335CrossRefPubMedGoogle Scholar
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    Sterz F, Singer E, Böttiger B, Chamberlain D, Baskett P, Bossaert L, Steen P (2002) A serious threat to evidence based resuscitation within the European Union. Resuscitation 53:237–238Google Scholar
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    Visser H (2001) Non therapeutic research in the EU in adults incapable of giving consent? Lancet 357:818–819CrossRefPubMedGoogle Scholar
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    Kompanje EJO, Maas AIR (2004) ‘Treat first, ask later?’ Emergency research in acute neurology and neurotraumatology in the European Union. Intensive Care Med 30:168–169CrossRefPubMedGoogle Scholar
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    Lemaire F (2004) Patient care versus research: does clinical research provide “individual benefit “ to patients enrolled in trials? Curr Opin Crit Care: 10:565–569Google Scholar
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    Lacombe D (1998) Insuring international clinical trials; an Academic viewpoint. Appl Clin Trials 8:24–29Google Scholar
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    Mayor S (2004) Squeezing academic research in a commercial straitjacket. BMJ 328:1036Google Scholar

Copyright information

© Springer-Verlag 2005

Authors and Affiliations

  • ESICM Task Force on Legislation Affecting Clinical Research in the Critically Ill Patient
  • F. Lemaire
    • 1
  • J. Bion
    • 2
  • J. Blanco
    • 3
  • P. Damas
    • 4
  • C. Druml
    • 5
  • K. Falke
    • 6
  • J. Kesecioglu
    • 7
  • A. Larsson
    • 8
  • J. Mancebo
    • 9
  • D. Matamis
    • 10
  • A. Pesenti
    • 11
  • J. Pimentel
    • 12
  • M. Ranieri
    • 13
  1. 1.ParisFrance
  2. 2.BirminghamUK
  3. 3.ValladolidSpain
  4. 4.LiegeFrance
  5. 5.ViennaAustria
  6. 6.BerlinGermany
  7. 7.UtrechtThe Netherlands
  8. 8.CopenhagenDenmark
  9. 9.BarcelonaSpain
  10. 10.SalonikaGreece
  11. 11.MonzaItaly
  12. 12.CoimbraPortugal
  13. 13.TurinItaly

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