Intensive Care Medicine

, Volume 33, Issue 2, pp 316–318

Clinical research in Italy in adult patients unable to consent: after implementation of the European Union's Directive 2001/20/CE

  • Christian J. Wiedermann
  • Mauro Almici
  • Salvatore Mangione
  • Antonello Giarratano
  • Oswald Mayr


  1. 1.
    Anonymous (2001) Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Off J Eur Communities L121:34–44Google Scholar
  2. 2.
    Hemminki A, Kellokumpu-Lehtinen PL (2006) Harmful impact of EU clinical trials directive. BMJ 332:501–502PubMedCrossRefGoogle Scholar
  3. 3.
    Heidenreich K, Moritz A, Loffler H, Oberle-Rolle B (2005) Clinical trials in Germany and in the EU in the new legislative environment. An analysis from the industry's point of view. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 48:415–422PubMedCrossRefGoogle Scholar
  4. 4.
    Baeyens AJ (2004) Impact of the European Clinical Trials Directive on academic clinical research. Med Law 23:103–110PubMedGoogle Scholar
  5. 5.
    Grienenberger A (2004) Establishing pan-European clinical trials: regulatory compliance and other practical considerations. J Biolaw Bus 7:58–63Google Scholar
  6. 6.
    Stocchetti N, Dearden M, Karimi A, Lapierre F, Maas A, Murray GD, Ohman J, Persson L, Servadei F, Trojanowski T, Unterberg A (2004) New European directive on clinical trials: implications for traumatic head injury research. Intensive Care Med 30:517–518PubMedCrossRefGoogle Scholar
  7. 7.
    Druml C, Singer EA (2004) The European Directive: a further blow to science in intensive care medicine in Austria. Intensive Care Med 30:335PubMedCrossRefGoogle Scholar
  8. 8.
    Liddell K, Chamberlain D, Menon DK, Bion J, Kompanje EJ, Lemaire F, Druml C, Vrhovac B, Wiedermann CJ, Sterz F (2006) The European Clinical Trials Directive revisited: the VISEAR recommendations. Resuscitation 69:9–14PubMedCrossRefGoogle Scholar
  9. 9.
    Liddell K, Kompanje EJ, Lemaire F, Vrhovac B, Menon DK, Bion J, Chamberlain D, Wiedermann CJ, Druml C; Working Group of the Vienna Initiative to Save European Academic Research (2006) Recommendations in relation to the EU clinical trials directive and medical research involving incapacitated adults. Wien Klin Wochenschr 118:183–191PubMedCrossRefGoogle Scholar
  10. 10.
    Lemaire F, Bion J, Blanco J, Damas P, Druml C, Falke K, Kesecioglu J, Larsson A, Mancebo J, Matamis D, Pesenti A, Pimentel J, Ranieri M; ESICM Task Force on Legislation Affecting Clinical Research in the Critically Ill Patient (2005) The European Union Directive on Clinical Research: present status of implementation in EU member states' legislations with regard to the incompetent patient. Intensive Care Med 31:476–479PubMedCrossRefGoogle Scholar
  11. 11.
    Geisler I, Hofmann HP, Nickel L (2005) Harmonisation of regulatory requirements for clinical trials on medicinal products for human use in the Directive 2001/20/EC and complementary guidance. Implementation of the 12th law amending the German drug law. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 48:141–146PubMedCrossRefGoogle Scholar
  12. 12.
    Silverman HJ, Druml C, Lemaire F, Nelson R (2004) The European Union Directive and the protection of incapacitated subjects in research: an ethical analysis. Intensive Care Med 30:1723–1729PubMedCrossRefGoogle Scholar
  13. 13.
    Cohen AF (2003) European guideline for the quality of non-commercial clinical trials: elegant implementation in the Netherlands via the amended Dutch medical research involving human subjects act. Ned Tijdschr Geneeskd 147:1493–1495PubMedGoogle Scholar
  14. 14.
    Singer EA, Mullner M (2002) Implications of the EU directive on clinical trials for emergency medicine. BMJ 324:1169–1170PubMedCrossRefGoogle Scholar
  15. 15.
    Tomino C (2005) Osservatorio Nazionale sulla Sperimentazione Clinica dei medicinali. 3° Rapporto Nazionale—2004. Agenzia Italiana del Farmaco, Rome, pp 16–29Google Scholar
  16. 16.
    Torbica A, Fattore G (2005) The “Essential levels of care” in Italy: when being explicit serves the devolution of powers. Eur J Health Econ [Suppl]:46–52Google Scholar

Copyright information

© Springer-Verlag 2006

Authors and Affiliations

  • Christian J. Wiedermann
    • 1
  • Mauro Almici
    • 2
  • Salvatore Mangione
    • 3
  • Antonello Giarratano
    • 3
  • Oswald Mayr
    • 4
  1. 1.Department of Internal MedicineCentral Hospital of BolzanoBolzanoItaly
  2. 2.Ethics Committee of the Regional Health Unit of BolzanoBolzanoItaly
  3. 3.Department of Anesthesiology, Intensive Care and EmergencyUniversity of PalermoPalermoItaly
  4. 4.Division of Anesthesiology and Intensive Care MedicineCentral Hospital of BolzanoBolzanoItaly

Personalised recommendations