Skip to main content
SpringerLink
Log in

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

  • News
  • Published:
Intensive Care Medicine Aims and scope Submit manuscript

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

References

  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 L121:34–44

    Google Scholar 

  2. Hemminki A, Kellokumpu-Lehtinen PL (2006) Harmful impact of EU clinical trials directive. BMJ 332:501–502

    Article  PubMed  Google Scholar 

  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 48:415–422

    Article  PubMed  CAS  Google Scholar 

  4. Baeyens AJ (2004) Impact of the European Clinical Trials Directive on academic clinical research. Med Law 23:103–110

    PubMed  CAS  Google Scholar 

  5. Grienenberger A (2004) Establishing pan-European clinical trials: regulatory compliance and other practical considerations. J Biolaw Bus 7:58–63

    Google Scholar 

  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 30:517–518

    Article  PubMed  Google Scholar 

  7. Druml C, Singer EA (2004) The European Directive: a further blow to science in intensive care medicine in Austria. Intensive Care Med 30:335

    Article  PubMed  Google Scholar 

  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 69:9–14

    Article  PubMed  Google Scholar 

  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 118:183–191

    Article  PubMed  Google Scholar 

  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 31:476–479

    Article  PubMed  CAS  Google Scholar 

  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 48:141–146

    Article  PubMed  CAS  Google Scholar 

  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 30:1723–1729

    Article  PubMed  Google Scholar 

  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 147:1493–1495

    PubMed  CAS  Google Scholar 

  14. Singer EA, Mullner M (2002) Implications of the EU directive on clinical trials for emergency medicine. BMJ 324:1169–1170

    Article  PubMed  Google Scholar 

  15. Tomino C (2005) Osservatorio Nazionale sulla Sperimentazione Clinica dei medicinali. 3° Rapporto Nazionale—2004. Agenzia Italiana del Farmaco, Rome, pp 16–29

    Google Scholar 

  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]:46–52

Download references

Author information

Authors and Affiliations

  1. Department of Internal Medicine, Central Hospital of Bolzano, L. Böhler Street 5, 39100, Bolzano, Italy

    Christian J. Wiedermann

  2. Ethics Committee of the Regional Health Unit of Bolzano, Bolzano, Italy

    Mauro Almici

  3. Department of Anesthesiology, Intensive Care and Emergency, University of Palermo, Palermo, Italy

    Salvatore Mangione & Antonello Giarratano

  4. Division of Anesthesiology and Intensive Care Medicine, Central Hospital of Bolzano, Bolzano, Italy

    Oswald Mayr

Authors
  1. Christian J. Wiedermann
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Mauro Almici
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Salvatore Mangione
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Antonello Giarratano
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Oswald Mayr
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Christian J. Wiedermann.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Wiedermann, C.J., Almici, M., Mangione, S. et al. Clinical research in Italy in adult patients unable to consent: after implementation of the European Union's Directive 2001/20/CE. Intensive Care Med 33, 316–318 (2007). https://doi.org/10.1007/s00134-006-0458-1

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00134-006-0458-1

Keywords

Search

Navigation