Skip to main content
SpringerLink
Log in

The European Directive 2001/20 for clinical research: friend or foe?

  • Editorial
  • 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. Veelo D, Spronk P, Kuiper M, Korevaar J, van der Voort P, Schultz M (2006) A change in the Dutch Directive on medical research involving human subjects strongly increases the number of eligible intensive care patients: an observational study. Intensive Care Med DOI 10.1007/s00134-006-0384-2

  2. van Dijk Y, van der Voort P, Kuiper M, Kesecioglu J (2003) Research on subjects incapable of giving consent: the situation in Dutch intensive care departments. Intensive Care Med 20:2100–2101

    Article  Google Scholar 

  3. Harvey SE, Elbourne D, Ashcroft J, Jones C, Rowan K (2006) Informed consent in clinical trials in crtitical care: experience from the PAC-man study. Intensive Care Med

  4. van der Voort P, Kesecioglu J (2006) Changes in the Dutch law on medical research. Intensive Care Med DOI 10.1007/s00134-006-0385-1

  5. Meunier F, Lacombe C (2003) European organisation for research and treatment of cancer's point of view. Lancet 362:663

    Article  PubMed  Google Scholar 

  6. Lemaire F, Bion J, Blanco J, Damas P, Druml C, Falke K, Kesecioglu J, Larsson A, Mancebo A, Matamis D, Pesenti A, Pimentel J, Ranieri M (2005) The EU 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 

  7. Menon DK, Liddell K (2004) Consent for research. J Intensive Care Soc 5:98–99

    Google Scholar 

  8. Coats TJ, Shakur H (2005) Consent in emergency research: new regulations. Emerg Med J 22:683–685

    Article  PubMed  CAS  Google Scholar 

  9. Sprumont D (1999) Legal protection of human research subjects in Europe. Eur J Health Law 6:25–43

    Article  PubMed  Google Scholar 

  10. Grimes DA, Hubacher D, Nanda K, Schulz KF, Moher D, Altman DG (2005) The good clinical practice guideline: a bronze standard for clinical research. Lancet 366:172–174

    Article  PubMed  Google Scholar 

  11. Lemaire F, Brun-Buisson C (2000) Are institutional review boards effective in safeguarding patients in ICU? Curr Op 13:195–201

    CAS  Google Scholar 

  12. Vlahakes GJ (2006) The value of phase 4 clinical testing. N Engl J Med 354:413–415

    Article  PubMed  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Intensive Care Medicine Unit, Henri Mondor Hospital, Creteil, France

    François Lemaire

Authors
  1. François Lemaire
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to François Lemaire.

Additional information

This editorial refers to the articles available at: http://dx.doi.org/10.1007/s00134-006-0384-2 and http://dx.doi.org/10.1007/s00134-006-0385-1

Rights and permissions

Reprints and permissions

About this article

Cite this article

Lemaire, F. The European Directive 2001/20 for clinical research: friend or foe?. Intensive Care Med 32, 1689–1690 (2006). https://doi.org/10.1007/s00134-006-0386-0

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00134-006-0386-0

Search

Navigation