Intensive Care Medicine

, Volume 30, Issue 2, pp 177–179 | Cite as

A waiver of consent for intensive care research?

Editorial

Keywords

Supplement Issue Belmont Report Emergency Research Proxy Consent Incompetent Patient 

References

  1. 1.
    Annane D, Outin H, Fisch C, Bellissant E (2003) Informed consent for randomised controlled trials in critically ill patients: the case of septic shock. Intensive Care Med (http://dx.doi.org/10.1007/s00134-003-2065-8)Google Scholar
  2. 2.
    Annane D, Sebille V, Charpentier C, Bollaert P-E, Francois B, Korach J-M, Capellier G, Cohen Y, Azoulay E, Troche G, Chaumet-Riffaut P, Bellissant E (2002) Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock. JAMA 288:862–871CrossRefPubMedGoogle Scholar
  3. 3.
    Freeman B, Danner R, Banks S, Natanson C (2001) Safeguarding patients in clinical trials with high mortality rates. Am J Respir Crit Care Med 164:190–192CrossRefPubMedGoogle Scholar
  4. 4.
    Lemaire F, Brun-Buisson C (2000) Are institutional review boards effective in safeguarding patients in intensive care units? Curr Opinion Anaesth 13:195–200CrossRefGoogle Scholar
  5. 5.
    Miller FG, Rosenstein DL (2003) The therapeutic orientation to clinical trials. N Engl J Med 348:1383–1386CrossRefPubMedGoogle Scholar
  6. 6.
    National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979) Belmont report: ethical principles and guidelines for the protection of human subjects of research. US Government Printing Office, Washington, DCGoogle Scholar
  7. 7.
    Karlawish JHT (2003) Research involving cognitively impaired adults. N Engl J Med 348:1389–1392CrossRefPubMedGoogle Scholar
  8. 8.
    Luce J (2003) Is the concept of informed consent applicable to clinical research involving critically ill patients? Crit Care Med 31 (Suppl):S153–S160CrossRefPubMedGoogle Scholar
  9. 9.
    Bigatello LM, George E, Hurford WE (2003) Ethical considerations for research in critically ill patients. Crit Care Med 31 (Suppl):S178–S181CrossRefPubMedGoogle Scholar
  10. 10.
    Ferrand E, Bachoud-Levi AC, Rodrigues M, Maggiore S, Brun-Buisson C, Lemaire F (2001) Decision-making capacity and surrogate designation in French ICU patients. Intensive Care Med 27:1360–1364CrossRefPubMedGoogle Scholar
  11. 11.
    Luce J (2003) California’s new law allowing surrogate consent for clinical research involving subjects with impaired decision-making capacity. Intensive Care Med 29:1024–1025CrossRefPubMedGoogle Scholar
  12. 12.
    Steinbrook R (2003) How best to ventilate? Trial design and patient safety in studies of the acute respiratory distress syndrome. N Engl J Med 348:1393–1401CrossRefPubMedGoogle Scholar
  13. 13.
    Ster 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 53:237–238CrossRefGoogle Scholar
  14. 14.
    Visser H (2001) Non therapeutic research in the EU in adults incapable of giving consent? Lancet 357:818–819CrossRefPubMedGoogle Scholar
  15. 15.
    Singer EA, Müllner M (2002) Implications of the EU directive on clinical trials for emergency medicine. BMJ 324:1169–1170CrossRefPubMedPubMedCentralGoogle Scholar

Copyright information

© Springer-Verlag 2004

Authors and Affiliations

  1. 1.Hopital Henri MondorService de Reanimation MedicalCreteilFrance

Personalised recommendations