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

Intensive Care Medicine

Volumn 32, Issue 11, 2006, Pages 1689-1690

  Lemaire, François ^a  

^a HENRI MONDOR HOSPITAL   (France)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL RESEARCH; DRUG RESEARCH; EDITORIAL; HUMAN; LAW; MEDICAL INFORMATION; PUBLIC HEALTH;

EUROPE; HUMANS; INTENSIVE CARE UNITS; NETHERLANDS; PATIENT SELECTION; RESEARCH SUBJECTS; THIRD-PARTY CONSENT;

EID: 33750217114     PISSN: 03424642     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00134-006-0386-0     Document Type: Editorial

References (9)

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
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
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
7. Menon DK, Liddell K (2004) Consent for research. J Intensive Care Soc 5:98-99
8. Coats TJ, Shakur H (2005) Consent in emergency research: new regulations. Emerg Med J 22:683-685
9. Sprumont D (1999) Legal protection of human research subjects in Europe. Eur J Health Law 6:25-43