A European Directive for clinical research

Intensive Care Medicine

Volumn 29, Issue 10, 2003, Pages 1818-1820

  Lemaire, François J P ^a  

^a HENRI MONDOR HOSPITAL   (France)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL PRACTICE; CLINICAL RESEARCH; DATA BASE; DRUG SCREENING; EMERGENCY; EUROPE; INTENSIVE CARE; LAW; MEDICAL ETHICS; MEDICOLEGAL ASPECT; NOTE;

BIOMEDICAL RESEARCH; CRITICAL CARE; EUROPEAN UNION;

EID: 0242593847     PISSN: 03424642     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00134-003-1963-0     Document Type: Note

References (15)

1. European Parliament (2001) Directive 2001/20/EC of the European Parliament and Council of 4 April 2001. Official Journal L121:34-44
2. Horton R (1999) Time to register randomized trials. BMJ 319:865-866
3. Tonks A (2002) A clinical trials register for Europe. BMJ 325:1314-1315
4. Mann H (2002) Research ethics committees and public dissemination of clinical trial results. Lancet 359:406-408
5. Levine R (1986) Ethics and regulation of clinical research, 2nd edn. Urban and Schwarzenberg, Baltimore
6. Lacombe D (1998) Insuring international clinical trials: an Academic viewpoint. Appl Clin Trials 8:24-29
7. 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 27:1360-1364
8. Dijk Y van, van der Voort PH, Kuiper MA, Kesecioglu J (2003) Research on subjects incompetent of giving informed consent: the situation in Dutch intensive care departments. Intensive Care Med (in press)
9. British Medical Association (1999) Withholding and withdrawing life-prolonging medical treatments: guidance for decision making. BMJ, London
10. United States Food and Drug Administration (1996) Protection of human subjects: informed consent and waiver of informed consent in certain emergency research; final rules. Federal Register 51497-51531
11. Luce J (2003) California's new law allowing surrogate consent for clinical research involving subjects with impaired decision-making capacity. Intensive Care Med 29:1024-1025
12. Visser H (2001) Non therapeutic research in the EU in adults incapable of giving consent? Lancet 357:818-819
13. Lemaire F (2002) Clinical research in the ICU; an official statement of the ESICM. Intensive Care Med 28:1218-1219
14. 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 53:237-238
15. Watson R (2003) EU legislation threatens clinical trials. BMJ 326:1348