Consent for observational studies in critical care: Time to open Pandora's box

Anaesthesia

Volumn 58, Issue 1, 2003, Pages 1-3

  Reade, Michael C ^a   Young, J Duncan ^a  

^a UNIVERSITY OF OXFORD   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL RESEARCH; CONFLICT; CRITICAL ILLNESS; EDITORIAL; HEALTH CARE POLICY; HUMAN; INFORMED CONSENT; INTENSIVE CARE; LAW; LEGAL ASPECT; MEDICAL ETHICS; PATIENT INFORMATION; PATIENT RIGHT; PRACTICE GUIDELINE; PROBABILITY; SELF DISCLOSURE;

BIOMEDICAL AND BEHAVIORAL RESEARCH;

CLINICAL TRIALS; CRITICAL CARE; ETHICS, RESEARCH; EUROPE; HUMANS; INFORMED CONSENT; PRACTICE GUIDELINES; RESEARCH;

EID: 0037240191     PISSN: 00032409     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1365-2044.2003.03002.x     Document Type: Editorial

References (15)

1. Johnstone E, Doyle L, Grubb A, Povey S, Quirke P, Sadeque S, Silman A, Stamp G. Human Tissue and Biological Samples for Use in Research: Operational and Ethical Guidelines. London: Medical Research Council, 2001.
2. Truog RD, Robinson W, Randolph A, Morris A. Is informed consent always necessary for randomized, controlled trials? New England Journal of Medicine 1999; 340: 804-7.
3. Lotjonen S. Medical research in clinical emergency settings in Europe. Journal of Medical Ethics 2002; 28: 183-7.
4. Council of Europe. Recommendation R (90) 3 of the Committee of Ministers to the Member States Concerning Medical Research on Human Beings, 1990.
5. Michels R. Are research ethics bad for our mental health? New England Journal of Medicine 1999;340:1427-30.
6. World Medical Association Declaration of Helsinki. Recommendations guiding physicians in biomedical research involving human subjects. Journal of the American Medical Association 1997; 277: 925-6.
7. Short R, Birley JLT, Dodds-Smith IC, Kendell RE, Wells WH, Wing JK. The Ethical Conduct of Research on the Mentally Incapacitated. London: Medical Research Council, 1991.
8. McRae AD, Weijer C. Lessons from everyday lives: A moral justification for acute care research. Critical Care Medicine 2002; 30: 1146-51.
9. The Royal Liverpool Children's Inquiry Report. London, House of Commons, 2001: http://www.rlcinquiry.org.uk/.
10. Coppolino M, Ackerson L. Do surrogate decision makers provide accurate consent for intensive care research? Chest 2001; 119: 603-12.
11. Lemaire F, Blanch L, Cohen SL, Sprung C. Informed consent for research purposes in intensive care patients in Europe - Part II. An official statement of the European Society of Intensive Care Medicine. Working Group on Ethics. Intensive Care Medicine 1997; 23: 435-9.
12. Lemaire F, Blanch L, Cohen SL, Sprung C. Informed consent for research purposes in intensive care patients in Europe - Part I. An official statement of the European Society of Intensive Care Medicine. Working Group on Ethics. Intensive Care Medicine 1997; 23: 338-41.
13. Steering Committee on Bioethics (CDBI). Draft Additional Protocol to the Convention on Human Rights and Biomedicine, on Biomedical Research. Strasbourg: Council of Europe, 2001.
14. Reade MC, Young JD. Of mice and men (and rats): Implications of species and stimulus differences for the interpretation of studies of nitric oxide in sepsis. British Journal of Anaesthesia 2003, in press.
15. Protection of Human Subjects United States Department of Health and Human Services, 1981: Title 45, Code of Federal Regulations, Part, 46.116 (d).