Informed consent in clinical trials in critical care: Experience from the PAC-Man Study

Intensive Care Medicine

Volumn 32, Issue 12, 2006, Pages 2020-2025

  Harvey, Sheila E ^a   Elbourne, Diana ^b   Ashcroft, Joanne ^c   Jones, Carys M ^d   Rowan, Kathryn ^a  

^a and London School of Hygiene Tropical Medicine   (United Kingdom)

^b LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^c UNIVERSITY OF MANCHESTER   (United Kingdom)

^d ROYAL BERKSHIRE HOSPITAL   (United Kingdom)

Author keywords

Clinical trial; Consent; Ethics; Intensive care

Indexed keywords

ARTICLE; CLINICAL STUDY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CRITICALLY ILL PATIENT; DESCRIPTIVE RESEARCH; DOCUMENTATION; FEMALE; HOSPITAL PATIENT; HUMAN; INFORMED CONSENT; INTENSIVE CARE; MAJOR CLINICAL STUDY; MALE; MEDICAL ETHICS; MEDICAL RESEARCH; MENTAL CAPACITY; MORTALITY; OUTCOMES RESEARCH; PATIENT PARTICIPATION; PROFESSIONAL STANDARD; RANDOMIZED CONTROLLED TRIAL; RELATIVE;

CRITICAL CARE; DOCUMENTATION; HUMANS; INFORMED CONSENT; MENTAL COMPETENCY; MULTICENTER STUDIES; RANDOMIZED CONTROLLED TRIALS; THIRD-PARTY CONSENT;

EID: 33750223042     PISSN: 03424642     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00134-006-0358-4     Document Type: Article

References (25)

1. Freedman B (1987) Equipoise and the ethics of clinical research. N Engl J Med 317:141-145
2. Beauchamp TL, Childress JF (1994) Principles of biomedical ethics. 4th edn. Oxford University Press, New York
3. Silverman HJ, Luce JM, Schwartz J (2004) Protecting subjects with decisional impairment in research: the need for a multifaceted approach. Am J Respir Crit Care Med 169:10-14
4. Annane D, Outin H, Fisch C, Bellissant E (2004) The effect of waiving consent on enrollment in a sepsis trial. Intensive Care Med 30:321-324
5. Harvey S, Harrison DA, Singer M, Ashcroft J, Jones CM, Elbourne D, Brampton W, Williams D, Young D, Rowan K, PAC-Man study collaboration (2005) Assessment of the clinical effectiveness of pulmonary artery catheters in management of patients in intensive care (PAC-Man): a randomised controlled trial. Lancet 366:472-477
6. Baren JM, Anicetti JP, Ledesma S, Biros MH, Mahabee-Gittens M, Lewis RJ (1999) An approach to community consultation prior to initiating an emergency research study incorporating a waiver of informed consent. Acad Emerg Med 6:1210-1215
7. Lewis RJ, Berry DA, Cryer H, Fost N, Krome R, Washington GR, Houghton J, Blue JW, Bechhofer R, Cook T, Fisher M (2001) Monitoring a clinical trial conducted under the Food and Drug Administration regulations allowing a waiver of prospective informed consent: the Diaspirin Cross-Linked Hemoglobin Traumatic Hemorrhagic Shock Efficacy Trial. Ann Emerg Med 38:397-404
8. Booth MG, Lind A, Read E, Kinsella J (2005) Public perception of emergency research: a questionnaire. Eur J Anaesthesiol 22:933-937
9. Smithline HA, Gerstle ML (1998) Waiver of informed consent: a survey of emergency medicine patients. Am J Emerg Med 16:90-91
10. McClure KB, DeIorio NM, Gunnels MD, Ochsner MJ, Biros MH, Schmidt TA (2003) Attitudes of emergency department patients and visitors regarding emergency exception from informed consent in resuscitation research, community consultation, and public notification. Acad Emerg Med 10:352-359
11. Roberts I, Yates D, Sandercock P, Farrell B, Wasserberg J, Lomas G, Cottingham R, Svoboda P, Brayley N, Mazairac G, Laloe V, Munoz-Sanchez A, Arango M, Hartzenberg B, Khamis H, Yutthakasemsunt S, Komolafe E, Olldashi F, Yadav Y, Murillo-Cabezas F, Shakur H, Edwards P, CRASH trial collaborators (2004) Effect of intravenous corticosteroids on death within 14 days in 10008 adults with clinically significant head injury (MRC CRASH trial): randomised placebo-controlled trial. Lancet 364:1321-1328
12. CESAR Trial, http://www.cesartrial. org (accessed 25 October 2005)
13. TracMan Trial, http://www.tracman.org.uk (accessed 25 October 2005)
14. CRASH Trial Management Group (2004) Research in emergency situations: with or without relatives' consent. Emerg Med J 21:703
15. Mariner WK (1995) Research in emergency care without consent: new proposed FDA rules. Lancet 346:1505-1506
16. Chalmers I, Silverman WA (1987) Professional and public double standards on clinical experimentation. Control Clin Trials 8:388-391
17. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001, http://eudract.emea.eu.int/docs/Dir2001-20_en.pdf (accessed 25 October 2005)
18. Medicines for Human Use (Clinical Trials Regulations) 2004. Informed consent in clinical trials (7th February 2005), http://www.corec.org.uk/ applicants/help/docs/Informed_Consent_in_CTIMPsv1.1.doc (accessed 25 October 2005)
19. Corrigan OP, Williams-Jones B (2003) Consent is not enough - putting incompetent patients first in clinical trials. Lancet 361:2096-2097
20. Chalmers I (2003) Provision of consent. Lancet 362:663-664
21. Klepstad P, Dale O (2006) Further restrictions for ICU research. Intensive Care Med 32:175
22. Druml C (2004) Informed consent of incapable (ICU) patients in Europe: existing laws and EU Directive. Curr Opin Crit Care 10:570-73
23. Lemaire F (2004) A waiver of consent for intensive care research. Intensive Care Med 30:177-79
24. Coats TJ, Shakur H (2005) Consent in emergency research: new regulations. Emerg Med J 22:683-685
25. Foex BA (2001) The problem of informed consent in emergency medicine research. Emerg Med J 18:198-204