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Emerg Med J. May 2001; 18(3): 198–204.
PMCID: PMC1725573

The problem of informed consent in emergency medicine research

Abstract

The CRASH Trial (Corticosteroid Randomisation After Significant Head injury), which started in April 1999 hopes to answer the question of whether or not there is any benefit to giving high dose corticosteroids after significant head injuries. To do this patients are randomised to receive either the standard care for head injuries, as defined by the receiving hospital, or standard care plus a 48 hour infusion of corticosteroids. This is to be started within eight hours of injury, preferably as soon as possible. As all eligible patients will have a reduced level of consciousness informed consent has been deemed unnecessary. In this review the issue of consent in human experimentation is presented with a special emphasis on the problems faced in emergency medicine research, and the way these have been tackled.

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Selected References

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  • Yates D, Farrell B, Teasdale G, Sandercock P, Roberts I. Corticosteroids in head injury--the CRASH trial. J Accid Emerg Med. 1999 Mar;16(2):83–84. [PMC free article] [PubMed]
  • Vollmann J, Winau R. Informed consent in human experimentation before the Nuremberg code. BMJ. 1996 Dec 7;313(7070):1445–1449. [PMC free article] [PubMed]
  • Rothman DJ. Ethics and human experimentation. Henry Beecher revisited. N Engl J Med. 1987 Nov 5;317(19):1195–1199. [PubMed]
  • Beecher HK. Ethics and clinical research. N Engl J Med. 1966 Jun 16;274(24):1354–1360. [PubMed]
  • Josefson D. US compensates subjects of radiation experiments. BMJ. 1996 Dec 7;313(7070):1421–1421. [PubMed]
  • Watson R. European bioethics convention signed. BMJ. 1997 Apr 12;314(7087):1066–1066. [PubMed]
  • Levine RJ. The need to revise the Declaration of Helsinki. N Engl J Med. 1999 Aug 12;341(7):531–534. [PubMed]
  • Brennan TA. Proposed revisions to the Declaration of Helsinki--will they weaken the ethical principles underlying human research? N Engl J Med. 1999 Aug 12;341(7):527–531. [PubMed]
  • Smithells RW. Iatrogenic hazards and their effects. Postgrad Med J. 1975;51 (Suppl 2):suppl 15–15:52. [PubMed]
  • Truog RD, Robinson W, Randolph A, Morris A. Is informed consent always necessary for randomized, controlled trials? . N Engl J Med. 1999 Mar 11;340(10):804–807. [PubMed]
  • HILL AB. Medical ethics and controlled trials. Br Med J. 1963 Apr 20;1(5337):1043–1049. [PMC free article] [PubMed]
  • Hughes JH. Widow's fight for husband's sperm. No one can give consent on behalf of an incompetent adult patient. BMJ. 1996 Dec 7;313(7070):1477–1477. [PMC free article] [PubMed]
  • Abramson NS, Meisel A, Safar P. Informed consent in resuscitation research. JAMA. 1981 Dec 18;246(24):2828–2830. [PubMed]
  • Abramson NS, Meisel A, Safar P. Deferred consent. A new approach for resuscitation research on comatose patients. JAMA. 1986 May 9;255(18):2466–2471. [PubMed]
  • Abramson NS, Safar P. Deferred consent: use in clinical resuscitation research. Brain Resuscitation Clinical Trial II Study Group. Ann Emerg Med. 1990 Jul;19(7):781–784. [PubMed]
  • Mariner WK. Research in emergency care without consent: new proposed FDA rules. Lancet. 1995 Dec 9;346(8989):1505–1506. [PubMed]
  • Bickell WH, Wall MJ, Jr, Pepe PE, Martin RR, Ginger VF, Allen MK, Mattox KL. Immediate versus delayed fluid resuscitation for hypotensive patients with penetrating torso injuries. N Engl J Med. 1994 Oct 27;331(17):1105–1109. [PubMed]
  • Wichman A, Sandler AL. Research involving critically ill subjects in emergency circumstances: new regulations, new challenges. Neurology. 1997 May;48(5):1151–1155. [PubMed]
  • Smith R. Informed consent: the intricacies. BMJ. 1997 Apr 12;314(7087):1059–1060. [PMC free article] [PubMed]
  • Bhagwanjee S, Muckart DJ, Jeena PM, Moodley P. Does HIV status influence the outcome of patients admitted to a surgical intensive care unit? A prospective double blind study. BMJ. 1997 Apr 12;314(7087):1077–1084. [PMC free article] [PubMed]
  • Dennis M, O'Rourke S, Slattery J, Staniforth T, Warlow C. Evaluation of a stroke family care worker: results of a randomised controlled trial. BMJ. 1997 Apr 12;314(7087):1071–1077. [PMC free article] [PubMed]
  • Doyal L. Informed consent in medical research. Journals should not publish research to which patients have not given fully informed consent--with three exceptions. BMJ. 1997 Apr 12;314(7087):1107–1111. [PMC free article] [PubMed]
  • Baum M. Do we need informed consent? Lancet. 1986 Oct 18;2(8512):911–912. [PubMed]

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