A review of informed consent and how it has evolved to protect vulnerable participants in emergency care research.
capacity
emergency care research
good clinical practice guidelines
informed consent
refusal of treatment
vulnerable participants
Journal
EFORT open reviews
ISSN: 2058-5241
Titre abrégé: EFORT Open Rev
Pays: England
ID NLM: 101695674
Informations de publication
Date de publication:
Feb 2020
Feb 2020
Historique:
entrez:
17
3
2020
pubmed:
17
3
2020
medline:
17
3
2020
Statut:
epublish
Résumé
A vulnerable participant in research lacks capacity to consent or may be exposed to coercion to participate. Capacity may be temporarily impaired due to loss of consciousness, hypoxia, pain and the consumption of alcohol or elicit substances.To advance emergency care, providing life-threatening measures in life-threatening circumstances, vulnerable patients are recruited into research studies. The urgent need for time-critical treatment conflicts with routine informed consent procedures.This article reviews ethical considerations and moral obligations to safeguard these participants and preserve their autonomy.A particular focus is given to research methodology to waive consent, and the role of ethics committees, research audits, research nurses and community engagement.Research on the acutely unwell patient who lacks capacity is possible with well-designed research trials that are led by investigators who are sufficiently trained, engage the community, gain ethical approval to waive consent and continuously audit practice. Cite this article:
Identifiants
pubmed: 32175093
doi: 10.1302/2058-5241.5.180051
pii: 10.1302_2058-5241.5.180051
pmc: PMC7047905
doi:
Types de publication
Journal Article
Langues
eng
Pagination
73-79Informations de copyright
© 2020 The author(s).
Déclaration de conflit d'intérêts
ICMJE Conflict of interest statement: The authors declare no conflict of interest relevant to this work.
Références
Acad Emerg Med. 1999 Aug;6(8):776-80
pubmed: 10463547
JAMA. 2004 Oct 6;292(13):1593-601
pubmed: 15467062
J Intensive Care Med. 2011 Jul-Aug;26(4):237-49
pubmed: 21764767
J Law Med Ethics. 2006 Fall;34(3):592-9, 481
pubmed: 17144183
Lancet. 2003 Mar 15;361(9361):918-22
pubmed: 12648970
Ann Intensive Care. 2011 Apr 13;1(1):8
pubmed: 21906335
Hastings Cent Rep. 1983 Aug;13(4):40-7
pubmed: 6629749
Acad Emerg Med. 2011 Mar;18(3):292-6
pubmed: 21362099
J Nurs Scholarsh. 2014 Nov;46(6):423-31
pubmed: 25130209
BMJ. 2011 Jan 05;342:c7452
pubmed: 21209060
Bone Joint J. 2016 Mar;98-B(3):410-3
pubmed: 26920968
J Surg Res. 2009 Nov;157(1):115-22
pubmed: 19765724
PLoS One. 2009 May 29;4(5):e5738
pubmed: 19478950
J Intensive Care Med. 2015 Mar;30(3):141-50
pubmed: 24019298
J Bone Joint Surg Am. 2007 Feb;89(2):418-26
pubmed: 17272462
BMJ. 2014 Jul 24;349:g4483
pubmed: 25059747
JAMA. 2015 Mar 10;313(10):1037-47
pubmed: 25756440
Surgery. 2015 Jan;157(1):10-9
pubmed: 25444222
Sci Eng Ethics. 2016 Dec;22(6):1605-1626
pubmed: 26602908
J Trauma Stress. 2004 Oct;17(5):363-72
pubmed: 15633915
Trials. 2014 Mar 14;15:80
pubmed: 24628821
J Trauma Acute Care Surg. 2015 May;78(5):1014-20
pubmed: 25909424
Ann Surg Oncol. 2013 Oct;20(10):3184-7
pubmed: 23975308
J Med Ethics. 2008 Sep;34(9):e16
pubmed: 18757616
Arch Intern Med. 2000 Apr 24;160(8):1142-6
pubmed: 10789607
JAMA. 2000 May 24-31;283(20):2701-11
pubmed: 10819955
Perspect Clin Res. 2013 Jan;4(1):53-7
pubmed: 23533983
Account Res. 2004 Apr-Jun;11(2):119-39
pubmed: 15675053
Account Res. 2004 Apr-Jun;11(2):141-59
pubmed: 15675055
Intensive Care Med. 2014 May;40(5):700-22
pubmed: 24737256
J Med Ethics. 2015 May;41(5):391-7
pubmed: 24855070
Bull World Health Organ. 2001;79(4):373-4
pubmed: 11357217
N Engl J Med. 2004 Aug 12;351(7):637-46
pubmed: 15306665
Kennedy Inst Ethics J. 2014 Jun;24(2):141-57
pubmed: 25109093
Emerg Med J. 2015 Dec;32(12):911-5
pubmed: 26598629
Emerg Med J. 2002 Sep;19(5):423-7
pubmed: 12204990
Dimens Crit Care Nurs. 2010 Jul-Aug;29(4):173-4
pubmed: 20543620
IRB. 2004 Mar-Apr;26(2):1-8
pubmed: 15069970
Sci Eng Ethics. 2010 Dec;16(4):675-91
pubmed: 21063801
BMJ Open. 2015 Sep 18;5(9):e009162
pubmed: 26384729
Rev Infect Dis. 1980 Jan-Feb;2(1):129-39
pubmed: 6994200
Intensive Care Med. 2013 Jul;39(7):1282-9
pubmed: 23612757