Guide to the design and review of emergency research when it is proposed that consent and consultation be waived

Emergency Medicine Journal

Volumn 31, Issue 10, 2014, Pages 794-795

  Davies, Hugh ^a   Shakur, Haleema ^b   Padkin, Andrew ^c   Roberts, Ian ^b   Slowther, Anne Marie ^d   Perkins, Gavin D ^d  

^a Health Research Authority   (United Kingdom)

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

^c ROYAL UNITED HOSPITALS BATH NHS FOUNDATION TRUST   (United Kingdom)

^d UNIVERSITY OF WARWICK   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

EMERGENCY CARE; HUMAN; INFORMED CONSENT; LEGAL ASPECT; MEDICAL RESEARCH; METHODOLOGY; NOTE; PATIENT REFERRAL; PATIENT SAFETY; PHYSICIAN; RESEARCH ETHICS; EMERGENCY MEDICINE; ETHICS; STANDARDS;

BIOMEDICAL RESEARCH; EMERGENCY MEDICINE; ETHICS, RESEARCH; HUMANS; INFORMED CONSENT; RESEARCH DESIGN;

EID: 84907169469     PISSN: 14720205     EISSN: 14720213     Source Type: Journal    
DOI: 10.1136/emermed-2014-203675     Document Type: Note

References (16)

1. Largent EA, Wendler D, Emanuel E, et al. Is emergency research without initial consent justified?: the consent substitute model. Arch Intern Med 2010;170:668-74.
2. Coats TJ, Ng G, Shakur H. Consent in emergency research. Emerg Med J 2006;23:489-90.
3. Directive 2001/20/EC of the European Parliament and Council. The approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. European Union. 2001. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:121:0034:0044:en:PDF
4. The Medicines for Human Use (Clinical Trials) Regulations 2004 - SI 2004/1031. Secondary The Medicines for Human Use (Clinical Trials) Regulations 2004 - SI 2004/1031. http://www.legislation.gov.uk/uksi/2004/1031/contents
5. The Medicines for Human Use (Clinical Trials) Amendment (No.2) Regulations 2006 - SI 2006/2984. Secondary The Medicines for Human Use (Clinical Trials) Amendment (No.2) Regulations 2006 - SI 2006/2984. http://www.legislation.gov.uk/uksi/2006/2984/pdfs/uksi-20062984-en.pdf
6. Adults with Incapacity (Scotland) Act 2000. Secondary Adults with Incapacity (Scotland) Act 2000. http://www.legislation.gov.uk/asp/2000/4/contents
7. Mental Capacity Act 2005. Secondary Mental Capacity Act 2005. http://www.legislation.gov.uk/ukpga/2005/9/contents
8. Roberts I, Shakur H, Edwards P, et al. Trauma care research and the war on uncertainty. BMJ 2005;331:1094 -6.
9. Nolan JP, Hazinski MF, Billi JE, et al. Part 1: Executive summary: 2010 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Resuscitation 2010;81:e1-25.
10. Perkins GD, Cottrell P, Gates S. Is adrenaline safe and effective as a treatment for out of hospital cardiac arrest? BMJ 2014;348:g2435.
11. Lin S, Callaway CW, Shah PS, et al. Adrenaline for out-of-hospital cardiac arrest resuscitation: a systematic review and meta-analysis of randomized controlled trials. Resuscitation 2014;85:732-40.
12. Patanwala AE, Slack MK, Martin JR, et al. Effect of epinephrine on survival after cardiac arrest: a systematic review and meta-analysis. Minerva Anestesiologica 2014;80:831-43.
13. Smyth M, Quinn T, Nolan J, et al. Clinicians' views on the effectiveness of adrenaline to treat cardiac arrest. Resuscitation 2014;85:S20-1.
14. Donnino MW, Salciccioli JD, Howell MD, et al. Time to administration of epinephrine and outcome after in-hospital cardiac arrest with non-shockable rhythms: retrospective analysis of large in-hospital data registry. BMJ 2014;348:g3028.
15. Koscik C, Pinawin A, McGovern H, et al. Rapid epinephrine administration improves early outcomes in out-of-hospital cardiac arrest. Resuscitation 2013;84:915-20.
16. Roberts I, Prieto-Merino D, Shakur H, et al . Effect of consent rituals on mortality in emergency care research. Lancet 2011;377:1071-2.