New European Union regulation of clinical trials is conflicting on deferred consent in emergency situations

BMJ (Online)

Volumn 346, Issue , 2013, Pages

  Gamble, Carrol ^a   Woolfall, Kerry ^b   Williamson, Paula ^b   Appleton, Richard ^a   Young, Bridget ^b  

^a ALDER HEY CHILDREN'S NHS FOUNDATION TRUST   (United Kingdom)

^b UNIVERSITY OF LIVERPOOL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

DEFERRED CONSENT; EMERGENCY CARE; ETHICAL DECISION MAKING; EUROPEAN UNION; HELP SEEKING BEHAVIOR; HUMAN; INFORMED CONSENT; LEGAL ASPECT; LETTER; MEDICAL ETHICS; PRACTICE GUIDELINE; PRIORITY JOURNAL; THERAPY DELAY; CLINICAL TRIAL (TOPIC); NOTE;

CLINICAL TRIALS AS TOPIC; HUMANS;

EID: 84875655944     PISSN: None     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.f667     Document Type: Letter

References (6)

1. Gøtzsche PC. Deficiencies in proposed new EU regulation of clinical trials. BMJ 2012;345:e8522. (20 December.)
2. Roberts I, Prieto-Merino D, Shakur H, Chalmers I, Nicholl J. Effect of consent rituals on mortality in emergency care research. Lancet 2011;377:1071-2.
3. Gamble C, Nadel S, Snape D, McKay A, Hickey H, Williamson P, et al. What parents of children who have received emergency care think about deferring consent in randomised trials of emergency treatments: postal survey. PLoS One 2012;5:e35982.
4. National Institute for Health Research Health Technology Assessment Programme. CATheter Infections in Children - the CATCH trial. 2011. www.hta.ac.uk/1867.
5. Maitland K, Molyneux S, Boga M, Kiguli S, Lang T. Use of deferred consent for severely ill children in a multi-centre phase III trial. Trials 2011;12:90.
6. Jansen TC, Bakker J, Kompanje EJ. Inability to obtain deferred consent due to early death in emergency research: effect on validity of clinical trial results. Intensive Care Med 2010;36:1962-5.