Evolution of European Union legislation on emergency research

Resuscitation
Spyros D MentzelopoulosGraham Nichol

Abstract

Emergency research is necessary to prevent exposure of patients to unvalidated clinical practice (nonmaleficence), and to improve the dismal prognosis of disorders requiring emergent treatment such as cardiac arrest (beneficence). Regulations that govern clinical research should conform to bioethical principles of respect for nonmaleficence, beneficence, autonomy, and justice. Our objectives are to review the evolution of European Union (EU) legislation on emergency research, and to identify potentially remaining problems. EU legislative sources on clinical research and medical literature describing the impact of EU Regulations on emergency research. Article 5 of EU Directive 2001/20/EC required consent before enrolment in a research study to ensure the autonomy of potentially incapacitated research subjects. However, obtaining such consent is often impossible in emergency situations. Directive 2001/20/EC was criticized for potentially preventing emergency research. Several EU Member States addressed this problem by permitting deferred consent. International ethical guidelines supporting deferred consent were also cited by Good Clinical Practice Directive 2005/28/EC. However, Directive 2001/20/EC was not revised to achieve harm...Continue Reading

References

Apr 26, 1995·JAMA : the Journal of the American Medical Association·R J Levine
May 1, 1994·The American Journal of Medicine·D P SulmasyP B Terry
May 23, 2002·BMJ : British Medical Journal·Ernst A Singer, Marcus Müllner
Jun 4, 2002·Journal of Medical Ethics·S Lötjönen
Oct 29, 2002·Intensive Care Medicine·F Lemaire, UNKNOWN European Society of Intensive Care Medicine
May 3, 2003·Lancet·Nino StocchettiAndreas Unterberg
Nov 25, 2003·Intensive Care Medicine·Erwin J O Kompanje, Andrew I R Maas
Jan 10, 2004·Intensive Care Medicine·Djillali AnnaneEric Bellissant
Jul 3, 2004·Intensive Care Medicine·Henry J SilvermanUNKNOWN European Union Directive
Oct 22, 2004·Emergency Medicine Journal : EMJ·UNKNOWN CRASH Trial Management Group
Dec 24, 2004·Current Opinion in Critical Care·Christiane Druml
Feb 16, 2005·Intensive Care Medicine·F LemaireUNKNOWN ESICM Task Force on Legislation Affecting Clinical Research in the Critically Ill Patient
Apr 30, 2005·European Journal of Clinical Investigation·F Lemaire
Sep 29, 2005·Emergency Medicine Journal : EMJ·T J Coats, H Shakur
Oct 4, 2005·Resuscitation·Christie AtwoodThomas D Rea
Jun 15, 2006·Wiener klinische Wochenschrift·Kathleen LiddellUNKNOWN Working Group of the Vienna Initiative to Save European Academic Research
Jan 23, 2008·Science and Engineering Ethics·Malcolm G Booth
Dec 19, 2008·The New England Journal of Medicine·Bernd W BöttigerUNKNOWN European Resuscitation Council Study Group
Oct 13, 2009·Resuscitation·Michelle H BirosKathleen Miller
Apr 10, 2010·American Journal of Critical Care : an Official Publication, American Association of Critical-Care Nurses·Karen E A BurnsDeborah J Cook
Dec 16, 2010·Current Opinion in Critical Care·Katy Robinson, Peter J D Andrews
Jan 1, 2010·International Journal of Emergency Medicine·Joshua N GoldsteinCarlos A Camargo
Mar 29, 2011·Lancet·Ian RobertsJon Nicholl
Apr 9, 2011·Europace : European Pacing, Arrhythmias, and Cardiac Electrophysiology : Journal of the Working Groups on Cardiac Pacing, Arrhythmias, and Cardiac Cellular Electrophysiology of the European Society of Cardiology·Ronan MargeyJoseph Galvin
Apr 18, 2012·Academic Emergency Medicine : Official Journal of the Society for Academic Emergency Medicine·Robert SilbergleitUNKNOWN NETT Investigators
Dec 19, 2012·Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine·Pamela HiltunenUNKNOWN Finnresusci Prehospital Study Group
Jun 14, 2013·Intensive Care Medicine·Mihaela MateiFrancois Lemaire
Nov 26, 2013·The British Journal of Surgery·T J Coats
Jan 18, 2014·Critical Care Medicine·Clifton W Callaway
Mar 22, 2014·Intensive Care Medicine·F Lemaire
Feb 13, 2015·Critical Care : the Official Journal of the Critical Care Forum·Scott A GoldbergPaul E Pepe

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Citations

Jan 19, 2016·Resuscitation·Spyros D MentzelopoulosTheodoros Xanthos
Oct 20, 2015·Resuscitation·Koenraad G MonsieursUNKNOWN ERC Guidelines 2015 Writing Group
Oct 20, 2015·Resuscitation·Leo L BossaertUNKNOWN ethics of resuscitation and end-of-life decisions section Collaborators
Aug 9, 2019·Journal of Empirical Research on Human Research Ethics : JERHRE·Lucinda Manda-TaylorJamie Rylance
May 12, 2018·Intensive Care Medicine·Spyros D MentzelopoulosLeo Bossaert
Jun 8, 2021·Notfall & Rettungsmedizin·Spyros D MentzelopoulosLeo Bossaert

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