Regulatory ambiguity and ethical issues still pose major challenges to the conduct
of much-needed randomised controlled emergency research in Europe.
1.
,
2.
The European Union (EU) Clinical Trials Regulation permits using deferred consent
to enroll incapacitated patients in trials evaluating potentially beneficial and low-risk
pharmaceutical interventions.
1.
However, there are still no specific EU-level regulatory provisions for trials evaluating
device interventions.
1.
,
2.
,
3.
,
4.
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References
- Evolution of European Union legislation on emergency research.Resuscitation. 2015; 91: 84-91
- European Resuscitation Council Guidelines 2021: Ethics of resuscitation and end of life decisions.Resuscitation. 2021; 161: 408-432
- Targeted Temperature Management for Cardiac Arrest with Nonshockable Rhythm.N Engl J Med. 2019; 381: 2327-2337
Inoue A, Hifumi T, Sakamoto T, Kuroda Y. Extracorporeal Cardiopulmonary Resuscitation for Out-of-Hospital Cardiac Arrest in Adult Patients. J Am Heart Assoc. 2020;9:e015291.
- Neurologic outcomes after extracorporeal membrane oxygenation assisted CPR for resuscitation of out-of-hospital cardiac arrest patients: A systematic review.Resuscitation. 2018; 130: 146-158
- Extracorporeal life support during cardiac arrest and cardiogenic shock: a systematic review and meta-analysis.Intensive Care Med. 2016; 42: 1922-1934
- Extracorporeal Membrane Oxygenation Bridge to No Recovery.Circulation. 2019; 139: 428-430
- Neurological injury in adults treated with extracorporeal membrane oxygenation.Arch Neurol. 2011; 68: 1543-1549
- International Liaison Committee on Resuscitation’s (ILCOR) Advanced Life Support and Pediatric Task Forces. Extracorporeal cardiopulmonary resuscitation for cardiac arrest: A systematic review.Resuscitation. 2018; 131: 91-100
- Advanced reperfusion strategies for patients with out-of-hospital cardiac arrest and refractory ventricular fibrillation (ARREST): a phase 2, single centre, open-label, randomised controlled trial.Lancet. 2020; 396: 1807-1816
Suverein MM, Shaw D, Lorusso R, et al. Ethics of ECPR Research. Resuscitation. 2021; 169:136–142.
Bougouin W, Dumas F, Lamhaut L, et al. Sudden Death Expertise Center investigators. Extracorporeal cardiopulmonary resuscitation in out-of-hospital cardiac arrest: a registry study. Eur Heart J. 2020;41:1961–1971.
- Adaptive design methods in clinical trials - a review.Orphanet J Rare Dis. 2008; 3: 11
- Adaptive group sequential test for clinical trials with changing patient population.J Biopharm Stat. 2007; 17: 1227-1238
- Duration of veno-arterial extracorporeal life support (VA ECMO) and outcome: an analysis of the Extracorporeal Life Support Organization (ELSO) registry.Crit Care. 2017; 21: 45
- and International In-Hospital Costs of Extracorporeal Membrane Oxygenation: a Systematic Review.Appl Health Econ Health Policy. 2015; 13: 341-357
- 2019 American Heart Association Focused Update on Advanced Cardiovascular Life Support: Use of Advanced Airways, Vasopressors, and Extracorporeal Cardiopulmonary Resuscitation During Cardiac Arrest: An Update to the American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care.Circulation. 2019; 140: e881-e894
- Recommendations for extracorporeal cardiopulmonary resuscitation (eCPR): consensus statement of DGIIN, DGK, DGTHG, DGfK, DGNI, DGAI, DIVI and GRC.Clin Res Cardiol. 2019; 108: 455-464
- Predictors of favourable outcome after in-hospital cardiac arrest treated with extracorporeal cardiopulmonary resuscitation: A systematic review and meta-analysis.Resuscitation. 2017; 121: 62-70
- World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.JAMA. 2013; 310: 2191-2194
- Ethical challenges in resuscitation.Intensive Care Med. 2018; 44: 703-716
- Extracorporeal Cardiopulmonary Resuscitation for Refractory Out-of-Hospital Cardiac Arrest: The State of the Evidence and Framework for Application.Can J Cardiol. 2018; 34: 146-155
- Prevalence, natural history, and time-dependent outcomes of a multi-center North American cohort of out-of-hospital cardiac arrest extracorporeal CPR candidates.Resuscitation. 2017; 117: 24-31
- Ethics in the use of extracorporeal cardiopulmonary resuscitation in adults.Resuscitation. 2015; 91: 73-75
- Extracorporeal cardiopulmonary resuscitation should not be performed on confirmed or suspected COVID-19 patients.Resuscitation. 2020; 153: 6-7
- Reply to: Coronavirus disease 2019 and ethical considerations for extracorporeal cardiopulmonary resuscitation.Resuscitation. 2020; 154: 129-130
- Initial ELSO Guidance Document: ECMO for COVID-19 Patients with Severe Cardiopulmonary Failure.ASAIO J. 2020; 66: 472-474
- Coronavirus disease 2019 and ethical considerations for extracorporeal cardiopulmonary resuscitation.Resuscitation. 2020; 154: 127-128
- Universal Do-Not-Resuscitate Orders, Social Worth, and Life-Years: Opposing Discriminatory Approaches to the Allocation of Resources During the COVID-19 Pandemic and Other Health System Catastrophes.Ann Intern Med. 2020; 173: 230-232
- Effectiveness of Covid-19 Vaccines against the B.1.617.2 (Delta) Variant.N Engl J Med. 2021; 385: 585-594
Article info
Publication history
Published online: September 15, 2021
Accepted:
September 6,
2021
Received:
September 5,
2021
Identification
Copyright
© 2021 Elsevier B.V. All rights reserved.
ScienceDirect
Access this article on ScienceDirectLinked Article
- Ethics of ECPR researchResuscitationVol. 169
- PreviewThe design of emergency medicine trials can raise several ethical concerns – risks may be greater, and randomisation may have to occur before consent. Research in emergency medicine is thus an illuminating context to explore the interplay between risk and randomisation, and the consequences for consent. Using a currently running trial, we describe possible concerns, considerations, and solutions to reconcile the conflicting interests of scientific inquiry, ethical principles, and clinical reality in emergency medicine research.
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