Top

Published in:

01-04-2014 | Review

Medical research in emergency research in the European Union member states: tensions between theory and practice

Authors: Erwin J. O. Kompanje, Andrew I. R. Maas, David K. Menon, Jozef Kesecioglu

Published in: Intensive Care Medicine | Issue 4/2014

Abstract

In almost all of the European Union member states, prior consent by a legal representative is used as a substitute for informed patient consent for non-urgent medical research. Deferred (patient and/or proxy) consent is accepted as a substitute in acute emergency research in approximately half of the member states. In 12 European Union member states emergency research is not mentioned in national law. Medical research in the European Union is covered by the Clinical Trial Directive 2001/20/EC. A proposal for a regulation by the European Commission is currently being examined by the European Parliament and the Council and will replace Directive 2001/20/EC. Deferred patient and/or proxy consent is allowed in the proposed regulation, but does not fit completely in the practice of emergency research. For example, deferred consent is only possible when legal representatives are not available. This criterion will delay inclusion of patients in acute life-threatening conditions in short time frames. As the regulation shall be binding in its entirety in all member states, emergency research in acute situations is still not possible as it should be.

European Union (2012) Proposal for a regulation of the European Parliament and the Council on clinical trails on medicinal products for human use, and repealing Directive 2001/20/EC. COM(2012) 369 final, 2012/0192 (COD)

Visser HKA (2001) Non-therapeutic research in the EU in adults incapable of giving consent? Lancet 357:818–819PubMedCrossRef

Bayens AJ (2002) Implementation of the Clinical Trials Directive: pitfalls and benefits. Eur J Health Law 9:31–47

Sterz F, Singer EA, Böttiger B, Chamberlain D, Baskett P, Bossaert L, Steen P (2002) A serious threat to evidence based resuscitation within the European Union. Resuscitation 53:237–238PubMedCrossRef

Lemaire FJP (2003) A European Directive for clinical research. Intensive Care Med 29:1818–1820PubMedCrossRef

Kompanje EJO, Maas AIR (2004) ‘Treat first, ask later?’ Emergency research in acute neurology and neurotraumatology in the European Union. Intensive Care Med 30:168–169PubMedCrossRef

Silvermann HJ, Druml C, Lemaire F, Nelson R (2004) The European Union directive and the protection of incapacitated subjects in research: an ethical analysis. Intensive Care Med 30:1723–1729CrossRef

Druml C (2004) Informed consent of incapable (ICU) patients in Europe: existing laws and the EU Directive. Curr Opin Crit Care 10:570–573PubMedCrossRef

Lemaire F, Bion J, Blanco J, Damas P, Druml C, Falke K, Kesecioglu J, Larsson A, Mancebo J, Matamis D, Pesenti A, Pimentel J, Ranieri M (2005) The European Union Directive on clinical research: present status of implementation in EU member states’ legislations with regard to the incompetent patient. Intensive Care Med 31:476–479PubMedCrossRef

10.

Wiedermann CJ, Almici M, Mangione S, Giarratono A, Mayr O (2006) Clinical research in Italy in adult patients unable to consent: after implementation of the European Union’s Directive 2001/20/EC. Intensive Care Med 33:316–318

11.

Liddell K, Kompanje EJO, Lemaire F, Vrhovac B, Menon DK, Bion J, Chamberlain D, Wiedermann CJ, Druml C (2006) Recommendations in relation to the EU clinical trials directive and medical research involving incapacitated adults. Wien Klin Wochenschr 118:183–191PubMedCrossRef

12.

Liddell K, Chamberlain D, Menon DK, Bion J, Kompanje EJO, Lemaire F, Druml C, Vrhovac B, Widermann CJ, Sterz F (2006) The European clinical trials directive revisited: the VISEAR recommendations. Resuscitation 69:9–14PubMedCrossRef

13.

Lewis RJ, Duber HC, Biros MH, Cone DC (2009) International resuscitation research, exception from informed consent, and the European Union Directive 2001/20/EC. Eur J Emerg Med 16:234–241PubMedCrossRef

14.

Kompanje EJO, Maas AIR, Slieker FJA, Stocchetti N (2007) Ethical implications of time frames in a randomized controlled trial in acute severe traumatic brain injury. Prog Brain Res 161:243–250PubMedCrossRef

15.

Gamble C, Woolfall K, Williamson P, Appleton R, Young B (2013) New European Union regulation of clinical trials is conflicting on deferred consent in emergency situations. BMJ 346:f667PubMedCrossRef

16.

Matei M, Kompanje EJO, Maas AIR, Menon DK, Lemaire F (2013) Clinical research into the ICU: clouds at the horizon, once again. Intensive Care Med. doi:10.1007/s00134-013-2974-0 PubMed

17.

Weijer C, Miller PB (2004) When are research risks reasonable in relation to anticipated benefits? Nature Med 10(6):570–573PubMedCrossRef

18.

Weijer C, Miller PB (2007) Evaluating benefits and harms in intensive care research. Intensive Care Med 33:1819–1822PubMedCrossRef

19.

Liddell K, Bion J, Chamberlain D, Druml C, Kompanje EJO, Lemaire F, Menon D, Vrhovac B, Wiedermann CJ (2006) Medical research involving incapacitated adults: implications of the EU Clinical Trials Directive 2001/20/EC. Med Law Rev 14:367–417PubMedCrossRef

20.

Roupie E, Santin A, Boulme R et al (2000) Patients preferences concerning medical information and surgery: results of a prospective study in a French emergency department. Intensive Care Med 26:52–56PubMedCrossRef

21.

Sulmasy DP, Haller K, Terry PB (1994) More talk, less paper: predicting the accuracy of substituted judgments. Am J Med 96:432–438PubMedCrossRef

22.

Coppolino M, Ackerson L (2001) Do surrogate decision makers provide accurate consent for intensive care research? Chest 119:603–612PubMedCrossRef

23.

Mason S, Barrow H, Phillips A et al (2006) Brief report on the experience of using proxy consent for incapacitated adults. J Med Ethics 32:61–62PubMedCentralPubMedCrossRef

24.

Ciroldi M, Cariou A, Adrie C et al (2007) Ability of family members to predict patient’s consent to critical care research. Intensive Care Med 33:807–813PubMedCrossRef

25.

Sugarman J (2000) Is the emperor really wearing new clothes? Informed consent for acute coronary syndromes. Am Heart J 140:2–3PubMedCrossRef

26.

Ditto PH, Danks JH, Smucker WD et al (2001) Advance directives as acts of communication: a randomized controlled trial. Arch Intern Med 161:421–430PubMedCrossRef

27.

Matheis-Kraft C, Roberto KA (1997) Influence of a values discussion on congruence between elderly women and their families on critical health care decisions. J Women Aging 9:5–22PubMedCrossRef

28.

Potter JE, MaKinley S, Delaney A (2013) Research participants’ opinions of delayed consent for a randomized controlled trial of glucose control in intensive care. Intensive Care Med 39:472–480PubMedCrossRef

29.

Barrett KA, Ferguson ND, Athaide V et al (2012) Surrogate decision makers’ attitudes towards research decision making for critically ill patients. Intensive Care Med 38:1616–1623PubMedCrossRef

30.

Mehta S, Quittnat Pelletier F, Brown M et al (2012) Why substitute decision makers provide or decline consent for ICU research studies: a questionnaire study. Intensive Care Med 38:46–54

31.

Hsieh M, Dailey MW, Calloway CW (2001) Surrogate consent by family members for out-of-hospital cardiac arrest research. Acad Emerg Med 8:851–853PubMedCrossRef

32.

Kucia AM, Horowitz JD (2000) Is informed consent to clinical trials an ‘upside selective’ process in acute coronary syndromes? Am Heart J 139:94–97CrossRef

33.

Woolley N (1990) Crisis theory: a paradigm of effective intervention with families of critically ill people. J Adv Nursing 15:1402–1408CrossRef

34.

Jansen TC, Kompanje EJO, Bakker J (2009) Deferred consent in emergency critical care research: ethically valid and practically feasible. Crit Care Med 37(Suppl):S65–S68

Title: Medical research in emergency research in the European Union member states: tensions between theory and practice
Authors: Erwin J. O. Kompanje
Andrew I. R. Maas
David K. Menon
Jozef Kesecioglu
Publication date: 01-04-2014
Publisher: Springer Berlin Heidelberg
Published in: Intensive Care Medicine / Issue 4/2014
Print ISSN: 0342-4642
Electronic ISSN: 1432-1238
DOI: https://doi.org/10.1007/s00134-014-3243-6

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Medical research in emergency research in the European Union member states: tensions between theory and practice

Abstract

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Please log in to get access to this content

Other articles of this Issue 4/2014

Cardiopulmonary resuscitation among mechanically ventilated patients

Noninvasive mechanical ventilation in acute respiratory failure: trends in use and outcomes

High-flow nasal cannula (HFNC) support in interhospital transport of critically ill children

Understanding hypovolaemia

Energy expenditure in the critically ill performing early physical therapy

Dynamics of myosin degradation in intensive care unit-acquired weakness during severe critical illness