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Intensive Care Medicine

, Volume 40, Issue 4, pp 496–503 | Cite as

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

  • Erwin J. O. KompanjeEmail author
  • Andrew I. R. Maas
  • David K. Menon
  • Jozef Kesecioglu
Review

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.

Keywords

Emergency research Deferred consent Informed consent EU Directive 2001/20/EC Autonomy 

Notes

Conflicts of interest

EJOK, AIRM, DKM: This work has been established in collaboration with the CENTER-TBI Consortium, who is supported by the FP7 program of the European Commission, Grant agreement no. 602150-2. The Commission has not influenced the design or outcome of the work.

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Copyright information

© Springer-Verlag Berlin Heidelberg and ESICM 2014

Authors and Affiliations

  • Erwin J. O. Kompanje
    • 1
    Email author
  • Andrew I. R. Maas
    • 2
  • David K. Menon
    • 3
  • Jozef Kesecioglu
    • 4
  1. 1.Department of Intensive Care MedicineErasmus MC University Medical CenterRotterdamThe Netherlands
  2. 2.Department of NeurosurgeryUniversity Hospital AntwerpAntwerpBelgium
  3. 3.Division of AnaesthesiaUniversity of CambridgeCambridgeUK
  4. 4.Department of Intensive Care MedicineUniversity Medical CenterUtrechtThe Netherlands

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