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Research ethics committees in Europe: trials and tribulations

  • Legal and Ethical Issues in Clinical Research
  • Published:
Intensive Care Medicine Aims and scope Submit manuscript

Abstract

Introduction

Ethics committees have been an integral part of clinical research since 1975, when they were introduced through the amendment of the Declaration of Helsinki. Every proposal for clinical research on human subjects has to be submitted to an independent ethics committee for review and approval. The European Clinical Trials Directive 2001/20/EC was implemented in 2004 to harmonise the legislative framework for clinical research in Europe in order to make Europe more competitive in clinical research while at the same time improving the protection of research participants.

Results

We have evaluated the situation of ethics committees in Europe five years after the implementation of the new law with special consideration of the number of Ethics Committees per European Member State and the number of members within the specific committees, including the selection of members, also in regard to gender aspects and training requirements, the remuneration or compensation of members in regard of their review obligations, and also issues of conflicts of interest.

Conclusion

Inadequate remuneration for professional services and gender imbalance are universal concerns across Europe. As the position of ethics committees changes continuously towards greater responsibility, further guidance is needed to uniformly adapt their structures to those needs.

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Notes

  1. World Medical Association (2002) World Medical Association Declaration of Helsinki: Recommendations Guiding Physicians in Biomedical Research Involving Human Subjects. Adopted by the 18th World Medical Assembly Helsinki, Finland, June 1964. Amended by the 29th World Medical assembly, Tokyo, Japan, October 1975; 35th World Medical Assembly, Venice, Italy, October 1983; 41st World Medical Assembly, Hongkong; 48th General Assembly, September 1989, Somerset West, Republic of South Africa, October 1996 and the 52nd General Assembly, Edinburgh, Scotland, October 2000 and the Note of Clarification on Paragraph 29 added by the World Medical Association General Assembly, Washington 2002.

  2. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.

  3. Sweden: The act on ethics review of research involving humans (2003:460).

  4. http://www.efgcp.be/icrel.

  5. ICREL final report, http://efgcp.be/ICREL/#report.

  6. Recommendations with Gender Reference for Ethics committees and Clinical Studies; Opinion of the Bioethics Commission at the Federal Chancellery, Austria (15 Nov 2008) http://www.bundeskanzleramt.at/DocView.axd?CobId=33153.

References

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Authors and Affiliations

  1. Ethics Committee of the Medical University of Vienna, Borschkegasse 8b, 1090, Vienna, Austria

    Christiane Druml, M. Wolzt, J. Pleiner & E. A. Singer

Authors
  1. Christiane Druml
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  2. M. Wolzt
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  3. J. Pleiner
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  4. E. A. Singer
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Corresponding author

Correspondence to Christiane Druml.

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Druml, C., Wolzt, M., Pleiner, J. et al. Research ethics committees in Europe: trials and tribulations. Intensive Care Med 35, 1636–1640 (2009). https://doi.org/10.1007/s00134-009-1544-y

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  • DOI: https://doi.org/10.1007/s00134-009-1544-y

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