Harmonisation of ethics committees' practice in 10 European countries

R. Hernandez, M. Cooney, C. Dualé, M. Gálvez, S. Gaynor, G. Kardos, C. Kubiak, S. Mihaylov, J. Pleiner, G. Ruberto, N. Sanz, M. Skoog, P. Souri, C. O. Stiller, A. Strenge-Hesse, A. Vas, D. Winter, X. Carné

Research output: Contribution to journalArticle

Abstract

Background: The Directive 2001/20/EC was an important first step towards consistency in the requirements and processes for clinical trials across Europe. However, by applying the same rules to all types of drug trials and transposing the Directive's principles into pre-existing national legislations, the Directive somewhat failed to meet its facilitation and harmonisation targets. In the field of ethics, the Directive 2001/20/EC conditioned the way of understanding and transposing the "single opinion" process in each country. This led to a situation in which two models of research ethics committees organisation systems exist, being the model in which the "single opinion" is considered to be the decision made by a single ethics committee more effective and simpler in terms of administrative and logistic workload. Method: A survey was conducted in 10 European countries. Members of the European Clinical Research Infrastructures Network working party number 1, with expertise in the field of ethics, responded. Results: There is a major heterogeneity in the composition of ethics committees among the surveyed countries based on the number of members, proportion of experts versus lay members and expertise of the scientific members. A harmonised education of the ethics committees' membership based in common curricula is recommended by the majority of countries. Conclusions: Despite the efforts for harmonisation of the European Clinical Trial Directive, from an ethical point of view, there remains a plurality of ethics committees' systems in Europe. It is important to comprehend the individual national systems to understand the problems they are facing.

Original languageEnglish
Pages (from-to)696-700
Number of pages5
JournalJournal of Medical Ethics
Volume35
Issue number11
DOIs
Publication statusPublished - Nov 2009

Fingerprint

Ethics Committees
harmonization
moral philosophy
Ethics
Clinical Trials
Committee Membership
Codes of Ethics
European Community
Research Ethics Committees
expertise
Workload
Legislation
Curriculum
research ethics
Organizations
Education
workload
Harmonization
Directives
logistics

ASJC Scopus subject areas

  • Health Policy
  • Health(social science)
  • Issues, ethics and legal aspects

Cite this

Hernandez, R., Cooney, M., Dualé, C., Gálvez, M., Gaynor, S., Kardos, G., ... Carné, X. (2009). Harmonisation of ethics committees' practice in 10 European countries. Journal of Medical Ethics, 35(11), 696-700. https://doi.org/10.1136/jme.2009.030551

Harmonisation of ethics committees' practice in 10 European countries. / Hernandez, R.; Cooney, M.; Dualé, C.; Gálvez, M.; Gaynor, S.; Kardos, G.; Kubiak, C.; Mihaylov, S.; Pleiner, J.; Ruberto, G.; Sanz, N.; Skoog, M.; Souri, P.; Stiller, C. O.; Strenge-Hesse, A.; Vas, A.; Winter, D.; Carné, X.

In: Journal of Medical Ethics, Vol. 35, No. 11, 11.2009, p. 696-700.

Research output: Contribution to journalArticle

Hernandez, R, Cooney, M, Dualé, C, Gálvez, M, Gaynor, S, Kardos, G, Kubiak, C, Mihaylov, S, Pleiner, J, Ruberto, G, Sanz, N, Skoog, M, Souri, P, Stiller, CO, Strenge-Hesse, A, Vas, A, Winter, D & Carné, X 2009, 'Harmonisation of ethics committees' practice in 10 European countries', Journal of Medical Ethics, vol. 35, no. 11, pp. 696-700. https://doi.org/10.1136/jme.2009.030551
Hernandez R, Cooney M, Dualé C, Gálvez M, Gaynor S, Kardos G et al. Harmonisation of ethics committees' practice in 10 European countries. Journal of Medical Ethics. 2009 Nov;35(11):696-700. https://doi.org/10.1136/jme.2009.030551
Hernandez, R. ; Cooney, M. ; Dualé, C. ; Gálvez, M. ; Gaynor, S. ; Kardos, G. ; Kubiak, C. ; Mihaylov, S. ; Pleiner, J. ; Ruberto, G. ; Sanz, N. ; Skoog, M. ; Souri, P. ; Stiller, C. O. ; Strenge-Hesse, A. ; Vas, A. ; Winter, D. ; Carné, X. / Harmonisation of ethics committees' practice in 10 European countries. In: Journal of Medical Ethics. 2009 ; Vol. 35, No. 11. pp. 696-700.
@article{5225cc4323c64728984719b596bb35ba,
title = "Harmonisation of ethics committees' practice in 10 European countries",
abstract = "Background: The Directive 2001/20/EC was an important first step towards consistency in the requirements and processes for clinical trials across Europe. However, by applying the same rules to all types of drug trials and transposing the Directive's principles into pre-existing national legislations, the Directive somewhat failed to meet its facilitation and harmonisation targets. In the field of ethics, the Directive 2001/20/EC conditioned the way of understanding and transposing the {"}single opinion{"} process in each country. This led to a situation in which two models of research ethics committees organisation systems exist, being the model in which the {"}single opinion{"} is considered to be the decision made by a single ethics committee more effective and simpler in terms of administrative and logistic workload. Method: A survey was conducted in 10 European countries. Members of the European Clinical Research Infrastructures Network working party number 1, with expertise in the field of ethics, responded. Results: There is a major heterogeneity in the composition of ethics committees among the surveyed countries based on the number of members, proportion of experts versus lay members and expertise of the scientific members. A harmonised education of the ethics committees' membership based in common curricula is recommended by the majority of countries. Conclusions: Despite the efforts for harmonisation of the European Clinical Trial Directive, from an ethical point of view, there remains a plurality of ethics committees' systems in Europe. It is important to comprehend the individual national systems to understand the problems they are facing.",
author = "R. Hernandez and M. Cooney and C. Dual{\'e} and M. G{\'a}lvez and S. Gaynor and G. Kardos and C. Kubiak and S. Mihaylov and J. Pleiner and G. Ruberto and N. Sanz and M. Skoog and P. Souri and Stiller, {C. O.} and A. Strenge-Hesse and A. Vas and D. Winter and X. Carn{\'e}",
year = "2009",
month = "11",
doi = "10.1136/jme.2009.030551",
language = "English",
volume = "35",
pages = "696--700",
journal = "Journal of Medical Ethics",
issn = "0306-6800",
publisher = "BMJ Publishing Group",
number = "11",

}

TY - JOUR

T1 - Harmonisation of ethics committees' practice in 10 European countries

AU - Hernandez, R.

AU - Cooney, M.

AU - Dualé, C.

AU - Gálvez, M.

AU - Gaynor, S.

AU - Kardos, G.

AU - Kubiak, C.

AU - Mihaylov, S.

AU - Pleiner, J.

AU - Ruberto, G.

AU - Sanz, N.

AU - Skoog, M.

AU - Souri, P.

AU - Stiller, C. O.

AU - Strenge-Hesse, A.

AU - Vas, A.

AU - Winter, D.

AU - Carné, X.

PY - 2009/11

Y1 - 2009/11

N2 - Background: The Directive 2001/20/EC was an important first step towards consistency in the requirements and processes for clinical trials across Europe. However, by applying the same rules to all types of drug trials and transposing the Directive's principles into pre-existing national legislations, the Directive somewhat failed to meet its facilitation and harmonisation targets. In the field of ethics, the Directive 2001/20/EC conditioned the way of understanding and transposing the "single opinion" process in each country. This led to a situation in which two models of research ethics committees organisation systems exist, being the model in which the "single opinion" is considered to be the decision made by a single ethics committee more effective and simpler in terms of administrative and logistic workload. Method: A survey was conducted in 10 European countries. Members of the European Clinical Research Infrastructures Network working party number 1, with expertise in the field of ethics, responded. Results: There is a major heterogeneity in the composition of ethics committees among the surveyed countries based on the number of members, proportion of experts versus lay members and expertise of the scientific members. A harmonised education of the ethics committees' membership based in common curricula is recommended by the majority of countries. Conclusions: Despite the efforts for harmonisation of the European Clinical Trial Directive, from an ethical point of view, there remains a plurality of ethics committees' systems in Europe. It is important to comprehend the individual national systems to understand the problems they are facing.

AB - Background: The Directive 2001/20/EC was an important first step towards consistency in the requirements and processes for clinical trials across Europe. However, by applying the same rules to all types of drug trials and transposing the Directive's principles into pre-existing national legislations, the Directive somewhat failed to meet its facilitation and harmonisation targets. In the field of ethics, the Directive 2001/20/EC conditioned the way of understanding and transposing the "single opinion" process in each country. This led to a situation in which two models of research ethics committees organisation systems exist, being the model in which the "single opinion" is considered to be the decision made by a single ethics committee more effective and simpler in terms of administrative and logistic workload. Method: A survey was conducted in 10 European countries. Members of the European Clinical Research Infrastructures Network working party number 1, with expertise in the field of ethics, responded. Results: There is a major heterogeneity in the composition of ethics committees among the surveyed countries based on the number of members, proportion of experts versus lay members and expertise of the scientific members. A harmonised education of the ethics committees' membership based in common curricula is recommended by the majority of countries. Conclusions: Despite the efforts for harmonisation of the European Clinical Trial Directive, from an ethical point of view, there remains a plurality of ethics committees' systems in Europe. It is important to comprehend the individual national systems to understand the problems they are facing.

UR - http://www.scopus.com/inward/record.url?scp=72449169560&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=72449169560&partnerID=8YFLogxK

U2 - 10.1136/jme.2009.030551

DO - 10.1136/jme.2009.030551

M3 - Article

C2 - 19880708

AN - SCOPUS:72449169560

VL - 35

SP - 696

EP - 700

JO - Journal of Medical Ethics

JF - Journal of Medical Ethics

SN - 0306-6800

IS - 11

ER -