Ethics committee (European Union)
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The ethics committee, according to Directive 2001/20/EC, is an independent body in a
member state of the European Union, consisting of healthcare professionals and non-
medical members, whose responsibility is to protect the rights, safety and well being of
human subjects involved in a clinical trial and to provide public assurance of that
protection, by, among other things, expressing an opinion on the clinical trial protocol,
the suitability of the investigators involved in the trial and the adequacy of facilities, and
on the methods and documents to be used to inform trial subjects and obtain
their informed consent.
With the Clinical Trials Directive, the European Union (EU) envisioned a harmonisation
of research ethics committees (RECs) across Europe, including the time taken to
assess a trial proposal and the kinds of issues a committee should take into account.
Local terms for a European ethics committee include:
A Research Ethics Committee (REC) in the United Kingdom
A Medical Research Ethics Committee (MREC) in the Netherlands.
An Ethical Vetting Board in Sweden - (Etikprövningsnämnden in Swedish)
A Comités de Protection des Personnes (CPP) in France.
See also[edit]
Research ethics
Ethics committee
EudraLex
Directive 2005/28/EC
Qualified Person
Institutional Review Board (IRB)
Regulation of therapeutic goods
European Medicines Agency
Investigator's brochure
References[edit]
Directive 2001/20/EC of the European Parliament and of the Council.
Implementing texts for Directive 2001/20/EC
A Hedgecoe, F Carvalho, P Lobmayer and F Raka, Research ethics committees
in Europe: implementing the directive, respecting diversity, Journal of Medical Ethics
2006;32:483-486.
External links[edit]
National Research Ethics Service (NRES (Formerly COREC), UK)
National ethics committees (EU)
New Zealand Health and Disability Ethics Committees
Research Ethics Committees - Documents
This article about a philosophy-related organization is a stub. You can help Wikipedia by expanding
it.
Ethics committee (European Union)
From Wikipedia, the free encyclopedia
(Redirected from Ethics Committee (European Union))
Jump to navigationJump to search
The ethics committee, according to Directive 2001/20/EC, is an independent body in a
member state of the European Union, consisting of healthcare professionals and non-
medical members, whose responsibility is to protect the rights, safety and well being of
human subjects involved in a clinical trial and to provide public assurance of that
protection, by, among other things, expressing an opinion on the clinical trial protocol,
the suitability of the investigators involved in the trial and the adequacy of facilities, and
on the methods and documents to be used to inform trial subjects and obtain
their informed consent.
With the Clinical Trials Directive, the European Union (EU) envisioned a harmonisation
of research ethics committees (RECs) across Europe, including the time taken to
assess a trial proposal and the kinds of issues a committee should take into account.
Local terms for a European ethics committee include:
A Research Ethics Committee (REC) in the United Kingdom
A Medical Research Ethics Committee (MREC) in the Netherlands.
An Ethical Vetting Board in Sweden - (Etikprövningsnämnden in Swedish)
A Comités de Protection des Personnes (CPP) in France.
See also[edit]
Research ethics
Ethics committee
EudraLex
Directive 2005/28/EC
Qualified Person
Institutional Review Board (IRB)
Regulation of therapeutic goods
European Medicines Agency
Investigator's brochure
References[edit]
Directive 2001/20/EC of the European Parliament and of the Council.
Implementing texts for Directive 2001/20/EC
A Hedgecoe, F Carvalho, P Lobmayer and F Raka, Research ethics committees
in Europe: implementing the directive, respecting diversity, Journal of Medical Ethics
2006;32:483-486.
External links[edit]
National Research Ethics Service (NRES (Formerly COREC), UK)
National ethics committees (EU)
New Zealand Health and Disability Ethics Committees
Research Ethics Committees - Documents
This article about a philosophy-related organization is a stub. You can help Wikipedia by expanding
it.
