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    Ethics Committee (European Union)

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    Deen
    The ethics committee is an independent body consisting of healthcare professionals and non-medical members in European Union member states. It is responsible for protecting the rights and welfare of subjects in clinical trials. This includes reviewing trial protocols, investigators, and informed consent documents. The European Union aims to harmonize research ethics committees across Europe to standardize the review process and issues considered. Local terms for ethics committees vary between countries such as Research Ethics Committees in the UK and Comités de Protection des Personnes in France.

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    Ethics Committee (European Union)

    Uploaded by

    Deen
    20 views3 pages
    The ethics committee is an independent body consisting of healthcare professionals and non-medical members in European Union member states. It is responsible for protecting the rights and welfare of subjects in clinical trials. This includes reviewing trial protocols, investigators, and informed consent documents. The European Union aims to harmonize research ethics committees across Europe to standardize the review process and issues considered. Local terms for ethics committees vary between countries such as Research Ethics Committees in the UK and Comités de Protection des Personnes in France.

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    Ethics Committee (European Union) basics

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    The ethics committee is an independent body consisting of healthcare professionals and non-medical members in European Union member states. It is responsible for protecting the rights and welfare of subjects in clinical trials. This includes reviewing trial protocols, investigators, and informed consent documents. The European Union aims to harmonize research ethics committees across Europe to standardize the review process and issues considered. Local terms for ethics committees vary between countries such as Research Ethics Committees in the UK and Comités de Protection des Personnes in France.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    20 views3 pages

    Ethics Committee (European Union)

    Uploaded by

    Deen
    The ethics committee is an independent body consisting of healthcare professionals and non-medical members in European Union member states. It is responsible for protecting the rights and welfare of subjects in clinical trials. This includes reviewing trial protocols, investigators, and informed consent documents. The European Union aims to harmonize research ethics committees across Europe to standardize the review process and issues considered. Local terms for ethics committees vary between countries such as Research Ethics Committees in the UK and Comités de Protection des Personnes in France.

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    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
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    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.

    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.

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