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Provision of Support for Producing a European Directory of Local Ethics Committees

  • Abstract:
    EU Member States in order to protect persons participating in research have established local ethics committees to evaluate research protocols involving human beings. Directive 2001/20/EC was adopted by the European Commission to regulate the conduct of clinical trials, defining the role for ethics committees. However, its implementation into national legislation has yet to take place in the individual European countries. At the same time, the need for a closer co-operation among ethics committees has been acknowledged both by political bodies and by the scientific community. Corresponding initiatives are greatly encouraged by the European Commission, which has adopted the Action Plan on «Science and Society» (December 2001). A European Directory of Local Ethics Committees is one of the first studies to obtain an overview of the status quo, encompassing structure and assignment as well as difficulties.

    The purpose of this study is (1) to provide a complete directory of local ethics committees, (2) to analyse the main challenges and difficulties in the functioning of these committees and the main needs to improve their functioning. The target study countries are the EU Member States (Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, UK), the EU Candidate States (Bulgaria, Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Romania, Slovakia, Slovenia, Turkey) and other associated countries to the 5th and 6th Framework Programmes (Iceland, Israel, Liechtenstein, Norway, Switzerland). The object of the study are the local research ethics committees (LECs), i.e. all institutional or local/regional bodies dealing with ethical evaluation of research projects involving human beings.

    The study's tasks are: 

    1. to collect and analyse currently existing material on LECs, their activities, legal (international, European and national) establishment etc.;

    2. to set up initial contacts and interviews with relevant experts and selected members of LECs for the purpose to draw a draft database;

    3. to identify LECs in the target countries;

    4. to develop a questionnaire for consequent survey to gain statistical data and to identify the local particularities;

    5. to compare these findings with relevant information from the USA, Japan and India in order to clarify whether the organizational structures as well as the associated difficulties and restraints are due to geographic characteristics;

    6. to analyse the collected data focusing on (a) the identification of similarities and differences between LECs from different regions, (b) the practical difficulties and communicational obstacles arising hereof, and (c) the feasible scenarios to improve the working conditions and to foster an exchange of experiences between LECs; 

    7. to draw a set of recommendations for further activities and studies. 

    A Final Report will:

    1. contain the database with a directory of European LECs (including the structure, mandate, composition, decision-making process, resources, legal regulations, difficulties and challenges in their activities);

    2. summarise the major findings and evaluate the institutional make-ups to provide examples of excellence among the LECs;

    3. identify key elements for a fruitful co-operation between European LECs;

    4. include a set of recommendations for feasible strategies to meet challenges and difficulties in LECs functioning as well as recommendations for further studies and activities.

  • Partner:
    Dr. phil. Michael Fuchs (Project Director)
    Institut für Wissenschaft und Ethik, Bonn



  • Funding:
    European Commission, Research Directorate-General, Directorate C - Science and Society, Ethics and Science (Tender No RTD-C3-2002-01/1)


  • Funding period:
    January 2003 - September 2003


  • Working Group:
    Dr. phil. Michael Fuchs (Project Director)
    Institut für Wissenschaft und Ethik, Bonn

    Ruta Avulyte, M.A. (Project Coordinator)
    Institut für Wissenschaft und Ethik, Bonn

    Martin Heyer (legal data collection and analysis)
    Institut für Wissenschaft und Ethik, Bonn

    Nils Fischer (empirical data collection)
    Institut für Wissenschaft und Ethik, Bonn

    Dr. phil. Dietmar Hübner (Datenanalyse)
    Institut für Wissenschaft und Ethik, Bonn

    Angelika Maria Kappel (data base design, data processing)
    German Reference Centre for Ethics in the Life Sciences (DRZE), Bonn


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