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National Information: Spain

    CLINICAL RESEARCH ETHICS COMMITTEES IN SPAIN

    In Spain, the Clinical Research Ethics Committees (Comités de Ética en Investigación Clínica, CEIC) are the oversight bodies of methodological adequacy, ethical goodness and regulatory compliance regarding research on human subjects. They consist of an independent multidisciplinary group of people whose main role is to impartially assess, research projects involving humans in order to guarantee the protection of participants, ensuring that all projects meet the methodological requirements, respect basic ethical principles and human rights, and comply with the law.

    In Spain, a Royal Decree of 1978 named these committees "Clinical Trials Committees" (Comités de Ensayos Clínicos, CEC). This is the first legal text that established that all drug clinical trials were to be evaluated by these committees and, therefore, all centres that would perform such studies should have a CEC.

    The Law on Medicinal Products in 1990 and its subsequent development by the Royal Decree 561/1993 changed the name from Clinical Trials Committees to Clinical Research Ethics Committees (Comités de Ética en Investigación Clínica, CEIC) and established the basic and common aspects in terms of composition, functions and working procedures. Accreditation, scope and Standard Operating Procedures (SOPs) were at the discretion of the Autonomous Communities. So, now in Spain, similarly to other neighbouring countries such as the UK, there are institutional or local committees and others of regional level, without implying a hierarchy between them.

    Since August 1994 (date of entry into force the Royal Decree 561/1993, about the CEIC) until May 2004 (when the legislation that incorporates the European Directive on clinical trials entered into force) accredited CEICs were completely autonomous, acting independently, and evaluating each and every one of the drug clinical trial protocols to be performed in its scope of action and geographic area.

    In May 2004, came into force the Royal Decree 223/2004 transposing the European Directive (20/2001/CE). Although this Royal Decree partially modified some basic criteria CEIC (composition, functions and working procedures), the main change was the implementation of the "Single Opinion", for multicentre clinical drug trials whereby it is only necessary the approval of one CEIC (CEIC of reference) for each EU Member State.

    Currently, in Spain there are over 140 accredited CEIC, with many different scopes, and also highly variable levels of activity. It can be summarized in 3 types of CEIC: a first group consisting of a few highly active CEIC (evaluating over 200 drug clinical trials per year), usually acting as Reference Committee (CEIC de referencia, CEIC-Ref.); a second group with intermediate or important activity, but rarely acting as CEIC Ref, and a third group, rather large, of less active CEIC that have never or rarely been CEIC Ref. It is noteworthy that the promoter, primarily the pharmaceutical industry, is the one who chooses who the CEIC Ref. is.

    The Oviedo Convention is published in 1997 and comes into force in Spain in 2000. Since the last decade of the twentieth century many CEIC also assessed other research projects involving the use of personal data or human biological samples. This situation led to the creation of Research Ethics Committees (RECs) in Universities and Public Research Organizations (Organismos Públicos de Investigación, OPI). Their mission is to evaluate research projects involving human subjects, personal data or human biological samples (not drug trials). Some of these committees also review research on animals, or other studies that use biological agents or genetically modified organisms.

    The Research Ethics Committees of the Universities gather around a network called “Network of Ethics Committees in Universities and Public Research Centres in Spain” (Red de Comités de Ética de Universidades y Organismos Públicos de Investigación de España, RCE), consisting of 45 committees that hold regular meetings since 2002 (http://www.ub.edu/rceue/index2.htm).

    More recently, in July 2007, the Law of Biomedical Research (Ley de Investigación Biomédica, LIB) was enacted. This is a very necessary law as it came to fill a legal vacuum in relation to the ethical evaluation of research projects in human subjects, different from clinical drug trials.
    This law designates the Research Ethics Committees (Comités de Ética de la Investigación, CEI) for the review of all types of research projects involving humans, including drugs clinical trials and health products, studies using biological identified or identifiable samples, embryonic material, as well as when handling personal data. According to the LIB, the CEI may also act as an external ethic committee of biobank, ethically evaluating applications for the transfer of samples and data associated with them. The resolution of a CEI is binding, in case of being negative.

    To perform these tasks, the law requires that the CEIs have adequate resources and have standard operating procedures (SOPs) for proper operation.

    Currently different national institutions are working to reorganize the CEI and make their performance more efficient, for which national legislation is being reviewed according to international amendments (mainly European Union and the United States).

    A few months ago the National Association of Research Ethics Committees (Asociación Nacional de Comités de Ética de la Investigación, ANCEI) was formally constituted. The purpose of this organization is to promote the education and further training of those who are or will be part of the CEI. ANCEI aims to be the meeting place for the exchange of experiences related to the theoretical and practical aspects of research ethics in human subjects, for members of the Association and other groups formed for similar purposes, domestic and international. (For more information: www.ancei.es, @AnceiEs).

    Links / Contact / Addresses

    Website of the Asociación Nacional de Comités de Ética de la Investigación, ANCEI.
    http://www.ancei.es

    Twitter: @AnceiEs

    Website of the Coordinator centre for CEIC Information on contact points for each independent CEIC in available in this website.
    http://www.msc.es/profesionales/farmacia/ceic/home.htm

    Website of the Network of Ethics Committees in Universities and Public Research Centres in Spain.
    http://www.ub.edu/rceue/index2.htm

    Website of the Spanish Medicines Authority.
    http://www.agemed.es



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