Spain (two sites Sample Clauses

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