SPAIN

Legislation

ORGANIC LAW 15/1999, of December 13th, Protection of Personal Data (Ley Orgánica de Protección de Datos de Carácter Personal, BOE 298, December 14, 1999).

LAW 41/2002, of 14 November, regulating patient autonomy and rights and obligations of information and clinical documentation. (Ley básica reguladora de la autonomía del paciente y de derechos y obligaciones en materia de información y documentación clínica, BOE 274, November 15th, 2002).

Royal Decree 223/2004, of February 6th, which regulates clinical drug trials. (Real Decreto por el que se regulan los ensayos clínicos con medicamentos, BOE 33, February 1st, 2004).

LAW 29/2006, of July 26th, on guarantees and rational use of medicines and health products. (Ley de garantías y uso racional de los medicamentos y productos sanitarios, BOE 178 of July 27th, 2006).

Law 14/2007, of July 3rd, on Biomedical Research (Ley de Investigación Biomédica, BOE 159 of July 4th, 2007).

Royal Decree 1720/2007, of December 21th, which approves the regulation implementing Organic Law 15/1999 of December 13th on the protection of personal data in any type of clinical research. (Real Decreto por el que se aprueba el Reglamento de desarrollo de la Ley Orgánica 15/1999, de protección de datos de carácter personal, BOE 17 of January 19th, 2008).

Royal Decree 1591/2009, of October 16th, that regulates medical devices. (Real Decreto por el que se regulan los productos sanitarios, BOE 268 of November 6th, 2009).

Royal Decree 1616/2009, of October 26th, regulating the active implantable medical devices. (Real Decreto por el que se regulan los productos sanitarios implantables activos, BOE 268 of November 6th, 2009).

ORDER SAS/3470/2009, of December 16th, which publishes guidelines on post-authorization observational studies for drugs for human use. (Orden por la que se publican las directrices sobre estudios postautorización de tipo observacional para medicamentos de uso humano, BOE 310 of November 25th, 2009).

Law 14/2011, of June 1st on Science, Technology and Innovation. (Ley de la Ciencia, la Tecnología y la Innovación, BOE 131 of June 2nd, 2011).

Royal Decree 1716/2011, of November 18th, which establishes the basic requirements for authorization and operation of biobanks for biomedical research purposes and the treatment of human biological samples, and regulates the functioning and organization of the National Register of Biobanks for Biomedical Research (Real Decreto por el que se establecen los requisitos básicos de autorización y funcionamiento de los biobancos con fines de investigación biomédica y del tratamiento de las muestras biológicas de origen humano, y se regula el funcionamiento y organización del Registro Nacional de Biobancos para investigación biomédica, BOE 290 of December 2nd, 2011).

Research Ethics Committees

Short description of RECs system

The publication of Law 14/2007, of July 3, of Biomedical Research (known in Spanish as LIB) established a specific regulatory framework in Spain, in order to guarantee the performance of biomedical research with full respect for the rights of people who participate in the investigation. The LIB establishes that the Ethics Committees for Investigation (hereinafter CEI) corresponding to each center must evaluate all biomedical research involving human interventions or the use of their biological samples.

The Royal Decree 1090/2015, of 4 December, regulating clinical trials with medicinal products, Ethics Committees for Investigation with medicinal products and the Spanish Clinical Studies Registry, was published to adapt the Spanish legislation to the Regulation (EU) No 536/2014 of the European Parliament and of the Council, of 16 April 2014, on clinical trials on medicinal products for human use. This Royal Decree defines the Ethics Committee for Investigation as “an independent body with a multidisciplinary composition whose main purpose is to oversee the protection of the rights, safety and well-being of subjects participating in a biomedical investigation project and offer public assurance in this respect by giving an opinion on the corresponding documentation of the investigation project, taking into account the views of laypersons, in particular, patients or patient organisations”. It also defines the Research Ethics Committees with Medicines (CEIm) as "Research Ethics Committees that are also accredited according to the terms of this Royal Decree to issue an opinion in a clinical study with medicines and in a clinical investigation with medical devices".

The Royal Decree 1090/2015 allocates the responsibility for authorising clinical trials with medicinal products to the Spanish Agency for Medicinal Products and Medical Devices (hereinafter the AEMPS), determining that assessment of Part I of the trial shall be done jointly by the AEMPS and CEIm and allocating the latter responsibility for assessment of Part II. In addition, it states that the AEMPS shall establish the mechanisms and procedures for cooperation and exchange of information on clinical studies with medicinal products and clinical research with medical devices with the CEIm, which shall be made public. This has been set out in a "collaboration memo" specifying the responsibilities of the CEIm and the AEMPS, as a framework in which criteria regarding the assessment and authorisation of clinical trials with medicinal products in Spain should be standardized.

Currently, in Spain there are over 90 committees accredited as CEIm, and another 32 as CEI, all of them with many different scopes and levels of activity. Moreover, Research Ethics Committees of Universities and Public Research Organizations form part of 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). This network consists (includes) of 40 committees that hold regular meetings since 2002 (www.ub.edu/rceue)

To perform the tasks assigned by law, to both types of committees (CEI and CEIm), must have adequate resources and have standard operating procedures (SOPs) for proper operation.

In 2012 the National Association of Research Ethics Committees (Asociación Nacional de Comités de Ética de la Investigación, ANCEI) was constituted in order to promote the training of people who are part of the CEI. Another ANCEI aim is to offer a meeting place for the exchange of experiences related to the theoretical and practical aspects of research ethics in human subjects.

For more information: www.ancei.es; X: @AnceiEs

Relationship of CEI and CEIm accredited in Spain: www.aemps.gob.es/investigacionClinica/ceicsca.do

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

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