title: [Accreditation of Independent Ethics Committees].
abstract: OBJECTIVE
  According to Law 14/2007 and Royal Decree 1090/2015, biomedical research must be assessed by an Research Ethics Committee (REC), which must be accredited as an Research ethics committee for clinical trials involving medicinal products (RECm) if the opinion is issued for a clinical trial involving medicinal products or clinical research with medical devices. The aim of this study is to ascertain how IEC and IECm accreditation is regulated.
  
  
  METHODS
  National and regional legislation governing biomedical research was analysed.
  
  
  RESULTS
  No clearly-defined IEC or IECm accreditation procedures exist in the national or regional legislation.
  
  
  CONCLUSIONS
  Independent Ethics Committees are vital for the development of basic or clinical biomedical research, and they must be accredited by an external body in order to safeguard their independence, multidisciplinary composition and review procedures.
authors.affiliation: Comité de Ética de la Investigación, Cátedra 'Discapacidad, Enfermedad Crónica y Accesibilidad a los Derecho', Facultad de Derecho, Universidad de Alcalá, Alcalá de Henares, Madrid, España. Electronic address: miguelangel.ramiro@uah.es.
authors.forename: Miguel A
authors.initials: MA
authors.lastname: Ramiro Avilés
mesh_terms: D000068:Accreditation / Q000331:legislation & jurisprudence* / Q000592:standards; D035843:Biomedical Research / Q000941:ethics* / Q000331:legislation & jurisprudence*; D028744:Ethics Committees, Research / Q000331:legislation & jurisprudence*; D013030:Spain
keywords: Accreditation; Acreditación; Biomedical research; Clinical trials; Comité de ética de la investigación; Comité de ética de la investigación con medicamentos; Ensayos clínicos; Independent Ethics Committee; Independent Ethics Committee for clinical trials involving medicinal products; Investigación biomédica; Universidades; Universities