title: [Ethics guidelines for the creation and use of registries for biomedical research purposes].
abstract: The clinical information stored in registries and records of different types is a fundamental tool for biomedical research. Up until just a few years ago, hardly any limitations existed on the creation and use of epidemiological registries or the use of information from pre-existing records for research purposes. This situation has changed substantially due mainly to the growing importance current laws place upon the safeguarding of the privacy and confidentiality of personal data. Although the legal framework is already quite explicit, a certain degree of leeway exists for ethical debate and prudence advice for the purpose of conducting valid, useful research with this information which will also respect the rights of the subjects and the laws in force. These guidelines deal with those aspects which have been considered relevant from an ethical standpoint in the handling of records and registries for research-related purposes, including not only the use but also the creation proper of the registries. A total of twenty-four recommendations are provided, grouped into ten sections: warranting of the creation of registry, organization and definition of responsibilities, scientific validity of the research project, ethical requirements of the collections of anonymous and anonymized data, ethical requirements of the registries including personal data, uses of medical records for research purposes, use of historical records of deceased individuals, contact with the research subjects, notification of results and review by a Research Ethics Committee.
authors.affiliation: Comité de ética, Instituto de Investigación de Enfermedades Raras, Instituto de Salud Carlos III, Madrid.
authors.forename: Francisco J de
authors.initials: FJ
authors.lastname: Abajo Iglesias
authors.forename: Lydia
authors.initials: L
authors.lastname: Feito Grande
authors.forename: Javier
authors.initials: J
authors.lastname: Júdez Gutiérrez
authors.forename: M Concepción
authors.initials: MC
authors.lastname: Martín Arribas
authors.forename: Benedetto
authors.initials: B
authors.lastname: Terracini
authors.forename: Teresa
authors.initials: T
authors.lastname: Pàmpols Ros
authors.forename: Jaime
authors.initials: J
authors.lastname: Campos Castelló
authors.forename: Amelia
authors.initials: A
authors.lastname: Martín Uranga
authors.forename: Moisés
authors.initials: M
authors.lastname: Abascal Alonso
authors.forename: Joaquín
authors.initials: J
authors.lastname: Herrera Carranza
authors.forename: María José
authors.initials: MJ
authors.lastname: Sánchez Martínez
mesh_terms: D035843:Biomedical Research / Q000941:ethics*; D026690:Ethics, Clinical; D006287:Health Planning Guidelines; D006801:Humans; D012042:Registries