title: [The ethical aspects of population screening programme of rare diseases].
abstract: The Committee on Ethics of the Instituto de Investigación de Enfermedades Raras (CEIIER) of the Spanish National Institute of Health Carlos III, presents this article dealing with ethical guidelines regarding the implementation of screening population programmes with special emphasis on genetic screening. After a critical review it has been addressed 24 recommendations concerning 14 topics: evaluation of the opportunity of the programme, including ethical analysis besides scientific evidences and cost/benefits issues; the need to differentiate between research and public health intervention and to built a specific and comprehensive programme; the creation of an interdisciplinary working group which control its implementation and prepare a protocol including justification, development, therapeutic or preventive actions and follow-up activities; the review of the programme by an independent Ethical committee; the guarantee of the voluntary, universal and equitable population access, which requires sufficient information on the programme and their specific relevant facts, as incidental detection of heterozygous state in minors in newborn screening and the relevance of non directive genetic counselling specially in prenatal screening offered to pregnant women; considerations regarding future uses of samples for research purposes; total quality and periodic programme evaluation; guarantee of personal data confidentiality and the conflict of interest statement of the members of all the Committees involved in the programme.
authors.affiliation: Comité de Etica, Instituto de Investigación de Enfermedades Raras (IIER), Spain.
authors.forename: Teresa
authors.initials: T
authors.lastname: Pàmpols Ros
authors.forename: Benedetto
authors.initials: B
authors.lastname: Terracini
authors.forename: Francisco J
authors.initials: FJ
authors.lastname: de Abajo Iglesias
authors.forename: Lydia
authors.initials: L
authors.lastname: Feito Grande
authors.forename: M Concepción
authors.initials: MC
authors.lastname: Martín-Arribas
authors.forename: José María
authors.initials: JM
authors.lastname: Fernández Soria
authors.forename: Tomás
authors.initials: T
authors.lastname: Redondo Martín Del Olmo
authors.forename: Jaime
authors.initials: J
authors.lastname: Campos Castelló
authors.forename: Joaquín
authors.initials: J
authors.lastname: Herrera Carranza
authors.forename: Javier
authors.initials: J
authors.lastname: Júdez Gutiérrez
authors.forename: Moisés
authors.initials: M
authors.lastname: Abascal Alonso
authors.forename: Antonio
authors.initials: A
authors.lastname: Morales Piga
mesh_terms: D006801:Humans; D008403:Mass Screening / Q000941:ethics*; D035583:Rare Diseases / Q000175:diagnosis*