[The ethical aspects of population screening programme of rare diseases].
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.
Pàmpols Ros
Teresa
T
Comité de Etica, Instituto de Investigación de Enfermedades Raras (IIER), Spain.
Terracini
Benedetto
B
de Abajo Iglesias
Francisco J
FJ
Feito Grande
Lydia
L
Martín-Arribas
M Concepción
MC
Fernández Soria
José María
JM
Redondo Martín Del Olmo
Tomás
T
Campos Castelló
Jaime
J
Herrera Carranza
Joaquín
J
Júdez Gutiérrez
Javier
J
Abascal Alonso
Moisés
M
Morales Piga
Antonio
A
D006801:Humans; D008403:Mass Screening / Q000941:ethics*; D035583:Rare Diseases / Q000175:diagnosis*