SciELO - Scientific Electronic Library Online

 
vol.82 issue1Evidence Based Public Health: Resources on Efectiveness of Community InterventionsEpidemiology of falls in the elderly in Spain: A systematic review, 2007 author indexsubject indexarticles search
Home Pagealphabetic serial listing  

Services on Demand

Journal

Article

Indicators

Related links

  • On index processCited by Google
  • Have no similar articlesSimilars in SciELO
  • On index processSimilars in Google

Share


Revista Española de Salud Pública

On-line version ISSN 2173-9110Print version ISSN 1135-5727

Abstract

ABAJO IGLESIAS, Francisco J. de et al. Ethics Guidelines for the Creation and Use of Registries for Biomedical Research Purposes. Rev. Esp. Salud Publica [online]. 2008, vol.82, n.1, pp.21-42. ISSN 2173-9110.

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.

Keywords : Registries; Research; Bioéthics; Data protection; Ethics Committees; Confidentiality; Epidemiology.

        · abstract in Spanish     · text in Spanish     · Spanish ( pdf )

 

Creative Commons License All the contents of this journal, except where otherwise noted, is licensed under a Creative Commons Attribution License