title: Integrating Advance Research Directives into the European Legal Framework.
abstract: The possibility of using advance directives to prospectively consent to research participation in the event of dementia remains largely unexplored in Europe. Moreover, the legal status of advance directives for research is unclear in the European regulations governing biomedical research. The article explores the place that advance research directives have in the current European legal framework, and considers the possibility of integrating them more explicitly into the existing regulations. Special focus is placed on issues regarding informed consent, the role of proxies, and the level of acceptable risks and burdens.
authors.forename: Roberto
authors.initials: R
authors.lastname: Andorno
authors.forename: Eloïse
authors.initials: E
authors.lastname: Gennet
authors.forename: Karin
authors.initials: K
authors.lastname: Jongsma
authors.forename: Bernice
authors.initials: B
authors.lastname: Elger
mesh_terms: D016223:Advance Directives / Q000331:legislation & jurisprudence*; D002986:Clinical Trials as Topic; D003704:Dementia; D005062:European Union; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D035842:Research Subjects / Q000331:legislation & jurisprudence*