title: Medical research on patients with dementia--the role of advance directives in European legal instruments.
abstract: Current international legal instruments recognise the use of advance directives to carry on the will of the dementing research participant beyond the boundaries of her present legal capacity. Advance directives are gaining greater recognition in patient care than in medical research, where their legal status is still somewhat unclear. In particular, the three major international documents on medical research - the Council of Europe Convention on Biomedicine and Human Rights (ETS 164), its Additional Protocol on Biomedical Research (ETS 195), and Directive 2001/20/EC on Clinical Trials on Medicinal Products--give conflicting messages on the legal status of advance directives in medical research. This article examines the provisions in these documents and their national applications in Finland and the United Kingdom.
authors.affiliation: The University of Manchester, United Kingdom.
authors.forename: Salla
authors.initials: S
authors.lastname: Lötjönen
mesh_terms: D016223:Advance Directives / Q000331:legislation & jurisprudence* / Q000523:psychology; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000523:psychology; D003704:Dementia / Q000523:psychology / Q000628:therapy; D034723:Double Effect Principle; D016021:Epidemiologic Studies; D005060:Europe; D005387:Finland; D006805:Human Experimentation / Q000331:legislation & jurisprudence*; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence / Q000523:psychology; D016743:Mental Competency / Q000331:legislation & jurisprudence* / Q000523:psychology; D010344:Patient Advocacy / Q000331:legislation & jurisprudence / Q000523:psychology; D028701:Patient Rights / Q000331:legislation & jurisprudence*; D018579:Patient Selection; D026684:Personal Autonomy; D010686:Philosophy, Medical; D035842:Research Subjects / Q000331:legislation & jurisprudence* / Q000523:psychology; D006113:United Kingdom