Informed consent, dementia and clinical research

  • Defanti C. A. 
Original Articles
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Abstract

The problem of informed consent in clinical research involving demented patients is more and more vexed. Together with an historical review of the most authoritative international statements taken since Nuremberg till today, the document on this topic recently published in the Italian Journal of Neurological Sciences and prepared by members of the Bioethics and Neurology Working Group of the Italian Society of Neurology (including the author) is further commented.

The critique on distinction between therapeutic and non-therapeutic research and the recommendations of the Group in relation to the different phases of pharmacological research are among the subjects dealt with.

Key words

dementia informed consent clinical research 

Sommario

Il problema del consenso informato nella ricerca clinica sui pazienti dementi è sempre più dibattuto.

Insieme ad una revisione storica sulle posizioni assunte da Norimberga ad oggi sull'argomento, viene commentato il contributo dei componenti del Gruppo di studio Bioetica e Neurologia della Società Italiana di Neurologia, di cui fa parte l'autore, già pubblicato in precedenza sull'Italian Journal of Neurological Sciences.

Tra i temi affrontati vi sono la critica alla distinzione tra ricerca terapeutica e non terapeutica e la presentazione e discussione delle posizioni del gruppo nei confronti delle diverse fasi delle sperimentazioni farmacologiche.

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References

  1. [1]
    Società Italiana di Neurologia.Bioethics and Neurology Working Group. Ethical issues concerning research in people with dementia. Ital J Neurol Sci 1996; 17: 371–375.Google Scholar
  2. [2]
    Bernard B.Introduction à la médecine expérimentale. Paris, 1865.Google Scholar
  3. [3]
    Beecher HK.Ethics in clinical research. N Engl J Med 1966; 274: 1354–1360.PubMedGoogle Scholar
  4. [4]
    Buchanan A andBrock D.Deciding for Others. Cambridge University Press, Cambridge (USA), 1989.Google Scholar
  5. [5]
    Warren JW, Sobal J et al.Informed consent by proxy: an issue in research with advanced dementia of the Alzheimer type. JAMA, 1986; 256: 2210–2213.PubMedGoogle Scholar

Copyright information

© Masson S.p.A 1997

Authors and Affiliations

  • Defanti C. A. 
    • 1
  1. 1.Neurological Division IOspedali RiunitiBergamo

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