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Biomedical research involving patients with disorders of consciousness: ethical and legal dimensions
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. (Bioethics)
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
2014 (English)In: Annali dell'Istituto Superiore di Sanità, ISSN 0021-2571, Vol. 50, no 3, 221-228 p.Article in journal, Editorial material (Refereed) Published
Abstract [en]

The directive 2001/20/UE and the research involving patients with docs. Researchinvolving patients with disorders of consciousness (DOCs) deserves special ethical andlegal attention because of its Janus-faced nature. On the one hand, it raises concernsabout the risk to expose the involved subjects to disproportionate risks not respectingtheir individual dignity, particularly their right to be cared for; on the other hand, researchis an essential tool in order to improve the clinical condition of patients withDOCs. The present paper concerns the ethical and legal dimensions of biomedical researchinvolving patients with disorders of consciousness. In particular, it focuses oninformed consent to experimental treatments, which is a challenging issue both from anethical and legal point of view. The first part reads the Directive 2001/20/EU in the lightof the experimentation of patients with DOCs, and suggests a revision in order to betterassess the issue of informed consent.The particular case of informed consent for observational studies of non-communicativepatients. The second part presents an informed consent form for studies throughvideo-recording of patients unable to communicate their own consent. This form hasbeen elaborated by the bioethics unit of the project “Review of the nosography of vegetativestates: application of methods of behavioral analysis to individuals in coma orvegetative state” developed at the Italian National Institute of Health.Relevance of the suggested form. The paper describes the conceptual framework ofthe form for informed consent to studies through video-recoding, which is a relevantexample of what issues should be included in an informed consent for any type of studiesthrough video-recording of patients unable to express their own consent. The article hasbeen sent on November the 7th 2013, before the adoption of the Regulation (EU) no.536/2014 (and consequent abrogation of the Directive 2001/20/EU) and the release ofthe new edition of the Italian Code of Medical Ethics.

Place, publisher, year, edition, pages
2014. Vol. 50, no 3, 221-228 p.
Keyword [en]
Research Ethics, bioethics, neuroscience
National Category
Medical Ethics Ethics
Research subject
URN: urn:nbn:se:uu:diva-234879DOI: 10.4415/ANN_14_03_04OAI: oai:DiVA.org:uu-234879DiVA: diva2:758208
Available from: 2014-10-24 Created: 2014-10-24 Last updated: 2014-10-27Bibliographically approved

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Farisco, MicheleEvers, Kathinka
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