Dissemin is shutting down on January 1st, 2025

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BioMed Central, BMC Medical Ethics, 1(16), 2015

DOI: 10.1186/s12910-015-0009-9

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Research involving subjects with Alzheimer’s disease in Italy: the possible role of family members

Journal article published in 2015 by Corinna Porteri, Carlo Petrini ORCID
This paper is made freely available by the publisher.
This paper is made freely available by the publisher.

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Abstract

Abstract Background Alzheimer’s disease is a very common, progressive and still incurable disease. Future possibilities for its cure lie in the promotion of research that will increase our knowledge of the disorder’s causes and lead to the discovery of effective remedies. Such research will necessarily involve individuals suffering from Alzheimer’s disease. This raises the controversial issue of whether patients with Alzheimer’s disease are competent to give their consent for research participation. Discussion We discuss the case of subjects with Alzheimer’s disease who may have impaired decision-making capacity and who could be involved in research protocols, taking into consideration aspects of the Italian normative framework, which requires a court-appointed legal representative for patients who are not able to give consent and does not recognise the legal value of advance directives. We show that this normative framework risks preventing individuals with Alzheimer’s disease from taking part in research and that a new policy that favours research while promoting respect for patients’ well-being and rights needs to be implemented. Summary We believe that concerns about the difficulty of obtaining fully valid consent of patients with Alzheimer’s disease should not prevent them from participating in clinical trials and benefiting from scientific progress. Therefore, we argue that the requirement for patients to have a legal representative may not be the best solution in all countries and clinical situations, and suggest promoting the role of patients’ family members in the decision-making process. In addition, we outline the possible role of advance directives and ethics committees.