Abstract
BackgroundAlzheimer’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.DiscussionWe 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.SummaryWe 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.
Highlights
Alzheimer’s disease is a very common, progressive and still incurable disease
We outline the possible role of advance directives and ethics committees
Summary In accordance with the National Bioethics Advisory Commission report [61], we stress the importance of research aimed to increase knowledge of the decisionmaking capacity of individuals with mental disorders, the best ways of assessing that capacity, and the methods that can improve the process of informed consent
Summary
Consent for research by incompetent patients Informed consent is a fundamental ethical and legal requirement of biomedical research to ensure that participants are not objects of exploitation but, on the contrary, are considered autonomous subjects entitled to be informed and make decisions for themselves. With regard to the family members of patients who are invited to take part in a research study, ethics committees should acknowledge their role as persons who extend the autonomy of patients and who are strongly interested in the patient’s health and well-being In this sense, ethics committees should accept family members’ opinions about the patient’s participation in a clinical trial as valid decisions regarding the patient’s enrolment. To ensure that every effort to respect patients’ autonomy and wishes has been made [60], ethics committees should require research protocols to describe the planned informed consent process, as follows: the methods and instruments used to assess patients’ competence, the possible presence of an independent evaluator of competence and an independent auditor of the informed consent process, the method used to identify the patients’ representatives, and the value given to advance directives expressed by patients when they were fully competent.
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