Under the shadow of the Japanese cherry trees

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The impact of the COVID-19 pandemic on people with neurological disorders: an urgent need to enhance the health care system's preparedness

The major ethical issue posed by the COVID 19 pandemic are discussed with special reference to the impact on acute and chronic neurological disorder

Advance directives as a tool to respect patients’ values and preferences: discussion on the case of Alzheimer’s disease

Abstract Background The proposal of the new criteria for the diagnosis of Alzheimer’s disease (AD) based on biomarker data is making possible a diagnosis of AD at the mild cognitive impairment (MCI) or predementia/prodromal– stage. Given the present lack of effective treatments for AD, the opportunity for the individuals to personally take relevant decisions and plan for their future before and if cognitive deterioration occurs is one the main advantages of an early diagnosis. Main body Advance directives are largely seen as an effective tool for planning medical care in the event the subject becomes incompetent. Nevertheless, their value has been questioned with regard to people with dementia by scholars who refer to the arguments of personal identity and of patient’s changing interests before and after the onset of dementia. In this paper, I discuss the value of advance directives in Alzheimer’s disease and other kind of dementia. Despite critics, I argue that advance directives are especially advisable in dementia and provide reasons in favor of their promotion at an early stage of the disease as a valuable tool to respect patients’ values and preferences on medical treatment, including participation in research and end of life decisions. I mainly support advance directives that include both decisions regarding health care and the appointment of an attorney in fact. Conclusion I conclude that patients with AD at a prodromal or early stage should be offered the opportunity to execute an advance directive, and that not to honor a demented individual’s directive would be an unacceptable form of discrimination towards those patients

Biomarker-based diagnosis of mild cognitive impairment due to Alzheimer's disease: how and what to tell. A kickstart to an ethical discussion

New criteria for the diagnosis of Alzheimer's disease (AD) based on biomarker results have recently been developed and are currently undergoing extensive validation. The next few years may represent a time window where the diagnostic validity of biomarkers will be studied in highly specialized research settings. Biomarkers results will be used to direct clinical diagnosis and, whenever appropriate, therapy and management. This piece aims to stimulate discussion by identifying the ethical challenges involved in the use of biomarkers to make a diagnosis of mild cognitive impairment due to AD and disclose it to patients. At the individual level, these challenges are related to (i) the ethical appropriateness of implementing an ecological diagnostic research protocol, (ii) the related informed consent process, and (iii) the diagnostic disclosure. We justify the ethical legitimacy of implementing a research diagnostic protocol by referring to the respect of patients' subjectivity and autonomy, and we suggest guidelines for informed consent development and diagnostic disclosure. All of the above points are discussed in light of the unique features of AD, currently scanty treatment options, and knowledge and uncertainties regarding the diagnostic value of biomarkers

A proposal for a model of informed consent for the collection, storage and use of biological materials for research purposes

OBJECTIVE: To suggest a model of informed consent for the collection, storage and use of biological materials in local biobanks for health research purposes. METHODS: Review of the major ethical issues related to collection, storage and use of human biological materials for research purposes. RESULTS: An informed consent form for the collection and use of biological materials in a specific research project, and an informed consent form for the collection, storage and use of biological materials in a biobank were separately developed. Two main rules govern the proposed model, as follows: the informed consent for the use of biological materials shall (i) give donors sufficient information to take informed decisions about possible present and future uses of their biological materials and (ii) consider the specific biological and genetic aims of the research being performed. CONCLUSION: Even if informed consent for the collection, storage and use of biological materials is a hard process, donors can actually be provided with sufficient information and choices to give a 'really informed consent'. PRACTICE IMPLICATIONS: The proposed model can be a useful guideline for the development of specific informed consent forms to be used by researchers. It can also be a good tool to let the donors know which information and guarantees they can request from researchers.status: publishe

Participation in biobanks for research by incapacitated adults: review and discussion of current guidelines

OBJECTIVE: Biobanks for research and genetic research are important opportunities to create new understanding of complex disorders, such as psychiatric disorders and dementia. The management of biobanks for subjects with psychiatric disorders or dementia raises additional challenges because of the ethical issues regarding the potentially impaired decision-making capacities of the subjects. The aim of this paper is to study (i) how guidelines address the matter and (ii) how they can be implemented in real research situations with patients suffering from psychiatric disorders and dementia. METHOD: We collected and analysed all the relevant guidelines and position papers from national and international organizations dealing with research on biological materials and selected documents mentioning the participation of incapacitated adults in genetic research and biobanks. RESULTS: Eighteen of the 30 analysed documents contain explicit references to adults who are unable to give consent. The main topics addressed by the guidelines are the following: (i) informed consent; (ii) principles of non-therapeutic research; and (iii) ethics committee review. CONCLUSIONS: In biomedical research, guidelines are an important instrument for facilitating research while promoting subjects' rights and well-being. Compared with legally binding documents, guidelines are more flexible and can be more easily revised according to evolving research situations and for adaptation to real persons and research settings. We suggest measures to implement the analysed guidelines taking into consideration the case for the participation of patients with neuropsychiatric disorders, who can have impairment of decision-making capacities without being obviously incompetent, in genetic research and biobanks.status: publishe