[Organ donation and organ assessment after primary circulatory death and secondary brain death]. / Organspende und Organassessment nach primärem Herz-Kreislauf-Stillstand und sekundärem Hirntod.

BACKGROUND: The global organ shortage is the biggest obstacle to expand urgently needed liver transplantation activities. In addition to donation after brain death (DBD), donation after primary circulatory death (DCD) has also been introduced in many European countries to increase the number of donated organs. OBJECTIVE: This article summarizes the legal and ethical aspects of DCD, the practical donation process of DCD, the clinical results of DCD liver transplantation with a special focus on organ assessment before a planned DCD liver transplantation. RESULTS: In Europe 11 countries have active DCD liver transplantation programs and a total of 1230 DCD liver transplantations were performed in Europe in 2023. The highest proportion of DCD liver transplantations were recorded in Belgium (52.8%), the Netherlands (42.8%) and Switzerland (32.1%). The adequate selection of donors and recipients is crucial in DCD transplantation and the use of DCD livers particularly depends on the preparedness of the healthcare system for routine machine perfusion. The leaders are Belgium, France and Italy which implant around 68-74% of DCD organs. With an adequate organ assessment, the long-term results of DBD and DCD liver transplantations are comparable. To assess mitochondrial damage and thus organ quality, hypothermic oxygenated machine perfusion (HOPE) was introduced and has the secondary benefit of mitochondrial protection through oxygenation. The establishment of aerobic metabolism in mitochondria under hypothermia leads to a reduction of toxic metabolites and the restoration of ATP storage, which subsequently leads to a reperfusion light during implantation. CONCLUSION: Expanding the donor pool with DCD donors can counteract the global organ shortage. With adequate patient selection and routine organ assessment short-term and also long-term outcomes of DBD and DCD liver transplantation are comparable.

In vitro human cell culture models in a bench-to-bedside approach to epilepsy.

Epilepsy is the most common chronic neurological disease, affecting nearly 1%-2% of the world's population. Current pharmacological treatment and regimen adjustments are aimed at controlling seizures; however, they are ineffective in one-third of the patients. Although neuronal hyperexcitability was previously thought to be mainly due to ion channel alterations, current research has revealed other contributing molecular pathways, including processes involved in cellular signaling, energy metabolism, protein synthesis, axon guidance, inflammation, and others. Some forms of drug-resistant epilepsy are caused by genetic defects that constitute potential targets for precision therapy. Although such approaches are increasingly important, they are still in the early stages of development. This review aims to provide a summary of practical aspects of the employment of in vitro human cell culture models in epilepsy diagnosis, treatment, and research. First, we briefly summarize the genetic testing that may result in the detection of candidate pathogenic variants in genes involved in epilepsy pathogenesis. Consequently, we review existing in vitro cell models, including induced pluripotent stem cells and differentiated neuronal cells, providing their specific properties, validity, and employment in research pipelines. We cover two methodological approaches. The first approach involves the utilization of somatic cells directly obtained from individual patients, while the second approach entails the utilization of characterized cell lines. The models are evaluated in terms of their research and clinical benefits, relevance to the in vivo conditions, legal and ethical aspects, time and cost demands, and available published data. Despite the methodological, temporal, and financial demands of the reviewed models they possess high potential to be used as robust systems in routine testing of pathogenicity of detected variants in the near future and provide a solid experimental background for personalized therapy of genetic epilepsies. PLAIN LANGUAGE SUMMARY: Epilepsy affects millions worldwide, but current treatments fail for many patients. Beyond traditional ion channel alterations, various genetic factors contribute to the disorder's complexity. This review explores how in vitro human cell models, either from patients or from cell lines, can aid in understanding epilepsy's genetic roots and developing personalized therapies. While these models require further investigation, they offer hope for improved diagnosis and treatment of genetic forms of epilepsy.

Ethical aspects of conducting clinical trials of human medicinal products.

The conduct of clinical trials of investigational medicinal products brings, in clinical research with the participation of human subjects, various ethical concerns, which should be competently addressed. In clinical research, adherence to ethical principles plays an essential role in the safety of clinical trial participants, as well as in minimizing risks to the integrity and validity of data collected and analyzed during the conduct of clinical trials. The article contains an overview of the most important legal regulations and ethical standards that regulate the field of clinical trials. Furthermore, the paper focuses on some of the most important ethical aspects representing potential risk areas during clinical trials. The article also presents two case studies in which investigational medicinal products were not applied in compliance with the clinical trial requirements and which provide insight into the potential ethical implications that may occur when clinical trials of human medicinal products are performed incorrectly.

[Generative artificial intelligence and large language models in healthcare]. / La médecine du futur Intelligence artificielle générative et modèle linguistique large en soins de santé. Du battage médiatique à la réalité.

Generative artificial intelligence (GAI) and large language models (LLM) made their fulgurant irruption in our society at all levels, inclusive in health care. Possible applications and proofs of concept are everywhere. There is without any reasonable doubt an enormous potential, especially nowadays as we are facing an ever-growing imbalance between the flux of data and the availability of human resources. The creativity of GAI will be highlighted in the quest of defining protein structures and search for new medications, as well as for the development and use of digital twins in clinical research. As far as LLM's are concerned, we need to make a distinction between general models and models dedicated specifically to healthcare. Again, making an extensive overview of used cases is becoming impossible today, facing the numerous publications in the field.

Les mots intelligence artificielle générative (GAI) et modèles linguistiques larges (LLM) sont devenus ubiquitaires et incontournables en un temps record. En médecine aussi, le nombre d'applications possibles et preuves de concept foisonnent. Le potentiel est effectivement énorme, en particulier aujourd'hui, dans un monde de soins en déséquilibre, caractérisé par un flux énorme de données et un manque de moyens humains. La force créative de la GAI est illustrée par un exemple issu de la recherche protéomique et le développement de nouveaux médicaments, ainsi que dans le monde de la recherche clinique avec le développement des jumeaux digitaux. Pour le LLM, il faut faire la distinction entre modèles généralistes et spécialisés (adaptés au monde des soins). Là aussi, il devient de plus en plus difficile aujourd'hui d'en faire une revue exhaustive, car la littérature abonde de cas d'usage.

European Association of Urology Guidelines on Penile Size Abnormalities and Dysmorphophobia: Summary of the 2023 Guidelines.

CONTEXT: Recommendations regarding the management of penile size abnormalities and dysmorphophobia are important in guiding evidence-based clinical practice. OBJECTIVE: To present a summary of the 2023 European Association of Urology sexual and reproductive health evidence-based recommendations for the management of penile size abnormalities and dysmorphophobia. EVIDENCE ACQUISITION: A broad and comprehensive scoping exercise covering all areas of the guidelines was performed. Databases searched included Medline, EMBASE, and the Cochrane Libraries. A level of evidence and a strength of recommendation were assigned for each recommendation according to the evidence identified. The evidence cutoff date for the 2023 guidelines is June 1, 2022. EVIDENCE SYNTHESIS: Well-structured studies reporting high level of evidence, with standardized PROMS were deficient on penile size abnormalities and dysmorphohobia. A shared definition for short penis/micropenis was also lacking. Categorisation of penile abnormalities according to congenital, acquired, and dysmorphophobic aetiology is deemed compulsory. A detailed medical and psychosexual history and precise measurements of penile size are essential in the diagnostic pathway. Patients with normal penile size who are seeking penile augmentation should be referred for psychological evaluation for potential dysmorphophobic disorders. Penile length and girth enhancements can be achieved via a multitude of treatments, but a personalised management plan is crucial for satisfactory results. Endocrinological therapies, when indicated, are effective in the prepubertal setting only. Vacuum therapy has a limited evidence base in treatment protocols, although acceptable outcomes have been reported for penile traction therapy. Surgical techniques to enhance penile length and girth have limited evidence and should only be proposed after extensive patient counselling. CONCLUSIONS: Management of penile abnormalities and dysmorphophobia is a complex issue with considerable ethical concerns. The adoption of a structured diagnostic and therapeutic pathway is crucial, as recommended in the guidelines. PATIENT SUMMARY: Requests for medical/surgical treatments to increase penis size have increased dramatically worldwide. Several conservative and surgical treatments are available. However, few patients receive clear information on the benefits and possible harms of these treatments. These guidelines aim to provide a structured path to guide both physicians and patients in the selection of appropriate treatment(s) to increase penis size.

Ethical aspects of tissue and organ transplantation.

Along with the development of medicine and new therapeutic methods, the options of tissue and organ transplantation are constantly evolving, which brings a whole range of ethical connotations. The paper presents the legislative requirements and ethical principles that should be followed in transplant medicine, as well as their mutual connection. The article focuses on the ethical aspects which occur in connection with tissue and organ procurement and transplantation in everyday practice. The article also deals with modern methods that are currently being intensively developed and, in the future, could be helpful in solving contemporary issues in the field of transplantation. This concerns the ethical context of xenotransplantation, and the possibility of using artificial intelligence technologies for ethical decision-making in transplant medicine.

Advancements in multi-omics strategies in personalized medicine and the ethical, legal and criminological considerations

Los avances en las estrategias multiómicas, tanto a nivel analítico como computacional, han llevado al desarrollo de la medicina personalizada, que adapta el tratamiento médico al individuo basado en la comprensión de su composición biológica. Este enfoque tiene el potencial de revolucionar la atención médica, al proporcionar tratamientos más efectivos y eficientes. Sin embargo, la implementación de la medicina personalizada plantea importantes cuestiones éticas, legales y sociales. Las consideraciones éticas y legales en torno a las pruebas multiómicas, los desafíos de implementar la medicina personalizada en países de rentas bajas y el papel de las leyes de propiedad intelectual en la configuración del acceso a tratamientos personalizados son temas de creciente preocupación. Algunas consideraciones incluyen cuestiones de privacidad, consentimiento informado y posibles discriminaciones. Consideraciones relevantes, en términos penales, por los importantes avances que se van a producir en los próximos años en el análisis multiómico. Los estudios ómicos van a conllevar una mayor comprensión de los mecanismos biológicos que contribuyen a enfermedades mentales y comportamientos agresivos (Jakovljevic and Jakovljevic 2019). La biología humana, que subyace a determinados trastornos que tienen gran influencia en la cuestión penal, va a ser explicada mejor por el sistema multicapa que las pruebas multiómicas propician y va a posibilitar biomarcadores bioquímicos de la agresión que nos proporcionarán gran información en los ámbitos penal y criminológico. Un aspecto ético importante es el derecho a la privacidad de la información genética. Los pacientes pueden dudar en someterse a pruebas genéticas si temen que su información sea compartida o utilizada de formas que no pretendían. El consentimiento informado es otra consideración ética y legal importante. ... (AU)

Advances in multi-omics strategies, both analytical and computational, have led to the development of personalized medicine, which tailors medical treatment to the individual based on an understanding of their biological makeup. This approach has the potential to revolutionize medical care by providing more effective and efficient treatments. However, the implementation of personalized medicine raises important ethical, legal, and social issues. Ethical and legal considerations surrounding multiomics testing, the challenges of implementing personalized medicine in low-income countries, and the role of intellectual property laws in shaping access to personalized treatments are issues of growing concern. Some considerations include issues of privacy, informed consent, and possible discrimination, considerations that may apply in criminal terms because of the significant advances that will be made in the coming years in multi-omics analysis. Omics studies are going to lead to a greater understanding of the biological mechanisms that contribute to mental illness and aggressive behaviors (Jakovljevic and Jakovljevic 2019). Human biology, which underlies certain disorders that have a great influence on the criminal issue, will be better explained by the multi-layered system that multi-omics testing provides and will reveal biochemical biomarkers of aggression that will provide us with vital information in the criminal and criminological fields. An important ethical aspect is the right to privacy of genetic information. Patients may hesitate to undergo genetic testing if they fear that their information will be shared or used in ways they did not intend. Informed consent is another important ethical and legal consideration. The potential for discrimination is also an important legal consideration surrounding genetic testing. ... (AU)

Ethical Perspectives on Implementing AI to Predict Mortality Risk in Emergency Department Patients: A Qualitative Study.

Artificial intelligence (AI) is predicted to improve health care, increase efficiency and save time and recourses, especially in the context of emergency care where many critical decisions are made. Research shows the urgent need to develop principles and guidance to ensure ethical AI use in healthcare. This study aimed to explore healthcare professionals' perceptions of the ethical aspects of implementing an AI application to predict the mortality risk of patients in emergency departments. The analysis used an abductive qualitative content analysis based on the principles of medical ethics (autonomy, beneficence, non-maleficence, and justice), the principle of explicability, and the new principle of professional governance, that emerged from the analysis. In the analysis, two conflicts and/or considerations emerged tied to each ethical principle elucidating healthcare professionals' perceptions of the ethical aspects of implementing the AI application in emergency departments. The results were related to aspects of sharing information from the AI application, resources versus demands, providing equal care, using AI as a support system, trustworthiness to AI, AI-based knowledge, professional knowledge versus AI-based information, and conflict of interests in the healthcare system.

Current possibilities and risks of donating some tissues, cells, and organs from living donors.

Transfusion, transplantation, and regenerative medicine are rapidly developing fields. The authors of the text want to inform about upcoming legislative changes at the EU level and briefly describe and compare the difficulty of some donation procedures from the point of view of a living donor, as well as their risks, including psychosocial risks. The study is based on a qualitative expert investigation. Comparing the complexity of procedures from the perspective of donors is important, for example, for setting compensations. The tables show that the current compensations are disproportionate.

Is suffering a sufficient legitimation for UTx?

Uterus transplantation is a relatively new intervention. A woman with absolute uterine factor infertility receives, by a surgical procedure, a transplanted uterus, most often by living donation. The uterus recipient may thus become pregnant and conceive her own child. As with any other medical treatment, UTx requires legitimation. The anticipated benefits must outweigh the risks of the medical intervention. The risks and benefits of UTx are by no means unequivocal and cannot be easily determined. The benefits depend on the final evaluation of the suffering to be alleviated by the intervention. In the following, we will analyze the suffering addressed by UTx and discuss its normative value. First, we point out that (a) suffering is generally considered an important normative criterion in medicine as well as in the context of UTx; (b) we then describe the risks and anticipated benefits of UTx for the three persons directly concerned: the child, the donor, and the recipient; (c) we further analyze the suffering addressed by UTx. The intervention addresses a form of existential suffering. We discuss the common notion that existential suffering should be evaluated from the subjective perspective of the sufferer; (d) afterwards, we argue that in a social practice like medicine, a one-sided evaluation stemming from the sufferer alone is not sufficient; and (e) finally, arguments from a societal perspective lead us to the conclusion that the existential suffering addressed by UTx does not possess a sufficiently strong normative value to legitimize a high-risk, expensive procedure.

Would you consider donating your left-over embryos to treat Parkinson's disease? Interviews with individuals that underwent IVF in Sweden.

BACKGROUND: Parkinson's disease (PD) has been considered to be one of the most promising target diseases for forthcoming cell-based therapy. The aim of this study is to explore the views of individuals with cryopreserved embryos on using human embryonic stem cells for treating PD. METHODS: The study was performed as a qualitative, semi-structured interview study in June-October 2020. Participants were recruited at a private fertility clinic located in one of the larger Swedish cities. The clinic provides both publicly financed and privately financed IVF-treatments. All interviews were performed by telephone and analyzed using thematic content analysis. Five main categories emerged from 27 sub-categories. RESULTS: In total, 18 interviews were performed with 22 individuals, as either a couple (n = 16) or separately (n = 6). Participants had different views on what a cryopreserved embryo is. Some participants addressed cryopreserved embryos as 'a lump of cells', and some in terms of their 'unborn child'. Conditions for donation of cryopreserved embryos for cell-based treatment in PD were: not losing control of what is happening to the embryo, that donating must be voluntary and based on informed consent with time for reflection, that reimbursement, equality and transparency. CONCLUSIONS: Using cryopreserved embryos to treat PD is associated with fundamental ethical and practical issues. This study shows that IVF couples with left-over embryos may be supportive but there is a need for future research to assess people's views on using cryopreserved embryos for cell-based treatment in PD on a more aggregated level.

Health Literacy in the Context of Implant Care-Perspectives of (Prospective) Implant Wearers on Individual and Organisational Factors.

The continuous development of medical implants offers various benefits for persons with chronic conditions but also challenges an individual's, and the healthcare system's, ability to deal with technical innovation. Accessing and understanding new information, navigating healthcare, and appraising the role of the implant in body perceptions and everyday life requires health literacy (HL) of those affected as well as an HL-responsive healthcare system. The interconnectedness of these aspects to ethically relevant values such as health, dependence, responsibility and self-determination reinforces the need to address HL in implant care. Following a qualitative approach, we conducted group discussions and a diary study among wearers of a cochlear, glaucoma or cardiovascular implant (or their parents). Data were analysed using the documentary method and grounded theory. The data reveal the perceptions of implant wearers regarding the implant on (1) the ability to handle technical and ambiguous information; (2) dependence and responsibility within the healthcare system; and (3) the ethical aspects of HL. Knowing more about the experiences and values of implant wearers is highly beneficial to develop HL from an ethical perspective. Respective interventions need to initially address ethically relevant values in counselling processes and implant care.

Ethical connotations of conducting clinical trials during the COVID-19 pandemic.

The paper focuses on conducting clinical trials on medicinal products for human use during the COVID-19 pandemic, which has brought entirely new ethical dilemmas to clinical research professionals, as well as to the general public. Growing ethical concerns emphasized the need for partially modified or completely new procedures in order to ensure the safety of clinical trial participants, compliance with good clinical practice, and minimizing risks to the clinical trial integrity and validity of data obtained from clinical trials conducted during the pandemic. The paper acquaints with emergency measures issued by the State Institute for Drug Control during the COVID-19 public health emergency, discusses quality management, methods of efficient verification of the safety of subjects and data validity, and last but not least, presents risk areas and their ethical aspects in conducting clinical trials during the COVID-19 pandemic.

Edible Insects as Food-Insect Welfare and Ethical Aspects from a Consumer Perspective.

A growing number of studies underline consumers' concerns about the importance of animal welfare as a general concept for consumers' purchase decisions. In particular, consumers perceive animal husbandry to be one of the most important aspects of animal welfare. Since intensive livestock production is criticized across society, the acceptance of current intensive production systems of edible insects is an issue of investigation. Criteria of insect welfare might differ from vertebrate welfare. One might argue that it is difficult to define standards for insect welfare due to their large diversity in living environments and feed requirements. In addition, it is debated whether insects are conscious and suffer from pain. It has been demanded to rear insects preferably under natural living conditions and some researchers proposed to consider them as sentient beings. Basic welfare and ethical aspects of insects as food and feed include species-specific mass rearing conditions and euthanasia, i.e., killing procedures. Consumers' opinions and concerns regarding this issue have hardly been considered so far. In this paper, the animal welfare of prevalent livestock is defined and outlined, and relevant criteria are transferred to insect welfare. Different ways consumers might arrive at an animal welfare understanding are discussed, along with an overview of the few consumer studies on insect welfare. Furthermore, we consider how insects are presented in the public discourse and infer how this might be relevant to consumers' perceptions of insect welfare.

Health Technology Assessment for In Silico Medicine: Social, Ethical and Legal Aspects.

The application of in silico medicine is constantly growing in the prevention, diagnosis, and treatment of diseases. These technologies allow us to support medical decisions and self-management and reduce, refine, and partially replace real studies of medical technologies. In silico medicine may challenge some key principles: transparency and fairness of data usage; data privacy and protection across platforms and systems; data availability and quality; data integration and interoperability; intellectual property; data sharing; equal accessibility for persons and populations. Several social, ethical, and legal issues may consequently arise from its adoption. In this work, we provide an overview of these issues along with some practical suggestions for their assessment from a health technology assessment perspective. We performed a narrative review with a search on MEDLINE/Pubmed, ISI Web of Knowledge, Scopus, and Google Scholar. The following key aspects emerge as general reflections with an impact on the operational level: cultural resistance, level of expertise of users, degree of patient involvement, infrastructural requirements, risks for health, respect of several patients' rights, potential discriminations for access and use of the technology, and intellectual property of innovations. Our analysis shows that several challenges still need to be debated to allow in silico medicine to express all its potential in healthcare processes.

[Ethical, legal and social implications in the use of artificial intelligence-based technologies in surgery : Principles, implementation and importance for the user]. / Ethische, legale und soziale Implikationen bei der Anwendung künstliche-Intelligenz-gestützter Technologien in der Chirurgie : Grundlagen, Umsetzung und Bedeutung für den Anwender.

Ethical, legal and social aspects are gaining increasingly more attention in the development and during the initial clinical application of medical devices. The introduction of elements of artificial intelligence (AI) and systems which are using AI makes this already complex topic even more challenging. The introduction of so-called dynamic AI or dynamic machine learning (ML) algorithms in this respect represents a turning point. Unlike conventional medical devices, the development of systems using dynamic AI is not yet complete at the beginning of the clinical application. The aim of a dynamic AI system is to continuously improve through practical use and by the processing of usage data. This continuous evolution, along with the lack of transparency regarding internal work processes, could make it difficult to understand the underlying rationale for the assessments made by the algorithms. This aspect affects the acceptance of the technology both by clinicians and patients and furthermore questions the autonomy of patients and clinicians in the course of the treatment process. A way out of this ethical and regulatory dilemma must urgently be found and will require extreme efforts from all stakeholders. At present, no consensual solution is apparent. What is quite certain, however, is that users, i.e. in concrete terms surgeons, must play a much more active role than they have done in the past when dealing with AI-based medical devices and should prepare themselves to actively accompany the software life cycle of AI technologies.

Ethics and acceptance of smart homes for older adults.

Societal challenges associated with caring for the physical and mental health of older adults worldwide have grown at an unprecedented pace, increasing demand for health-care services and technologies Despite the development of several assistive systems tailored to older adults, the rate of adoption of health technologies is low. This review discusses the ethical and acceptability challenges resulting in low adoption of health technologies specifically focused on smart homes for older adults. The findings have been structured in two categories: Ethical Considerations (Privacy, Social Support, and Autonomy) and Technology Aspects (User Context, Usability, and Training). The findings conclude that older adults community is more likely to adopt assistive systems when four key criteria are met. The technology should: be personalized toward their needs, protect their dignity and independence, provide user control, and not be isolating. Finally, we recommend researchers and developers working on assistive systems to: (1) provide interfaces via smart devices to control and configure the monitoring system with feedback for the user, (2) include various sensors/devices to architect a smart home solution in a way that is easy to integrate in daily life, and (3) define policies about data ownership.

Obstetric Violence as an Infringement on Basic Bioethical Principles. Reflections Inspired by Focus Groups with Midwives.

BACKGROUND: obstetric violence is still far too invisible; the word "violence" generates rejection and obstetric violence is complex to define and typify, as it is a subjective experience. It has been widely analyzed from legal, sociological, and clinical perspectives, but not equally so from the bioethical point of view. This article sets out to take a more in-depth look at the experiences of midwives in order to describe the ethical perspectives of obstetric violence. We intend to describe the effects that malpractice and violence within obstetric care have on American and European bioethical principles. METHODOLOGY: A qualitative methodology of the phenomenological tradition was used: 24 midwives participated in three focus groups. RESULTS AND DISCUSSION: four categories were arrived at; they are "the maleficence of forgetting my vulnerability", "beneficence requires respect for my integrity and dignity", "my autonomy is being removed from me" and "a problem of social justice towards us, women". CONCLUSION: obstetric violence infringes on the main bioethical principles (non-maleficence, beneficence, autonomy, justice, vulnerability, dignity, and integrity). Beyond whether it is called violence or not, what matters from an ethical perspective is that, as long as women have such negative experiences during pregnancy and childbirth, obstetric care needs better humanizing.

"Same same but different"? On the questionable but crucial differentiation between ethical and social aspects in health technology assessment.

INTRODUCTION: In health technology assessment (HTA), the demarcation of ethical and social aspects in two separate domains is a given fact. While an overlapping of ethical and social aspects is possible, this also raises theoretical and methodological questions, such as why overlaps happen (on the basis of which understanding of ethical and social aspects), or whether they are legitimate from a methodological point of view. METHODS: We analyzed, on a basis of purposive sampling, a) two well-known HTA frameworks (HTA Core Model, INTEGRATE-HTA), b) methodological literature about ethical and/or social aspects in HTA, and c) published HTA reports from the German DAHTA database and the international CRD database regarding statements on the understanding (definition/characterization) and relationship between ethical and social aspects. RESULTS: The frameworks use identical definitions for ethical aspects but deviate when it comes to social aspects. Methodological papers do not always provide a definition of social and ethical aspects. In the context of ethical aspects, they often refer back to ethics as a base discipline that deals with the motives and consequences of good and bad actions for ethical aspects, while for social aspects, there is orientation towards already existing checklists and methods, without reference to a base discipline such as sociology. The analyzed HTA reports barely offered details on their understanding of ethical or social aspects (7% of n = 33). DISCUSSION: The problem of defining/characterizing and differentiating ethical and social aspects exists in both theory and practice. The impression is that little attention is paid to demarcations and overlaps, and that also the methodological literature has not yet thoroughly addressed the issue. While there are also pragmatic reasons for the possible ambiguity between the ethical and the social domains, deeper epistemological issues related to the multi-/interdisciplinarity nature of HTA will have to be considered, too, such as the danger of "disciplinary capture" (pressure on some domains and their basic disciplines, e.g., ethics, to adopt the concepts and standards of other domains that are more dominant in HTA, e.g., efficacy assessment/evidenced-based medicine). CONCLUSION: The domains in HTA reports should be better described epistemologically and brought into a coherent relationship with each other. This is important to avoid unreasonable overlapping and possible problematic redundancy. Further, this could help with questions of adequate expertise and methods for the processing of all relevant information for solid technology assessment.

Ethical aspects in dementia care - The use of psychosocial interventions.

The use of psychosocial interventions for people with dementia is common and recommended because they focus on the underlying problem and well-being of the person. The promotion of well-being is a relevant dimension in person-centred care, where the aim is to confirm the person's 'personhood'. Most literature about ethics in dementia care instructs us on how and when to include people with dementia in our research. Little is written about the ethical aspects regarding the use of psychosocial interventions in daily care. In clinical practise, several challenges arise about the use of psychosocial interventions. Those include questions about the person's ability to participate in decision-making and how we know what is best for them. Furthermore, we must consider what kinds of psychosocial interventions are best for everybody, or if intervention causes discomfort for the person. This article emphasizes the necessity to consider the ethical aspects of the implementation of psychosocial interventions while taking into consideration the persons individual needs. A particular ethical challenge arises when a person with dementia is unable to express themselves verbally. Therefore, it is essential that the staff know the history and preferences of each person with dementia. The ethical aspects of psychosocial interventions for people with dementia will be discussed using Beauchamp and Childress four ethical principles: respect for autonomy, beneficence, non-maleficence and justice. The person-centred approach proposed by Kitwood's and Brooker.