Affectivity and Identity in the Treatment of mood Disorders

It is not uncommon to hear patients who suffer from depression complain that they are not themselves. Given that their lives during a depressive episode may be profoundly changed, it is often easy to agree. But what does it mean to agree here? "Not being themselves� in this context refers to qualitative changes that have occurred in their way of being, including changes in personality and self-understanding. I will use the term "self� to refer to periods of a distinguishable personality pattern in a person"s life, without further discussion of their metaphysical status or the criteria for a distinction between different selves

Ethical review and children’s research in Ireland.

A substantial increase in research into the lives of children has been experienced over the last 20 years in many countries, including Ireland. This increase is not only in the amount of research undertaken, but also in the multidisciplinary range of such research. Research with children involves working with potentially vulnerable participants, who not only require specific protection but also have the capacity for independent agency that necessitates respect from researchers. With the increase in research, there has been a related increase in awareness by the research community of the need to ensure that all research with children is carried out to the highest ethical standards. Until recently, ethical review of research was left to the discretion of the researchers, who were generally considered sufficiently trustworthy to safeguard their participants’ rights and well-being by virtue of their education and professional standing. Over the last two decades, however, it has become more common to convene Research Ethics Committees to review research proposals with the goal of ensuring that ethical requirements are fulfilled and to provide ethical oversight to researchers. This has resulted in an increase in the number of Research Ethics Committees operating worldwide, including in Ireland. In relation to children’s research, ethical review attempts to ensure that research projects have provisions in place that will enable researchers to do justice to the duties of both protection and respect of child participants. However, a variety of problematic issues have been highlighted. Research with children into the ethics of children’s research has identified tensions between balancing risk and benefit, on the one hand, and autonomy, competence and parental authority, on the other. The reliability and validity of review by Research Ethics Committee has also been brought into question: not only are requirements vastly different between countries (Hearnshaw, 2004), but there is ample evidence to show that decision-making by different Research Ethics Committees In the same country can differ significantly (Garfield, 1995), even when they are governed by the same authority (Angell et al, 2006). In order to counter this variability, it has been argued that increased regulation needs to be put in place and this has happened in some countries

Genuine participation in participant-centred research initiatives : the rhetoric and the potential reality

The introduction of Web 2.0 technology, along with a population increasingly proficient in Information and Communications Technology (ICT), coupled with the rapid advancements in genetic testing methods, has seen an increase in the presence of participant-centred research initiatives. Such initiatives, aided by the centrality of ICT interconnections, and the ethos they propound seem to further embody the ideal of increasing the participatory nature of research, beyond what might be possible in non-ICT contexts alone. However, the majority of such research seems to actualise a much narrower definition of ‘participation’—where it is merely the case that such research initiatives have increased contact with participants through ICT but are otherwise non-participatory in any important normative sense. Furthermore, the rhetoric of participant-centred initiatives tends to inflate this minimalist form of participation into something that it is not, i.e. something genuinely participatory, with greater connections with both the ICT-facilitated political contexts and the largely non-ICT participatory initiatives that have expanded in contemporary health and research contexts. In this paper, we highlight that genuine (ICT-based) ‘participation’ should enable a reasonable minimum threshold of participatory engagement through, at least, three central participatory elements: educative, sense of being involved and degree of control. While we agree with criticisms that, at present, genuine participation seems more rhetoric than reality, we believe that there is clear potential for a greater ICT-facilitated participatory engagement on all three participatory elements. We outline some practical steps such initiatives could take to further develop these elements and thereby their level of ICT-facilitated participatory engagement.Peer reviewe

Resource allocation and rationing in nursing care: A discussion paper

Driven by interests in workforce planning and patient safety, a growing body of literature has begun to identify the reality and the prevalence of missed nursing care, also specified as care left undone, rationed care or unfinished care. Empirical studies and conceptual considerations have focused on structural issues such as staffing, as well as on outcome issues – missed care/unfinished care. Philosophical and ethical aspects of unfinished care are largely unexplored. Thus, while internationally studies highlight instances of covert rationing/missed care/care left undone – suggesting that nurses, in certain contexts, are actively engaged in rationing care – in terms of the nursing and nursing ethics literature, there appears to be a dearth of explicit decision-making frameworks within which to consider rationing of nursing care. In reality, the assumption of policy makers and health service managers is that nurses will continue to provide full care – despite reducing staffing levels and increased patient turnover, dependency and complexity of care. Often, it would appear that rationing/missed care/nursing care left undone is a direct response to overwhelming demands on the nursing resource in specific contexts. A discussion of resource allocation and rationing in nursing therefore seems timely. The aim of this discussion paper is to consider the ethical dimension of issues of resource allocation and rationing as they relate to nursing care and the distribution of the nursing resource.</p

a potential solution to some of the challenges of modern biomedical research

Background Innovations in technology have contributed to rapid changes in the way that modern biomedical research is carried out. Researchers are increasingly required to endorse adaptive and flexible approaches to accommodate these innovations and comply with ethical, legal and regulatory requirements. This paper explores how Dynamic Consent may provide solutions to address challenges encountered when researchers invite individuals to participate in research and follow them up over time in a continuously changing environment. Methods An interdisciplinary workshop jointly organised by the University of Oxford and the COST Action CHIP ME gathered clinicians, researchers, ethicists, lawyers, research participants and patient representatives to discuss experiences of using Dynamic Consent, and how such use may facilitate the conduct of specific research tasks. The data collected during the workshop were analysed using a content analysis approach. Results Dynamic Consent can provide practical, sustainable and future-proof solutions to challenges related to participant recruitment, the attainment of informed consent, participant retention and consent management, and may bring economic efficiencies. Conclusions Dynamic Consent offers opportunities for ongoing communication between researchers and research participants that can positively impact research. Dynamic Consent supports inter-sector, cross- border approaches and large scale data-sharing. Whilst it is relatively easy to set up and maintain, its implementation will require that researchers re- consider their relationship with research participants and adopt new procedures

Ethical sharing of health data in online platforms – which values should be considered?

Intensified and extensive data production and data storage are characteristics of contemporary western societies. Health data sharing is increasing with the growth of Information and Communication Technology (ICT) platforms devoted to the collection of personal health and genomic data. However, the sensitive and personal nature of health data poses ethical challenges when data is disclosed and shared even if for scientific research purposes. With this in mind, the Science and Values Working Group of the COST Action CHIP ME ‘Citizen's Health through public-private Initiatives: Public health, Market and Ethical perspectives’ (IS 1303) identified six core values they considered to be essential for the ethical sharing of health data using ICT platforms. We believe that using this ethical framework will promote respectful scientific practices in order to maintain individuals’ trust in research. We use these values to analyse five ICT platforms and explore how emerging data sharing platforms are reconfiguring the data sharing experience from a range of perspectives. We discuss which types of values, rights and responsibilities they entail and enshrine within their philosophy or outlook on what it means to share personal health information. Through this discussion we address issues of the design and the development process of personal health data and patient-oriented infrastructures, as well as new forms of technologically-mediated empowerment

An EU comparative analysis of the regulation of clinical trials supervisory bodies in the aftermath of Regulation 536/2014

The new EU regulation on clinical trials is intended to promote a greater level of harmonization of European Union rules in this area. However, it does not elaborate a common normative framework regarding the functioning of research ethics committees, leaving this responsibility to the Member States. This article offers a comparative analysis of the resulting regulatory situation. It demonstrates that this scenario is defined by considerable variability in the regulation of ethics monitoring between the EU Member States. We argue that this disparity should not necessarily be a negative factor for the optimization of the trial supervision regime in the EU. Moreover, we consider that it may be a stimulus for the achievement of excellence in the performance of this monitoring task. On the other hand, we also highlight risks for the rights of participants if an adequate monitoring framework is not ensured. Under these circumstances, we observe how the EU faces a dilemma. On the one hand, it may promote a rigid uniformity between the regulation of ethics committees between Member States, but this might diminish the quality of their performance. On the other hand, it may opt for maintaining the current situation, but this might increase differences in the performance of the ethics committees between Member States, including the number trials performed by country. A third option would be to allow the competitive framework to remain for a set period of time, in order to learn from the best practices reached in individual Member States before finally harmonizing national legislative provisions on this basis.This work was supported by Eusko Jaurlaritza [grant number Ayudas a grupos de investigación IT-1066-16]; H2020 Science with and for Society [grant number GRANT AGREEMENT NUMBER — 788039 — PANELFIT]

Technologies to support community-dwelling persons with dementia: a position paper on issues regarding development, usability, effectiveness and cost-effectiveness, deployment, and ethics

Background: With the expected increase in the numbers of persons with dementia, providing timely, adequate, and affordable care and support is challenging. Assistive and health technologies may be a valuable contribution in dementia care, but new challenges may emerge. Objective: The aim of our study was to review the state of the art of technologies for persons with dementia regarding issues on development, usability, effectiveness and cost-effectiveness, deployment, and ethics in 3 fields of application of technologies: (1) support with managing everyday life, (2) support with participating in pleasurable and meaningful activities, and (3) support with dementia health and social care provision. The study also aimed to identify gaps in the evidence and challenges for future research. Methods: Reviews of literature and expert opinions were used in our study. Literature searches were conducted on usability, effectiveness and cost-effectiveness, and ethics using PubMed, Embase, CINAHL, and PsycINFO databases with no time limit. Selection criteria in our selected technology fields were reviews in English for community-dwelling persons with dementia. Regarding deployment issues, searches were done in Health Technology Assessment databases Results: According to our results, persons with dementia want to be included in the development of technologies; there is little research on the usability of assistive technologies; various benefits are reported but are mainly based on low-quality studies; barriers to deployment of technologies in dementia care were identified, and ethical issues were raised by researchers but often not studied. Many challenges remain such as including the target group more often in development, performing more high-quality studies on usability and effectiveness and cost-effectiveness, creating and having access to high-quality datasets on existing technologies to enable adequate deployment of technologies in dementia care, and ensuring that ethical issues are considered an important topic for researchers to include in their evaluation of assistive technologies. Conclusions: Based on these findings, various actions are recommended for development, usability, effectiveness and cost-effectiveness, deployment, and ethics of assistive and health technologies across Europe. These include avoiding replication of technology development that is unhelpful or ineffective and focusing on how technologies succeed in addressing individual needs of persons with dementia. Furthermore, it is suggested to include these recommendations in national and international calls for funding and assistive technology research programs. Finally, practitioners, policy makers, care insurers, and care providers should work together with technology enterprises and researchers to prepare strategies for the implementation of assistive technologies in different care settings. This may help future generations of persons with dementia to utilize available and affordable technologies and, ultimately, to benefit from them