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BackgroundThe neurotechnology behind brain-computer interfaces (BCIs) raises various ethical questions. The ethical literature has pinpointed several issues concerning safety, autonomy, responsibility and accountability, psychosocial identity, consent, privacy and data security. This study aims to assess BCI users’ experiences, self-observations and attitudes in their own right and looks for social and ethical implications.MethodsWe conducted nine semi-structured interviews with BCI users, who used the technology for medical reasons. The transcribed interviews were analyzed according to the Grounded Theory coding method.ResultsBCI users perceive themselves (...) as active operators of a technology that offers them social participation and impacts their self-definition. Each of these aspects bears its own opportunities and risks. BCIs can contribute to retaining or regaining human capabilities. At the same time, BCI use contains elements that challenge common experiences, for example when the technology is in conflict with the affective side of BCI users. The potential benefits of BCIs are regarded as outweighing the risks in that BCI use is considered to promote valuable qualities and capabilities. BCI users appreciate the opportunity to regain lost capabilities as well as to gain new ones.ConclusionsBCI users appreciate the technology for various reasons. The technology is highly appreciated in cases where it is beneficial in terms of agency, participation and self-definitions. Rather than questioning human nature, the technology can retain and restore characteristics and abilities which enrich our lives. (shrink)

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After achieving sustained graft functioning in animal studies, the next step in the progression of xenotransplantation towards clinical application is the initiation of the first clinical trials. This raises the question according to which criteria patients shall be selected for these trials. While the discussion regarding medical criteria has already commenced, ethical considerations must also be taken into account. This is essential, first, to establish a procedure that is ethically reasonable and justified. Second, it is a prerequisite for a publicly (...) acceptable and comprehensible implementation. This paper outlines a multicriteria approach for the selection of patients in first-in-human clinical trials of cardiac xenotransplantation with four ethical criteria: medical need, capacity to benefit, patient choice and compliance (as an exclusion criterion). Consequently, these criteria identify a primary target group of patients who exhibit a high medical need for cardiac xenotransplantation, face a high risk of morbidity and mortality without an organ replcaement therapy, have a substantial chance of benefiting from xenotransplantation, thereby also enhancing the scientific value of the trial, and qualify for an allotransplant to have a real choice between participating in a first-in-human xenotransplantation trial and waiting for a human organ. A secondary group would include patients for whom only the first two criteria are met, that is, who have a high medical need and a good capacity to benefit from xenotransplantation but who have a restricted choice because they do not qualify for an allotransplant. (shrink)

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The rapid expansion of research on Brain-Computer Interfaces is not only due to the promising solutions offered for persons with physical impairments. There is also a heightened need for understanding BCIs due to the challenges regarding ethics presented by new technology, especially in its impact on the relationship between man and machine. Here we endeavor to present a scoping review of current studies in the field to gain insight into the complexity of BCI use. By examining studies related to BCIs (...) that employ social research methods, we seek to demonstrate the multitude of approaches and concerns from various angles in considering the social and human impact of BCI technology. For this scoping review of research on BCIs’ social and ethical implications, we systematically analyzed six databases, encompassing the fields of medicine, psychology, and the social sciences, in order to identify empirical studies on BCIs. The search yielded 73 publications that employ quantitative, qualitative, or mixed methods. Of the 73 publications, 71 studies address the user perspective. Some studies extend to consideration of other BCI stakeholders such as medical technology experts, caregivers, or health care professionals. The majority of the studies employ quantitative methods. Recurring themes across the studies examined were general user opinion towards BCI, central technical or social issues reported, requests/demands made by users of the technology, the potential/future of BCIs, and ethical aspects of BCIs. Our findings indicate that while technical aspects of BCIs such as usability or feasibility are being studied extensively, comparatively little in-depth research has been done on the self-image and self-experience of the BCI user. In general there is also a lack of focus or examination of the caregiver’s perspective. (shrink)

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Brain-computer interfaces are envisioned to enable new abilities of action. This potential can be fruitful in particular when it comes to restoring lost motion or communication abilities or to implementing new possibilities of action. However, BCIs do not come without presuppositions. Applying the concept of ability expectations to BCIs, a wide range of requirements on the side of the users becomes apparent. We examined these ability expectations by taking the example of therapeutic BCI users who got enrolled into BCI research (...) studies due to particular physical conditions. Some of the expectations identified are quite explicit, like particular physical conditions and BCI “literacy”. Other expectations are more implicit, such as motivation, a high level of concentration, pain tolerance, emotion control and resources. These expectations may produce a conception of the human and a self-understanding among BCI users that objectify the body in favour of a brain-centred, cerebral notion of the subject which also plays its part in upholding a normality regime. (shrink)

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We are grateful for the thoughtful commentaries to our article on patient selection for first clinical trials of cardiac xenotransplantation1 because they give us the opportunity to clarify and further sharpen our arguments in this response. In our article, we proposed a multicriteria approach to selecting patients for first clinical trials of (cardiac) xenotransplantation, encompassing the four criteria medical need, capacity to benefit, patient choice and compliance (used as an exclusion criterion). We also argued that clinical trials following clearly defined (...) study protocols should be favoured over further single compassionate use cases to gather reliable and valid knowledge about the benefits and risks of xenotransplantation. Continuous poor outcomes in compassionate use cases can impede a technology’s development. For example, early heart transplants led to moratoria in several countries due to public and professional backlash. This historical concern is also echoed within the xenotransplantation research community and should be considered when arguing, as Aparicio et al do in their comment, for continuing the expanded access pathway to further establish clinical xenotransplantation.2 We agree with Aparicio et al that patients in general should have access to innovative treatment strategies via expanded access. In cardiac xenotransplantation, however, only a small number of patients can currently be offered a xenotransplant because of limited treatment capacities with …. (shrink)

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BackgroundThe transplantation of porcine islet cells provides a new potential therapy to treat patients with type 1 diabetes mellitus (T1DM). Compared to other biomedical technologies, xenotransplantation stands out in terms of its involvement of animals as graft sources, as well as the possible transmission of infectious diseases. As these aspects are especially relevant for potential xenotransplantation recipients, it is important to assess their opinion regarding this technology, in particular in terms of the requirements that should be met in the informed (...) consent process for xenotransplantation.MethodsWe conducted qualitative interviews with seven T1DM patients to assess their information needs prior to xenotransplantation. Before the interview, the participants received a model informed consent form for a clinical trial with porcine islet cells transplantation. The interviews were transcribed and analysed using qualitative content analysis.ResultsIn the interviews, we identified several requirements that are crucial for patients with T1DM in order to consider xenotransplantation as a potential treatment option: therapy-related requirements, professional care and supervision, successful behaviour and attitude management, improving quality of life, and managing control/self-determination challenges. Regarding the informed consent form, several of the participants’ questions remained open and should be addressed in more detail. The interviewees stressed the importance of personal consultations.ConclusionsTo become a sustainable therapeutic option, patients especially expected an improved diabetes control and a reduction of diabetes-related burdens. Health-related aspects prove to be pivotal for diabetic patients when considering porcine islet cell transplantation. The use of pigs as source for organ retrievals was not considered as problematic. (shrink)

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