Purpose We examine the levels of post-trial responsibility ascribed to different stakeholders, following a community-based clinical trial and how the ‘responsibility’ is understood. Methods We employed photovoice, unstructured observations and key informant interviews to gain insights into contexts of access to care following transition to the public health system post trial. We used an inductive narrative analysis to explore experiences and understandings of post-trial access. Results In their photovoice stories, many participants expressed a sense of abandonment after the trial. This (...) was viewed as a contributing factor to failing to re-engage with care available in the public health system. This led to the experiences of loss as some trial participants defaulted and died. Research investigators, department of health participants and sponsor agreed that PTA was especially important for communities in resource-limited settings. The government has an obligation towards its citizens while researchers have a responsibility to ensure a smooth transition of patients to public clinics. Sponsors have a responsibility to ensure that the trial is conducted in accordance with the protocol and post-trial agreements are in place and adhered to. Research partnerships among stakeholders were affected by power imbalances making it difficult to negotiate and plan for post-trial care responsibilities. Conclusions The research community still struggles with understanding the scope of PTA responsibilities. Power dynamics between public health actors and research sponsors need to be managed to ensure that government involvement is not tokenistic. The responsibility of trial participants and ethics committees needs to be investigated further. Data are available upon request. (shrink)

In research involving patients with implantable brain–computer interfaces (BCIs), there is a regulatory gap concerning post-trial responsibilities and duties of sponsors and investigators towards implanted patients. In this article, we analyse the case of patient R, who underwent non-voluntary explantation of an implanted BCI, causing a discontinuation in her sense of agency and self. To clarify the post-trial duties and responsibilities involved in this case, we first define the ontological status of the BCI using both externalist (EXT) and internalist (INT) (...) theories of cognition. We then give particular focus to the theories of extended and embedded cognition, hence considering the BCI either as a constitutive component of the patient’s mind or as a causal supporter of her brain-based cognitive capacities. We argue that patient R can legitimately be considered both as an embedded and extended cognitive agent. Then, we analyse whether the non-voluntary explantation violated patient R’s (neuro)rights to cognitive liberty, mental integrity, psychological continuity and mental privacy. We analyse whether and how different mental ontologies may imply morally relevant differences in interpreting these prima facie neurorights violations and the correlational duties of sponsors and investigators. We conclude that both mental ontologies support the identification of emerging neurorights of the patient and give rise to post-trial obligations of sponsors and investigators to provide for continuous technical maintenance of implanted BCIs that play a significant role in patients’ agency and sense of self. However, we suggest that externalist mental ontologies better capture patient R’s self-conception and support the identification of a more granular form of mental harm and associated neurorights violation, thus eliciting stricter post-trial obligations. (shrink)

BackgroundThe global COVID-19 pandemic confronts people with their fragility, vulnerability, and mortality. To date, scales to measure death awareness mainly focus on the anxiety-provoking aspect of mortality cues. This study aims to cross-culturally adapt and validate the Death Reflection Scale, a scale for measuring positive, growth-oriented cognitions of life reflection and prosocial behavior following confrontation with the finiteness of life.Materials and MethodsThe Death Reflection Scale was translated and adapted in a multi-step process to the German language. In this anonymous, cross-sectional, (...) online survey at a large university in Germany, students, healthcare professionals and other staff completed the DRS alongside comparison measures. Multi-group confirmatory factor analysis was used to assess configural, metric, and scalar measurement equivalence across four age and occupational groups. Convergent/divergent validity testing was done via Spearman correlations.Results1,703 participants provided data for a response rate of ∼5%. 24% of respondents were HCP, 22% students. Confirmatory factor analysis showed a higher-order structure of the DRS with a strong general factor and the originally proposed five subscales. Multi-group CFA showed partial metric equivalence across age groups and partial scalar invariance across occupational groups. Non-invariant scales were the Motivation to live, Putting life into perspective, and Legacy subscales. In the convergent validity testing, two hypotheses were fully confirmed, two partially and four were not confirmed. Experiencing a propensity for increased contemplation and life reflection during the pandemic together with spirituality showed correlations of moderate to large size to the DRS and its subscales.ConclusionFurther conceptual work for death awareness to explore the construct’s stability in different population groups needs to be undertaken. However, the DRS can be mostly used to assess positive and growth-oriented aspects of death awareness and death reflection which may be an important avenue when developing counseling and support interventions for groups experiencing a high burden during the pandemic. (shrink)

BackgroundWith the increased use of implanted medical devices follows a large number of explantations. Implants are removed for a wide range of reasons, including manufacturing defects, recovery making the device unnecessary, battery depletion, availability of new and better models, and patients asking for a removal. Explantation gives rise to a wide range of ethical issues, but the discussion of these problems is scattered over many clinical disciplines.MethodsInformation from multiple clinical disciplines was synthesized and analysed in order to provide a comprehensive (...) approach to the ethical issues involved in the explantation of medical implants.ResultsDiscussions and recommendations are offered on pre-implantation information about a possible future explantation, risk–benefit assessments of explantation, elective explantations demanded by the patient, explantation of implants inserted for a clinical trial, patient registers, quality assurance, routines for investigating explanted implants, and demands on manufacturers to prioritize increased service time in battery-driven implants and to market fewer but more thoroughly tested models of implants.ConclusionSpecial emphasis is given to the issue of control or ownership over implants, which underlies many of the ethical problems concerning explantation. It is proposed that just like transplants, implants that fulfil functions normally carried out by biological organs should be counted as supplemented body parts. This means that the patient has a strong and inalienable right to the implant, but upon explantation it loses that status. (shrink)