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  1. Investigation of post-trial access views among study participants and stakeholders using photovoice and semistructured interviews.Nothando Ngwenya, Collins Iwuji, Nabeel Petersen, Nompilo Myeni, Samukelisiwe Nxumalo, Ursula Ngema & Janet Seeley - 2022 - Journal of Medical Ethics 48 (10):712-717.
    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 (...)
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  • Cross-cultural validity of the Death Reflection Scale during the COVID-19 pandemic.Christina Ramsenthaler, Klaus Baumann, Arndt Büssing & Gerhild Becker - 2022 - Frontiers in Psychology 13.
    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, (...)
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  • The ethics of explantation.Sven Ove Hansson - 2021 - BMC Medical Ethics 22 (1):1-9.
    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 (...)
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  • Non-voluntary BCI explantation: assessing possible neurorights violations in light of contrasting mental ontologies.Guido Cassinadri & Marcello Ienca - forthcoming - Journal of Medical Ethics.
    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) (...)
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  • Human dignity as a basis for providing post-trial access to healthcare for research participants: a South African perspective.Pamela Andanda & Jane Wathuta - 2018 - Medicine, Health Care and Philosophy 21 (1):139-155.
    This paper discusses the need to focus on the dignity of human participants as a legal and ethical basis for providing post-trial access to healthcare. Debate about post-trial benefits has mostly focused on access to products or interventions proven to be effective in clinical trials. However, such access may be modelled on a broad fair benefits framework that emphasises both collateral benefits and interventional products of research, instead of prescribed post-trial access alone. The wording of the current version of the (...)
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