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  1. Body matters: rethinking the ethical acceptability of non-beneficial clinical research with children.Eva De Clercq, Domnita Oana Badarau, Katharina M. Ruhe & Tenzin Wangmo - 2015 - Medicine, Health Care and Philosophy 18 (3):421-431.
    The involvement of children in non-beneficial clinical research is extremely important for improving pediatric care, but its ethical acceptability is still disputed. Therefore, various pro-research justifications have been proposed throughout the years. The present essay aims at contributing to the on-going discussion surrounding children’s participation in non-beneficial clinical research. Building on Wendler’s ‘contribution to a valuable project’ justification, but going beyond a risk/benefit analysis, it articulates a pro-research argument which appeals to a phenomenological view on the body and vulnerability. It (...)
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  • The legal justification for donor optimisation procedures.Sarah-Jane Brown - 2016 - Clinical Ethics 11 (4):122-129.
    Current organ procurement policies in the UK include ante-mortem interventions to facilitate organ donation. However, a clear and unambiguous legal framework for these procedures does not currently exist. The Human Tissue Act 2004 does not provide authority for donor optimisation procedures before death, and there are a number of difficulties in encompassing these procedures within the Mental Capacity Act 2005 provisions on best interests. This article proposes a system of specific advance consent to enable best interests to take on its (...)
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  • The Best Interest Standard and the Child’s Right to an Open Future.Aliya O. Affdal & Vardit Ravitsky - 2018 - American Journal of Bioethics 18 (8):74-76.
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  • Neither the Harm Principle nor the Best Interest Standard Should Be Applied to Pediatric Research.Marcin Waligora, Karolina Strzebonska & Mateusz T. Wasylewski - 2018 - American Journal of Bioethics 18 (8):72-74.
    Application of either the harm principle or the best interest standard to medical decision making conflicts with some types of pediatric research that pose elevated risk without the reasonable prob...
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  • Child’s objection to non-beneficial research: capacity and distress based models.Marcin Waligora, Joanna Różyńska & Jan Piasecki - 2016 - Medicine, Health Care and Philosophy 19 (1):65-70.
    A child’s objection, refusal and dissent regarding participation in non-beneficial biomedical research must be respected, even when the parents or legal representatives have given their permission. There is, however, no consensus on the definition and criteria of a meaningful and valid child’s objection. The aim of this article is to clarify this issue. In the first part we describe the problems of a child’s assent in research. In the second part we distinguish and analyze two models of a child’s objection (...)
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  • The Principle of the Primacy of the Human Subject and Minimal Risk in Non-Beneficial Paediatric Research.Joanna Różyńska - 2022 - Journal of Bioethical Inquiry 19 (2):273-286.
    Non-beneficial paediatric research is vital to improving paediatric healthcare. Nevertheless, it is also ethically controversial. By definition, subjects of such studies are unable to give consent and they are exposed to risks only for the benefit of others, without obtaining any clinical benefits which could compensate those risks. This raises ethical concern that children participating in non-beneficial research are treated instrumentally; that they are reduced to mere instruments for the benefit of science and society. But this would make the research (...)
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  • Taking the principle of the primacy of the human being seriously.Joanna Różyńska - 2021 - Medicine, Health Care and Philosophy 24 (4):547-562.
    This paper targets an orphan topic in research ethics, namely the so called principle of the primacy of the human being, which states that the interests of the human subject should always take precedence over the interests of science and society. Although the principle occupies the central position in the majority of international ethical and legal standards for biomedical research, it has been commented in the literature mainly in passing. With a few notable exceptions, there is little in-depth discussion about (...)
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  • Data Access Committees.Jan Piasecki & Phaik Yeong Cheah - 2020 - BMC Medical Ethics 21 (1):1-8.
    BackgroundSharing de-identified individual-level health research data is widely promoted and has many potential benefits. However there are also some potential harms, such as misuse of data and breach of participant confidentiality. One way to promote the benefits of sharing while ameliorating its potential harms is through the adoption of a managed access approach where data requests are channeled through a Data Access Committee (DAC), rather than making data openly available without restrictions. A DAC, whether a formal or informal group of (...)
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