Titlebook: Ethics and Governance of Biomedical Research; Theory and Practice Daniel Strech,Marcel Mertz Book 2016 Springer International Publishing Sw

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What Does the Child’s Assent to Research Participation Mean to Parents? Empirical Findings in Paediance to give assent and who should be in charge of it. Our empirical findings indicate that parents want to give children a voice in the decision-making regarding research participation. Even though the child’s competence to rationally understand the research protocol is primarily discussed in the li

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Ethical Principles in Phase IV Studies) The weighing of risks and benefits is a shared responsibility between research ethics committees and sponsors/investigators. (F) In balancing risks and benefits, assuming a therapeutic orientation and applying expected utility theory, the following constraints are in order: the benefit utility tab

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Do Editorial Policies Support Ethical Research? A Thematic Text Analysis of Author Instructions in P performed similarly in this regard. Only every second psychiatry journal adheres to the ICMJE’s recommendation to inform authors about requirements for informed consent and ethics review. Furthermore, we argue that even the ICMJE’s recommendations in this regard are insufficient, at least for ethic

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Ensemble Space and the Ethics of Clinical Developmentand ethical debates in clinical development, such as how aggressively to design early phase studies, when to initiate randomized trials, and reporting requirements for early phase studies. We close by discussing some limitations of the concept of ensemble space.

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Towards an Alternative Account for Defining Acceptable Risk in Non-beneficial Paediatric Researchdren in a vaccination programme in the case of an infectious disease, which does not constitute a significant threat to them, can facilitate the definition of this threshold. Although the proposed account shares some of its strong points with those already existing, it does not lead to inconsistenci

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Big Biobanks: Three Major Governance Challenges and Some Mini-constitutional Responsesarch purposes and projects to be pursued are not specified in advance. Secondly, there is the hot topic of the moment, namely whether biobanks have any responsibility to return individual clinically-significant findings to participants who, because of the longitudinal nature of such research, remain

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