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

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Ensemble Space and the Ethics of Clinical Developmentte of delivery. Typically, these conditions are discovered over the course of early phase clinical testing. In what follows, we describe a conceptual tool—“ensemble space”—for understanding scientific decision-making in the early phases of clinical development. Briefly, we liken each condition to a

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Big Biobanks: Three Major Governance Challenges and Some Mini-constitutional Responsesity) is relatively new, and it is taking place at a time when the possibility of undertaking quite detailed genotyping and sequencing is assuming much greater prominence. Although there is much to debate concerning such biobanks, there is broad agreement that their good governance and legitimacy hin

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Ethical Dimensions of Dynamic Consent in Data-Intense Biomedical Research—Paradigm Shift, or Red Herthe limitations of traditional informed consent standards, which have been widely perceived as inadequate in large-scale biomedical studies. It uses the approach of a “dynamic consent” as an example, initially in particular in biobanks and genomics, in which participant and patient choices are to be

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Using Patent Law to Enforce Ethical Standards: Proposal of a New Patent Requirement to our translational efforts, they are also highly expensive. To save costs, they are often relocated into developing countries where the protection of study participants is minimal. Such relocation is not necessarily amoral, as those in charge might nevertheless adhere to high ethical standards. H

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Introduction,lenges. It is therefore no surprise that the same stakeholders and guidelines that highlight the need for biomedical research also stress the need to protect research participants and enhance the ethical and scientific quality of research by means of a set of governance tools.

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Should Research Ethics Encourage the Production of Cost-Effective Interventions?ffectiveness in research, including the difficulty of predicting effectiveness and cost at the research stage, concerns about limitations in cost-effectiveness analysis, and worries about overly limiting researchers’ freedom. I then consider the advantages and disadvantages of having certain partici

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