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Edited by Jelena Madir

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Edited by Jelena Madir

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Edited by Jelena Madir

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Edited by Jelena Madir

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Edited by Jelena Madir

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Edited by Thierry Vansweevelt and Nicola Glover-Thomas

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Informed Consent and Health

A Global Analysis

Edited by Thierry Vansweevelt and Nicola Glover-Thomas

Informed consent is the legal instrument that purports to protect an individual’s autonomy and defends against medical arbitrariness. This illuminating book investigates our evolving understanding of informed consent from a range of comparative and international perspectives, demonstrating the diversity of its interpretations around the world. Chapters offer a nuanced analysis of the problems that impede the understanding and implementation of the concept of informed consent and explore the contemporary challenges that continue to hinder both the patient and the medical community.
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Global Genes, Local Concerns

Legal, Ethical, and Scientific Challenges in International Biobanking

Edited by Timo Minssen, Janne R Herrmann and Jens Schovsbo

With interdisciplinary chapters written by lawyers, sociologists, doctors and biobank practitioners, Global Genes, Local Concerns identifies and discusses the most pressing issues in contemporary biobanking. Addressing pressing questions such as how do national biobanks best contribute to translational research and how could academic and industrial exploitation, ownership and IPR issues be addressed and facilitated, this book contributes to the continued development of international biobanking by highlighting and analysing the complexities in this important area of research.
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Edited by Timo Minssen, Janne R Herrmann and Jens Schovsbo

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Brian J. Clark and Tina Bossow

In the context of this chapter, “bioscience industries” refers to companies involved in research, development and manufacturing of products that improve diagnosis, treatment, or prevention of human diseases, or the provision of enabling technologies or services in support of the same aims. This diverse grouping includes the pharmaceutical, diagnostics, biotechnology, and research and development services industries. Many companies within the bioscience industries use biological samples derived from humans (“human biosamples”) in their research, development, or manufacturing processes and some finished products may contain human biosample components. While the for-profit business model of commercial companies sometimes leads to mistrust and questions over their legitimacy as users of human biosamples (HBS), such companies are and will remain essential for the discovery, development, and delivery of innovations in healthcare that are of benefit for populations. Therefore, the legitimacy of the bioscience industries as valid users of HBS for purposes intended to deliver public benefit should not be in doubt. Instead, the pivotal question should be whether the bioscience industries can demonstrate that they use HBS in ways that are socially responsible, ethical, compliant with applicable laws or regulations, and safe, such that they merit access to precious HBS. In fact, this same question should equally apply to any user of HBS, whether a for-profit industrial user or a not-for profit or public institutional user. All users should be able to demonstrate that they are legitimate and responsible users of HBS.