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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.