The Business of Biobanks: Ethical, Legal, and Practical Challenges in Commercial Biotechnology

James T. Reynolds
University of Warsaw, Poland

DOI:https://doi.org/10.5912/jcb2491

Abstract:

Biobanks provide critical repositories of biological samples that are used fueling the advancement of biotechnology, personalized medicine and drug development. On the one hand, they are increasingly commercialized, which poses ethical, legal and practical issues that have to be tackled to make their use responsible and fair for all. Donor consent, privacy and data security are ethical concerns, and intellectual property rights, regulatory compliance and data sharing across borders are issues for the law. Ultimately, given the practical pressures of sustainability, quality control and equitable access to resources, biobanks need to delineate the extent of their own particular dilemmas, particularly in the manner in which they are to be administered. Additionally, biobanks are commercialized and this can be problematic because of lack of transparency as to how money generated by research institutions is to be shared with private enterprises. These challenges are explored in this paper, with an emphasis on the importance of robust governance frameworks, ethical oversight, and clear legal policies on innovation – especially innovation relative to ethical responsibility. To continue to serve as a conduit of information about human drug trials and biological samples, as well as to maintain its potential as a source for the commercial development of biotechnology, biobanks will have to keep public trust and responsible management.