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A Trade Secret Model for Genomic Biobanking

Published online by Cambridge University Press:  01 January 2021

John M. Conley ,
Robert Mitchell ,
R. Jean Cadigan ,
Arlene M. Davis ,
Allison W. Dobson  and
Ryan Q. Gladden
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Extract

The current ethical norms of genomic biobankingcreating and maintaining large repositories of human DNA and/or associated data for biomedical researchhave generated criticism from every angle, at both the practical and theoretical levels. The traditional research model has involved investigators seeking biospecimens for specific purposes that they can describe and disclose to prospective subjects, from whom they can then seek informed consent. In the case of many biobanks, however, the institution that collects and maintains the biospecimens may not itself be directly involved in research, instead banking the biospecimens and associated data for other researchers. Moreover, the future uses of biospecimens may be unknown, if not unknowable, at the time of collection. Biobanking may thus stretch the meanings of inform and consent to their breaking point: if you cannot inform subjects about what their biospecimens will be used for (because you do not know), what can they consent to? Given that informed consent by individual subjects is the ethical gold standard, the seeming dilution of the concept in the context of biobanking is a profound problem.

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Independent
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Journal of Law, Medicine & Ethics , Volume 40 , Issue 3 , Fall 2012 , pp. 612 - 629
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Copyright © American Society of Law, Medicine and Ethics 2012

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