Biobanks: Let’s Regulate At Least One Banking Industry

Jake Meyer by Jake Meyer

Large repositories of biological samples (biobanks) are being collected for medical and scientific research.  Some biobanks are publicly funded, like the UK Biobank, a government plan to create a database of DNA samples of 500,000 volunteers aged 40-69 in order to improve prevention, diagnosis, and treatment of life-threatening illnesses.  Some biobanks are held by private companies, like Genizon Biosciences which contains samples from 47,000 patients who are direct descendants of the original French founders of Quebec (a relatively homogenous population useful for genetics research).  Other biobanks are public-private partnerships, such as the biobank operated by deCODE Genetics, in which the government of Iceland granted deCODE an exclusive license to Iceland's genealogical and medical records.

Scientists think that significant advances in medicine science might be achieved through the study of normal genomic variations across whole populations.  These studies must analyze the whole genome, in contrast to using traditional methods to analyze a single gene.  In order to perform studies of normal genomic variations, large-scale collections of samples are required.  One way to get the large number of samples required for this type of research on the whole human genome is through international collaboration and networking among biobanks.  Commentators Barth Maria Knoppers, Ma'n H. Abdul-Rahman, and Karine Bédard, have suggested that achieving international collaboration and networking among biobanks will require the establishment of international frameworks, standards, and norms

Currently, biobanking is governed by an assortment of international instruments (guidelines, declarations, and treaties) and national legislation.  Taken together, these international instruments and national laws are an incomplete framework.  Most international instruments are not legally binding (except for countries which have ratified treaties like the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine adopted by the Council of Europe in 1997) and there is no legally binding international instrument that applies specifically to biobanks.  These international instruments use varying definitions and contain policies that while they agree in some areas, are not uniform.  Some countries, like Iceland and Estonia, have enacted national legislation to specific biobanks.  However, national legislation is only enforceable within that country, limiting its ability to encourage collaboration among biobanks through global standards.  Further, national legislation governing biobanks is not uniform.

National legislation offers a "variety of positions–or no position at all–on issues such as data protection, access to and release of database materials, and possible commercialization" and does not cover issues involved with the networking of biobanks.  Biobanks governed by national legislation may disagree on provisions making collaboration and networking impossible.  In order to ensure networking and collaboration among biobanks, a comprehensive and effective international regulatory framework should be put in place to.  This would help provide researchers access to an unprecedented number of samples which would make study of rare genetic diseases and the study of normal genomic variations across whole populations possible.  Such a framework could help lead to new medical and scientific knowledge while also protecting research participants.

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