Legal Scholars Write Draft Bill for Biobank Legislation

April 23, 2015 by - Biobanking software, Lab management system, Lab sample tracking

Biobank software

For many doctors, patients and lawmakers across the United States, there is no doubt that biobanking is a necessary component of translational research and modern medicine. However, in recent months, this popular method of collecting biological information has repeatedly drawn fire: for example, at least one survey that potential donors grew more reluctant to consent when they considered different uses for the samples, while a movement in California has taken aim at a popular practice that gathers genetic information from newborns. Now, legal scholars at Loyola Marymount University (LMU) and Augsburg University are calling for biobanks to be legally regulated, even producing a draft bill that outlines a potential framework for biorepository management. But in a world that increasingly relies on a biobank’s freezer inventory and freezer software, why is a defined legal basis necessary?

According to Jens Kersten, Professor of Public Law and Administration at LMU, the need for legislation originates in the current lack of definition, which could become increasingly problematic as biobanking becomes more and more popular. Currently, Kersten says that no one in the industry can truly say which legal principles apply to the field, which causes uncertainty for researchers and bodes poorly for transparency as the technology expands. To explain the potential ramifications of this problem, he brings up a common topic: the possibility of uncovering disease. Most biobanks attempt to avoid potential privacy issues and other legal consequences by making the data in their freezer software anonymous. However, in the event that a serious health problem was uncovered over the course of a study, this would mean that the researchers could not inform the patient or further analyze the issue that has been uncovered.

Kersten argues that a potential biobanking law could have a number of benefits for the industry and patients alike. For example, if patients could track which studies their samples would be used in, he suggests that it might encourage people to donate to biobanks. Meanwhile, by establishing confidentiality clauses and other legislative actions, Kersten says that both biobanks and patients would know that their biological data is protected from seizure, while also ensuring that anyone who reveals genetic secrets is subject to prosecution. With freezer software and biobanking technology constantly improving and innovating, the case for legislating biobanks is becoming harder to ignore.



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