The Ethics of Big Data in Genomics: The Instructive Icelandic Saga of the Incidentalome

• Main Author: Gitter, Donna M.
• Format: Text
• Language: unknown
• Published: Washington University Open Scholarship 2019
• Subjects: Iceland; Nordic; biobanks; Biotechnology; Genetics; Incidentalome; health law; genomic research; Bioinformatics; Genetics and Genomics; Health Information Technology; Health Law and Policy; International Law; Law
• Online Access: https://openscholarship.wustl.edu/law_globalstudies/vol18/iss2/6; https://journals.library.wustl.edu/globalstudies/article/id/589

DeCODE Genetics, Inc., a pioneering Icelandic biotech firm, recently introduced a free website that permits Icelanders to learn whether they carry mutations in the BRCA2 gene that are known to increase cancer risk, even if these citizens have never participated in genetic testing. Approximately five thousand Icelanders have elected thus far to receive their status. This site is made possible by the consanguinity of Icelandic citizens, who number fewer than 350,000, and their detailed genealogical records dating back centuries, a set of circumstances that presents a unique opportunity to study genetic mutations and the medical disorders associated with them. Using such information, deCODE has the ability to impute genetic information about individuals without any legal requirement to obtain their informed consent. This ability to impute individuals’ genotypes without having gathered bio-specimens or medical information directly from them calls into question researchers’ duty to inform individuals about their health risks, and the individuals’ right not to know (“RNTK”), defined as the idea that people ought to be able to control their receipt of genetic information about themselves. The emergence of unanticipated and yet highly significant genetic findings is referred to as the “incidentalome.” Commentators use the phrase “incidental findings” (“IFs”) to refer to medically important information that arises from research but is unrelated to the goals of that research. This article analyzes the return by researchers of genetic IFs to individuals whose genotypic data has been imputed, and who therefore have not indicated their consent to receive such information. While Iceland is at the forefront of this issue due to its small, homogeneous population, other nations increasingly encounter the same need to balance individual autonomy with responsibility for public health. Part II of this Article will consider the global rise of biobanks and the concomitant challenges posed to the right not to know. Part III considers ...