Securing Sequences: Ensuring Adequate Protections for Genetic Samples in the Age of Big Data

47 Pages Posted: 11 Sep 2015

See all articles by Elizabeth R. Pike

Elizabeth R. Pike

U.S. Department of Health & Human Services

Date Written: September 9, 2015

Abstract

Bulk collection of our personal data is increasingly common. Our internet browser history leads to personalized, targeted advertising; credit card companies aggregate billions of our collective transactions to gain insight into our spending patterns; and, as recently revealed, the National Security Agency engaged in the widespread collection of our telephone data without our knowledge or consent. But what if the data being collected, stored, shared, and used without our knowledge or consent is arguably the most personal of all data — our unique genetic sequence? In ways under reported and under examined, the genetic information of nearly every American is likely to have been collected and stored without consent for possible subsequent use.

This Article is the first to recognize the range of routine interactions — a trip to the doctor’s office, the birth of a newborn, a decision to try direct-to-consumer genetic testing, even wandering through a crime scene — that can lead to the collection and storage of our genetic samples. With scant protection or third-party review, these collected samples can be used in research, commercialization, and criminal justice without consent. The justifications proffered for nonconsensual collection and use — that the genetic samples have been abandoned, that they have been de-identified so are unlikely to cause harm, that they are so useful that obtaining informed consent could stymie important biomedical progress, and that recognizing any ongoing interests affords donors undue control — do not withstand closer scrutiny.

Accordingly, this Article calls for the re-invigoration of the longstanding ethical principles of informed consent and third-party review — safeguards that are often discarded in the collection and use of genetic data. In addition to promoting the ethical collection and use of genetic data, these safeguards protect against potential backlash should individuals discover that the current system permits the mass, surreptitious, nonconsensual collection and use of their genetic data — a discovery that has already led to the incineration of millions of collected samples.

Keywords: big data, genetic, genetic testing, genetic databases, health law and policy, bioethics, direct-to-consumer genetic testing, criminal law, consent

Suggested Citation

Pike, Elizabeth R., Securing Sequences: Ensuring Adequate Protections for Genetic Samples in the Age of Big Data (September 9, 2015). Cardozo Law Review, Vol. 37, Forthcoming, Available at SSRN: https://ssrn.com/abstract=2658306

Elizabeth R. Pike (Contact Author)

U.S. Department of Health & Human Services ( email )

200 Independence Ave., SW
Washington, DC 20201
United States

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