Staking the Public Trust on Newborn Dried Blood Spot Retention: How the Beleno and Bearder Decisions May Impact Canadian Newborn Metabolic Screening Processes (Beleno V. Texas Department of State Health Services Settlement, Bearder V. Minnesota Dismissed Case‪)‬

Introduction Public trust is fickle. Hard to obtain, even harder to maintain, it can be lost in an instant. From the 1960s onward, the medical community in North America has advocated and implemented a series of tests for newborns to help target, treat and possibly eliminate certain genetic diseases. Newborn metabolic screening (NMS) takes blood drops from a heel poke of an infant, collected on filter paper, which is then sealed when dry. Samples are sent to centralized laboratories where they undergo a battery of tests including mass spectrometry and DNA microarray technology. Such advanced testing is said to help identify dozens of potentially dangerous genetic abnormalities that could affect the future health of a child. (1) What has placed NMS practices in many countries at odds with public perception, however, is what health authorities do with the dried blood spots (DBS) after the screening is completed. Samples are routinely stored for at least one year after testing to ensure there is a specimen available for re-testing if necessary and for on-going quality assurance/quality control of the tests being performed (2). Members of the public and privacy advocates have expressed concern about the longer term non-consensual retention of DBS for secondary uses such as research. (3) The collection and storage of DBS gives rise to tissue repositories or biobanks. Such collections raise numerous ethical questions, including issues related to access, informed consent and privacy. Canadian jurisdictions have yet to legislate on the practice of DBS retention and secondary use of stored DBS. The first legal challenge to DBS retention in Canada was initiated in British Columbia in May 2010 (4) and this case will provide an opportunity to address unsettled issues. This paper provides an overview of the NMS programs and DBS storage practices in Canada. This summary provides a foundation for a discussion of the legal and ethical dilemmas raised by the creation of DBS biobanks. Recent American cases of Beleno v. Texas Department of State Health Services (5) and Bearder v. Minnesota (6) groundbreaking precedents concerning the collection of DBS, are incorporated into a larger discussion related to the probable outcome of similar legal arguments in Canadian jurisprudence.