title: Newborn screening cards: a legal quagmire.
abstract: Newborn screening (NBS) programs are a well established and cost-effective method for early identification of genetic disorders. However, a raft of legal questions surrounds the collection, storage, ownership and secondary use of NBS cards. The absence of clear legal rules governing NBS programs in Australia means that there are few straightforward answers to these questions. A series of controversial incidents have exposed this uncertainty in Australia, and remarkably similar controversies have occurred in the United States and European Union. We review the situation, using Victoria as a case study. We also make the case for a dedicated regulatory regime for NBS programs, arguing that the lack of such a regime threatens public trust and the robust operation of NBS programs in Australia. New rules would likely introduce stricter requirements for informed consent at the point of blood collection than has been the norm to date. However, the scope for use of cards in research could expand rather than contract, and it may be possible to reduce the risk that vast card archives will need to be destroyed in response to future public outcries.
authors.affiliation: Melbourne School of Population Health, University of Melbourne, Melbourne, VIC, Australia. d.studdert@unimelb.edu.au
authors.forename: Diana M
authors.initials: DM
authors.lastname: Bowman
authors.forename: David M
authors.initials: DM
authors.lastname: Studdert
mesh_terms: D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D008297:Male; D015997:Neonatal Screening / Q000331:legislation & jurisprudence*; D011050:Policy Making; D014739:Victoria