Ethical and Regulatory Issues with Residual Newborn Screening Dried Bloodspots

DOI: 10.4236/ojpm.2015.510045   PDF   HTML   XML   4,465 Downloads   5,048 Views  


After newborn screening is completed, most states retain leftover dried bloodspots. These dried bloodspots are stored for varying lengths of time among different state newborn screening programs. Dried bloodspots are a unique and valuable resource for the development of new newborn screening tests, quality assurance and biomedical research. Recent changes to the 2014 Newborn Screening Reauthorization Saves Lives Act require explicit parental consent for the retention and use of dried bloodspots in federally funded research. This has raised several ethical and regulatory issues and highlighted the challenges of respecting individual autonomy and public health goals. This article provides an overview of these issues and discusses methods for obtaining parental consent. These issues may be applicable to consent for the storage and use of biospecimens among other settings according to proposed changes to the Common Rule.

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Rothwell, E. and R. Botkin, J. (2015) Ethical and Regulatory Issues with Residual Newborn Screening Dried Bloodspots. Open Journal of Preventive Medicine, 5, 409-415. doi: 10.4236/ojpm.2015.510045.

Conflicts of Interest

The authors declare no conflicts of interest.


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