TITLE:
Ethical and Regulatory Issues with Residual Newborn Screening Dried Bloodspots
AUTHORS:
Erin Rothwell, Jeffrey R. Botkin
KEYWORDS:
Residual Dried Blood Spots (DBS), Newborn Screening (NBS), Public Health, Population Research
JOURNAL NAME:
Open Journal of Preventive Medicine,
Vol.5 No.10,
October
22,
2015
ABSTRACT: 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.