title: State laws regarding the retention and use of residual newborn screening blood samples.
abstract: BACKGROUND
  After newborn screening has been completed, many states retain residual newborn screening dried blood samples for various purposes, including program evaluation, quality assurance, and biomedical research. The extent to which states possess legal authority to retain residual dried blood samples (DBS) and use them for purposes unrelated to newborn screening is unclear.
  
  
  OBJECTIVE
  The purpose of this study was to evaluate state laws regarding the retention and use of DBS.
  
  
  METHODS
  State statutes and regulations related to newborn screening of all 50 states plus the District of Columbia were accessed online between November 2008 and December 2009 and reviewed by 2 independent reviewers to determine the extent to which the retention and use of DBS were addressed.
  
  
  RESULTS
  The retention or use of DBS has not been addressed in 18 states. In 4 states, DBS becomes state property. Eight states require that parents be provided information regarding the retention of DBS. Parents in 5 states may request the destruction of their child's residual sample. Parental consent is required under certain circumstances to release DBS for research in 6 states. One state prohibits DBS from being used for research purposes.
  
  
  CONCLUSIONS
  States have wide variability in their policies regarding the retention and use of DBS. Many states have not addressed key issues, and some states that retain DBS may be acting outside the scope of their legal authority. The lack of transparency on the part of states in retaining DBS may undermine public trust in state newborn screening programs and the research enterprise.
authors: Genetics and Public Policy Center, Berman Institute of Bioethics, Johns Hopkins University, 1717 Massachusetts Ave., NW, Suite 530, Washington, DC 20036, USA. michellelewismd@yahoo.com
authors: Michelle H
authors: MH
authors: Lewis
authors: Aaron
authors: A
authors: Goldenberg
authors: Rebecca
authors: R
authors: Anderson
authors: Erin
authors: E
authors: Rothwell
authors: Jeffrey
authors: J
authors: Botkin
mesh_terms: D035843:Biomedical Research / Q000331:legislation & jurisprudence; D001800:Blood Specimen Collection; D003219:Confidentiality / Q000331:legislation & jurisprudence*; D005260:Female; D030661:Genetic Privacy / Q000331:legislation & jurisprudence; D006291:Health Policy / Q000331:legislation & jurisprudence*; D006801:Humans; D007231:Infant, Newborn; D007755:Laboratories, Hospital / Q000331:legislation & jurisprudence; D008297:Male; D015997:Neonatal Screening / Q000331:legislation & jurisprudence*; D010067:Ownership; D033282:Parental Consent / Q000331:legislation & jurisprudence*; D013048:Specimen Handling; D014481:United States