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Newborn Screening Saves Lives Reauthorization Act Restricts Use of Residual Newborn Screening Blood Spots for Research

posted on Wed, Jan 21 2015 12:14 pm by The Network for Public Health Law

Newborn screening is an important public health program that detects rare but serious genetic and metabolic disorders before symptoms appear. Disability and death can be prevented though early detection and treatment. Most screening tests require the collection a few drops of blood from the newborn's heel, but not all of the blood collected is used in the screening process. Many states allow these residual blood specimens (known as dried blood spots or “DBS”) to be used for research. State laws vary with regard to retention of DBS and conditions for research use, including whether or not consent is required for research use of anonymous or de-identified DBS and the specificity and terms of any required consent. A new federal law restricts release by states of residual DBS for research use. 

On December 18, 2014, the Newborn Screening Saves Lives Reauthorization Act of 2014 (Act) became effective. The Act amends the Public Health Service Act to revise and extend through FY 2019 a grant program for screening, counseling, and other services related to heritable disorders that can be detected in newborns. Section 12 of the Act directs the Department of Health and Human Services to update the Federal Policy for the Protection of Human Subjects (the Common Rule), not later than two years after enactment of the Act, to address research use of DBS. Until HHS updates the Common Rules, Section 12 applies the following provisions to DBS collected after March 18, 2015:

  • Requires federally funded research on newborn DBS to be considered research on human subjects, which requires informed consent of the subject, and
  • Eliminates the ability of an institutional review board (IRB) to waive informed consent requirements for research on newborn DBS under 45 CFR 46.116(c) and (d).

For further information on legal, ethical and policy issues related to secondary uses of newborn residual DBS, view the Newborn Screening Webinar Series jointly presented by the Newborn Screening Translational Network, the Network for Public Health Law, the National Newborn Screening and Genetics Resource Center and the Association for Public Health Laboratories.