Federal Newborn Screening Law Emphasizes Informed Consent

By Allison M. Whelan (Guest Blogger)

On December 18, 2014, President Obama signed into law the Newborn Screening Saves Lives Reauthorization Act of 2014. The Act includes new timeliness and tracking measures to ensure newborn babies with deadly yet treatable disorders are diagnosed quickly. These changes responded to a Milwaukee Journal Sentinel investigation that found thousands of hospitals delayed sending babies’ blood samples to state labs.  A primary purpose of newborn screening is to detect disorders quickly, so any delays increase the risk of illness, disability, and even death.

Although a major reason for the Act’s amendments is to address these problematic delays, another important addition to the Act establishes a parental consent requirement before residual newborn blood spots (NBS) are used in federally-funded research. The Act directs the Department of Health and Human Services (HHS) to update the Federal Policy for the Protection of Human Subjects (the “Common Rule”) to recognize federally-funded research on NBS as “human subjects” research. It also eliminates the ability of an institutional review board to waive informed consent requirements for NBS research.

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