CRG Presses US Senate for Privacy and Consent Protections in Newborn Screening

by admin 3. December 2014 21:44

H.R. 1281 is the Newborn Screening Saves Lives Reauthorization Act of 2014. It seeks to reauthorize and amend  a number of state grant programs and federal requirements for newborn screening. The bill passed the US House by a voice vote on June 24, 2014.             

Every US state conducts  a newborn screening test on every baby born within its borders. State law generally requires that a nurse takes a few drops of blood from the heel of each newborn, and submits it to a state laboratory. There, researchers test blood to look for 50 or so medical conditions that could be dangerous–generally metabolic,  genetic or endocrine conditions. Newborn screening has proven a very effective and successful health program. 

Unfortunately, once the initial testing is completed, the samples are not destroyed. Rather than discarding the screening tests, many state departments of health store the bloodspots for a period of time, even indefinitely, using them for quality control and sometimes research. Usually parents have no idea this is occurring.                              

In 2007, President Bush signed the Newborn Screening Saves Lives Act, which provides grants to state entities administering newborn screening programs. The intent of the law is to unify and nationalize the data collection resulting from state screening programs by standardizing data collection and reporting.

Notably, this law does not specify the protocol for sharing newborn screening data between research projects, and does not address issues that might arise if  the newborn’s information is linked or linkable to the newborn screening sample.  It furthermore does nothing to address parental consent with regard to data storage and sharing.

Newborn screening is one of the few types of genetic testing to which every American is exposed, yet few Americans are aware of the serious privacy and lack of consent issues with the storage and use of samples. CRG is working hard with Members of the US Senate to amend the legislation so that the important benefits of newborn screening are supported while upholding principles of privacy and parental consent. 

A copy of our letter to the Senate is below. 


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