CRG Victory! Privacy and consent provisions added to Senate passed newborn screening bill

by jeeg 9. December 2014 18:40


December 9, 2014

The U.S. Senate has passed H.R. 1281, the Newborn Screening Saves Lives Reauthorization Act, after adopting significant privacy and consent protections championed by the Council for Responsible Genetics.  

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. 

The Newborn Screening Saves Lives Reauthorization Act, which provides grants to state entities administering newborn screening programs, is intended to unify and nationalize the data collection resulting from state screening programs by standardizing data collection and reporting. Unfortunately it did not address the serious privacy and consent issues with the long term storage and use of such data.  

CRG has been working closely with the US Senate to include appropriate privacy and consent protections into this important legislation. Our report, Newborn Screening in America, and other materials from the CRG sponsored Genetic Privacy Network have been widely distributed on Capitol Hill and have become crucial resources on this issue.

We are pleased to announce that late last night, the Senate passed the bill after adding language designating any federally-funded research involving newborn bloodspots collected after March 2015 to be considered human subjects research for the purposes of the Common Rule. This means that such research will require informed consent from parents before these bloodspots can be used for research; it does not, however, apply to the screening of individual newborns for the required disorders. This provision does not require such consent to be obtained before the initial bloodspot is collected and tested. The bill now returns to the House of Representatives which is expected to quickly affirm changes made by the Senate. 

“Passage of the Newborn Screening Saves Lives Reauthorization Act with the addition of consent and privacy protections is a victory for both genetic information privacy and child health,” stated CRG President Jeremy Gruber. "The National Institutes of Health is currently working on updating the Common Rule for human subject research.  We fully expect that Congress' interest in establishing privacy and consent protections for newborn screening has now been communicated to the NIH, and will be carefully included as part of the Common Rule as a final draft develops."

Privacy protections for genetic information are possible!  CRG would like to thank the many members of the US Senate that made this victory possible.





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