Commentary

States Are Storing, Using, Disseminating and Researching Baby DNA Without Consent

By Twila Brase | October 31, 2017 | 10:10am EDT
Health professional takes a small sample of blood for lab tests from the side of the heel of a baby. (Global Health Media Project YouTube Screenshot))

Citizens’ Council for Health Freedom (CCHF, www.cchfreedom.org) has been working diligently to ensure that protections for Baby DNA, the genetic blueprint of America’s youngest residents, is protected in the final version of the “Federal Policy for the Protection of Human Subjects,” known as the Common Rule.

Since taking office, President Donald Trump has wisely put a hold on the Common Rule, which was published by the Obama administration on January 19, 2017, with implementation scheduled for a year later in January 2018. But according to news reports, the White House is planning to delay implementation another year, until January 2019.

On Friday, CCHF sent a letter to the Office of Management and Budget in Washington, D.C., urging OMB leadership to take into account the importance of Baby DNA and parental consent before the final Common Rule is released.

Our organization discovered the state-based “Baby DNA Warehousing” issue in 2003. As a result, four parent lawsuits (one in Indiana, one in Minnesota and two in Texas) have been filed, and judges have required millions of newborn DNA blood spot cards stored by state government to be incinerated. … Most parents, in the fog and exhaustion of labor and delivery, do not realize that: 1) newborn screening is a state government program, 2) the blood from the newborn heel prick is sent to the state public health laboratory and 3) many states are storing, using and disseminating the DNA without parental consent, including for genetic research.

In 2014, CCHF secured language in the Newborn Screening Saves Lives Reauthorization Act of 2014 (NBSSLRA) that required parental consent for the use of newborn DNA for federally funded research. The bill, which was signed into law by President Obama, also recognized research using newborn dried blood spots (DNA) as human-subjects research and prohibited any waiving of these parental consent requirements. CCHF worked with the Senate Steering Committee and the office of Sen. Rand Paul on the protective language, which was slated to expire when the Common Rule was finalized. CCHF and Paul’s office were assured the revised rule would include the parental consent requirements.

However, when the final Common Rule was released January 19, 2017, the day before the inauguration of President Trump, the rule specified that the 2014 statutory parental consent language expires, and the language is not retained in the rule. We know from our own research, research by others and through personal interactions that parents want to have the option to give consent to have their baby’s DNA stored and researched—or choose to keep it private and protected. Therefore, CCHF is requesting that the NBSSLRA’s 2014 statutory language on parental consent, designation of use of newborn DNA as human subjects research and prohibition of IRB waiving of parental consent be added to the federal Common Rule prior to release by OMB.

The DNA of newborn citizens should not be used for research without parental consent, or later without their own consent as adults who were minors when their blood/DNA was stored by state government without their consent. Government officials and agencies cannot take the DNA of adult citizens except under very defined circumstances, particularly law enforcement and criminal investigations. Yet the DNA of many of the 4 million children born each year is collected, stored, used, analyzed and shared without parental consent. Newborn DNA warehousing and research is a secret government “taking.” Most parents do not realize what is taking place in the midst of their exhaustion, joy and vulnerability at the hospital—and they are not asked. Our organization is asking the OMB to take action to protect the genetic privacy, constitutional and consent rights of our youngest American citizens.

Read the full CCHF letter on Baby DNA and parental consent language in the Common Rule here.

Twila Brase is president and co-founder of Citizens’ Council for Health Freedom (CCHF, www.cchfreedom.org), a Minnesota-based national organization dedicated to preserving patient-centered health care and protecting patient and privacy rights.

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