Citizens’ Council for Health Freedom: Trump’s Actions on Common Rule Will Protect Baby DNA and Restore Parental Rights
CCHF Advises the President and HHS Secretary Tom Price to Not Only Continue to Hold, But Change the Common Rule
ST. PAUL, Minn.—Citizens’ Council for Health Freedom (CCHF, www.cchfreedom.org) has been communicating with President Donald Trump through letters about important health care matters and his power to advance health freedom for all Americans.
One recent letter, also addressed to Health and Human Services Secretary Tom Price, praises the Trump administration for putting on hold the final Common Rule (“Federal Policy for the Protection of Human Subjects”), which was published by the Obama administration on January 19, 2017.
CCHF’s concerns about the Common Rule in its present state include that parental consent requirements for research using newborn DNA and the “human subject” designation for newborn DNA are not retained.
In December 2014, President Obama signed the Newborn Screening Saves Lives Reauthorization Act (NSSLRA), which included language CCHF worked with the office of Sen. Rand Paul and the Senate Steering Committee to develop. Hospitals routinely prick the heels of newborns and send the dried blood spots to state public health departments for government newborn genetic screening programs. The language in the NSSLRA required parental consent for the use of these blood spots for federally funded research. Unbeknownst to most parents, many states store the blood spots in perpetuity without parental consent.
“This 2014 federal law also designated the child’s newborn bloodspot as a ‘human subject’ and prohibited all waivers to the parental consent requirement,” Brase wrote to Trump and Price. “But the law dictates that this protective language would disappear from federal statute after the final Common Rule was published because, as CCHF was told, National Institutes of Health leadership had committed to include the 2014 statutory language in the final Common Rule.”
The problem is that when the rule was finalized, it did not include parental consent requirements or any other part of the protective language of Sen. Paul’s NSSLRA amendment. In fact, it specifies that the 2014 NSSLRA language “will no longer apply after the effective date of this rule, January 19, 2018.” And, specifically, the definition of “research” excludes “public health surveillance activities, including the collection and testing of information or biospecimens conducted, supported, requested, ordered, required, or authorized by a public health authority.”
After the contents of the final Common Rule were publicized, CCHF sought to have the Congressional Review Act (CRA) used to stop the rule, and thus protect the 2014 consent requirements that enable parents to protect the genetic rights of their children. However, in the flurry of those next 60 days, this procedural stop was not used.
“Thus, Citizens’ Council for Health Freedom is pleased that President Trump has put the Common Rule on hold,” Brase said. “To underscore the importance of this hold, CCHF has advised the president that the genetic privacy of the four million children born each year is at stake. Under the final Common Rule, the DNA of newborn citizens could be stored, used, accessed, analyzed and distributed by states without parent consent. These children will grow into voting adults who may or may not learn their genetic privacy rights were lost at birth. As an example of some of the intrusions over the years, newborn DNA has been used for barter in Texas, shared with the CDC for research in Minnesota and sent to the U.S. military to create a national mitochondrial DNA registry.”
CCHF first discovered the unconsented storage, use and sharing of newborn DNA by state health departments in Minnesota in 2003. Storage began in 1997, solely as an executive decision. No law authorized it. CCHF’s efforts against “Baby DNA” warehousing have led to three successful parent lawsuits in Texas and Minnesota, changes in laws and rules, media coverage by Science and Nature, and a television report disclosing 666 banker boxes of stored newborn dried blood spots in Indiana (23 years of newborns), now available to researchers without consent.
“But most Americans still have no idea that states are storing, using and sharing newborn DNA and conducting genetic research on children,” Brase wrote to Trump and Price. “These children who later become adults are also unaware. This acquisition of private property happens when new parents are exhausted, exhilarated, in pain, and according to newborn screening research, in a ‘fog.’ They think every lab test is a hospital test. They don’t know their baby’s DNA is being sent to the government.
“Most Americans also do not realize that the federal government in 2013 provided $25 million to four institutions for five-year research projects to sequence the genomes of newborn children and study the legal, ethical and social ramifications of genetic detailing at birth,” Brase added.
The Trump administration, says CCHF, now has an opportunity to right this wrong at the federal level by revising the Common Rule to include all the protective parental consent and “human subjects” language of the Newborn Screening Saves Lives Reauthorization Act of 2014. CCHF also recommends that HHS funding for state newborn genetic screening programs be contingent on the state’s annual attestation that no newborn dried blood spots have been stored or analyzed (beyond the child’s newborn screening test) or used, shared or sequenced without the consent of the child’s parents. Consent acknowledges that each individual’s genetic code and genetic traits are private and under the parent’s and, eventually, the adult child’s purview.
For more information about CCHF, visit www.cchfreedom.org, its Facebook page or its Twitter feed @CCHFreedom. Also view the media page for CCHF here. For more about CCHF’s initiative The Wedge of Health Freedom, visit www.JointheWedge.com, The Wedge Facebook page or follow The Wedge on Twitter @wedgeoffreedom.