Proposed Rule Would Gut Law That Protects Baby DNA



For Immediate Release
January 5, 2016

Deborah Hamilton, Hamilton Strategies, 215.815.7716, 610.584.1096, ext. 102, or Beth Harrison, 610.584.1096, ext. 104, 


Proposed Rule Would Gut 

Law That Protects Baby DNA


Citizens’ Council for Health Freedom Educating Americans About ‘Common Rule’ That Would Eliminate Certain Consent Requirements and Open Patients to Being Research Subjects Without Their Full Knowledge


ST. PAUL, Minn.Citizens’ Council for Health Freedom (CCHF, is educating Americans about a proposed “Common Rule” that would undo years of work to protect baby DNA. 


“Besides gutting the parent consent protections secured for baby DNA in the 2014 newborn screening law, this new proposed rule would allow doctors and hospitals to ask patients for ‘broad consent’ in a lab, hospital or doctor’s office—often at a trying time or during a stressful medical event—and create large repositories of identifiable patient data, blood, tissues and DNA collected in the past and 10 years into the future to be used for research without further consent or discussion about how the patient’s information is being used,” said Twila Brase, co-founder and president of CCHF. “This would give government and health care corporations the ability to use these patients as research subjects unless they understand the significance of the form and refuse to sign at a time when they may be most vulnerable.” 


CCHF, a patient-centered national health freedom organization based in St. Paul, Minn., existing to protect health care choices, individualized patient care, and medical and genetic privacy rights, was instrumental in the hard-fought—and successful—passage of language in the “Newborn Screening Saves Lives Reauthorization Act of 2014,” which required parental consent for federally funded research using newborn DNA. However, these consent requirements within the newborn screening law, signed on December 18, 2014, by President Obama, will be eliminated once the revisions to the Common Rule—the regulation that oversees all federally funded research—are finalized. 


Nineteen government agencies, including the National Institutes of Health, have issued the proposed revision. According to CCHF, the rule purports to add informed consent requirements, however, it also has eight exemptions (with room for a ninth) and 11 exclusions (with room for a 12th) to that requirement, meaning that certain research activities are “outside the scope of the regulations” and thus not required to follow the rules.


“Writers of this proposed rule were careful to exclude from federal oversight and consent requirements for certain government and institutional access and use of biospecimens, including newborn DNA, which is collected by state governments through state newborn screening programs,” Brase said. “Some states keep the newborn blood specimens indefinitely, and some keep them for several years. This rule will essentially gut the consent requirements we secured last year in law and make baby DNA accessible to the government and others for research purposes again—without parental consent. Thus, the newborn who’s been tested through newborn screening could become a subject of state research for test development purposes—with no knowledge on the part of the parents.”


The proposed rule will also affect a multitude of patients in other ways. In summary, CCHF provides three of the top negative issues that will result if the revisions to the rule are finalized:


  1. Parental consent requirements for the use of baby DNA in federally funded research are undone
  2. The rule will pave the way for one-time broad consent for 10 years of data collection and research per institution. The consent process is expected to take no more than 5 to 10 minutes of the patient’s time. This means, Brase says, that patients in hospitals and clinics may not have time to understand that this is a sweeping consent for all research into the near future. “Researchers of all sorts from around the world could access and use their DNA and private medical record,” Brase added. “There’s nothing that’s ‘unidentifiable’ anymore. The rule even says so. The consent may or may not talk about objectionable research, or why they may want to not sign. But at the time the consent is requested, who will fully read it, how many will know what it really says, what kind of pressure will they feel to sign it, and in what frame of mind is a patient to make such a monumental decision?”
  3. Consent requirements can be waived. This means, Brase says, that all the requirements of consent can be altered or completely disregarded by an Institutional Review Board (IRB). Although there are six options to do so in the current rule, the proposed rule adds four more waiver options, all for biospecimens, including DNA. “This is a huge loophole allowing researchers to get out from under rule’s consent requirements,” according to Brase.


Public comments on the rule can be submitted until Jan. 6, 2016 at 11:59 p.m., and CCHF submitted its written concerns directly to Jerry Menikoff, M.D., J.D., at the Office for Human Research Protections in Rockville, Md. Read CCHF’s public comments here


CCHF added in its communications to Menikoff that the rule is extremely hard to understand and full of legalese, virtually ensuing that most won’t know how the changes will affect their daily lives. 


“This proposed rule is voluminous and complex, making it difficult for the average American citizen—the person whose life will be most impacted by the rule—to understand what is being proposed or how to respond to the volumes of questions proposed,” Brase wrote in CCHF’s comments opposing the proposed rule. “There are, in fact, 129,609 words on 131 regulation-formatted pages … In short, it has not been written with the patient and the patient’s parents and representatives in mind. Yet, it proposes to impact their personal lives in ways they may not appreciate now or in the future.”


Brase added, “Furthermore, many newly proposed and ongoing regulatory loopholes have been added to the rule. These should be eliminated, and individuals should be asked for their voluntary, written, informed consent to participate in research projects.”


More than 10 years ago, CCHF began educating Americans on the use and storage of baby DNA without parental consent. CCHF successfully helped 21 Minnesota families win a lawsuit several years ago that eventually required that all baby DNA specimens be destroyed by the state health department. 


Brase talks about crucial health care issues during CCHF’s daily, 60-second Health Freedom Minute radio feature. Heard on 367 stations nationwide, including 200 on the American Family Radio Network and 100 on the Bott Radio Network, Health Freedom Minute helps listeners learn more about the agenda behind health care initiatives, as well as steps they can take to protect their health care choices, rights and privacy. The one-minute program is free for stations to run; for details, contact Michael Hamilton at or (610) 584-1096 or (215) 519-4838.

For more information or to interview Twila Brase, president and co-founder of Citizens’ Council for Health Freedom, contact Deborah Hamilton at 215-815-7716 or 610-584-1096, or Beth Harrison at 610-584-1096,

view pdf