Letter to OMB Director Mulvaney regarding Common Rule

October 27, 2017
 
The Honorable Mick Mulvaney
Director
The White House Office of Management & Budget
725 17th Street, NW
Washington, DC 20503
 
 
Dear Director Mulvaney,
 
I am writing to you with an urgent request regarding a regulation under OMB review: “Federal Policy for the Protection of Human Subjects: Proposed 1-Year Delay of the General Implementation Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Year.” (RIN: 0937-AA05).  
 
This is commonly called the Federal Common Rule. It is listed under “Pending EO 12866 Regulatory Review.” It was received on October 7, 2017.
 
Our organization discovered state-based “Baby DNA Warehousing” in 2003 -- and the use and sharing of newborn DNA for medical and genetic research without parental consent. As a result, four parent lawsuits (IN, MN, TX) have been filed and judges have required millions of newborn DNA blood spot cards stored by state government to be incinerated.
 
But most states that retain newborn DNA retain and use it without parent consent. 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 or its contractor and 3) many states are storing, using and disseminating the child’s DNA without parental consent, including for genetic research.
 
In 2014, our organization secured language in the Newborn Screening Saves Lives Reauthorization Act of 2014 (NBSSLRA) which required parental consent for the use of newborn DNA for federally funded research. The bill, which was signed into law in December 2014 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.
 
To secure the language in an amendment to the bill (by Sen. Rand Paul), we worked with the Senate Steering Committee and the office of Senator Rand Paul to negotiate the final language. The language was slated to expire when the federal Common Rule was finalized. While we didn’t like the expiration, we heard from the SSC staff that they and Paul’s office were assured by NIH staff that the revised Rule would include the parental consent requirements, etc.
 
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 and other requirements expires on the effective date, and the statutory language is not retained in the rule:
 
“Other developments include the enactment of the Newborn Screening Saves Lives Reauthorization Act of 2014 (Pub. L. 113–240) in December 2014. The law made a number of changes relevant to the HHS regulations for protecting research subjects, including asserting that research with newborn dried blood spots (DBS) that is federally funded pursuant to the Public Health Service Act is to be considered research with human subjects, and that the provisions allowing IRBs to waive consent would not apply. By statute, the changes made by this law applied only until changes to the Common Rule are promulgated. Thus, the changes made by this statute will no longer apply after the effective date of this rule, January 19, 2018.” (page 7152)
 
“Finally, with regard to the use of newborn DBS, retaining the pre-2018 approach toward nonidentified biospecimens resolves many of the concerns expressed by commenters who felt that important research involving newborn screening would be halted or inhibited under the NPRM. The Newborn Screening Saves Lives Reauthorization Act of 2014 (Pub. L. 113–240) will no longer be effective following the effective date of this final rule, given that its changes applied only until changes to the Common Rule were promulgated. As a result, under the final rule, secondary research with nonidentified newborn DBS would be treated in the same way as secondary research with any other type of nonidentified biospecimen. Such research would not be considered research with human subjects under the final rule, and thus would not be subject to the rule.” (page 7169)
 
  FINAL RULE: https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf
 
Parents want consent over research using their baby’s DNA.
 
In 2009, a group of Michigan-based researchers wrote a paper: “Not Without my Permission: Parents’ Willingness to Permit Use of Newborn Screening Samples for Research” (Public Health Genomics, Beth A. Tarini, et al, July 11, 2009, Accessed October 26, 2017: /pdf/tarini_biobanking%20paper_parent%20attitudes.pdf) “If permission is not obtained, only 28.2% of parents were ‘very or somewhat willing’” to have the newborn blood spot sample used for research.
 
Furthermore, researchers have shown that anonymous DNA can be reidentified. For example: “Harvard Professor Re-Identifies Anonymous Volunteers in DNA Study,” Adam Tanner, Forbes, April 25, 2013: https://www.forbes.com/sites/adamtanner/2013/04/25/harvard-professor-re-identifies-anonymous-volunteers-in-dna-study/#29d6d41492c9
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.
 
NOTE: after six months, the blood spots can no longer be using for newborn screening which is primarily a metabolic analysis of amino acids and acylcarnitines in the child’s dried blood spots which are exhibited due to a newborn genetic condition. After 6 months, these elements degrade in the dried blood sample. The only thing left of value is the DNA.
 
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.
 
 
OUR REQUEST
 
We request 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 before it is released by OMB.
 
Newborn DNA warehousing and research is a secret government “taking.” Most parents do not realize what is taking place the midst of their exhaustion, joy, and vulnerability at the hospital -- and they are not asked.
 
Our organization is asking you to take action to protect the genetic privacy, constitutional and consent rights of our youngest American citizens, and their parents who have the right to protect and make choices for their newborn and minor children.
 
Please contact me with questions or for additional information at our office: #651-646-8935.
 
I would be pleased to assist in whatever way possible to facilitate the retention the protective parental consent language we secured in statute in 2014.
 
Sincerely,
 
Twila Brase, RN, PHN
President and Co-founder

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