What You Need to Know About The Opt-Out Law for DNA Testing of Your Children

Newborn Screening

If you are not proactive your child will undergo screening, as it is standard practice in most hospitals. In the United States, all newborns are required, to undergo “newborn screening or a PKU test to identify metabolic, hereditary and congenital disorders that may result in significant health impairment. Most states don’t require parental consent, meaning the screening will happen unless you object for religious reasons. To clarify, you must go out of your way to object and opt out from the Newborn Genetic Screening. The screening test is included in the Standard Medical Procedure forms that the parent signs when checking into the hospital.

Newborn screening requires pricking the baby’s foot to draw blood. In most states participating in newborn screening also gives the state health department the right to use the blood samples for research. On December 18, 2014, as stated in an article by the Journal of the American Medical Association, “the Newborn screening Saves Lives Reauthorization Act of 2014 was signed into law. It stipulates that any research on newborn dried bloodspots must be classified as research involving human subjects, which requires explicit parental informed consent.”

Review a full breakdown of the newborn screening laws in each state, including whether an opt-out option exists and whether screening requires consent.

In some states, like Montana and West Virginia, objection to the screening is not an option.

Possession of Newborn Screening Specimens

For testing and research, with the consent of the parent, some states are permitted to keep newborn screening specimens and their demographic forms for approximately two years. You should ask yourself:

Should testing and research labs be able to make money off of your babies or your own DNA?
Do you want your child’s DNA as part of a database?
What, if any, reason is acceptable to take your child’s blood?

It is important to note that there are no clear laws on who owns your DNA once it leaves your body. Of course that hasn’t stopped the courts from hearing cases about the possession of one’s DNA. One such case resulted in a patient suing his doctor for a share of profits the doctor had received from using the patients DNA without consent. As of now, the Supreme Court says researchers can’t patent natural DNA. But, who knows down the road when that may change.

Objecting to Newborn Screening and State Possession of Newborn Specimens

The Citizens’ Council for Health Freedom shares a sample letter you can send to your state department to request a comprehensive accounting of your baby’s data and blood spots collected through the newborn screening program. According to The Citizens’ Council for Health Freedom, government data practices laws and rules allow citizens to request and receive data on themselves and their children.

When making this request you should do the following: note the first mailing date, make copies for you and save the materials in a safe file, set a reminder to follow-up if you have not heard back in sixty days.

Baby DNA Lawsuits

As the American public becomes more aware of newborn screening, the demands for transparency increase. In 2012 nine families filed a lawsuit against the Minnesota Department of Health, claiming that the state violated the Minnesota Genetic Privacy Act by not allowing parents to consent to the newborn screening that resulted in the blood samples. After the court ruling, the state department destroyed more than one million samples collected since 1997.

An earlier lawsuit was filed in Texas in 2010, claiming that the Texas State Department of Health sold samples of newborn data to Biomerieux, Inc. and the Armed Forces Institute of Pathology. The samples were collected prior to 2007 when the law changed to require parental consent to stored blood samples.

What You Need to Know

As an expecting parent you should know that some states:

Perform newborn screening without parents’ knowledge (unless you opt out).
Do not provide an opt-out for newborn screening.
Provide the right to opt out of all newborn screening.
Use the newborn DNA for research

You also should realize that newborn screening includes collecting the baby’s blood and DNA via pricking a foot and storing, using and disseminating/sharing the blood and DNA for educational purposes.

If you choose to opt out of newborn screening, download and complete the appropriate forms and hang this sign on your hospital door to ensure that all medical professionals working with your baby know and understand your decision.

Your baby’s DNA as well as your own DNA should belong to you. Your rights and your baby’s rights to privacy, religion and cultural beliefs should not be infringed upon by the state or government.