Protecting our children’s DNA

by jeeg 5. March 2015 22:11


Before they are more than a couple of days old, 98 percent of the roughly 4 million babies born in the U.S. each year have a small sample of blood taken and screened for a variety of inherited conditions. Caught early, many of these conditions can be successfully treated, preventing death and disability.

Newborn screening is one of the great public health success stories in this country, but what happens to the samples after the screening process is completed raises serious and troubling questions of consent and privacy.

Newborn screening is the only widespread health testing in the U.S. conducted not by an individual’s doctor, hospital, or health care provider but by individual state departments of public health. It’s these state agencies that often continue to store these biological samples long after the screening process is over. Indeed, 19 states store the biological samples of newborns for more than two years.

In the case of California and a handful of other states, these samples are indefinitely stored in state repositories and made available to researchers — for a fee. If there is one commonality among state newborn screening practices, it’s the complete lack of transparency of the entire process.

Most parents are poorly informed about screening programs; having just had a baby and still in the hospital they often don’t see any written materials and such programs are rarely explained in person.

Nevertheless, parents in California and most states are assumed to have consented to long-term storage and third-party use of their child’s biological sample unless they explicitly refuse in writing. Parents, understandably, want to be actively involved in decision-making regarding their children’s personal health information. That choice is currently being denied.

The concern of parents that states retain their children’s biological information is heightened because storage procedures and security at these state facilities are arcane and we still have few laws that truly protect the privacy of genetic information. We are at a critical time in the development of medicine: the mapping of the human genome has provided powerful new tools to understand the genetic basis of disease and genetic tests can help diagnose genetic conditions, guide treatment decisions, help predict risk of future disease, inform reproductive decision-making and assist medication selection.

Californians are enthusiastic about the promise of genetic medicine; but are understandably fearful about how this powerful information can be abused. The sheer amount of genetic data being generated today, and its commercialization, raises serious medical privacy concerns. Many individuals are legitimately concerned that their genetic information will be used against them and are unwilling to participate in medical research or be tested clinically, even when they are at risk for serious disease.

The government has not classified the collection and use of newborn screening data as research and its unclear whether the Common Rule, which requires informed consent for human subject research, would apply. This lack of clarity leaves newborn data ripe for misuse.

Consent not only allows parents to make choices about their child’s genetic privacy but is crucial to promoting greater governmental transparency. Such transparency is especially important because newborn screening and storage is often exempted from state genetic privacy laws. Researchers and administrators working with these samples know very well how alarming newborn blood spot biobanking can sound to most people, which explains why many of these clinicians, researchers and state labs would prefer newborn screening practices keep a low profile. That desire shouldn’t trump the public’s interest. Moreover, there’s just no evidence to indicate that better consent and privacy policies would affect any actual benefits from these biobanks.

Newborn screening is one of the few forms of genetic testing to which almost everyone is exposed. Yet parental and just general public knowledge of newborn screening and storage practices is extremely limited.

Assemblyman Mike Gatto, D-Glendale, has recently introduced a bill (AB 170) to address some of these concerns. It requires the state Department of Health to do a better job of informing Californians about the state’s newborn sample storage policies.

The bill also offers parents, and children when they reach adulthood, more control over the decision-making process regarding the retention and use of these samples.

California must revise its approach to long-term storage and use of newborn DNA samples, and include parents in the decision-making process. With no overall governing privacy framework to ensure individual privacy and control over one’s own information, a public debate around newborn screening protections can’t happen soon enough.


Jeremy Gruber is president and executive director of the Council for Responsible Genetics, a public policy organization, U-T San Diego


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