Privacy activists decry bill to restore newborn blood sample storage

The Minnesota Department of Health would regain broad authority to test and store blood samples from newborn babies under legislation that has pitted medical privacy activists against advocates of public health and medical research.

The bill, which has passed key committees in the House and Senate, would reverse the direction of recent court rulings, allowing the Health Department to retain blood samples for medical research unless parents specifically say no.

Physicians and state health officials say the tiny blood spots, typically drawn about 24 hours after a baby is born, allow early detection and treatment of dozens of hereditary illnesses, and then, once stored, help scientists study pediatric diseases.

"Minnesota was always the model across the nation for newborn screening, and we have fallen a long way in the last couple years off that," said Rep. Kim Norton, DFL-Rochester, chief author of the House bill. "And we can return to that and still allow people to opt out."

Twila Brase, president of the Citizens' Council for Health Freedom, who has emerged as an influential voice on medical privacy, said the bill would give the state unsettling power to store and use babies' genetic information.

"Anything having to do with newborn screening has to do with looking into the genetics, into the DNA, of the child," she said. The bill, she said, would allow "a vast array of research that is going to be done without consent."

At issue in the legislation is whether parents must "opt out" of having their newborns' blood sampled and stored, or "opt in."

Bill proponents say that approach decreases the number of babies tested and samples retained because, in the stressful atmosphere of a hospital after birth, many parents would fail to fill out the consent paperwork, even if they wouldn't otherwise object to the pediatric research.

The bill would allow the department to keep the samples, regardless of the test results, unless the parents fill out a form saying they want them destroyed. Parents or guardians could opt out of testing altogether or out of just storing the spots after testing.

The bill also says the Health Department can use the blood samples for calibrating machines to prevent false positives and to develop future tests that could find more diseases than those screened for now. Any researchers who want to use the blood samples would still have to contact the families and get consent first.

Allowing parents to "opt out" would respect parents' rights while maintaining a large archive of blood samples, according to Sen. John Marty, DFL-Roseville, chief author of the Senate bill.

"It's such a lifesaving thing, I think the default ought to be that we're trying to take interest in the kid's well-being," Marty said. "If you have strong moral objections, then you do have the authority as a parent to opt out, but the default should be to protect the interest of the kid."

Brase said she thinks passing the bill would result in fewer families participating in the test, because they don't trust the state to handle their babies' genetic data responsibly. Having an opt-in model would ensure that parents know what the state will do with their babies' data, Brase said, because they'll have filled out a form saying they understand.

In addition to the "opt out" provisions, the bill would require the Health Department to educate more families about the newborn screening program before they get to the hospital, such as through Lamaze classes.

But the bill text says education materials only have to include the "benefits" of newborn screening. Brase said if it were a true education component, it would also include the risks.