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Uninformed Consent

Lawmakers said Monday that the state's newborn disease screening program — which has been used to warehouse infant blood samples for biomedical and forensics research — has misled parents and given them few options to protect their babies' DNA.

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The state health department stored infant blood samples for years without parental consent, using them for research projects and selling or trading the valuable specimens to biomedical companies. On Monday, state lawmakers demanded to know why, drilling Department of State Health Services Commissioner David Lakey on the details of a program they said has misled parents and given them few options to protect their babies’ DNA.

“Do you see why we’re concerned up here? There seems to be this pushback on transparency and full disclosure on the most intimate information of a person’s life,” state Rep. Jodie Laubenberg, R-Parker, told state health officials at a meeting of the House Public Health Committee. “Research is good, but people need to know and give their permission. … Think about a new mom trying to understand all this. We have got to make this easier and clearer.”

Lakey acknowledged that the state needs to be more protective of its baby blood spots — which are drawn to test newborns for birth defects and disease but are stored by the health department — by being more choosy about its research partners and clients. Lakey said that from now on, he will personally review every request for blood spots made by private companies or researchers outside of the agency. 

“If there’s another mechanism to get the blood … it’s probably correct for us as the agency to say, ‘This may be well and good, but you need to get blood from some other source,’” Lakey said.

But lawmakers indicated that’s not enough. They pledged to pass a bill next session that gives parents far greater control over how the state uses the newborn blood spots — including informed consent that could even be specific to individual research projects.

“If you look at banks, at financial [institutions], when you give them your money, you expect certain things, and they have to inform you of what they’re doing,” said state Rep. Lois Kolkhorst, R-Brenham, who chairs the public health committee. “When we’re talking about blood spots, and DNA retention, I don’t think we have developed the policy and the protections that the people really deserve.”

Last year, the state health department quickly settled a lawsuit with parents who argued that their babies’ blood was being used for purposes they hadn’t authorized. The state agreed to destroy more than 5 million blood samples it had stored. Meanwhile, lawmakers looked forward, passing legislation to give parents easier options to opt out of storing their babies' blood spots after newborn screening.

But neither has calmed the rancor.

The Texas Tribune learned in February that authorities had turned over hundreds of samples to a federal armed services lab between 2003 and 2007 to help build a mitochondrial DNA database — despite telling lawmakers and parents they’d only performed research on childhood cancer, birth defects and environmental toxins. Early this month, KXAN-TV in Austin reported that the state had also gained from the blood spots — trading roughly 230,000 of them to a private company in exchange for nearly half a million dollars in lab supplies and maintenance services. The media scrutiny has also revealed internal e-mails that document the agency's effort to limit the public’s knowledge of aspects of the newborn blood program, and to manage the debate around it.

On Monday, lawmakers questioned whether state health officials had been either incomplete or elusive when they failed to disclose the federal armed services project in a hearing last legislative session. Health officials said it was an oversight and that their intention was not to mislead lawmakers.

Lawmakers also asked for more details about the health department’s relationship with a private company in Finland — a company that sells the newborn screening equipment to Texas. Health officials say they have provided Texas baby bloodspots to Perkin Elmer in return for equipment parts and supplies worth about $2 per blood spot. The company uses Texas' de-identified spots to test the new equipment it’s developing.

And they argued that the Institutional Review Board — the expert body that decides whether a research project should receive Texas’ baby blood spots — was unfairly stacked against parents; of the 13 members, 12 are state health officials. Lakey agreed that should probably change. “That might decrease the perception that it’s all internal,” he said.

The crux of the issue on Monday was the ownership of the blood spots. Some states have ruled that such newborn blood spots are the property of their state health departments; others have determined they belong to parents. In Texas, state health officials long believed they had free rein with the blood spots — but lawmakers now appear to think otherwise. 

State Rep. Jim McReynolds, D-Lufkin, said state health officials need to be up front with parents and let them decide how their babies’ blood is used.

“If you tell me up front that [for] research purposes, [the blood spots] are de-identified, what fear would I have? If it could save a life, three cheers,” he said. “If we improve what we’re doing with people … you might find a lot of support for your research.”

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