State health officials can no longer use infant blood samples for non-approved purposes without parental approval, under a measure Senate lawmakers approved today.
The bill follows a lawsuit parents filed against the state after they learned the state had stored infant blood samples — collected for disease and defect screenings — for years without consent, using them for research projects and selling or trading them with biomedical companies.
“I believe this is a balanced approach that deals with the concerns while still keeping the program strong,” said Sen. Bob Deuell, R-Greenville, the Senate sponsor of the bill.
The newborn screening program tests babies for a variety of common and sometimes deadly diseases. Participation in the program is mandated by the state, and parents can only choose not to participate for religious reasons. Currently, parents can sign a waiver to opt out of participation in any program that would use their child's blood spots for forensic research or any purpose other than monitoring public health.
House Bill 411 would flip the procedure around by requiring parents to opt in — rather than opt out — before the department could use the blood samples for any purpose other than screening for disease. The bill would also prevent the department from releasing any information that could be used to identify the child with the samples. The commissioner of the Department of State Health Services and an institutional review board made up of three members not affiliated with a state health agency must approve how blood samples may be used. All approved uses must be posted clearly on the department's website.
Under the proposed legislation, Deuell said, “parents can revoke consent at any time, as can their children when they reach a decision making age.” He added an amendment, which requires the department to destroy blood spots within two years after the child's birth and gives the department 60 days to destroy a sample if the parents revoke consent.
Supporters say the bill would increase transparency on how the samples are used and protect privacy rights. But opponents say the bill “would jeopardize the nation’s largest sample of de-identified newborn genetic material in the country.” The newborn screening program has been essential to breakthroughs in biomedical research, they say.
The Senate also adopted an amendment by Sen. Carlos Uresti, D-San Antonio, which mirrors Senate Bill 270, that passed the Senate and has been left pending in the House Calendars committee. The amendment requires birthing facilities to test newborns' hearing and sets up guidelines for follow-up care if the newborn fails to pass the hearing screening.
The bill now moves back to the House for approval of the amendments added by the Senate.