Innocent blood: Use of newborn heel sticks spurs legal challenges
Should parents be given option to 'opt out'?
It's likely one of the first medical procedures most newborn babies undergo — a simple heel stick, as blood samples are taken to screen for a variety of disorders that might not otherwise be apparent at birth.
It also could be a child's first experience as a research participant. Many in the research community argue that newborn screening programs, which are performed in all 50 states and include a huge percentage of the country's newborns, may be a valuable source of biological specimens for research.
Possible uses of blood spots left over from screening range from quality assurance activities such as testing the effectiveness of a new screening procedure to studying the incidence of a particular disease in the population or looking for genetic markers for inheritable diseases.
Jeffrey R. Botkin, MD, MPH, associate vice president for research integrity at the University of Utah in Salt Lake City, says blood spots have been used for research since the 1980s, when several states were using them to determine the prevalence of HIV infection.
"Some states have been interested in heavy metal exposure for women prenatally — are there pockets of exposure within state communities, what is the level of exposure, etc.," Botkin says. "Others are also interested, of course, in genetic epidemiology and that's probably been the prevalent use of these things. How common are certain genes within the population? How often would you get a positive test on a particular type of condition that you might be considering for a new newborn screening test?"
However, venturing into this realm brings questions for researchers and for IRBs about the ethics of conducting research without specific consent from the babies' parents. In most states, the collection of blood samples from newborns is mandatory — some states allow exemptions for religious or other reasons, while others allow no exemptions at all. In addition, most states do not give parents detailed information about possible secondary uses of the blood spots.
The issue has come to the forefront this year as parents in two states — Minnesota and Texas — sued their state health departments over the unauthorized use of their children's biological samples. Parents in Texas alleged that the research use of the blood spots constituted an illegal search and seizure, while in Minnesota, parents said the research violated the state's genetic privacy law.
Despite assurances that research would only be conducted with deidentified samples, parents are concerned about the potential for their children's genetic privacy to be breached, says James C. Harrington, director of the Texas Civil Rights Project, which is representing five families in their suit against the Texas Department of State Health Services and Texas A&M University, where the state's blood spots are stored.
He notes that there have been nationally publicized cases in recent years in which patients' personal information has been accidentally breached.
"Everybody can say 'Don't worry,' but history shows of course that there is a legitimate basis for worry," Harrington says. "And when they cannot articulate a justification for the research, as they can't at this point, then it raises the question about what's going on in terms of gathering personal information generally by the government?"
Opt out or opt in?
Harrington's suit led to state legislation that changed the rules regarding the storage and secondary use of newborn screening blood spots in Texas. The state now provides detailed information about the program to parents at the time of birth and allows them to withdraw their children's blood spots for up to 60 days afterward.
Harrington says his group is still negotiating with the state over what to do about the 4 million existing samples currently sitting in storage. He would like to see them destroyed, while the state is proposing a public information program with mechanisms for people who want their children's (or their own) samples removed.
Texas' so-called "opt-out" procedure is one way that states are handling the issue of how to provide parents with information and choices regarding their children's samples, says Aaron Goldenberg, PhD, MPH, assistant director of the Center for Genetic Research Ethics and Law at Case Western University in Cleveland, OH.
Goldenberg says a different approach is being taken by Michigan's Department of Community Health, which is establishing the Michigan Biotrust for Health, a systematized repository for babies' blood spots.
He says that when Michigan officials first began looking at what to do with blood spots, they approached researchers, ethicists and community groups to ask for their input. From those discussions came the decision to create a scientific advisory board and community advisory board that would have some say in what kinds of research could be done with the blood spots.
Michigan also asked the state health department's IRB for guidance. After consulting with the Office for Human Research Protections (OHRP), the IRB made two determinations, Goldenberg says:
—Because the state is setting up a repository for the purpose of conducting future research, samples collected going forward will require informed consent from parents — a so-called "opt-in" approach.
"The state is in the process of doing this — saying we need to get prospective signed informed consent to allow storage for research," Goldenberg says. He notes that the information will have to carefully distinguish the newborn screening (which is mandatory and requires no consent) from the later research use.
—For samples collected prior to this decision, the IRB will grant a waiver of informed consent as long as the state creates educational activities to inform the public about the use of samples and provides a way for parents to have the sample destroyed or taken out of use for research if they wish.
Balancing concerns
When states are trying to decide how to approach this issue, they must balance competing interests, say Goldenberg and Botkin. Among them are the interests of parents , who want as much control as possible over their children's samples. On the other hand, researchers worry that if too many people opt out, the collection of blood spots would lose value as a research tool since it may no longer represent the state's entire newborn population.
Another vital interest is that of newborn screening itself.
"If you don't provide parents with some opportunity to opt out of research, then they may opt out of the whole newborn screening program, and that would be a problem," Botkin says. "We don't want research opportunities with these specimens to in any way impair the efficacy of the newborn screening programs themselves."
For that reason, Goldenberg says, many states are choosing not to get involved in possible research use of blood spots at all. "They say, 'We do not want to disrupt the newborn screening process — we're not even going to talk about it.'"
Goldenberg says that eventually all states will have to develop some sort of plan for what to do with newborn blood spots, even if it is to simply destroy them after a period of time.
In the meantime, Botkin recommends better education programs aimed at parents, to explain what their states are doing and what their options are. He believes that education should be done not just in the hospital once a baby has been born, but prenatally.
"Folks are pregnant for nine months, and they're eager to learn about anything that might be relevant to their baby," he says. "So why not talk about it then?"
It's likely one of the first medical procedures most newborn babies undergo a simple heel stick, as blood samples are taken to screen for a variety of disorders that might not otherwise be apparent at birth.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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