Disputes over Research with Residual Newborn Screening Blood Specimens
Research
Karen J. Maschke, 09/08/2009

Disputes over Research with Residual Newborn Screening Blood Specimens

(Research) Permanent link

A few months ago, a federal lawsuit filed by the Texas Civil Rights Project led to significant change in Texas’s newborn screening program, giving parents more information and more control over how blood samples taken from their children are used. 

The lawsuit is a prime example of a fresh round of disputes over state newborn screening programs that could have an impact on a new federal effort to facilitate research with blood samples taken from babies for newborn screening. As the disputes reveal, policymakers and researchers still have much to learn about the ethical, legal, and social implications of medical research with biospecimens.

The lawsuit alleged that the program, which retained newborn babies’ dried blood specimens after they were used for mandated disease screening and made them available to researchers without parents’ consent, was conducting unconstitutional searches and seizures. In response to the lawsuit, the Texas legislature passed a law that requires the Texas Department of State Health Services to tell parents how it uses and manages their children’s genetic material and give them the opportunity to prohibit the department from retaining the material after newborn screening is completed or from using it for any other purpose.

Texas is not the first state that’s had to respond to parental complaints about the use of residual newborn dried blood specimens, and similar disputes are taking place in Michigan and Minnesota. Moreover, the issues regarding consent and the confidentiality of genetic information in the broader context of research with human biospecimens are not new. These issues have been examined and discussed since at least the early 1990s, and a wide range of stakeholders continue to grapple with them as large-scale initiatives to collect, store, and conduct research with biospecimens – including genetic research – move forward in the U.S. and elsewhere.

One of the routine activities that take place soon after a child is born is the heel stick. A few drops of blood are taken from the newborn’s heel and placed on special preprinted filter paper that preserves the specimen in a way that makes it viable for laboratory testing for various rare metabolic, hormonal, functional, and genetic disorders. With few exceptions, the screening takes place without parental consent. All 50 states and the District of Columbia mandate screening, although a few states have provisions for informed parental decision-making about screening and a handful of states permit parents to refuse screening for limited reasons (usually on religions grounds).

It’s unclear whether clinicians have routinely informed parents about newborn screening, including the ability to opt out in states that permit it. Recommendations from professional organizations, such as the American Academy of Pediatrics, that promote parental notification suggest that it has not been the norm. Although there is scant empirical data, several studies indicate that most newborn screening programs retain dried blood specimens, some for as little as a few weeks after screening and others indefinitely.

The primary reason for retaining specimens is that they can be used for quality assurance and test improvement within newborn screening programs. But some programs have also permitted researchers to obtain portions of specimens for various types of disease- and population-based research.  Researchers have used the specimens to examine the prevalence of fetal exposure to drug and environmental agents, determine the risk factors for birth defects and developmental disabilities, and for a wide range of environmental and epidemiological studies.

A controversy that erupted in 2002 in South Carolina should have been a wake-up call to newborn screening programs – as well as to federal policymakers who support a national biorepository of residual dried blood specimens for research. After public outcry about the release of 500 residual dried specimens to a private research company and another 500 to the state’s law enforcement division, the South Carolina legislature passed a law regulating the collection, storage, and research use of residual dried specimens.

At the time the law was passed, residual specimens were stored indefinitely, without parent’s knowledge or consent. The statute, which is less restrictive than the original draft, requires parents to be informed about the newborn screening program’s retention policy and given the opportunity to opt out of having their child’s residual specimen stored after the newborn screening.

Some commentators contend that if biospecimens are not identifiable – that is, they cannot be traced to the individuals from whom they were obtained – and if the research poses a minimal risk of harm to those individuals, then consent is not required. Opinions differ as to whether research with unidentifiable biospecimens requires prior review and approval from an institutional review board.

Even if IRB review and approval is required for the scenario described above, the presumption is that the ethical principle of respect for persons is not violated when consent is not obtained for research with unidentifiable biospecimens and that such research constitutes minimal risk of harm.

Yet recent survey research – as well as disputes over the use of residual newborn screening specimens – suggests that some people do not share those views. For instance, although most people surveyed say they support research – including genetic research – with biospecimens collected for nonresearch purposes (such as biopsies), some people want to be informed that their biospecimens will be used in research, even if the biospecimens are unidentifiable. Some even say their permission should be sought and that they should be able to say no.

Moreover, when it’s genetic material that researchers want, the issues of consent, identifiability, and research risks take on greater significance. Some parents in Texas have said that if they had been informed about the state’s retention and research policies and asked for permission to keep and use their newborn’s genetic material, they probably would have said yes. But not knowing that the state has retained millions of dried blood specimens and what measures it takes to protect the confidentiality of their child’s genetic information led some parents to take legal action.

In response to the current disputes, federal policymakers and other stakeholders are now scrambling to take control of what could be a serious setback to develop a federally funded Newborn Screening Translational Research Network that will include a repository of residual dried blood specimens for research. 

In August, the U.S. Secretary of Health and Human Services’ Advisory Committee on Heritable Disorders in Newborns and Children released a briefing paper, “Considerations and Recommendations for a National Policy Regarding the Retention and Use of Dried Blood Spot Specimens after Newborn Screening.” It makes seven recommendations regarding the development of transparent policies for retaining and using residual dried blood specimens and stresses the need for input from multidisciplinary parties, including consumers.

In September, the American College of Medical Genetics – which was awarded the federal grant to establish the Newborn Screening Translational Research Network Coordinating Center – will host with other stakeholders a public/professional forum and Internet Webinar titled “Blood Spots, Genetic Research and Privacy.”

These responses are good first steps. But there are several take-home points from the disputes in Texas and elsewhere that policymakers, newborn screening programs, biobanking initiatives, and researchers would be wise to pay attention to going forward:

One: Telling people that their biospecimens are retained and used for important research, that strict privacy and confidentiality protections are in place, and that “we’re good stewards” of the biospecimens without providing accessible, clear information about those policies, fails to meet even minimum standards of transparency.

Two: Failure to acknowledge that public attitudes and values about consent, genetic research, and privacy/confidentiality may conflict with those of researchers and policymakers can lead to pubic distrust of biospecimen research and impede important research.

Three: Genuine public engagement in developing policies for biobanking initiatives takes time and resources. But the payoff – trust in the research enterprise and willingness to provide biospecimens – is worth the effort.

Posted by Jacob Moses at 09/08/2009 08:47:07 AM | 


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