Challenges and Opportunities in Using Residual Newborn Screening Samples for Translational Research Workshop Summary (2010) / Chapter Skim
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4 Concerns About the Use of Residual Newborn Screening Samples
4 Concerns About the Use of Residual Newborn Screening Samples
Pages 19-30
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From page 19... ...
• Transparency and oversight are essential to counter concerns about the use of residual newborn screening samples. SEPARATING CONCERNS FROM ISSuES The concerns that people feel about newborn screening should be separated from the issues surrounding screening, said Ann Waldo, senior counsel at Genetic Alliance.
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From page 20... ...
"Even if all newborn screening programs disappeared, which would be a tragedy, genetics is going to be advancing, and we are going to have to face these tough questions about what to do with knowledge." Newborn screening programs also raise difficult issues concerning autonomy, control, and choice. In the preface of the Texas lawsuit, one of the plaintiffs was repeatedly quoted as saying, "If they'd only asked me for permission, I would have said yes." Waldo expressed some puzzlement over this statement.
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From page 21... ...
People sometimes ask in public meetings whether dried blood spots can be used to obtain convictions -- or exonerations -- of family members. The expressed interest of some government agencies in using remaining newborn screening samples for forensics has raised the profile of this issue, said Waldo.
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From page 22... ...
(Parental and public education is the topic of Chapter 6.) Kardia also noted that in Michigan a frequent concern is that the use of residual dried blood spots will undermine community-based research networks, which are very active in investigating local health concerns in that state.
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From page 23... ...
These decisions should not be made by a narrow group of people, because a narrow group cannot imagine what harm looks like to other people at other times. CONCERNS ABOuT PRIVACy AND SECuRITy Sharon Terry, president and CEO of Genetic Alliance, elaborated on the many concerns involving privacy and security associated with residual newborn screening samples.
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From page 24... ...
What are the responsibilities of individuals, nations, and all human beings? "Those are all really, really hard questions," Terry said, "and translational research runs into them all the time." STATE LAWS AND PRACTICES As of May 2010, at least 18 states had laws or regulations that specifically addressed both the storage and use of newborn screening samples: California, Indiana, Iowa, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Hampshire, North Dakota, Oklahoma, South Carolina, Texas, Utah, Washington, and Wisconsin.
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From page 25... ...
Most state policies that permit research use of residual dried blood samples employ an opt-out approach, with samples being released for approved research unless parents indicate otherwise, but in Nebraska and New Hampshire researchers must obtain written consent from the parents of individuals whose specimens are being requested. In some states children, once they reach the age of 18, can request the destruction or return of a specimen.
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From page 26... ...
Similarly, policies in at least eight states require that information provided to parents regarding the newborn screening program discuss storage and use of residual dried blood specimens. LEGAL CONCERNS REGARDING THE uSE OF RESIDuAL DRIED BLOOD SPOTS The issues surrounding state laws have become more prominent, said Ellen Wright Clayton, the Rosalind E
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From page 27... ...
Human subjects research requires one to consider the risks and benefits as well as whether informed consent is required and whether it can be waived or limited in any way. If these provisions do not apply, research using residual newborn screening samples need not take these steps.
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From page 28... ...
But Native American populations have always been sensitive about using their blood samples for ancestry testing, Clayton observed. "There needs to be oversight and accountability to make sure that those kinds of decisions -- which are just not good decisions -- do not happen." Most of the decisions made about the use of residual dried blood spots would be sustained with oversight.
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From page 29... ...
For example, it would be difficult for a legislature to pass a law requiring newborn blood spots to be retained for quality assurance and research but did not allow law enforcement to access them under any circumstances. Or it is possible that the Department of Homeland Security might claim to have a right to access whatever samples a state holds.
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