use is program quality assurance and test validation. Samples are needed to ensure that tests are accurate. “It is not heartening to hear some legislators or programs in some states discarding samples after a few weeks or 30 days,” Fleischman said, since this makes it more challenging to fulfill quality assurance needs in those states.

Second, residual samples are needed to develop new screening methods. This is part of the public health program and should be seen as an essential component of the mandatory screening process, according to Fleischman.

Third, parents are increasingly requesting additional testing, particularly in the case of sudden or unexpected death. Such testing is not possible if samples have been destroyed.

Fourth, samples have the potential to be used for forensic purposes by the police, the Federal Bureau of Investigation, Homeland Security, and other governmental bodies. The possibility of such use raises many difficult questions, Fleischman said.

The challenge, Fleischman said, is to balance respect for parental involvement in decisions about the storage and use of residual blood spots with the importance of the newborn screening public health program. Residual blood spots are an “incredibly important resource,” and their secondary uses, including research, should not be allowed to interfere with the public health mission of the screening itself. “The public health program is mandatory in this country. Research, though laudable, is optional.”

STAKEHOLDERS IN NEWBORN SCREENING

Many individuals and groups are stakeholders in the use of blood spots. The child is the first and most important stakeholder with regard to the screening process itself, since it is in the child’s interest to have the program. The importance to the child is why parents should not be allowed to opt out of newborn screening, Fleischman said, even if they are allowed to opt out of subsequent uses of samples.

The family is also a stakeholder in newborn screening, since the use of residual dried blood spots can have implications for the privacy and identity of family members. When parents attend meetings about the use of residual dried blood spots, Fleischman said, they often express concerns about how the use of those samples will affect not only their children but other members of the family.

Scientists and clinicians are stakeholders in the use of residual blood spots for research, because their job is to use this important resource to generate new knowledge in ways that will help all children and families. And governments and the public health departments are also similar stakeholders because they are the stewards of this important resource. Taken together, these are the primary stakeholders, Fleischman said, and each needs to have a voice in how newborn screening samples are used.



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement