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Bioethicists Say Researchers Should Advocate for Use of Newborn Screening Samples

NEW YORK (GenomeWeb News) – Blood samples that are left over from newborn screening tests offer a treasure trove of research materials for scientists seeking to uncover the role of genes in diseases and health, and the science community should be pushing for policies that promote their use in research while protecting donor privacy, a group of bioethicists said in a policy paper this week.

There are nearly 4 million newborn babies in the US who undergo mandatory screening every year, according to the paper in Science Translational Medicine, and privacy-related and ethical concerns about what happens to the remaining blood spots and how they are used could hinder the use of these unique resources in research.

The use of these residual dried blood samples (DBS) has bred controversy, as parents in Minnesota and Texas have sued their states for retaining these samples without parental permission on the grounds that the practice was a violation of their constitutional right to privacy.

The settlement in the Texas suit resulted in the destruction of 5.3 million archived blood samples, and the Minnesota Supreme Court ruled that informed consent will be required for the blood samples to be retained for use in research, and that state now plans to start destroying leftover samples when newborn screening is completed.

Policies such as these in Texas and Minnesota could impair development of new medical breakthroughs by keeping these samples from ever making their way to the lab, argued the authors of the paper.

"The potential value to biomedical research for improving both public health and individual health must be part of the public discussion about what should happen to residual dried blood samples from newborn screening," Michelle Huckaby Lewis, lead author of the paper and a research scholar at the Genetics and Public Policy Center of the Johns Hopkins Berman Institute of Bioethics, said in a statement yesterday.

Researchers have used dried blood samples to detect environmental toxins, to conduct public health surveillance activities such as the detection of HIV seroprevalance rates, to conduct post-mortem metabolic or genetic testing on children who die unexpectedly, and they have contributed to current knowledge about the mechanistic bases and origin of childhood leukemia, the authors pointed out.

"The research community must advocate for policies that support the retention of these samples and their use in biomedical research," Lewis said.

"We should be the generation that recognizes the potential value of these samples and commits to developing them as a resource to promote public and individual health. The scientific community has a responsibility to the nation and its citizens to use these resources ethically, but also to the fullest extent possible to improve the health of our citizenry," Lewis and her co-authors wrote.

While the privacy concerns that parents have about these biosamples are valid, the authors say, the "erosion of trust in the research enterprise" on the part of the parents is the real issue that threatens to keep researchers from accessing these dried blood spot samples.

Lewis and her co-authors urged that public education efforts about the value these samples have to biomedical research should be a cornerstone of any policies addressing or governing how they should be used.

Privacy concerns also should be addressed by "the establishment of strong mechanisms to prevent the misuse of DBSs," including criteria for secure storage and specifications covering who may access the samples, the authors argued.

"In this way, the loss of a valuable resource can be prevented and the public trust in the research enterprise can be restored," they stated.

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