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  • Leftover Newborn Blood Samples Need Better Regulation, Ethicists Say
  • 28. January 2021
  • 0 comments
  • Maria Bauer
  • Uncategorized

Leftover Newborn Blood Samples Need Better Regulation, Ethicists Say

The tiny spots of blood left after routine tests on newborns could provide valuable information for researchers, but clear policies that govern their use are needed so that the samples are not destroyed or otherwise lost entirely, experts say.

Each year, 4 million babies in the United States are screened for certain genetic disorderswith a routine blood test. The leftover blood from these tests has a variety of potential uses, and could allow researchers to create genetic databases to learn how genes influence both rare and common diseases, said Michelle Huckaby Lewis, a bioethicist at the Genetics and Public Policy Center at Johns Hopkins University.

But few states have laws specifying what can be done with these leftover samples, and as a result, their use has been controversial.

In Texas, families brought a lawsuit against the department of health after learning that leftover samples were used for research without consent from the parents. As part of the lawsuit settlement in 2009, 5 million archived blood samples were destroyed. And Minnesota plans to destroy all samples so that they cannot be used for any purpose other than the newborn screening tests.

Experts say the destruction of these samples is a lost opportunity for future research.

“There are few other ways to get a reasonable snapshot genetic change,” said Arthur Caplan, a bioethicist at New York Univesrity School of Medicine’s Division of Medical Ethics, referring to the genetic information that would come from examining years’ worth of samples. “To throw it away, or not use it, I think is shortsighted and doesn’t serve anybody’s interest,” Caplan said.

Scientists should advocate for policies that would support the retention of these samples, while at the same time, taking into consideration the ethics of patient consent.

Currently, the most common use of these leftover blood samples is to test equipment used in newborn screening to make sure it is working properly, Lewis said. Some researchers have used the samples to examine the prevalence of HIV, and detect environmental toxins. Before the samples in Texas were destroyed, some researchers had planned to use them to look for genes linked to a rare brain disease.

So far, six states have laws requiring parents to consent before their infants’ blood can be used for research purposes. In Michigan, one state with such a law, the samples are sent to a biotrust for potential future research. Six states have laws that prohibit using the samples for research. In 10 states, samples are kept for less than a year, Lewis said.

Because of what happened in Texas and Minnesota, states that do not have laws to address the issue may be reluctant to retain the samples for research because they do not want the controversy to affect parents’ participation in newborn screening, Lewis said.

Public health departments should be more transparent about how they plan to use the samples, Lewis said. The best way to do this would be an “opt-in” approach that asks parents whether they consent to have their child’s leftover blood sample used for research, Lewis said.

There should also be more public education about the benefits that could come out of research on the blood samples, Lewis said.

In terms of what to do about older samples that were kept without the consent of the parents, Caplan said it is still possible to use these samples ethically.

Researchers should work with the community and patient advocacy groups to set up a panel in each state to review what their state has collected, Caplan said. Then, the panel should ensure the infants’ identities are removed from the samples before they are used for research, he said.

“The crucial step is to make sure that the public understands that no person today will have anything found out about them,” Caplan said.

Another potential solution that has been suggested in Ireland is to make the public aware of the existence of these archived samples, and giving individuals the opportunity to have their specific sample destroyed if they chose, Lewis said.

Pass it on: Clear policies are needed to govern the use of leftover blood samples from newborn screening so that the resource is not lost entirely, researchers say.

Follow Rachael Rettner on Twitter @RachaelRettner, or MyHealthNewsDaily @MyHealth_MHND. We’re also on Facebook & Google+.

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Maria-Cakehealth
Maria Bauer

Maria is our expert for medicine, fitness and general health. Her contributions are particularly convincing through completeness, accuracy and her own personal experience. Maria also writes for other health magazines, which has enabled her to build up her expert status.

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