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Preliminary Guidance for Newborn Blood Spot Work

The US National Institutes of Health has released preliminary guidance informing study investigators that they'll need to get parental permission before using newborn dried blood spots for government-funded research. 

The NIH guidance reflects Section 12 of the "Newborn Screening Saves Lives Reauthorization Act of 2014," which went into effect March 18. The act reauthorizes $20 million in funding for state-based newborn screening programs for treatable genetic disorders and includes provisions to educate parents about screening and establish standards.

Under a last-minute amendment to this legislation, NIH-funded research using dried blood spots derived at the time of newborn screening on or after that date is considered non-exempt human subjects research and must abide by regulations under 45 CFR part 46. "Waiver of parental permission for such research is not permitted under this legislation," NIH states.

Ethicists and policy experts from the NIH and the National Human Genome Research Institute recently penned an editorial in the Journal of the American Medical Association warning that the amendment on parental research consent can hurt public health investigations and have called for more discussion before changing consent policies. According to the JAMA authors, stringent consent procedures could deplete state dried bloodspot repositories, which have fueled research that has helped diagnose leukemia and improved understanding of rare illnesses.

Under the preliminary guidance issued by NIH, investigators that have received continuing awards to use newborn dried blood spots collected on or after March 18, 2015 will also have to comply with this guidance. However, non-identifiable blood spots collected before this date without parental permission will not fall under this regulation.

Research that falls under this regulation must have institutional review board approval. Grant applications using such materials will have to "include a complete human subjects section per relevant NIH instructions including plans for inclusion on the basis of sex/gender, race, ethnicity, and age per the NIH Policies on the Inclusion of Women, Minorities, and Children," the regulation states.

NIH advises investigators conducting government-funded research involving newborn dried blood spots to keep informed of developments in this regard, and says that the Department of Health and Human Service Office for Human Research Protections will also issue additional guidance on this law.

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