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On December 18, 2014, the Newborn Screening Saves Lives Reauthorization Act of 2014 was signed into law, renewing federal funding for the state-run newborn screening programs1 that have proven to be extraordinarily effective at saving children from lifelong disability.2 The bill included a last-minute amendment, however, that has generated immense concern among state newborn screening program officials and biomedical researchers. The amendment, which remains in effect until an updated Common Rule is released, stipulates that research on deidentified newborn dried bloodspots must be classified as research involving human subjects, thus requiring explicit parental informed consent. Public health officials’ major concern is that requiring explicit consent from parents may reduce the number of samples available for research and could even negatively affect newborn screening participation overall.3
Bayefsky MJ, Saylor KW, Berkman BE. Parental Consent for the Use of Residual Newborn Screening BloodspotsRespecting Individual Liberty vs Ensuring Public Health. JAMA. 2015;314(1):21-22. doi:10.1001/jama.2015.6175