Apr 06 2015
On December 18, 2014 the Newborn Screening Saves Lives Reauthorization Act of 2014 (Public Law No: 113-240), an extension of the Newborn Screening Saves Lives Act of 2008 was signed into law. The bill includes an amendment addressing research uses of newborn dried blood spots, requiring immediate new interpretations of the current Federal Policy for the Protection of Human Subjects effective 90 days from the enactment of the law. The amendment also requires HHS to promulgate proposed revisions to Federal Policy for the Protection of Human Subjects within six months and final regulations within two years.
The law includes two significant changes to the human subjects regulations as they apply to research with newborn dried blood spots. First, the law requires that all research funded pursuant to the Public Health Service Act using newborn dried spots be considered human subjects research regardless of whether the specimens are identifiable. This is contrary to established regulatory approaches in which biological specimens that are not linked to identifying information are not considered identifiable and therefore do not constitute “human subjects” as defined at 45 CFR 46.102(f). Second, the law eliminates the ability of the IRB to approve alterations or waivers of informed consent under 45 CFR 46.116(c) and 116(d) for research involving newborn dried blood spots. This is contrary to long-established IRB practices in which research involving stored identifiable clinical specimens and data could be carried out under a waiver of informed consent if the IRB determined that the ethical and regulatory requirements were satisfied.
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