APHL collaborates with state newborn screening programs and legal counsels to monitor legal and legislative issues affecting state newborn screening programs. It conducts these activities through the Legal and Legislative Issues in Newborn Screening Workgroup. APHL also disseminates related policy resources.
Newborn Screening Saves Lives Reauthorization Act, 2014
The informed consent provisions included in the Newborn Screening Saves Lives Reauthorization Act (NBSSLRA) went into effect on March 16, 2015. 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. Second, the law eliminates the ability of the Institutional Review Board to approve alterations or waivers of informed consent under 45 CFR 46.116(c) and 116(d) for research involving newborn dried blood spots. The informed consent provisions of the NBSSLRA will remain in effect until the Common Rule is updated.
Notice of Proposed Rulemaking to the Common Rule
The Common Rule outlines the body of regulations that protect human subjects in research. In 2015, the Department of Health and Human Services and the Office for Human Research Protections issued a notice of proposed rulemaking to update the Rule. The most notable change that will impact public health laboratories is that residual, de-identified biospecimens will require informed consent for future research use.
In response to the NPRM, APHL submitted recommendations outlining areas where OHRP can make improvements to allow public health laboratories to continue to use de-identified biospecimens while still protecting the interests of human subjects
Legal and Legislative News
In January 2016, Senate Bill 164 was introduced in Indiana by Senator Patricia Miller. The bill proposes the addition of six lysosomal storage disorders to the state newborn screening panel: Krabbe disease, Pompe disease, Niemann-Pick disease, Gaucher disease, Fabry disease, Hurler syndrome.