Are you using or planning to use newborn blood spots? If so, we’d like to make you aware of some recent regulatory changes related to informed consent and human subjects involvement that affect you.
A new provision of the Newborn Screening Saves Lives Reauthorization Act of 2014 (P.L. 113-240) requires federally funded research using newborn dried blood spots collected on or after March 18, 2015 to be considered non-exempt human subjects research. The need for this research to now follow HHS Protection of Human Subjects regulations has several implications, such as the requirement to obtain parental permission to use newborn dried blood spots in research.
Read NOT-OD-15-127 for more information on how this affects you.
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