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From 2017: Other developments include the enactment of the Newborn Screening Saves Lives Reauthorization Act of 2014 (Pub. L. 113–240) in December 2014. The law made a number of changes relevant to the HHS regulations for protecting research subjects, including asserting that research with newborn dried blood spots (DBS) that is federally funded pursuant to the Public Health Service Act is to be considered research with human subjects, and that the provisions allowing IRBs to waive consent would not apply.

https://www.federalregister.gov/documents/2017/01/19/2017-01058/federal-policy-for-the-protection-of-human-subjects

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