February 6, 2019
OHRP posted on its website a Frequently Asked Question and Answer (FAQ), titled “Section 12 of the Newborn Screening Saves Lives Reauthorization Act of 2014 changed the ability of investigators to conduct certain federally funded research with newborn dried blood spots regardless of the identifiability of the blood spots. Are these requirements of the Act still in effect?” The use of the word “must” in OHRP guidance means that something is required under HHS regulations at 45 CFR part 46. The use of the word “should” in OHRP guidance means that something is recommended or suggested, but not required.
The FAQ can be accessed at: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/2018-requirements-faqs/index.html
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