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Human Subjects Division (HSD)

Regulatory Updates

OHRP: Clarification of "Noninvasive" in Expedited Review Category 3

Oct 4, 2010 at 7:45am

OHRP has posted a new item of correspondence on its view about the meaning of "noninvasive" as the term is used in expedited review category 3, which is the expedited review category that applies to the prospective collection of biological specimens for research purposes by noninvasive means. OHRP's statement can be viewed at:


Specifically, that statement clarifies that OHRP agrees with the Food and Drug Administration's position that for purposes of expedited review category 3, the following procedures are considered noninvasive:

Vaginal swabs that do not go beyond the cervical os; Rectal swabs that do not go beyond the rectum; and Nasal swabs that do not go beyond the nares.