21 C.F.R. § 56.105
Waiver of IRB requirement.
Cite as 21 C.F.R. § 56.105 (2026)
On the application of a sponsor or sponsor-investigator, the Food and Drug Administration may waive any of the requirements contained in these regulations, including the requirements for IRB review, for specific research activities or for classes of research activities, otherwise covered by these regulations.