This document describes the requirements and procedures for research that is subject to the regulations of the Food and Drug Administration (FDA).
Added language regarding electronic consent 08.24.2018
Clean up of FDA language regarding the ruling that now allows minimal risk waivers of consent. (Updated 6.8, removed 6.8.1 regarding enforcement discretion.) – 10.27.2017
Updated per new FDA guidance regarding waiving consent for minimal risk FDA-regulated studies – 08.25.2017
Updated links and document titles – 07.20.2017