FDA Final Rule Allows IRBs to Ease Informed Consent Requirements for Minimal-Risk Studies
- December 22, 2023
The Food and Drug Administration (FDA) published December 21 a final rule (88 Fed. Reg. 88228) aimed at better aligning its regulations on human subject protections (21 C.F.R. pt. 50) and Institutional Review Boards (IRBs) (21 C.F.R. pt. 56) with the Department of Health and Human Services' (HHS') regulations known as the Common Rule (45 C.F.R. pt. 46).
ARTICLE TAGS
You must be logged in to access this content.