21 CFR § 56.105 - Waiver of IRB requirement.

---
identifier: "/us/cfr/t21/s56.105"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 56.105 - Waiver of IRB requirement."
title_number: 21
title_name: "Food and Drugs"
section_number: "56.105"
section_name: "Waiver of IRB requirement."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "A"
subchapter_name: "GENERAL"
part_number: "56"
part_name: "INSTITUTIONAL REVIEW BOARDS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351, 352, 353, 355, 360, 360c-360f, 360h, 360i, 360j, 360hh-360ss, 371, 379e, 381; 42 U.S.C. 216, 241, 262."
regulatory_source: "46 FR 8975, Jan. 27, 1981, unless otherwise noted."
cfr_part: "56"
---


# 56.105 Waiver of IRB requirement.

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.