eCFR Reference Browser

---

title: "21 CFR §56.105"

source: "https://www.ecfr.gov/current/title-21/section-56.105"

title_number: "21"

volume_number: "1"

chapter_number: "Unknown"

subchapter_code: "A"

subchapter_subject: "GENERAL"

part_code: "56"

part_subject: "INSTITUTIONAL REVIEW BOARDS"

subpart_code: "A"

subpart_subject: "General Provisions"

section_number: "56.105"

section_subject: "Waiver of IRB requirement."

cfr_reference: "21 CFR 56.105"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 1 to 99"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

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.

§56.105 - Waiver of IRB requirement.