eCFR Reference Browser

---

title: "21 CFR §56.113"

source: "https://www.ecfr.gov/current/title-21/section-56.113"

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: "C"

subpart_subject: "IRB Functions and Operations"

section_number: "56.113"

section_subject: "Suspension or termination of IRB approval of research."

cfr_reference: "21 CFR 56.113"

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"

---

An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, appropriate institutional officials, and the Food and Drug Administration.

§56.113 - Suspension or termination of IRB approval of research.