Reference:USA 45 CFR Part 46 09-Apr-2025 Subpart E

Document information
Reference	USA 45 CFR Part 46 09-Apr-2025
Validity area	USA
Scope(s)	G
Document name	45 CFR Part 46
Version / Revision	09-Apr-2025
Status	Current
Document type	Legal act
Language(s)	EN
Description	Title 45—Public Welfare Subtitle A—Department of Health and Human Services Subchapter A—General Administration Part 46 Protection of Human Subjects https://www.ecfr.gov/current/title-45
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Module	Module 1 — Unit 1.5.3
Scope	G
Document part	Subpart E
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Ethics committee, Requirements, Compliance
Comment	IRB registration requirements

Content

Subpart E—Registration of Institutional Review Boards […] § 46.501 What IRBs must be registered? Each IRB that is designated by an institution under an assurance of compliance approved for federalwide use by the Office for Human Research Protections (OHRP) under § 46.103(a) and that reviews research involving human subjects conducted or supported by the Department of Health and Human Services (HHS) must be registered with HHS. An individual authorized to act on behalf of the institution or organization operating the IRB must submit the registration information.

§ 46.502 What information must be provided when registering an IRB? [...] § 46.503 When must an IRB be registered? [...] § 46.504 How must an IRB be registered? [...] § 46.505 When must IRB registration information be renewed or updated? [...]