IRB Registration Requirements and Procedures
This guidance assists Institutional Review Boards (IRBs) in complying with FDA's requirement for IRB registration. It applies to all IRBs in the United States that review FDA-regulated studies and provides voluntary registration options for non-U.S. IRBs.
Recommended Actions
- Register IRB through the HHS electronic system if not already registered
- Ensure all required information is provided accurately
- Implement a process to track registration renewal every 3 years
- Establish procedures to update registration information within required timeframes:
- 90 days for contact information changes
- 30 days for changes in types of products reviewed
- 30 days for IRB disbandment
- Maintain documentation of registration and updates
- Monitor compliance with registration requirements as part of quality system
- Train relevant personnel on registration requirements and procedures
Key Considerations
Other considerations
- IRBs must register through the HHS Internet-based registration system
- Required registration information includes:
- Institution and senior officer contact details
- IRB name and contact information
- IRB chairperson details
- Number of active protocols involving FDA-regulated products
- Types of FDA-regulated products reviewed
- Registration must be renewed every 3 years
- Changes to contact information must be updated within 90 days
- Changes to types of products reviewed must be reported within 30 days
- Disbandment must be reported within 30 days
- Non-compliance with registration requirements may result in FDA inspection
Relevant Guidances
- IRB Responsibilities for Reviewing Investigator Qualifications, Research Sites, and IND/IDE Requirements
- Minutes of Institutional Review Board (IRB) Meetings - Content and Documentation Requirements
- Written Procedures for Institutional Review Boards (IRBs): Administrative Requirements and Operations
Related references and norms
- 21 CFR Part 56: Institutional Review Boards
- 21 CFR Part 312: Investigational New Drug Application
- 21 CFR Part 812: Investigational Device Exemptions
Original guidance
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