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.
What You Need to Know? 👇
What are the key requirements for IRB registration under FDA regulations?
All U.S. IRBs reviewing FDA-regulated studies must register electronically through the HHS system. Required information includes institution details, IRB contact information, chairperson details, number of active protocols, and types of FDA-regulated products reviewed. Registration must be renewed every 3 years.
When must IRBs update their registration information after initial submission?
IRBs must update contact or chairperson information within 90 days of changes. Changes in types of FDA-regulated products reviewed or discontinuation of FDA-regulated research must be reported within 30 days. IRB disbandment must be reported within 30 days of permanent cessation.
Does IRB registration with FDA constitute accreditation or certification of compliance?
No, IRB registration is not accreditation or certification. It doesn’t imply full compliance with 21 CFR Part 56 or meeting particular competence standards. Registration is simply a regulatory requirement for tracking IRBs that review FDA-regulated studies, not a quality assurance measure.
What are the consequences for sponsors using unregistered IRBs for FDA-regulated studies?
Sponsors and investigators using unregistered IRBs could be considered noncompliant with FDA regulations. Since regulations require using IRBs compliant with 21 CFR Part 56, and registration is mandatory, using unregistered IRBs violates regulatory requirements and may result in enforcement actions.
How does the FDA IRB registration system relate to OHRP registration requirements?
FDA uses a modified version of OHRP’s registration system. IRBs already registered with OHRP must add FDA-required information. Both agencies use the same electronic platform, but each has specific requirements. IRBs may be subject to one or both registration requirements.
What information from IRB registration is publicly available under FOIA?
Organization and IRB names and locations are publicly available on OHRP’s website. Other registration information is subject to Freedom of Information Act requests and FDA’s public information regulations, though certain information may be withheld or require individual consent for disclosure.
What You Need to Do 👇
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): Content and Organization
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