IRB Requirements
US-unique
The US IRB system operates under 21 CFR Part 56 for FDA-regulated studies and 45 CFR Part 46 (the "Common Rule") for HHS-funded research. While other countries have ethics committees, the US framework has specific procedural requirements.
What is an IRB?
An Institutional Review Board (IRB) is a review body that applies research ethics principles to protect human subjects in clinical investigations. For FDA-regulated device studies, IRB approval is required under 21 CFR Part 56.
IRB requirements for device studies
- All clinical investigations of devices subject to 21 CFR Part 812 must have IRB approval — whether SR or NSR
- The IRB must review and approve the study before it begins
- The IRB must conduct continuing review at least annually
- The IRB must review and approve any protocol amendments
What the IRB evaluates
- Risks to subjects are minimised and reasonable in relation to anticipated benefits
- Subject selection is equitable
- Informed consent is obtained and documented
- Adequate monitoring for subject safety
- Protection of privacy and confidentiality
FDA inspection of IRBs
FDA has authority to inspect IRBs and clinical investigators. IRB records must be retained for at least 3 years (or 3 years after completion of the study).