An IRB review is meant assure the following:
- Risks to subjects minimized
- Risks to subjects are reasonable
- Selection of subjects is equitable
- Informed consent will be obtained
- Data will be monitored
- Protection of subject privacy and confidentiality of data
- Additional safeguards for vulnerable subjects
- Expedited review procedures
The IRB review should include the following documents:
- Clinical trial protocol/amendments
- Written informed consent process
- Investigator’s Brochure (IB)
- Payments/compensation to subjects
- Form 1572/CVs
- Subject recruitment procedures (ads)
- Subject information
The IRB review should provide the following for clinical trial documentation:
- Provide approval
- Modifications required
- Disapproval
- Termination/suspension
- Reasons for (if applicable) in writing.
