IRB Responsibilities for Reviewing Investigator Qualifications, Research Sites, and IND/IDE Requirements

Recommended Actions

1. Develop written procedures for:
   • Evaluating investigator qualifications
   • Assessing research site adequacy
   • Making SR/NSR determinations for device studies
2. Implement process to verify investigator qualifications through:
   • CV review
   • License verification
   • Previous experience assessment
   • FDA compliance history check
3. Establish site adequacy assessment procedures:
   • Document facility capabilities
   • Verify staffing and equipment
   • Confirm emergency care availability
4. Create IND/IDE verification process:
   • Request determination documentation
   • Establish communication procedures with sponsors
   • Document risk determinations
   • Define escalation process for disputed determinations
5. Train IRB staff on:
   • Qualification review procedures
   • Site assessment requirements
   • IND/IDE determination verification
   • Risk assessment criteria

Key Considerations

Clinical testing

• IRBs must review investigator qualifications to conduct and supervise the proposed research
• Additional scrutiny needed for sponsor-investigators, studies outside investigator’s expertise, or high-risk studies
• IRBs should check FDA’s website for investigator inspection history and compliance information

Safety

• IRBs must assess adequacy of research sites including:
  • Appropriate staffing and equipment
  • Availability of emergency/specialized care if needed
  • Facility resources relevant to the research

Other considerations

• IRBs must verify IND/IDE determinations:
  • Ask investigators about IND/IDE requirements and basis for determination
  • Review sponsor’s risk determination for device studies (SR/NSR)
  • Follow procedures for resolving disputed determinations
  • Document SR/NSR determinations in meeting minutes

    Relevant Guidances

• IDE Clinical Investigation Decision Process and Requirements
• Early Feasibility Medical Device Clinical Studies Including First in Human (FIH) Studies
• Design Considerations for Medical Device Pivotal Clinical Studies

Related references and norms

• ICH E6: Good Clinical Practice: Consolidated Guidance

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Original guidance

• IRB Responsibilities for Reviewing Investigator Qualifications, Research Sites, and IND/IDE Requirements
• HTML / PDF
• Issue date: 2013-08-27
• Last changed date: 2021-07-22
• Status: FINAL
• Official FDA topics: Medical Devices, Good Clinical Practice (GCP), Drugs, Biologics, Administrative / Procedural
• ReguVirta summary file ID: cda1aafe9b282df31f0449f2119db7e7