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

What You Need to Know? 👇

What are the key IRB responsibilities when reviewing investigator qualifications for FDA-regulated research?

IRBs must review investigator qualifications to ensure they can conduct proposed research safely. This includes assessing training, experience, credentials, and specific expertise relevant to the study, particularly for high-risk studies or vulnerable populations.

How can IRBs access FDA information about clinical investigator inspection history?

IRBs can check FDA’s website for investigator inspection lists, Warning Letters, and disqualification proceedings. The Inspections, Compliance, Enforcement, and Criminal Investigations website provides comprehensive information about investigator compliance history.

What factors should IRBs consider when evaluating research site adequacy?

IRBs must assess whether sites have appropriate staff, equipment, and emergency care capabilities for the proposed research. For unfamiliar sites, IRBs should obtain statements confirming facility adequacy or request detailed facility descriptions.

When is an IND/IDE determination particularly critical for IRB review?

IRB verification is crucial for sponsor-investigator studies, device studies requiring significant risk determinations, and when investigators are uncertain about regulatory requirements. IRBs should request documentation supporting IND/IDE determinations.

How should IRBs handle disagreements about significant risk device study classifications?

If IRBs disagree with a sponsor’s nonsignificant risk determination, they must inform the investigator and sponsor that the study is significant risk, requiring FDA IDE approval before proceeding.

What resources are available to help IRBs make complex regulatory determinations?

IRBs can contact FDA review divisions directly for guidance on IND/IDE requirements. CDER, CBER, and CDRH provide specific contact information and assistance for regulatory determination questions.

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What You Need to Do 👇

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

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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 ID: cda1aafe9b282df31f0449f2119db7e7