IRB Compliance Auditor
Audit IRB protocols and identify compliance risks systematically
by nextlevelbuilderResearch & AcademiaAcademic ServicesInstitutional Review Board AdministratorAuditingWhat You Can Do
You receive a detailed systematic audit of your IRB protocol against federal regulations, institutional policies, and ethical standards. The skill identifies specific compliance gaps, maps findings to regulatory citations, and generates documented recommendations for remediation. You get a structured compliance assessment that pinpoints risk areas before submission or inspection.
Features
Analyzes complete IRB protocols against 45 CFR 46, FDA regulations, and institutional requirements to ensure all required elements are present and compliant.
Flags potential compliance issues, categorizes them by severity (critical, major, minor), and explains the regulatory violation or ethical concern for each finding.
Cross-references every finding to specific CFR sections, FDA guidance documents, Common Rule requirements, and institutional policy to provide regulatory context.
Generates a structured audit report with executive summary, detailed findings, risk levels, affected regulations, and evidence from the protocol.
Provides specific, actionable corrective actions for each finding with priority sequencing and implementation guidance.
Creates a visual mapping of protocol elements against required regulatory components to identify missing or incomplete sections.
Checks for appropriate protections and consent language when protocols involve vulnerable populations (minors, pregnant women, prisoners, cognitively impaired).
Documents current protocol status, outstanding risks, and provides a checklist for monitoring remediation progress and follow-up review.
Example Output
Audit Summary
- Total Findings: 7 (1 critical, 3 major, 3 minor)
- Compliance Risk Level: Moderate
- Estimated Remediation Time: 5–7 business days
Critical Finding: Informed Consent
- Issue: Consent form lacks adequate risk disclosure for Study Arm B
- Citation: 45 CFR 46.116(a)(2) — must describe reasonably foreseeable risks
- Recommendation: Add specific risk rates, side effects, and mitigation strategies to consent document
Major Finding: Vulnerable Population Protection
- Issue: Protocol involves children but lacks assent procedures for ages 7–11
- Citation: 45 CFR 46 Subpart D (Children)
- Recommendation: Develop age-appropriate assent form; document justification if assent waived
Remediation Checklist
- Revise consent form (due date: 2 weeks)
- Add assent procedures (due date: 2 weeks)
- Re-submit amended protocol to IRB
- Follow-up audit in 30 days
What's Included
- Compliance Audit Checklist: Comprehensive review template covering protocol content, informed consent, research design, data safety, subject protections, and regulatory requirements.
- Risk Assessment Matrix: Structured framework to evaluate each finding by severity (critical/major/minor), likelihood, and regulatory impact with color-coded urgency levels.
- Regulatory Reference Guide: Quick-lookup reference linking Common Rule sections, FDA guidance, institutional policies, and ethical standards to protocol audit findings.
- Findings Report Template: Formatted audit report with executive summary, detailed findings, regulatory citations, evidence excerpts, and prioritized remediation roadmap.
- Remediation Action Plan: Structured tracking tool to document corrective actions, responsible parties, deadlines, and verification steps for each identified gap.
- Special Population Checklist: Targeted review for children, prisoners, pregnant women, and cognitively impaired subjects with subpart-specific regulatory requirements.
Who It's For
- IRB Coordinators & Administrators
- Compliance Officers
- Research Protocol Managers
- Ethics Committee Members
- Research Compliance Specialists
Best For
- Initial protocol screening before IRB submission
- Compliance audits and regulatory inspections
- Gap analysis for remediation planning
- Protocol amendments and continuing review
- Regulatory readiness and quality assurance
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