compliance/irb.rs - IRB Compliance Documentation Generator Abstract

High-Level Purpose

Comprehensive Institutional Review Board (IRB) compliance system that automatically generates ethics approval documentation, risk assessments, consent forms, and regulatory compliance reports for human subjects research across multiple jurisdictions.

Key Data Structures and Relationships

  • IRBComplianceGenerator: Central compliance orchestration with institutional context
  • Risk Assessment Framework: Structured risk evaluation with categorization, mitigation, and monitoring
  • Consent Management: Multi-template consent form generation with regulatory compliance
  • Data Protection Planning: Comprehensive data security and privacy compliance framework
  • Regulatory Adaptation: Multi-jurisdiction support (US, EU, Canada, UK) with appropriate regulatory frameworks

Main Data Flows

  • Application Generation: Automated IRB application creation from experiment specifications
  • Risk Analysis Pipeline: Systematic risk identification, assessment, and mitigation planning
  • Consent Form Creation: Template-based consent form generation with regulatory element compliance
  • Document Package Export: Complete IRB submission package generation with supporting documentation
  • Compliance Monitoring: Ongoing compliance status assessment and reporting

External Dependencies

  • serde: Serialization for compliance documentation and export
  • chrono: Date/time management for regulatory timelines and compliance tracking
  • Standard library for file I/O and document generation

State Management Patterns

  • Institutional Context: Maintained institutional and PI information for application consistency
  • Risk Registry: Comprehensive risk assessment database with mitigation tracking
  • Template Library: Consent form templates with population-specific customization
  • Compliance Status: Real-time compliance monitoring with issue tracking and recommendations

Core Algorithms and Business Logic Abstractions

  • Risk Stratification: Multi-dimensional risk assessment with probability-severity matrices
  • Regulatory Mapping: Automatic application of appropriate regulatory frameworks based on jurisdiction
  • Consent Optimization: Dynamic consent form generation based on study characteristics and populations
  • Documentation Automation: Intelligent document generation from structured study metadata
  • Compliance Validation: Comprehensive pre-submission validation and completeness checking

Regulatory Compliance Features

  • Multi-Jurisdiction Support: Full compliance with US (45 CFR 46), EU (GDPR), and other international standards
  • Vulnerable Population Protection: Specialized handling of children, prisoners, and other protected populations
  • Risk Minimization: Systematic risk identification and mitigation planning
  • Data Protection Integration: Comprehensive data security and privacy compliance frameworks
  • Audit Trail Integration: Complete documentation lifecycle tracking for regulatory inspection

Ethical Research Support

  • Systematic Risk Assessment: Evidence-based risk evaluation with standardized methodologies
  • Transparent Documentation: Complete documentation of ethical considerations and mitigation strategies
  • Stakeholder Communication: Clear, accessible consent forms and participant communications
  • Ongoing Monitoring: Continuous compliance monitoring with automated reporting and alerting