ITWC IRB

powered By Sova Healthcare Innovation Systems

Serving Indigenous Communities & Healthcare Innovation

Advanced IRB Management for SOVA Health

Secure, compliant research ethics oversight for AI-powered healthcare innovation. Built with HIPAA-minded patterns and Indigenous governance principles.

IRB Sponsor
Intertribal Wellness Coalition
Developer
Innovation Systems, Inc.
Operator
Platform, Inc.
Data Steward
Health Data Trust, LLC

Complete IRB Management Platform

Purpose-built for research ethics oversight with advanced security, compliance features, and streamlined workflows.

Protocol Management

Comprehensive study protocol tracking with version control and audit trails

  • • SOVA-MRP Master Protocol
  • • SPA-A through SPA-G Studies
  • • Markdown-based documentation
  • • Automated PDF generation

Role-Based Access

Granular permissions for IRB members, PIs, coordinators, and auditors

  • • IRB Chair & Member roles
  • • Principal Investigator access
  • • Community Advisory Board
  • • External auditor support

Submission Workflow

Streamlined review process from initial submission to final approval

  • • Initial & continuing review
  • • Amendment processing
  • • Reportable event handling
  • • Automated notifications

Consent Management

Digital consent collection with e-signatures and multi-language support

  • • English & Spanish forms
  • • Electronic signatures
  • • Version tracking
  • • Cultural governance disclosure

Security & Compliance

HIPAA-minded architecture with comprehensive audit trails and data protection

  • • End-to-end encryption
  • • Comprehensive audit logs
  • • PII/PHI protection
  • • Secure file storage

AI Integration Ready

Built-in support for AI model governance and predetermined change control plans

  • • Voice-to-chart systems
  • • AI triage & navigation
  • • RPM telemetry analysis
  • • PCCP framework support

Research Governance Structure

Comprehensive oversight structure ensures ethical conduct and regulatory compliance across all SOVA Health research initiatives.

Research Oversight Framework

Master Research Protocol

SOVA-MRP v1.0 - Integrating Modern Technology & AI into the Patient Care Process. Comprehensive framework governing 7 Sub-Protocol Addenda (SPAs) with FDA-IRB oversight.

Active Sub-Studies

SPA-A: AI Voice-to-Chart (Clinical NLP)
SPA-B: AI Triage & Care Navigation
SPA-C: Remote Patient Monitoring (RPM) Telemetry
SPA-D: Behavioral Health & Care Experience
SPA-E: Culturally Aligned Care
SPA-F: Chronic Pain Management
SPA-G: Home Health Sleep Trials

Regulatory Framework

FDA-IRB Registration #011985 with OHRP compliance, NIST AI RMF alignment, and comprehensive PCCP/ACP framework for AI model lifecycle management.

Dual Sovereignty

IRB + Community Governance framework integrating federal oversight with tribal sovereignty, data sovereignty protections, and Indigeneopathic Medicine collaboration.

Ready to Streamline Your IRB Operations?

Join the platform designed specifically for research ethics oversight in AI-powered healthcare innovation.

Access IRB System