Regulatory & Ethics

Ethical, transparent, and compliant research starts with strong governance.

This section provides the tools, guidelines, and SOPs you need to meet Canadian regulatory and ethics requirements, support consistent REB processes, reduce delays, strengthen oversight, and build trust across every stage of a study.

Whether you’re setting up new systems or improving existing ones, these resources help you conduct research that’s ethical, compliant, and trusted.

Research Ethics Board (REB) SOPs

N2 CAREB-ACCER REB SOPs

Available in English and French | Open Source

N2 and CAREB-ACCER jointly developed these SOPs to provide a standardized Canadian framework for Research Ethics Boards (REBs) reviewing health-sciences research. They meet Canadian and U.S. regulatory and ethics requirements and are available open access in English and French.

These SOPs support a single national standard, helping streamline REB processes, improve consistency, and uphold high ethical and regulatory expectations.

Note: Modifying the SOPs may affect compliance. SOPs are provided as print-only PDFs to maintain integrity.

Access resource

Regulatory Agencies & Key Guidelines

These resources link directly to the primary regulations and ethics frameworks that guide clinical research in Canada.

Health Canada
Medical Devices

 

Tri-Council Policy Statement (TCPS 2, 2022)

  • TCPS 2
    Ethical guidance for all research involving humans in Canada.

U.S. Food and Drug Administration (FDA)

 

Quality, Risk & Compliance Tools

Available in English and French | Member Access Only

Quality Management Tools

Tools to help institutions develop, evaluate, and strengthen their internal quality systems, SOPs, and oversight processes.

Includes:

      • Risk Management Tools
        Tools that help teams identify and manage study-level and institutional risks.

      • Quality Management System (QMS) Templates
        Tools to support strong quality systems, SOPs, and oversight processes.

      • Audit & CAPA Tools
        Tools for audits, classifying findings, and planning effective CAPA activities

Health Canada Inspection Guidances

Tools to help research teams prepare for Health Canada inspections, meet regulatory expectations, and respond effectively to audit findings.

Includes:

  • Full guidance documents (step-by-step instructions, checklists, planning tools)

  • Quick-reference one-pagers for real-time inspection readiness

  • Resources supporting delegation, protocol deviation management, and essential documentation

 

Cannabis Research Compliance Tools

These tools support researchers and institutions conducting cannabis-related studies in Canada. Developed to align with Health Canada’s licensing and Good Production Practices requirements, these checklists and templates help ensure compliance throughout study startup and monitoring.

Includes:

  • Step-by-step Cannabis Application Checklist for individual licensing

  • Monitoring Checklist for ongoing compliance during research

  • Roles & Responsibilities guidance for key personnel under a cannabis research licence

  • Good Production Practices (GPP) reference tools for sanitation, environmental controls, security, and product handling

    Privacy Guidance Documents

    Tools that support privacy, confidentiality, and PHI compliance in health research.

    Includes:

    • Hospital privacy toolkit

    • PHIPA FAQs

    • Privacy guidance documents

    • Health Canada privacy guidance

    • Privacy reference summary