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safety

The safety block centralizes risk assessments, biosafety classifications, and mitigation measures required to run the protocol responsibly.

Field Reference

Field Type Required Units Allowed Types Constraints / Enum Example
biosafety_level string optional - enum BSL-1, BSL-2, BSL-3, BSL-4, non-applicable "BSL-1"
ethics_approval_type string optional - enum IRB, IACUC, HREC, internal, none "IRB"
ethics_approval_id string optional - string Institutional approval identifier "IRB2025-01"
ethics_approval_date date optional - ISO 8601 Approval date with YYYY-MM-DD format "2025-02-01"
notes string optional - string Additional handling instructions "Handle reagents with gloves"

You may extend the section with arrays such as controls[], hazards[], ppe[], or references[] if you want to link into a local safety management system or Standard Operating Procedures (SOPs).

Enum Notes

  • Biosafety levels (BSL) indicate containment requirements:
  • BSL-1 - routine teaching labs; minimal risk.
  • BSL-2 - moderate risk organisms; requires biological safety cabinets.
  • BSL-3 - high-risk airborne pathogens; controlled facility entry.
  • BSL-4 - maximum containment for dangerous agents.
  • non-applicable - no biological agents involved.
  • Ethics approval types map to governance bodies:
  • IRB (Institutional Review Board) - human subjects research.
  • IACUC - animal care and use committee.
  • HREC - human research ethics committee (common outside the US).
  • internal - company or lab-internal committee.
  • none - ethics approval not required (explain rationale in notes).

Documentation Guidance

  • Record PPE expectations (notes, ppe[]) such as gloves, goggles, or respirators.
  • Link to SOPs or emergency procedures using references objects ({ id, title, url }).
  • Capture waste disposal guidance, spill response, or decontamination steps to satisfy institutional audits.
  • When work spans multiple BSL zones, document location-specific requirements (notes: "Phase 1 in BSL-1, transfer to BSL-2").

Alignment with Materials and Devices

  • Cross-reference high-risk materials via materials[].hazards to keep messaging consistent.
  • Tie in equipment dependencies (e.g., biosafety_cabinet IDs) describing where certain steps must be performed.

Validation Notes

  • Enumerations are case-sensitive; deviations raise schema errors.
  • Dates must be ISO 8601; missing or malformed entries trigger S-class syntax warnings.
  • When used with attachments, ensure referenced SOP documents exist and match the declared access level.

Additional Reading