IRB Application Assistant

2. Protocol Compliance Review

Checks a research protocol against IRB requirements and flags missing or non-compliant sections.

python scripts/main.py --task compliance-check \
  --protocol protocol.json \
  --ruleset federal-common-rule \
  --output compliance_report.txt

3. Application Form Generation

Generates completed IRB application forms (e.g., initial review, continuing review, amendment) from structured study data.

python scripts/main.py --task generate-application \
  --form-type initial-review \
  --config study_config.json \
  --output irb_application.docx

4. Submission Checklist Validation

Validates that all required documents and fields are present before submission.

python scripts/main.py --task validate-submission \
  --package irb_package/ \
  --output validation_report.txt

Recommended Workflow

Follow these steps for a complete IRB submission:

1. Prepare study configuration — Populate study_config.json with study title, PI details, participant population, risk level, and procedures.
2. Run compliance check — Use --task compliance-check to identify gaps in the protocol before drafting documents.
   • ⛔ Checkpoint: If the compliance report flags ANY errors, resolve ALL flagged items and re-run --task compliance-check before proceeding. Do not advance to step 3 with unresolved compliance errors.
3. Generate consent document — Use --task consent to produce a compliant informed consent form tailored to the study.
4. Generate application forms — Use --task generate-application to produce the required IRB submission forms.
5. Validate submission package — Use --task validate-submission to confirm all required documents are present and fields are complete.
   • ⛔ Checkpoint: If validation fails, follow this loop: review errors in validation_report.txt → fix each issue → re-run --task validate-submission → only proceed when the report shows zero blocking errors.
6. Review and submit — Manually review any remaining warnings in the compliance and validation reports before submitting to the IRB.

Quality Checklist

• Protocol includes all required sections (purpose, procedures, risks, benefits, confidentiality)
• Informed consent language is at appropriate reading level for participant population
• Risk level classification is justified and documented
• All required attachments (recruitment materials, surveys, data management plan) are included
• Compliance report reviewed and all flagged items resolved
• Submission package validated with zero blocking errors

References

• references/guide.md — Detailed documentation and field descriptions
• references/examples/ — Sample protocols, consent forms, and completed applications

Skill ID: 952 | Version: 1.0 | License: MIT