Patient Consent Simplifier

Transform complex informed consent documents into patient-friendly language while maintaining regulatory compliance and ethical standards.

Quick Check

python -m py_compile scripts/main.py
python scripts/main.py --help
python scripts/main.py --text "Audit validation sample with explicit methods, findings, and conclusion."

When to Use

• Use this skill when simplifying informed consent documents for clinical trials or medical procedures.
• Use this skill when adapting research summaries for lay audiences or patients with limited health literacy.
• Do not use this skill to remove required legal elements, downplay significant risks, or produce documents that bypass regulatory review.

Workflow

1. Sensitive Data Check: Before processing, check whether the input document contains patient identifiers (name, DOB, MRN, address). If found, emit a mandatory warning: "This document appears to contain patient PII/PHI. Ensure the document has been de-identified or that you have authorization to process it before proceeding."
2. Confirm the input document, target reading level, and whether legal elements must be preserved.
3. Validate that the request is for consent simplification, not legal drafting or regulatory submission.
4. Apply simplification rules: break long sentences, replace jargon, use active voice, maintain required elements.
5. Assess readability and check compliance against required elements checklist.
6. Return the simplified document with a readability report and compliance status.
7. If inputs are incomplete, state which fields are missing and request only the minimum additional information.

Usage

# Simplify from text
python scripts/main.py --text "Lumbar puncture will be performed under sterile conditions..."

# Simplify from file
python scripts/main.py --input consent_form.pdf --output simplified_consent.pdf --target-grade 8

# Check compliance only
python scripts/main.py --input document.pdf --check compliance

Parameters

Target Reading Levels

• General population: 8th grade
• Vulnerable populations: 6th grade
• Health literacy challenges: 4th–5th grade

Required Consent Elements (must be preserved)

Purpose of research · Procedures · Risks and discomforts · Benefits · Alternatives · Confidentiality · Compensation · Contact information · Voluntary participation

Simplification Rules

• Break sentences longer than 20 words
• Replace medical jargon with common terms
• Use active voice and second person ("you")
• Add visual aid placeholders where appropriate
• Never remove required legal elements