| name | patient-consent-simplifier |
| title | Patient Consent Simplifier |
| description | Simplify informed consent documents into patient-friendly language while maintaining regulatory compliance (FDA 21CFR50, ICH-GCP, HIPAA) and required legal elements. |
| author | aipoch |
| author_url | https://github.com/aipoch/medical-research-skills/tree/main/scientific-skills/Other/patient-consent-simplifier |
| license | MIT |
| version | 0.1.0 |
| execution_mode | open |
| jurisdiction | us |
| practice | healthcare |
| language | en |
Source: https://github.com/aipoch/medical-research-skills
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
- 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."
- Confirm the input document, target reading level, and whether legal elements must be preserved.
- Validate that the request is for consent simplification, not legal drafting or regulatory submission.
- Apply simplification rules: break long sentences, replace jargon, use active voice, maintain required elements.
- Assess readability and check compliance against required elements checklist.
- Return the simplified document with a readability report and compliance status.
- 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
| Parameter | Type | Required | Description |
|---|
--input | file path | No |
