Simplify informed consent documents into patient-friendly language while maintaining regulatory compliance (FDA 21CFR50, ICH-GCP, HIPAA) and required legal elements.
Transform complex informed consent documents into patient-friendly language while maintaining regulatory compliance and ethical standards.
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."
# 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
| Parameter | Type | Required | Description |
|---|---|---|---|
--input | file path | No | Input consent document (PDF or text) |
--text | string | No | Inline consent text to simplify |
--output | file path | No | Output file path |
--target-grade | integer | No | Target reading grade level (default: 8) |
Purpose of research · Procedures · Risks and discomforts · Benefits · Alternatives · Confidentiality · Compensation · Contact information · Voluntary participation
For complex multi-constraint requests, always include these explicit blocks:
scripts/main.py fails, report the failure point, summarize what still can be completed safely, and provide a manual fallback.This skill accepts: informed consent documents or text passages for readability simplification, with a target reading level and compliance preservation requirement.
If the request does not involve consent document simplification — for example, asking to draft new legal consent forms from scratch, provide regulatory legal advice, or simplify non-consent documents — do not proceed with the workflow. Instead respond:
"patient-consent-simplifier is designed to simplify existing informed consent documents for patient readability while preserving regulatory compliance. Your request appears to be outside this scope. For drafting new consent forms, consult your institution's IRB template library or a regulatory affairs specialist. Please provide a consent document or text, or use a more appropriate tool."
Use the following fixed structure for non-trivial requests:
If the request is simple, you may compress the structure, but still keep assumptions and limits explicit when they affect correctness.