patient-consent-simplifier

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

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

Parameter	Type	Required	Description
--input	file path	No