---
name: irb-protocol
description: "Develop IRB/ethics protocols for human subjects research. Use when: (1) Planning studies involving humans, (2) Preparing IRB applications, (3) Ensuring ethical compliance, (4) Addressing informed consent."
allowed-tools: Read, Write
version: 1.0.0
---

# IRB Protocol Development Skill

## Purpose
Create comprehensive ethical protocols for institutional review board approval.

## Key IRB Components

**1. Study Purpose**
- Research question
- Scientific justification
- Expected benefits

**2. Study Design**
- Methodology overview
- Sample size justification
- Duration and timeline

**3. Participant Selection**
- Inclusion/exclusion criteria
- Recruitment methods
- Vulnerable populations addressed

**4. Risks and Benefits**
- Potential risks identified
- Risk mitigation strategies
- Benefits to participants/society
- Risk-benefit analysis

**5. Informed Consent**
- Voluntary participation
- Right to withdraw
- Clear language (8th grade level)
- Comprehension assessment

**6. Privacy and Confidentiality**
- Data protection measures
- Anonymization/de-identification
- Data storage and security
- Data sharing plans

**7. Compensation**
- Payment amount and schedule
- Justified as not coercive

## Risk Categories

**Minimal Risk**: No greater than daily life
**More than Minimal**: Requires full board review

---
**Version:** 1.0.0