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skills/irb-protocol/SKILL.md

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+---
+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