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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

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Version: 1.0.0