59 lines
1.4 KiB
Markdown
59 lines
1.4 KiB
Markdown
---
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name: irb-protocol
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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."
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allowed-tools: Read, Write
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version: 1.0.0
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---
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# IRB Protocol Development Skill
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## Purpose
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Create comprehensive ethical protocols for institutional review board approval.
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## Key IRB Components
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**1. Study Purpose**
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- Research question
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- Scientific justification
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- Expected benefits
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**2. Study Design**
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- Methodology overview
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- Sample size justification
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- Duration and timeline
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**3. Participant Selection**
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- Inclusion/exclusion criteria
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- Recruitment methods
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- Vulnerable populations addressed
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**4. Risks and Benefits**
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- Potential risks identified
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- Risk mitigation strategies
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- Benefits to participants/society
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- Risk-benefit analysis
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**5. Informed Consent**
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- Voluntary participation
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- Right to withdraw
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- Clear language (8th grade level)
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- Comprehension assessment
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**6. Privacy and Confidentiality**
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- Data protection measures
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- Anonymization/de-identification
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- Data storage and security
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- Data sharing plans
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**7. Compensation**
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- Payment amount and schedule
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- Justified as not coercive
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## Risk Categories
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**Minimal Risk**: No greater than daily life
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**More than Minimal**: Requires full board review
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---
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**Version:** 1.0.0
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