IRB Protocol Development Skill
irb-protocol
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.
SKILL.md
Full skill instructions
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