| 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
