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.
When & Why to Use This Skill
This Claude skill streamlines the development of comprehensive IRB and ethics protocols for human subjects research, ensuring full compliance with institutional standards and ethical guidelines. It assists researchers in structuring essential components such as study design, risk mitigation, and informed consent to facilitate smoother institutional approvals.
Use Cases
- Academic researchers planning new studies involving human participants to ensure ethical integrity and scientific justification.
- Graduate students preparing detailed IRB applications for thesis or dissertation projects to meet university requirements.
- Research compliance officers reviewing protocols to identify potential risks and ensure robust data protection measures.
- Healthcare professionals designing clinical trials that require clear informed consent documentation and participant recruitment strategies.
| 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