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.

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Install this agent skill to your Project

npx add-skill https://github.com/majiayu000/claude-skill-registry/tree/main/skills/development/irb-protocol

SKILL.md

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