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.

majiayu000 Updated 567 repo stars

File contents

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

majiayu000/claude-skill-registry-data/tree/main/data/irb-protocol commit 828aa4a38e

Frequently asked questions

npx skillmds@latest add majiayu000/irb-protocol