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irb-protocol

@astoreyai/ai_scientist
2
0

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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SKILL.md

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