playbooks

home / skills / a5c-ai / babysitter / research-ethics-irb-navigation

research-ethics-irb-navigation skill

/plugins/babysitter/skills/babysit/process/specializations/domains/social-sciences-humanities/humanities/skills/research-ethics-irb-navigation

This skill helps prepare ethics applications and navigate IRB processes for human subjects research, ensuring informed consent and ongoing compliance.

npx playbooks add skill a5c-ai/babysitter --skill research-ethics-irb-navigation

Review the files below or copy the command above to add this skill to your agents.

Files (1)
SKILL.md
2.1 KB
---
name: research-ethics-irb-navigation
description: Prepare ethics applications, develop informed consent protocols, and navigate institutional review processes for human subjects research
allowed-tools: Read, Grep, Write, Edit, Glob, WebFetch
---

# Research Ethics and IRB Navigation

Prepare ethics applications, develop informed consent protocols, and navigate institutional review processes for human subjects research.

## Overview

This skill enables ethical conduct of human subjects research. It encompasses ethics application preparation, informed consent development, and IRB process navigation to ensure research meets ethical standards and regulatory requirements.

## Capabilities

### Ethics Application
- Protocol development
- Risk assessment
- Benefit justification
- Population protection
- Methodology description

### Informed Consent
- Consent document drafting
- Plain language writing
- Comprehension verification
- Special populations
- Ongoing consent processes

### IRB Navigation
- Submission requirements
- Review categories
- Response to conditions
- Amendment procedures
- Renewal processes

### Ongoing Compliance
- Adverse event reporting
- Protocol modifications
- Annual reviews
- Audit preparation
- Record maintenance

## Usage Guidelines

### Application Process
1. Review IRB requirements
2. Develop research protocol
3. Assess risks and benefits
4. Draft consent documents
5. Complete application forms
6. Submit for review
7. Respond to conditions

### Consent Best Practices
- Use plain language
- Include all required elements
- Explain voluntariness
- Describe risks clearly
- Provide contact information

### Compliance Maintenance
- Follow approved protocol
- Report changes promptly
- Document consent process
- Maintain records
- Submit renewals timely

## Integration Points

### Related Processes
- Ethnographic Fieldwork Planning
- Research Ethics Review
- Oral History Collection Protocol

### Collaborating Skills
- oral-history-interview-technique
- ethnographic-coding-thematics
- grant-narrative-writing

## References

- Belmont Report
- Common Rule
- IRB guidelines
- Research ethics literature

Overview

This skill helps researchers prepare ethics applications, develop informed consent protocols, and navigate institutional review board (IRB) processes for human subjects research. It focuses on creating clear protocols, minimizing participant risk, and maintaining compliance through the lifecycle of a study. The goal is practical readiness for submission and ongoing regulatory adherence.

How this skill works

I inspect project aims, methods, participant populations, and data flows to draft compliant protocols and consent materials. I map required IRB submission components, flag likely review categories, and generate responses to common IRB conditions or queries. I also produce templates and checklists for reporting, amendments, renewals, and adverse events to support ongoing compliance.

When to use it

  • Preparing an initial IRB application for new human subjects research
  • Drafting or revising informed consent forms for clarity and legal completeness
  • Assessing study risk/benefit and planning participant protections
  • Responding to IRB stipulations, conditions, or requests for clarification
  • Planning amendments, renewals, or adverse event reporting during a study

Best practices

  • Start by reviewing the specific IRB’s submission checklist and local regulations
  • Write consent documents in plain language tailored to the participant population
  • Document procedures that minimize risk and monitor participant safety
  • Keep versioned records of protocols, consent forms, and communications
  • Respond to IRB queries promptly and provide clear, evidence-backed amendments

Example use cases

  • Create a full protocol and consent packet for a minimal-risk survey study
  • Convert a complex clinical protocol into a clear IRB-ready submission
  • Draft assent and guardian consent forms for studies involving minors
  • Prepare an IRB response letter addressing requested revisions
  • Develop an adverse event reporting template and annual review checklist

FAQ

Can this skill adapt consent language for special populations?

Yes. I provide plain-language versions, age-appropriate assent, and accommodations for cognitive or language differences tied to the population you specify.

Will it determine whether my study qualifies for exempt or expedited review?

I can evaluate study features against common review categories and suggest likely classifications, but final determination rests with the IRB.