---
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
graph:
  domains: [domain:humanities]
  specializations: [specialization:digital-humanities]
  skillAreas: [skill-area:compliance-automation, skill-area:data-governance, skill-area:data-protection-dlp]
  workflows: [workflow:peer-review-cycle]
  roles: [role:compliance-officer, role:privacy-engineer]
---

# 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


---
Source attribution: a5c-ai
Original project: https://github.com/a5c-ai/babysitter/blob/feb68abe397acc14f32b34984975c48fedba2b33/library/specializations/domains/social-sciences-humanities/humanities/skills/research-ethics-irb-navigation/SKILL.md
License: MIT
License information: https://opensource.org/license/mit
Original upstream instructions; downloaded from Dave AI.

## Upstream license notice

# MIT License

Copyright (c) 2025 A5C AI

Permission is hereby granted, free of charge, to any person obtaining a copy
of this software and associated documentation files (the "Software"), to deal
in the Software without restriction, including without limitation the rights
to use, copy, modify, merge, publish, distribute, sublicense, and/or sell
copies of the Software, and to permit persons to whom the Software is
furnished to do so, subject to the following conditions:

The above copyright notice and this permission notice shall be included in all
copies or substantial portions of the Software.

THE SOFTWARE IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND, EXPRESS OR
IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE
AUTHORS OR COPYRIGHT HOLDERS BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER
LIABILITY, WHETHER IN AN ACTION OF CONTRACT, TORT OR OTHERWISE, ARISING FROM,
OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE
SOFTWARE.



# Dave AI resource metadata

Creator / publisher: a5c-ai
Original project: https://github.com/a5c-ai/babysitter/blob/feb68abe397acc14f32b34984975c48fedba2b33/library/specializations/domains/social-sciences-humanities/humanities/skills/research-ethics-irb-navigation/SKILL.md
Attribution basis: Source repository record

Fields of work: Education & Research, Healthcare & Life Sciences
Roles: Academic Writer, Clinical Research, Curriculum Designer, Researcher, Tutor / Instructor
Specialties: Specialty not specified
Tools: Tool not specified
Country applicability: Country not specified
Classification basis: Source catalog labels
Instruction SHA-256: d7d09da51ec7ed818cf626a8f61cb6850ed088d16bd1e75f48a84eaa0f2ec8e2