research-ethics
Guides research ethics compliance including IRB protocol preparation, informed consent document drafting, research integrity standards, data management plans, and ethical considerations for human/animal subjects; trigger when users discuss IRB, ethical approval, consent forms, or responsible conduct of research.
Best use case
research-ethics is best used when you need a repeatable AI agent workflow instead of a one-off prompt.
Guides research ethics compliance including IRB protocol preparation, informed consent document drafting, research integrity standards, data management plans, and ethical considerations for human/animal subjects; trigger when users discuss IRB, ethical approval, consent forms, or responsible conduct of research.
Teams using research-ethics should expect a more consistent output, faster repeated execution, less prompt rewriting.
When to use this skill
- You want a reusable workflow that can be run more than once with consistent structure.
When not to use this skill
- You only need a quick one-off answer and do not need a reusable workflow.
- You cannot install or maintain the underlying files, dependencies, or repository context.
Installation
Claude Code / Cursor / Codex
Manual Installation
- Download SKILL.md from GitHub
- Place it in
.claude/skills/research-ethics/SKILL.mdinside your project - Restart your AI agent — it will auto-discover the skill
How research-ethics Compares
| Feature / Agent | research-ethics | Standard Approach |
|---|---|---|
| Platform Support | Not specified | Limited / Varies |
| Context Awareness | High | Baseline |
| Installation Complexity | Unknown | N/A |
Frequently Asked Questions
What does this skill do?
Guides research ethics compliance including IRB protocol preparation, informed consent document drafting, research integrity standards, data management plans, and ethical considerations for human/animal subjects; trigger when users discuss IRB, ethical approval, consent forms, or responsible conduct of research.
Where can I find the source code?
You can find the source code on GitHub using the link provided at the top of the page.
SKILL.md Source
## When to Trigger Activate this skill when the user mentions: - IRB (Institutional Review Board), ethics committee approval - Informed consent, assent forms, consent waivers - Human subjects research, vulnerable populations - IACUC, animal research protocols, the 3Rs - Research integrity, fabrication, falsification, plagiarism - Data management plans, data sharing obligations - Conflicts of interest, dual-use research - HIPAA, GDPR, data privacy in research ## Step-by-Step Methodology 1. **Determine regulatory framework** - Identify applicable regulations: Common Rule (45 CFR 46) for US federally funded human research, FDA regulations for clinical trials, IACUC guidelines for animal research. Determine if international guidelines apply (Declaration of Helsinki, ICH-GCP). 2. **Risk assessment** - Classify research risk level: exempt, expedited, or full board review. Identify potential physical, psychological, social, legal, and economic risks to participants. Evaluate risk-benefit ratio. 3. **Protocol development** - Draft IRB protocol including: study objectives, design and procedures, participant population and recruitment methods, inclusion/exclusion criteria, risks and benefits, data security measures, and compensation plans. 4. **Informed consent preparation** - Write consent documents at appropriate reading level (8th grade for general populations). Include: purpose, procedures, risks, benefits, alternatives, confidentiality protections, voluntary participation statement, and contact information. Address special populations (children require assent + parental consent, prisoners, cognitively impaired). 5. **Data protection planning** - Develop data management plan addressing: identifiable vs. de-identified data, encryption and storage, access controls, retention period, sharing and archival policies. Ensure HIPAA compliance for health data, GDPR for EU participants. 6. **Research integrity framework** - Establish responsible conduct practices: proper authorship attribution (ICMJE criteria), conflict of interest disclosure, data integrity protocols, record keeping standards, and procedures for reporting misconduct. 7. **Ongoing compliance** - Plan for: annual continuing review, adverse event reporting, protocol amendments, audit readiness, participant withdrawal procedures, and study closure. ## Key Resources - **OHRP (Office for Human Research Protections)** - Federal guidance documents - **Belmont Report** - Foundational ethical principles - **CIOMS Guidelines** - International ethical guidelines - **ARRIVE Guidelines** - Animal research reporting standards - **NIH Data Management and Sharing Policy** - Data sharing requirements ## Output Format - IRB protocol as a structured document with all required sections. - Informed consent forms with proper formatting and reading level. - Risk assessment as a table: risk category, likelihood, severity, mitigation strategy. - Data management plan following funder-specific templates (NIH, NSF). - Ethics checklist for study-specific considerations. ## Quality Checklist - [ ] Applicable regulatory framework identified and cited - [ ] Risk level classification justified - [ ] Informed consent written at appropriate reading level - [ ] Vulnerable population protections addressed if applicable - [ ] Data security measures commensurate with data sensitivity - [ ] Confidentiality and anonymization procedures specified - [ ] Conflict of interest disclosures complete - [ ] Adverse event reporting procedures defined - [ ] Cultural sensitivity considered in consent and recruitment materials
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