# 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.

- Skill: `beita6969/research-ethics` (Agent Skill)
- Install (CLI): `npx skillmds@latest add beita6969/research-ethics`
- Raw SKILL.md: https://api.skillmd.com/api/skills/beita6969/research-ethics/raw
- Safety review: pending
- Works with: Claude Code, Claude.ai, OpenAI Codex
- Category: Research & Search
- Author: beita6969 (https://skillmd.com/u/beita6969)
- Updated: 2026-09-09
- Page: https://skillmd.com/skills/beita6969/research-ethics

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## 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