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
- 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).
- 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.
- - 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.