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.
- 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.
- 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).
- 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.
- 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.
- 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