Research Ethics

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