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.
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.
Verwandte Skills
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