Last Updated: December 12, 2024
SECTION 1: FUNDAMENTAL PRINCIPLES
1. Ethical Framework
□ Based on:
- Declaration of Helsinki
- Belmont Report Principles
- ICH-GCP Guidelines
- Local/National Regulations
2. Core Principles
□ Must ensure:
- Respect for persons
- Beneficence
- Justice
- Scientific validity
- Social value
SECTION 2: INSTITUTIONAL REVIEW REQUIREMENTS
1. Ethics Committee Approval
□ Mandatory requirements:
- IRB/EC approval before study initiation
- Protocol review documentation
- Approval number citation
- Annual review confirmation
- Protocol amendments approval
2. Documentation Required
□ Authors must submit:
- IRB approval letter
- Protocol number
- Study registration details
- Amendments (if any)
- Continuing review approvals
SECTION 3: INFORMED CONSENT
1. Consent Process
□ Requirements:
- Written informed consent
- Language appropriate to participants
- Time for consideration
- Documentation of process
- Witness requirements (when applicable)
2. Consent Documentation
□ Must include:
- Study purpose and procedures
- Risks and benefits
- Alternatives to participation
- Confidentiality measures
- Compensation details
- Contact information
- Right to withdraw
3. Special Circumstances
□ Guidelines for:
- Electronic consent
- Verbal consent
- Proxy consent
- Assent from minors
- Emergency research
- Waiver of consent
SECTION 4: VULNERABLE POPULATIONS
1. Definition and Categories
□ Including:
- Children (<18 years)
- Pregnant women
- Prisoners
- Mentally impaired individuals
- Economically disadvantaged
- Educational disadvantaged
2. Additional Protections
□ Requirements for:
- Justification for inclusion
- Additional safeguards
- Risk minimization
- Benefit assessment
- Appropriate consent procedures
SECTION 5: PRIVACY AND CONFIDENTIALITY
1. Data Protection
□ Requirements:
- Data anonymization
- Secure storage
- Access controls
- Data sharing restrictions
- Long-term protection
2. Identifiable Information
□ Guidelines for:
- Collection justification
- Storage methods
- Use limitations
- Sharing protocols
- Destruction procedures
SECTION 6: RISK ASSESSMENT AND MANAGEMENT
1. Risk Categories
□ Classification of:
- Minimal risk
- Greater than minimal risk
- High risk
- Risk-benefit ratio
2. Risk Mitigation
□ Requirements for:
- Safety monitoring
- Adverse event reporting
- Protocol modifications
- Emergency procedures
- Follow-up care
SECTION 7: CLINICAL TRIALS
1. Registration Requirements
□ Mandatory registration in:
- ClinicalTrials.gov
- WHO ICTRP
- Regional registries
- Before participant enrollment
2. Reporting Requirements
□ Must include:
- CONSORT guidelines adherence
- Protocol deviations
- Primary/secondary outcomes
- Adverse events
- Statistical analyses
SECTION 8: INTERNATIONAL RESEARCH
1. Multi-jurisdictional Studies
□ Requirements for:
- Local IRB approval
- Cultural sensitivity
- Translation of materials
- Local regulations compliance
- Community engagement
2. Capacity Building
□ Guidelines for:
- Local researcher involvement
- Resource sharing
- Training provisions
- Sustainable development
- Post-study obligations
SECTION 9: PUBLICATION REQUIREMENTS
1. Ethical Statements
□ Must include:
- IRB approval details
- Consent procedures
- Trial registration
- Funding sources
- Conflicts of interest
2. Data Sharing
□ Guidelines for:
- De-identified data
- Access procedures
- Usage restrictions
- Time limitations
- Repository requirements
APPENDIX A: REQUIRED DOCUMENTATION CHECKLIST
1. Pre-submission
□ Required documents:
- IRB approval letter
- Consent forms
- Protocol summary
- Registration details
- CONSORT checklist (if applicable)
2. During Review
□ Additional materials:
- Response to ethical queries
- Updated approvals
- Protocol modifications
- Safety reports
For human subjects research inquiries:
Email: ethics@globalhematology.com