Last Updated: December 12, 2024
SECTION 1: GENERAL PRINCIPLES
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1. Purpose and Scope
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□ This process applies to:
- All research involving human participants
- Animal research studies
- Clinical trials
- Observational studies
- Secondary data analysis with identifiable information
2. Core Principles
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□ Must ensure:
- Protection of participant rights and welfare
- Compliance with ethical standards
- Scientific validity
- Transparency and accountability
SECTION 2: SUBMISSION REQUIREMENTS
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1. Required Documentation
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□ Authors must submit:
- Ethics committee (IRB/IACUC) approval letter
- Protocol number
- Study registration details (if applicable)
- Amendments (if any)
- Continuing review approvals
2. Study Registration
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□ Mandatory for:
- Clinical trials (e.g., ClinicalTrials.gov, WHO ICTRP)
- Observational studies (if required by funders)
- Systematic reviews/meta-analyses (e.g., PROSPERO)
SECTION 3: REVIEW PROCESS
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1. Initial Screening
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□ Editorial office responsibilities:
- Verify submission of ethics approval documents
- Confirm study registration (if applicable)
- Check for completeness of documentation
2. Ethics Committee Verification
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□ Requirements:
- Validity of approval letter
- Consistency with study protocol
- Compliance with local/national regulations
3. Additional Review
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□ For studies involving:
- Vulnerable populations
- High-risk procedures
- International/multi-site research
- Ethical controversies
SECTION 4: POST-APPROVAL REQUIREMENTS
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1. Amendments and Updates
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□ Authors must:
- Submit protocol amendments for review
- Provide updated ethics approvals
- Notify of significant changes to study design
2. Adverse Event Reporting
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□ Requirements for:
- Reporting serious adverse events (SAEs)
- Providing safety monitoring reports
- Submitting corrective action plans
SECTION 5: PUBLICATION REQUIREMENTS
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1. Ethical Statements
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□ Must include:
- Ethics committee approval details
- Protocol number
- Study registration information
- Compliance with ethical guidelines
2. Transparency
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□ Authors must:
- Disclose any ethical concerns
- Provide justification for exceptions
- Address reviewer/editor queries
SECTION 6: NON-COMPLIANCE
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1. Identification of Issues
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□ Editorial office responsibilities:
- Identify missing or invalid ethics approvals
- Flag inconsistencies in documentation
2. Resolution Process
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□ Steps include:
- Requesting additional information
- Consulting external ethics experts
- Rejecting submissions for non-compliance
APPENDIX A: REQUIRED DOCUMENTATION CHECKLIST
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1. Pre-submission
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□ Required documents:
- Ethics approval letter
- Protocol summary
- Study registration details
2. During Review
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□ Additional materials:
- Response to ethical queries
- Updated approvals
- Protocol modifications