IRB Submission Checklist
A clear, step-by-step guide listing required documents, timelines, and common mistakes to avoid when preparing IRB applications.
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Ethics Made Simple. Research Made Possible.
Guiding Research with Integrity, Compliance, and Excellence.
About Us
Ethics First Centre is a research ethics, regulatory compliance, and data governance consultancy dedicated to helping organizations and investigators navigate the increasingly complex landscape of responsible research.
We believe that ethical research is not merely about obtaining approvals, it is about protecting participants, respecting communities, safeguarding data, and generating evidence responsibly.
Our team provides end-to-end support throughout the research lifecycle, ensuring studies remain compliant from conception to completion while meeting local and international requirements.
Vision
To become a globally trusted leader in research ethics, regulatory compliance, and responsible data governance, enabling organizations to conduct impactful research with integrity, accountability, and public trust.
Mission
To advance ethical, equitable, and participant-centered research by empowering investigators with expert guidance while protecting the rights, dignity, and interests of research participants through responsible governance, regulatory compliance, data stewardship, and capacity building.
Why Choose Ethics First Centre?
01 Expertise
Years of experience supporting ethical and regulatory compliance across diverse research settings.
02 End-to-End Support
We remain involved from study conception through ethics approval, implementation, monitoring, dissemination, and closure.
03 Practical Solutions
Our recommendations help researchers move forward efficiently while protecting participants and maintaining regulatory compliance.
04 Global Perspective
We support organizations worldwide, with particular expertise in research conducted across Africa and the wider Global South.
Services
We provide expert guidance in research ethics, compliance, and IRB processes to ensure responsible studies.
IRB and Ethics Support
Research proposal and protocol development
Protocol review and refinement
Preparation of ethics application packages
Development and review of informed consent documents
Participant information sheets
Recruitment materials review
Supporting documents preparation
Submission guidance
Reviewer response preparation
Ethics committee correspondence
Resubmissions after comments
Study Amendments & Modifications
Protocol amendments
Changes to study procedures
Addition or removal of study sites
Addition of investigators
Consent form updates
Research tool modifications
Budget-related changes affecting participants
Timeline extensions
Recruitment strategy revisions
Annual Renewals & Continuing Review
Continuing review applications
Annual renewals
Progress reports
Enrollment updates
Safety reporting
Compliance documentation
Renewal submissions before expiry
End-of-Study Closure
Final study reports
Ethics closure submissions
Regulatory notifications
Data archiving plans
Data destruction documentation
Research record management
Final compliance reviews
Community Engagement Services
Community entry planning
Stakeholder mapping
Government engagement
Local authority coordination
Community leader consultations
Public sensitization strategies
Participant feedback mechanisms
Community dissemination planning
Feedback and accountability mechanisms
Data Protection & Privacy Compliance
Data protection compliance assessments
Privacy policy development
Data management plans
Data management policy development
Data sharing agreements
Data retention policies
Cross-border data transfer guidance
Research data governance frameworks
Compliance documentation
Data governance strategy development
Data Controller, Collector & Processor Registration
Data Controller, Data Collector, and Data Processor registration
Documentation preparation and regulatory submissions
Data protection compliance and advisory support
Research Institution & ISERC/IRB/REC Registration
Research institution registration
ISERC/IRB/REC establishment and registration
Ethics governance and policy development
Development of Standard Operating Procedures (SOPs)
Data management and governance policy development
Accreditation and regulatory support
Capacity Building & Research Ethics Training
Principles of research ethics
Human participant protections
Informed consent
Data protection and privacy
Good Clinical Practice (where applicable)
Good Research Practice
Responsible Conduct of Research
Research misconduct prevention
Ethics committee requirements
Community engagement best practices
Data management and governance
Research compliance systems
Institutional ethics capacity strengthening
Compliance Monitoring
Site monitoring visits
Ethics compliance audits
Consent verification
Documentation reviews
Corrective action planning
Quality assurance assessments
Internal monitoring systems
Research compliance reviews
Data governance audits
Countries We Have Worked With
Resources
Access guides, regulations, and insights to support ethical research practices.
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Concept of the Informed Consent Form
A customizable sample consent form demonstrating best practices for clarity, participant understanding, and compliance.
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Community Engagement Guide
A short, practical guide on designing respectful and effective community engagement strategies before and during research.
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Data Management & Protection Basics
Key principles and best practices for ensuring confidentiality, secure storage, and compliance with GDPR/ODPC and local regulations.
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Ethical Dilemmas: Quick Reference Guide
A short collection of common research ethics dilemmas with tips on how to approach and resolve them responsibly.
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The Research Lifecycle: A Step-by-Step Formula
This step-by-step guide walks researchers through the entire research ethics process, from IRB submission and approval to study completion and report generation.
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Contact
Whether you're preparing your first ethics application, seeking national research licenses, strengthening your institution's governance framework, developing a data management policy, or managing a complex multi-country study, Ethics First Centre is here to guide you every step of the way.
Contact us today to discuss your research ethics and compliance needs.Address
Akai Plaza, 3rd Floor , Roasters, Nairobi- Kenya
Call Us
+254 715 762 929
Email Us
info@ethicsfirstcenter.com
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