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Submit a protocol, Track progress, and get certified consent for your study.
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Follow the guidelines and prepare necessary documents before you submit a protocol
Protocol Submission Process
Take an easy steps for the Protocol Submission Process.
Sign Up to the system
Make sure that you have correct access right to submit your protocol to our system. Update your personal profile, Yous CV s and directorates accordingly.
Submit Your protocol
Read the protocol submission guidelines and prepare your documents required for the submission. Send the application accordingly and wait for the response.
Track the progress
Once your protocol received by our IRB Secretariat, follow the protocol status and the progress untill your application get an approval clearance and archived to our system.
EPHI IRB Protocol Submission Guideline and Procedure
Institutional Review Board (IRB) — Scientific and Ethical Review Office (SERO)Overview and scope
This page provides a complete, practical guide for researchers, students, and collaborators submitting human subjects research protocols to the Ethiopian Public Health Institute (EPHI) Institutional Review Board (IRB) through the Scientific and Ethical Review Office (SERO). It covers preparation, submission, review, and post-approval obligations.
Audience: Principal Investigators (PIs), Co-investigators, Students, Data Managers, and Study Coordinators
Eligibility and when IRB review is needed
Studies requiring IRB review
- Research involving human participants, identifiable biospecimens, or personal data
- Interventional or observational public health studies conducted under EPHI auspices
- Secondary use of existing data if it is identifiable or can be re-identified
- International collaborations involving data or sample transfer
Possible exemptions (confirm with IRB)
- De-identified datasets with no re-identification risk
- Quality improvement activities without research intent
- Publicly available data with no privacy concerns
Always request an exemption determination from IRB; do not self-exempt.
Required documents and templates
Prepare the following documents. Use EPHI’s latest templates where applicable.
Core protocol package
- Protocol document (objectives, methods, risk/benefit, consent process, data plan)
- Investigator CVs and roles (PI, Co-I, coordinator)
- Consent forms in relevant local languages; assent forms for minors
- Data management plan (security, retention, sharing, governance)
- Sample management plan (collection, storage, chain-of-custody)
- Community engagement plan, if applicable
Supporting materials
- Questionnaires, interview guides, case report forms
- Recruitment materials (flyers, scripts, radio messaging)
- Letters of support and site permissions
- Collaboration/MoU agreements; data/material transfer agreements (DTA/MTA)
- Budget and funding details; conflict of interest disclosure
Compliance and approvals
- National and institutional approvals relevant to the study
- Ethical compliance statements (vulnerable populations, compensation)
- Safety monitoring plan (DSMB/monitoring, if interventional)
Submission process and system access
Before you submit
- Confirm study classification (Exempt, Expedited, Full) with SERO/IRB coordinator.
- Complete required trainings (e.g., human subjects protection). Attach certificates.
- Ensure all documents are final, consistent across languages, and signed where needed.
How to submit
- Create or access your investigator profile in the IRB submission system or designated channel.
- Start a new submission, select “New Protocol,” and enter study metadata (title, PI, sites, populations).
- Upload all required files. Verify readability and correct versions.
- Complete declarations (risk level, data handling, compensation, vulnerable groups).
- Submit and record the protocol reference number for tracking.
Initial screening
The IRB office performs an administrative pre-review to check completeness and eligibility. You may receive a request for clarifications or missing items. Respond promptly to avoid delays.
| Stage | What happens | Investigator action |
|---|---|---|
| Pre-review | Completeness check; classification confirmation | Provide any missing documents or corrections |
| Assigned review | Reviewer(s) and meeting date scheduled | Be available for clarification; prepare presentations if requested |
| Decision | Outcome letter issued with conditions or revisions | Address conditions; submit revised documents |
Review pathways, timelines, and outcomes
Review categories
- Exempt review: minimal risk, specific criteria
- Expedited review: minimal risk, designated procedures
- Full board review: greater than minimal risk or special populations
Confirm category with the IRB coordinator during pre-review.
Indicative timelines
- Pre-review: ~5–10 business days
- Expedited review: ~10–20 business days
- Full board: scheduled meeting; decision typically within ~30–45 days
Actual timelines depend on completeness, complexity, and meeting schedules.
Possible outcomes
- Approval: Authorized to begin per approved documents.
- Conditional approval: Minor changes required before activation.
- Revise and resubmit: Substantive changes needed.
- Not approved: Ethical or methodological concerns not resolved.
Investigator responsibilities
Conduct and compliance
- Adhere to approved protocol, consent, and data plans.
- Train all team members; document delegation of duties.
- Maintain secure records and audit trails.
- Obtain renewed consent if procedures change materially.
Communication
- Report adverse events, unanticipated problems, or deviations promptly.
- Submit amendments before implementing changes.
- Respond to IRB queries within requested timelines.
Documentation
- Keep a regulatory binder: approvals, versions, logs, training, correspondence.
- Version control: label documents with version and date.
- Retention: store data/specimens per approved durations.
Amendments and continuing review
Amendments
Submit amendments for any change impacting consent, risk, procedures, populations, data sharing, or sites. Provide a summary of changes, tracked revisions, and updated materials. Do not implement changes before IRB approval unless required for immediate safety; report such deviations promptly.
Continuing review / renewal
- Track approval expiry dates and initiate renewal at least 30 days in advance.
- Provide progress reports, enrollment numbers, adverse events summary, and any updated plans.
- If closing, submit a study closure report and ensure proper data/specimen disposition.
Reporting adverse events and deviations
What to report
- Serious adverse events (SAEs) and unanticipated problems involving risks to participants
- Protocol deviations or violations
- Data breaches, confidentiality incidents, or specimen mislabeling
How and when
- Use the designated IRB reporting form or portal.
- Report SAEs promptly per IRB/DSMB requirements.
- Provide corrective and preventive action (CAPA) plans.
Data protection and sample handling
Data protection
- Apply least-privilege access; role-based permissions.
- Encrypt data at rest and in transit.
- Use secure, approved platforms for storage and analysis.
- De-identify or pseudonymize where appropriate; manage keys securely.
- Define sharing terms in DMP, DTA/MTA, and consent.
Sample handling
- Document chain-of-custody and labeling standards.
- Store per biosafety and biobank requirements.
- Track inventory and movements; reconcile regularly.
- Align export/import with regulatory approvals and MTAs.