Institutional Review Board
The Department of Public Health is committed to protecting the rights and welfare of all participants in research studies.
An Institutional Review Board is a committee established to review and approve research involving human subjects. Its aim is to ensure research is conducted in accordance with international and national ethical guidelines.
The Department's IRB (IRB-PH) consists of five members: four experts with extensive experience in social sciences research, and one community representative.
For ethics approval, an application must be submitted to the IRB committee. See the Investigator's Guide section below for details.
For additional information, email: irb@publichealth.ro
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Overview & Information
Accreditation
The IRB-PH has been approved by the U.S. Department of Health and Human Services (HHS).
View approval documentApplication review time
Maximum timeframe: 6 weeks (IRB-PH panel review) + 1 week (administrator) = 7 weeks total. Varies by type of review: exempt, expedited, or full.
IRB-PH Members
Investigator's Guide
To obtain IRB-PH approval for research involving human subjects, an application must be submitted in advance. The document below is the primary source for IRB-PH Standard Operating Procedure and Human Subjects Research Policy Guidance.
Landmark ethical documents
Submission & Review Process
IRB-PH approval must be obtained before any subject recruitment or data collection begins.
Submit application
New studies requiring full review: submit at least 6 weeks before next scheduled IRB meeting.
Initial assessment
All applications assessed within 1 week of receipt to determine review type needed.
Review
Depending on type: 3 weeks (exempt) to 6 weeks (full board review).
Decision
Researcher notified. Detailed letter sent within 4 weeks of meeting date.
New study applications
Submit no less than 6 weeks prior to next scheduled meeting. IRB-PH determines readiness.
Renewal applications
Submit no less than 6 weeks before expiration date. Renewal notice sent 6 weeks before expiry as a courtesy — but researcher is responsible for timely submission.
International grants
Submit protocol for human subjects review simultaneously with grant application, as funders may require IRB-PH certification.
Review order
Chronological order of receipt, except protocols needing full board review (scheduled at monthly meetings) and continuing studies near expiry.
Types of Review
Exempt level review
Min. 3 weeksReviewed by IRB-PH panel and Chair. Research may be approved as Exempt or re-assigned to a higher level.
When it applies
Low-risk research, de-identified data, no vulnerable populations, no significant confidentiality risk.
No submission deadlines. Submit at least 3 weeks before planned start. Approved exemptions do not require annual renewal unless protocol changes.
Expedited review
Up to 4 weeksReviewed and approved by a sub-IRB. Eligibility determined by IRB-PH Chair.
When it applies
Projects not requiring full IRB review and not qualifying as exempt.
Full IRB review
Up to 6 weeksTakes place at monthly IRB-PH meetings. Submit no less than 2 weeks before scheduled meeting. Decision sent within a week of meeting; detailed letter within 4 weeks.
When it applies
- Most physiological or medical research.
- Research involving vulnerable populations (children, prisoners, pregnant women).
- Research where identification of subjects could place them at risk of legal liability, financial harm, or stigmatization, with risk of confidentiality breach.
Who must apply: All projects with an expiration date that wish to continue beyond that date.
When to submit: At least 6 weeks before expiration.
Notification: Courtesy reminder sent ~6 weeks before expiry, but responsibility lies with researcher.
Exempt protocols: Not subject to annual renewal.
Review time: Up to 6 weeks. Full board studies scheduled at next monthly meeting.
When required: For all proposed revisions to: currently approved protocols; protocols submitted for continuation with major modifications; projects previously granted exempt status.
Process: Submit revised documents before implementing changes. Usually reviewed by Chair or sub-IRB; full board review if changes increase risk.
Timeline: Researcher notified within 4 weeks of submission.
What to Submit
Submit 2 copies, typed and collated, with original signatures.
- IRB-PH Application Cover Sheet
- Request for Determination of Exempt Status Form
- Protocol Narrative Form
- Informed consent materials for all adult subjects (written and/or verbal)
- Assent materials for minors and parental consent/permission form
- Certificate of Completion of a human subjects/research ethics course (required for graduate/undergraduate students as Lead Investigator or Key Personnel)
- Surveys, interview guides, and data collection instruments
- Recruitment materials (advertisements, letters, flyers, verbal scripts)
- Letters of permission from off-site institutions; IRB approvals from collaborating institutions; copy of grant proposal (if applicable)
De-identified/pre-existing data applications generally do not need protocol narrative or consent materials — provide dataset description, source, and data security measures instead.
All forms must be signed by the lead investigator, scanned, and submitted by email.
Submit to irb@publichealth.roFrequently Asked Questions
IRB stands for Institutional Review Board for Human Participants. Its primary role is to ensure the protection of human participants in research at the Department of Public Health. Any institution receiving funding to conduct research with human participants is required to establish an IRB. The IRB has authority to review, approve, disapprove, or require changes in research involving human participants.
All Human Subjects Research must receive IRB approval. If your research meets the definitions of both 'research' and 'human subjects', you must complete the IRB process.
Several mandated steps are required. Download the IRB-PH Application Form for a full overview.
All applications receive an initial assessment within 1 week of receipt to determine the review type. The full review process then takes 3–6 additional weeks depending on the type.
Department of Public Health | Cluj School of Public Health
No. 7 Pandurilor Street, Universitas Building, 9th floor, Cluj-Napoca, 400095, Romania
General: contact@publichealth.ro
IRB: irb@publichealth.ro