UAE Research Proposal (Study Protocol) Format + IRB/Ethics Checklist
For doctors/residents in Dubai, Abu Dhabi, and across the UAE who are preparing a research proposal / study protocol for IRB / Research Ethics Committee (REC) submission — including a clean sample size justification and a defensible statistical analysis plan.
- Protocol structure used for residency research (headings, methods, outcomes, timeline)
- IRB/REC essentials: consent/assent, confidentiality, data privacy, risk-benefit, safety
- Biostatistics plan: outcomes, effect size thinking, tests/models, missing data
- Formatting support: tables/figures/references for IRB/journal-ready submission
Common UAE terms: research proposal, study protocol, IRB submission, REC approval, ethics approval.
UAE Research Proposal / Study Protocol format (IRB-friendly)
Core sections (standard)
- Title + brief rationale
- Background + literature gap
- Research question (PICO) + objectives (primary/secondary)
- Study design (retrospective, prospective, cross-sectional, cohort, case-control, audit/QI)
- Setting (hospital/clinic), study period
- Eligibility criteria (inclusion/exclusion)
- Outcomes & variables (primary outcome defined precisely)
- Data collection (CRF, EMR variables, imaging/lab fields)
- Sample size justification / feasibility justification
- Statistical analysis plan (tests/models/confounders)
- Ethics/IRB/REC: consent, confidentiality, risks
- Timeline + limitations + references + appendices
Design-specific add-ons
- Retrospective chart review: de-identification + access control + consent waiver rationale
- Cross-sectional/survey: sampling + validity + bias minimization + response strategy
- Cohort/case-control: exposure/outcome definitions + confounding control
- Audit/QI: standards, audit cycle, implementation, re-audit timeline
- Interventional: safety monitoring + adverse event reporting + stopping criteria
IRB / REC / Ethics checklist (what reviewers expect)
- Risk–benefit (minimal risk vs more than minimal risk)
- Consent/assent approach (adult, pediatric assent, surrogate consent where applicable)
- Confidentiality: de-identification, coded datasets, limited access, secure storage
- Data governance: who extracts data, where it is stored, retention period
- Selection fairness: inclusion/exclusion justification
- Vulnerable groups safeguards (children, pregnancy, critical illness, etc.)
- Conflicts of interest disclosure
- Safety reporting for interventional studies
Sample size + statistical analysis plan (defensible)
Sample size logic (choose correctly)
- Comparative studies: effect size + power + alpha
- Prevalence studies: expected prevalence + precision
- Retrospective: feasible sample + precision/CI plan + sensitivity checks
- Audit/QI: baseline compliance + target improvement + re-audit plan
Statistics plan essentials
- Define variable types + summary measures
- Normality checks + appropriate tests
- Regression models where needed (confounding adjustment)
- Missing data strategy
- Effect sizes + confidence intervals
FAQ (UAE residency research)
What is the “thesis protocol” equivalent in the UAE?
In many UAE programs, the equivalent document is called a research proposal, study protocol, or IRB/REC submission. The content is similar: objectives, methodology, ethics, and statistics.
Do retrospective studies need IRB/REC review in the UAE?
Many institutions require IRB/REC review even for retrospective chart reviews. This commonly includes a confidentiality plan and, where applicable, a rationale for consent waiver/alteration.
What matters most for IRB acceptance?
Clear primary outcome, a consistent methods + analysis plan, and strong privacy/confidentiality safeguards (de-identification, access control, secure storage).
Can this help with audits, QI projects, and journal club research presentations?
Yes. Many residency projects are clinical audits or quality improvement proposals, and the same discipline of objectives → methods → analysis improves approval and publication readiness.