IRB Application Checklist for Researchers in Saudi Arabia

Study essentials

A specific title that names the design, population and setting.

One primary objective with how it will be measured, plus any secondary objectives.

The study design, setting, procedures, timeline and analysis plan.

A sample size with its justification: power or precision calculation, qualitative saturation, or a defined census of all eligible records.

Participants and consent

Concrete inclusion and exclusion criteria (age range, condition, setting, time window).

A consent process covering voluntary participation, the right to withdraw without penalty, risks, confidentiality, who obtains consent and a contact for questions — in Arabic and English where participants need it.

For retrospective record reviews, a consent waiver request that explains why consent is impracticable, why risk is minimal and how identities are protected. The committee decides whether to grant it.

Extra safeguards for children (guardian consent and child assent), students and employees (protection from pressure), and other vulnerable groups.

Data, risk and integrity

A data protection plan aligned with the Personal Data Protection Law: de-identification or coding, who can access the data and how it is secured, the retention period and disposal, and any transfer outside Saudi Arabia.

Realistic risks (including privacy and psychological risks) with a specific mitigation for each, and realistic benefits.

A conflict of interest statement — or a clear statement that there is none.

For clinical trials: trial registration plans (for example the Saudi Clinical Trials Registry) and any Saudi Food and Drug Authority (SFDA) authorization needed for drugs or devices.

No unresolved placeholders such as TBD, [MISSING] or [ASSUMPTION] left in the final text.