NCBE Ethical Guidelines for Research

Scope and Authority

The National Committee of BioEthics (NCBE) of Saudi Arabia establishes the national framework for ethical review of research involving humans, their data, or biological materials.

All institutions conducting research in the Kingdom must ensure IRB review aligns with NCBE regulations before research begins.

Core Ethical Principles

Respect for persons: voluntary participation, adequate information, and capacity to consent.

Beneficence: maximize anticipated benefits and minimize foreseeable harms.

Justice: equitable selection of subjects and fair distribution of research burdens and benefits.

Scientific validity: research must be methodologically sound before ethical approval is meaningful.

Informed Consent

Consent must be documented unless a waiver is ethically justified and IRB-approved.

Information must be presented in language understandable to participants, including purpose, procedures, risks, benefits, alternatives, confidentiality, and right to withdraw without penalty.

Vulnerable populations require additional safeguards, including assent procedures for minors and proxy consent where appropriate.

Privacy and Data Protection

Researchers must comply with Saudi Personal Data Protection Law (PDPL) and institutional policies.

Data should be collected only for stated research purposes, stored securely, and de-identified where feasible.

Cross-border data transfer requires appropriate legal basis and IRB approval.

Risk–Benefit Assessment

Applications must describe foreseeable risks, mitigation strategies, and expected benefits to participants and society.

Research with greater than minimal risk requires full board review unless expedited criteria are met.

Monitoring plans should be included for studies with ongoing safety concerns.