Governance Structures for Health Research Ethics in the Eastern Mediterranean Region.

Area of Science:

• Public Health
• Medical Ethics
• Health Policy

Background:

• Effective research ethics governance is crucial for protecting human subjects and ensuring the integrity of scientific research.
• The Eastern Mediterranean Region (EMR) faces unique challenges in establishing robust ethical review systems.
• Understanding the current landscape of research ethics governance in EMR countries is essential for targeted improvements.

Purpose of the Study:

• To map the current state of research ethics governance in EMR countries.
• To assess the legal provisions, regulatory frameworks, and operational aspects of Research Ethics Committees (RECs).
• To evaluate the ethical oversight mechanisms for clinical trials (CTs) within the region.

Main Methods:

• A descriptive study utilizing two survey tools distributed to EMR countries.
• The first tool collected data on legal provisions, regulatory frameworks, REC composition, resources, and procedures.
• The second tool focused on ethical oversight of CTs, including the coordination of ethical reviews.

Main Results:

• 85% of respondents reported national provisions requiring human subjects research to be reviewed by an REC.
• Approximately 46% have legal provisions for CT registration, 43% have national or institution-specific CT registries, and 54% protect participants from financial injury.
• Significant variations exist in the implementation and enforcement of ethical review processes across EMR countries.

Conclusions:

• EMR countries are encouraged to strengthen national and institutional Research Ethics Committees (RECs) and establish national CT registries.
• Enhancing the knowledge and skills of REC members is vital for compliance with international ethical standards.
• Continued efforts are needed to improve the ethical review and oversight of research, particularly clinical trials, in the EMR.