The BERC-Luso project: Legislative, institutional, and educational impact evaluation

Area of Science:

• Biomedical Ethics
• Regulatory Science
• Clinical Trial Governance

Background:

• Portuguese-Speaking African Countries (PSAC) face limited clinical trial activity.
• Untapped potential exists for advancing biomedical research in these regions.
• Existing ethical and regulatory capacities require enhancement.

Purpose of the Study:

• To bolster biomedical ethics and regulatory infrastructure in five PSAC nations.
• To create an environment conducive to clinical trials, ensuring participant safety and national benefit.
• To address legislative, institutional, and capacity-building needs.

Main Methods:

• Conducted legislative framework evaluations and recommended strengthening actions.
• Employed top-down and bottom-up approaches involving government ministries, policymakers, and stakeholders.
• Focused interventions on legislative, institutional, and capacity-building domains.

Main Results:

• Achieved a 78.59% success rate in meeting project targets.
• Engaged stakeholders, impacting over 71,149 professionals.
• Stimulated legislative reforms and initiatives across partner countries.

Conclusions:

• Significant progress was made in enhancing biomedical ethics and regulatory capacities.
• Further investment in capacity-building and best practice implementation is essential.
• BERC-Luso fostered inter-African research collaboration and a supportive research environment.