Zimbabwe is undertaking a national initiative to strengthen its health research ethics oversight system through the TRACE Project, implemented by the Medical Research Council of Zimbabwe (MRCZ) in collaboration with the Medicines Control Authority of Zimbabwe (MCAZ). Supported by the Gates Foundation, the project aims to align the country’s ethics review and regulatory framework with internationally recognized standards for quality, transparency, and accountability.

Zimbabwe’s regulatory and ethics oversight framework has evolved steadily over the past four decades, anchored in two central bodies:

• MRCZ, mandated to provide national ethical oversight for all health research involving human participants.
• MCAZ, mandated to regulate medicines, clinical trials, and related products, including granting scientific and regulatory approval for clinical research.

MRCZ’s role: 

MRCZ oversees ethical compliance by:

• Accrediting and supervising Institutional Review Boards (IRBs)
• Reviewing and approving health-related research
• Conducting monitoring visits and continuing review
• Protecting the rights, safety, and well-being of human research participants

MCAZ’s role: 

MCAZ regulates clinical trials and medical products through:

• Evaluation and approval of clinical trials
• Inspection of research sites
• Post-market surveillance
• Ensuring safety, efficacy, and quality of medicines