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Guidelines for Good Practice in the Conduct of Clinical Trials in Human Participants in South Africa

This, the first edition of South African guidelines for good practice in the conduct of clinical research, is closely related to the regulatory requirements of the country's Medicines Control Council and the National Department of Health. Noting that the South African context is an unusual combination of significant disease burden and extensive high-tech medical expertise and infrastructure, the guidelines set out "clearly articulated standards of good clinical practice in research that are also relevant to local realities and contexts". Guidance is also provided on the minimum standards that are acceptable for conducting clinical trials in South Africa. Very usefully, throughout this document there is reference to national and international guidance documents that have informed the drafting, and/or provide further context to the recommendations.

The guidance opens by setting out the principles of respect for persons, beneficence, non-maleficence and justice. These are considered to require that distinct components be built into research studies, including "relevant and appropriate study rationale, optimal study design, investigator competence, a balance of risks and benefits for participants, transparency, patient privacy, ethical review and impartial oversight of consent procedures". Specific sections of the guidance consider the review and approval process for research, the protection of study participants, the responsibilities of researchers and sponsors, quality assurance and data management. The final section focuses exclusively on ethical considerations for clinical and epidemiological research on HIV/AIDS.