The South African health research landscape is characterised by racial, ethnic and cultural diversity and by varied socio-economic statuses and literacy levels. South Africa provides a distinctive environment for health research and is internationally renowned for its clinical research capabilities.

South African law consists of the common law (previous decisions of the superior courts, and rules and principles discussed in the ‘old Roman-Dutch authorities’) and statutory law (acts of the national and provincial legislatures and governmental regulations). The law is not codified and, like many common law legal systems, must be sought in court decisions and individual statutes. Since 1994, the Constitution of the Republic of South Africa has been the country’s supreme law.

South Africa is a federal state, with provincial and local government authorities being empowered under the Constitution to adopt legislation or by-laws in areas over which they have been granted competence.

The South African Constitution established a Constitutional Court, which oversees the implementation of the basic rights and freedoms of all persons that are guaranteed within the Constitution. The Constitutional Court’s judgments are binding on all organs of government, including the parliament, the presidency, the police force, the army, the public service and courts at different levels of government. This means that the court has the power to declare an Act of parliament null and void if it conflicts with the constitution and to control executive action in the same way.

When interpreting the Constitution, the Court is required to consider international human rights law. The Constitutional Court is the highest court in the land for all constitutional matters, while the Supreme Court of Appeal is the highest court for all matters that do not involve the interpretation of the constitution. The Constitutional Court has final authority to determine which matters fall within its jurisdiction.

As a result of constitutional transformation, South Africa has adopted many progressive, human rights-based laws, regulations and policies. Several of these are directed at the regulation of health research and the National Health Act of 2003 consolidates most of the relevant legal and policy guidance on health. Chapter Two of the South African Constitution contains a Bill of Rights which explicitly states that everyone has the right to access health care services and this right of access to ‘basic health care services’ is reiterated in relation to children and other vulnerable groups including prisoners (ss 27 (1)(a), 28(l)(c) and 35 (2) (e), Constitution of the Republic of South Africa, 1996). The Constitution also specifically guarantees bodily integrity rights that are applicable within the context of human health research, including the right of everyone ‘not to be subjected to medical or scientific experiments without their informed consent’ (s 12(2)(c), Constitution of the Republic of South Africa, 1996).