n South African Medical Journal - Opinion - child research in South Africa : how do the new regulations help? : forum

Volume 105, Issue 11
  • ISSN : 0256-9574
  • E-ISSN: 2078-5135



Child research is governed by legal norms in the National Health Act (2003) and the Regulations. There is increasing harmony between the two on many issues, including the conditions under which children should be enrolled in research. The most striking disjuncture in the ethical-legal framework remains the allowable consent strategy for child research, where the law requires mandatory parental or legal guardian consent for all child research, while ethical guidelines afford research stakeholders the discretion to implement exceptions to this approach in specific justifiable circumstances.

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