National documentation available in pdf format!
National documentation available in pdf format!

National Legislation

  • Constitution of the Republic of South Africa, 1996 (Act No.108 of 1996)
  • National Health Act, 2003 (Act No. 61 of 2003)
  • Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)
  • Allied Health Professions Act, 1982 (Act No. 63 of 1982)
  • Health Professions Act, 1974 (Act No. 56 of 1974)
  • Human Sciences Research Council, 2008 (Act No. 17 of 2008)
  • Mental Health Act, 1973 (Act No. 18 of 1973)
  • Nursing Act, 1978 (Act No. 50 of 1978)
  • Pharmacy Act, 1974 (Act No. 53 of 1974)
  • Children’s Act, 2005 (Act No. 38 of 2005)
  • Choice of Termination of Pregnancy Act, 1996 (Act No. 92 of 1996)
  • Promotion of Access to Information Act, 2 of 2000

Regulations and Policies

  • Department of Health. (2006). Guidelines for Good practice in the conduct of clinical trials withn human participants in South Africa. (2nd ed.). Pretoria: Department of Health.
  • Government Gazette. (2012). Regulations relating to the use of human biological material, No.3599. 2 March 2012.
  • Health Professions Council of South Africa. (2008). Booklet 6: General ethics guidelines for health researchers.
  • National Health Research Ethics Council. (2012). Payment of trial participants in South Africa: Ethical considerations for Research Ethics Committees (RECs). National Health Research Ethics Committee.
  • South African National Health Research Ethics Council. (2004). Guidelines on ethics in health research: principles, structures and processes.
  • South African Medical Research Council. (2003).Guidelines on ethics for medical research. Book 1: General Principles including research on children, vulnerable populations groups international collaboration and epidemiology. Cape Town: South African Medical Research Council.
  • South African Medical Research Council. (2003). Guidelines on ethics for medical research. Book 5: HIV preventive vaccine research. Cape Town: South African Medical Research Council.
  • South African Law Commission, Assisted decision-making: Adults with impaired decision-making capacity, 2004, Discussion paper 105.
  • South African Law Reform Commission: Privacy and data protection, 2005, discussion paper 109. Introduction

Case Law

  • Jansen van Vuuren v Kruger 1993 (4) SA 842 (A).

Books and Chapters in Books

  • Heaton, J. (2008). The South African Law of Persons. (3rd ed.). Durban: Butterworths, Lexisnexis.
  • Wassenaar, D.R., & Mamotte, N. (2012). Ethical issues and ethics reviews in social science research. In M. Leach, M. Stevens, G. Lindsay, A. Ferrero, & Y. Korkut (Eds.) The Oxford handbook of international psychological ethics (pp. 268- 282). New York: Oxford.



  • Mamotte, N., Wassenaar, D.R., & Singh, N. (2013). Compensation for research-related injury in NIH sponsored HIV clinical trials in Africa. Journal of Empirical Research on Human Research Ethics, 8, 45-54.
  • Macklin, R. (2010). Enrolling pregnant women in biomedical research. The Lancet, 375, 632-633
  • Milford, C., Wassenaar, D.R., & Slack, C.M. (2006). Resources and needs of research ethics committees in Africa: Preparations for HIV vaccine trials. IRB 28(2), 1-9.
  • Zuch, M., Mason-Jones, A.J., Mathews, C. & Henley, L., (2012), ‘Changes to the law in consent in South Africa: implications for school-based adolescent sexual and reproductive health research’, BMC International Health and Human Rights 12(3), 1-5.

International guidance

  • US Department for Health and Human Services. (1996). International Conference on Harmonisation - Guideline for Good Clinical Practice.
  • National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). Belmont report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research.
  • UNAIDS/AVAC. (2011). Good Participatory Practice: Guidelines for Biomedical HIV prevention trials. (2nd ed.). Geneva: UNAIDS.
  • UNAIDS. (2012). Ethical considerations in biomedical HIV prevention trials. Geneva: UNAIDS.
  • World Medical Association. (2008). World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. Geneva: WMA

For reference purposes only – documents should not be considered official versions / Pour consultation seulement – ces documents n’ont pas de valeur officielle

Last modified: Wednesday, 5 March 2014, 10:23 AM