Humans​

According to the National Health Act (Act 61 of 2003) of the Department of Health (DoH):

No person shall carry out genetic health research unless approved by a registered Health Research Ethics Committee (HREC) (see Section 73(1) of the Act).

Human biological material must be removed and used by a competent person at an authorised institution with written informed consent from the donor or relevant representative. An authorised institution that performs genetic research or generates embryonic stem cell lines must have separate registers to record such genetic research or the generation of embryonic stem cell lines. The authorised institution must submit details of the registers to the Minister by the end of March of each year.

An authorised institution that keeps or discloses genetic material records and other individually identifiable or related health information in any form must ensure that the information is complete and kept confidential. If used for research purposes, the information is treated as anonymous. This includes bodies, tissue, blood and/or blood products, cultured cells, gametes, stem cells or embryos, foetal tissue, and zygotes.

1.1.1. Removal and use of biological material, stem cell therapy, genetic health research, DNA and/or RNA, and chromosome-based genetic testing
  • Health research referred to in Section 69(3) of the Act
  • Training referred to in Section 64(1)(a) of the Act
  • Studies of archaeological, medical, or heritage value on DNA obtained from human genetic material conducted in terms of the National Heritage Resources Act (Act 25 of 1999)

Health research includes any research that contributes to knowledge of:

  • The biological, clinical, psychological, or social processes in human beings
  • Improved methods for the provision of health services
  • Human pathology
  • Causes of disease
  • Effects of the environment on the human body
  • Development or new application of pharmaceuticals, medicines, and related substances
  • Development of new applications of health technology

 

1.1.2. Removal and donation of tissue, blood, and gametes from living persons for medical and dental purposes and handling human bodies and tissue after death

Requirements according to the National Health Act (Act 61 of 2003), Section 68, Notice R180 (General control of human bodies, tissue, blood, blood products, and gametes):

  • Written consent
  • Registers to be kept
  • Liaise with the health officer appointed by the Minister
1.1.3. Import or export any tissue or blood, blood product, cultured cells, stem cells, embryos, zygotes, or gametes

Requirements according to the National Health Act (Act 61 of 2003), Section 68, Notice R181:

  • Apply for a permit to import or export the listed biological materials
  • Keep a register of all imports and exports

- In the application form, indicate the exact volume/weight and number of samples in the “Quantity” column and attach any Material Transfer Agreement (MTA) and Ethics approvals when the application is submitted

- For Import permits, the application must be accompanied by a letter from the sender of the material indicating that they are sending the material to the applicant (researcher)

- Researcher(s) granted ethics approval must complete the application form

 

1.1.4. Transfer of human biological material from a provider to a recipient for use in research or clinical trials

Requirements according to the National Health Act (Act 61 of 2003), Notice 719 (Template for MTA of human biological materials):

  • Providers and recipients of biological material for research or clinical trials under the auspices of the HRECs shall use the MTA of Human Biological Materials

 

1.1.5. Transport of dangerous goods and infectious substances: human biological material, pathogenic microorganisms

The following legislation is applicable:

  • National Road Traffic Act (Act 93 of 1996) and regulations listed in South African National Standard (SANS) 10228
  • International Air Transport Association (IATA) and South African Civil Aviation Authority Regulations

        - IATA presents a certification course for packing and transporting infectious substances (Category A or B)

  • Convention on International Civil Aviation Annex 18 – The Safe Transport of Dangerous Goods by Air

Follow specific technical instructions for packaging in hazard subclass 6.2:

  • Category A Infectious substances affecting humans – UN2814
  • Category A Infectious substances only affecting animals – UN2900
  • Category B Biological substance (Diagnostic or clinical specimens – minimal likelihood of containing a pathogen) – UN3373
Additional Information:
1.2.1. Research with human participants

Requirements according to Sections 71 and 90, Notice R719 of the National Health Act (Act 61 of 2003):

  • If applicable, apply for approval by a registered HREC and South African Products Regulatory Authority (SAHPRA)
  • If it is a clinical trial, register the research in the South African National Clinical Trials Register and obtain written informed consent according to Section 5 of R719
  • Protocols for human participants' research that propose non-therapeutic research with minors must have ministerial consent

 

1.2.2. Clinical trials and bioequivalence studies

The following legislation and/or institutions are applicable:

  • Medicines and Related Substance Act (Act 101 of 1965)

      - Regulates control of human and veterinary medicines, medical devices, and complementary medicines

  • SAHPRA

       - Regulates medicines and clinical research

Requirements:

  • Apply for access to unregistered medicines to conduct clinical trials from SAHPRA
  • Follow South African Good Clinical Practice Guidelines (SA GCP)
  • Researchers must submit a completed clinical trial application on predetermined dates and obtain proof of delivery
1.2.3. Schedule 6-8 substances

If you acquire, use, possess, manufacture, or supply any Schedule 7 or Schedule 8 substance(s); or manufacture any specified Schedule 5 or Schedule 6 substance for the purposes of education, analysis, or research.

The following legislation and/or institutions are applicable:

  • Medicines and Related Substance Act (Act 101 of 1965) as amended
  • SAHPRA

 

Additional Information:
1.3.1. Microbiological laboratories

If the laboratory acquires, imports, handles, manipulates, maintains, stores, cultures, processes, issues, or disposes of human pathogens so acquired, received, or imported.

Requirements according to National Health Act (Act 61 of 2003) Section 68, Notice R178 (Regulations relating to the registration of microbiological laboratories and acquisition, importation, handling, maintenance, and supply of human pathogens):

  • Regulations 3-6(1):

     - Register a microbiological laboratory with the DOH and get assigned an appropriate Biosafety Level (BSL) code (lab registration valid for 2 years)

    - Get a permit for each event to perform the specified activities regarding human pathogens following the BSL codes 3-5. Permits are not required for registered labs that examine routine diagnostic specimens for human pathogens or BSL codes 1-2

  • An application for:

    - Registration of a microbiological laboratory

    - Authorisation to use, keep, or handle cultures or preparations of microorganisms must be submitted to the DoH

 

1.3.2. Import and export of human pathogens

Requirements according to the National Health Act (Act 61 of 2003), Section 68:

  • Apply for a permit to import or export human pathogens
  • Keep a register of all exports
  • For Import permits, the application must be accompanied by a letter from the sender of the material indicating that they are sending the material to the applicant (researcher)

       - Permits valid for one year

 

Additional Information:

Application for laboratory registration should be submitted to: [email protected]

Import and export permit applications should be submitted to: [email protected]