Researchers in the Faculty of Health Science should take note of the following:
- A pilot study constitutes research in terms of the National Health Act, which means ethics approval is a legal obligation prior to conducting a pilot study.
- It is a legal requirement that SAHPRA-approval (previously MCC) must be obtained for conducting clinical trials on medication, devices, implants and other health products irrespective of whether this medication or health product is registered or in commercial use.
- Note also when SAHPRA-approval is required for non-research purposes – e.g., importation or use of unregistered health products.
- A rule of thumb is that using a health product for a novel clinical indication (for example in “empirical” or off-label use) on more than three occasions would constitute research, meaning prior ethics approval is required.
- By law, exporting biological material from South Africa must be in terms of the gazetted Material Transfer Agreement duly agreed by all parties and only after an export permit has been granted.
- Protocols for clinical trials (on medication or any other clinical intervention) should usually meet with CONSORT criteria.
- Only the Principal Investigator (PI) may formally do the final e-submission of a study application to the REC, even though receiving assistance is acceptable with, for example, the uploading of documents. The PI’s submission of the ethics application constitutes a formal contractual undertaking by the PI pertaining to the declarations made in the application and the specifics of the submission. Delegating this contractual role would not be legally and ethically acceptable. A PI must thus not delegate this function or provide his/her e-signature or log-on details to another person, as this may constitute a dereliction of duty or even be used as evidence in a charge of fraud.