We have been asked to clarify permissions that need to be sought for working with international collaborators – so here are a few tips:
- If the exchange of patient information and/or samples is purely for the provision of clinical service, then no ethics approval is needed.
- If there is a research component to the exchange of patient information and/or samples, then the following documents are required – as per the National Health Act.
- Human Research Ethics Committee approval from Wits (Medical) for your South African site - this is required irrespective of whether there is approval from international study sites
- For sharing patient information, a Transfer Agreement is needed - Example Template.
- For sharing samples, the following is needed:
- The Human Research Ethics Committee approval certificate from Wits (Medical) for the research project. Login.
- A material transfer agreement between the two parties exchanging samples - Example Template.
- An export permit from the Department of Health - Example Template.
This might feel daunting, so to help you, we have included all the documents you need and if you’re still unsure please call us (011-356-6395) or pop into our office in the Max Price Building – we're here to help!