Research that extends across SA borders

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 (https://www.up.ac.za/media/shared/12/ZP_Files/health-act.zp122778.pdf)

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 Data Transfer Agreement (DTA) is recommended to give you, as the researcher, a chain of custody over your data. If identifiable data is exchanged, then a DTA is required; if de-anonymised data is exchanged, a DTA is not a requirement

For sharing samples, the following is needed:

The Human Research Ethics Committee approval certificate from Wits (Medical) for the research project

If samples will be biobanked, this requires a separate HREC approval from Wits (Biobanking Ethics Committee)

Consent from the participants for sharing their samples

A material transfer agreement (MTA) between the two parties exchanging samples (this is a legal requirement)

An export permit from the Department of Health (this is a legal requirement)

This might feel daunting, so to help you, we attached links to some of the documents you might 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!

The Clinical Research Office Team at WDGMC

Research that extends across SA borders

Some useful links