The idea of a data transfer agreement (DTA) template for the South African (SA) research community is receiving increasing attention. Whiledeveloping such a DTA template is certainly a worthwhile project, questions regarding the project’s practical execution should be addressed,including how to best operationalise the envisioned DTA template, and the content of the envisioned DTA template. It is proposed that anempowerment approach be followed in operationalising the envisioned DTA template, which is contrasted with the regulatory approachfollowed with the material transfer agreement (...) that the Minister of Health promulgated in 2018. While the regulatory approach would entailgovernment making the use of the envisioned DTA template compulsory regardless of the quality of such a template, the empowermentapproach, by contrast, entails a focus on developing a high-quality, professionally drafted DTA template for the SA research community andmaking the use thereof a matter of own choice. Regarding the content of the envisioned DTA template, four hot-button content provisionsare analysed, and it is argued that SA research institutions and researchers should be empowered to: (i) have clarity and legal certaintyregarding their ownership of data, where relevant; (ii) be able to commercialise their research findings without unnecessary contractualconstraints; (iii) avoid falling into the trap of unlawful benefit sharing with research participants; and (iv) be aware that their legal role asresponsible parties, where relevant, cannot be contracted out via a DTA. (shrink)

While open science gains prominence in South Africa with the encouragement of open data sharing for research purposes, there are stricter laws and regulations around privacy – and specifically the use, management and transfer of personal information – to consider. The Protection of Personal Information Act No. 4 of 2013 (POPIA), which came into effect in 2021, established stringent requirements for the processing of personal information and has changed the regulatory landscape for the transfer of personal information across South African (...) borders. At the same time, draft national policies on open science encourage wide accessibility to data and open data sharing in line with international best practice. As a result, the operation of research ethics committees (RECs) in South Africa is affected by the conflicting demands of the shift towards open science on the one hand, and the stricter laws protecting participants’ personal information and the transfer thereof, on the other. This article explores the continuing evolving role of RECs in the era of open data and recommends the development of a data transfer agreement (DTA) for the ethical management of personal health information, considering the challenges that RECs encounter, which centres predominantly on privacy, data sharing and access concerns following advances in genetic and genomic research and biobanking. (shrink)