Swales L, Botes M, Donnelly D, Thaldar D
School of Law, College of Law and Management Studies, University of KwaZulu-Natal, Durban, South Africa.
SnT Centre for Security, Reliability and Trust, University of Luxembourg, Luxembourg.
S Afr J Bioeth Law. 2023 Apr;16(1):13-18. doi: 10.7196/SAJBL.2023.v16i1.827. Epub 2023 May 8.
The idea of a data transfer agreement (DTA) template for the South African (SA) research community is receiving increasing attention. While developing 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 an empowerment approach be followed in operationalising the envisioned DTA template, which is contrasted with the regulatory approach followed with the material transfer agreement that the Minister of Health promulgated in 2018. While the regulatory approach would entail government making the use of the envisioned DTA template compulsory regardless of the quality of such a template, the empowerment approach, by contrast, entails a focus on developing a high-quality, professionally drafted DTA template for the SA research community and making the use thereof a matter of own choice. Regarding the content of the envisioned DTA template, four hot-button content provisions are analysed, and it is argued that SA research institutions and researchers should be empowered to: () have clarity and legal certainty regarding their ownership of data, where relevant; () be able to commercialise their research findings without unnecessary contractual constraints; () avoid falling into the trap of unlawful benefit sharing with research participants; and () be aware that their legal role as responsible parties, where relevant, cannot be contracted out via a DTA.
为南非研究界制定数据传输协议(DTA)模板的想法正受到越来越多的关注。虽然开发这样一个DTA模板无疑是一个有价值的项目,但应该解决有关该项目实际执行的问题,包括如何最好地实施设想的DTA模板以及设想的DTA模板的内容。有人建议在实施设想的DTA模板时采用赋权方法,这与卫生部2018年颁布的材料转让协议所采用的监管方法形成对比。监管方法将要求政府强制使用设想的DTA模板,而不论该模板的质量如何,相比之下,赋权方法则侧重于为南非研究界开发一个高质量、专业起草的DTA模板,并将其使用作为一种自主选择。关于设想的DTA模板的内容,分析了四个关键内容条款,并认为南非的研究机构和研究人员应被赋予权力:()在相关情况下,对其数据所有权有清晰的认识和法律确定性;()能够在没有不必要的合同限制的情况下将其研究成果商业化;()避免陷入与研究参与者进行非法利益分享的陷阱;以及()意识到在相关情况下,他们作为责任方的法律角色不能通过DTA外包出去。