Towards a data transfer agreement for the South African research community: The empowerment approach.

IF 0.5 Q4 MEDICAL ETHICS
L Swales, M Botes, D Donnelly, D Thaldar
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引用次数: 1

Abstract

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: (i) have clarity and legal certainty regarding their ownership of data, where relevant; (ii) be able to commercialise their research findings without unnecessary contractual constraints; (iii) avoid falling into the trap of unlawful benefit sharing with research participants; and (iv) be aware that their legal role as responsible parties, where relevant, cannot be contracted out via a DTA.

迈向南非研究界的数据转移协议:授权方法。
为南非(SA)研究界建立数据传输协议(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模板当然是一个有价值的项目,但应该解决有关项目实际执行的问题,包括如何最好地操作所设想的DTA模板,以及所设想的DTA模板的内容。建议在实施设想的DTA模板时采用授权方法,这与卫生部长于2018年颁布的材料转让协议所采用的监管方法形成对比。虽然监管方法需要政府强制使用预期的DTA模板,而不管该模板的质量如何,相反,授权方法需要重点为SA研究界开发一个高质量的,专业起草的DTA模板,并使其使用成为自己选择的问题。关于设想的DTA模板的内容,分析了四个热点内容条款,并认为应授权SA研究机构和研究人员:(i)在相关情况下,对其数据所有权具有明确和法律确定性;(ii)能够将其研究成果商业化,而不受不必要的合同限制;(iii)避免落入与研究参与者非法分享利益的陷阱;以及(iv)意识到他们作为相关责任方的法律角色不能通过DTA外包出去。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
1.10
自引率
11.10%
发文量
18
审稿时长
14 weeks
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