南非公共卫生应急准备和应对:审查与数据和生物样本共享有关的法律改革建议

IF 0.5 Q4 MEDICAL ETHICS South African Journal of Bioethics and Law Pub Date : 2021-12-31 DOI:10.7196/SAJBL.2021.v14i3.772
M. Steytler, D. Thaldar
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引用次数: 1

摘要

COVID-19暴露了数据和人类生物材料共享法律的缺陷。这对应对流行病构成了障碍,这需要加快公共卫生研究,进而需要有效和合法的HBM和数据共享。需要进行法律改革和发展,以确保HBM和数据有效、合法地共享。学者们建议进行重要的法律改革。首先是澄清HBM和HBM衍生物对所有权的敏感性,除其他外,包括卫生部长颁布了《南非物质转让协定》修订版。这将消除目前SA MTA永久捐赠者所有权条款的不确定性。第二个是发展数据信托,采用对研究数据的开放获取,以及建立非洲“数据走廊”。这将确保数据得到保护,同时允许为了集体利益和公众利益在研究人员之间有效地转移数据。第三是修订《空间事务法》,以扩大空间事务委员会的权力,包括管理通过利用地球观测和地理信息系统收集的数据。这将确保对外层空间数据的保护,为其在地球上的使用和共享制定法律。从卫生研究的角度来看,实施这些法律改革和发展将使南非更好地应对未来的流行病。
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Public health emergency preparedness and response in South Africa: A review of recommendations for legal reform relating to data and biological sample sharing
COVID-19 exposed flaws in the law regulating the sharing of data and human biological material (HBM). This poses obstacles to the epidemic response, which needs accelerated public health research and, in turn, efficient and legitimate HBM and data sharing. Legal reform and development are needed to ensure that HBM and data are shared efficiently and lawfully. Academics have suggested important legal reforms. The first is the clarification of the susceptibility of HBM and HBM derivatives to ownership, including, inter alia, the promulgation of a revised version of the South African Material Transfer Agreement (SA MTA) by the Minister of Health. This would remove uncertainty regarding the current SA MTA’s perpetual donor ownership clause. The second is the development of data trusts, the adoption of open access to research data, and the creation of an African ‘data corridor’. This would ensure that data are protected while allowing for the efficient transfer of data between researchers for the collective good and in the interest of the public. The third is the amendment of the Space Affairs Act to extend the powers of the Council of Space Affairs to include the management of data collected through the utilisation of Earth observation and geographical information systems. This would ensure the protection of outer space data, legislating its use and sharing once it lands on Earth. The implementation of these legal reforms and developments will better prepare SA to face future epidemics from a health research perspective.
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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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