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Genetic discrimination still casts a large shadow in 2022.2022年,基因歧视的阴霾依旧浓重。
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3
Ten years of dynamic consent in the CHRIS study: informed consent as a dynamic process.CHRIS 研究中的十年动态同意:知情同意作为一个动态过程。
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Why research institutions should indemnify researchers against POPIA civil liability.为何研究机构应为研究人员提供针对《个人信息保护法》民事责任的赔偿。
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10
Safeguarding the future of genomic research in South Africa: Broad consent and the Protection of Personal Information Act No. 4 of 2013.保障南非基因组研究的未来:广泛同意和 2013 年第 4 号个人信息保护法案。
S Afr Med J. 2019 Jun 28;109(7):468-470. doi: 10.7196/SAMJ.2019.v109i7.14148.

非洲研究中的跨境数据共享:对12个司法管辖区的数据保护和研究伦理要求的分析

Cross-border data sharing for research in Africa: An analysis of the data protection and research ethics requirements in 12 jurisdictions.

作者信息

Staunton Ciara, Edgcumbe Aliki, Abdulrauf Lukman, Gooden Amy, Ogendi Paul, Thaldar Donrich

机构信息

Eurac Research.

University of KwaZulu-Natal.

出版信息

Res Sq. 2024 Apr 15:rs.3.rs-4217849. doi: 10.21203/rs.3.rs-4217849/v1.

DOI:10.21203/rs.3.rs-4217849/v1
PMID:38699320
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11065056/
Abstract

BACKGROUND

In recent years, there has been a notable uptake in genomic and health-related research activities across the African continent. Similarly, there has been increased introduction of data protection legislation that affects the sharing of personal data such as health data and genomic data, including for research. Many of these statutes have stricter requirements when sharing personal data across borders. Consequently, the cross-border sharing of health data that includes genetic data requires careful navigation of the pertinent data protection legislation, in particular concerning the sharing of such data for research purposes. To help researchers navigate these legal frameworks, 12 African countries were analysed to develop country guides on cross-border data sharing.

RESULTS

Of the 12 countries that were analysed, ten have data protection laws in place (Botswana, Ghana, Kenya, Malawi, Nigeria, Rwanda, South Africa, Tanzania, Uganda, and Zimbabwe), while two countries (Cameroon and The Gambia) do not. With the exception of Ghana, all countries with data protection statutes or bills had additional requirements to be met when sharing personal data across borders. Consent and adequacy are the most common grounds for justifying the sharing of personal data across borders.

CONCLUSION

Given the limitations of the current models of consent, consent is not a suitable basis to transfer large quantities of data for research. Adequacy is a common ground, but there are national differences in the implementation of this ground. Researchers must therefore analyse each national legal framework and make decisions on a case-by-case and country-by-country basis.

摘要

背景

近年来,非洲大陆的基因组学及健康相关研究活动显著增加。同样,影响健康数据和基因组数据等个人数据共享(包括用于研究目的)的数据保护立法也日益增多。其中许多法规在跨境共享个人数据时提出了更严格的要求。因此,包括基因数据在内的健康数据的跨境共享需要谨慎遵循相关数据保护立法,特别是在出于研究目的共享此类数据方面。为帮助研究人员应对这些法律框架,对12个非洲国家进行了分析,以制定跨境数据共享的国家指南。

结果

在分析的12个国家中,10个国家(博茨瓦纳、加纳、肯尼亚、马拉维、尼日利亚、卢旺达、南非、坦桑尼亚、乌干达和津巴布韦)有数据保护法律,而两个国家(喀麦隆和冈比亚)没有。除加纳外,所有有数据保护法规或法案的国家在跨境共享个人数据时都有其他要求需要满足。同意和充分性是跨境共享个人数据的最常见正当理由。

结论

鉴于当前同意模式的局限性,同意并非用于研究目的传输大量数据的合适依据。充分性是一个常见理由,但在这一理由的实施方面存在国家差异。因此,研究人员必须分析每个国家的法律框架,并逐案、逐国做出决策。