背景近年来,在整个非洲大陆,基因组和与健康相关的研究活动都有了显着的吸收。同样,越来越多地引入了影响个人数据(如健康数据和基因组数据)共享的数据保护立法,包括研究。这些法规中的许多法规在跨境共享个人数据时都有更严格的要求。因此,包括遗传数据在内的健康数据的跨境共享需要仔细浏览相关的数据保护立法,特别是关于为研究目的共享此类数据。为了帮助研究人员驾驭这些法律框架,对12个非洲国家进行了分析,以制定关于跨境数据共享的国家指南。在分析的12个国家中,十个国家制定了数据保护法(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),而两个国家(喀麦隆和冈比亚)则没有。除了加纳,所有拥有数据保护法规或法案的国家在跨境共享个人数据时都需要满足其他要求。同意和充分性是证明跨境共享个人数据的最常见理由。结论鉴于当前同意模式的局限性,同意不是转移大量数据进行研究的合适基础。充足是一个共同点,但是在执行这一立场方面存在国家差异。因此,研究人员必须分析每个国家的法律框架,并在个案和国别基础上作出决定。
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.