撒哈拉以南非洲卒中生物库和基因组学研究的象征性立法和监管。

Muyiwa Adigun, Babatunde Ojebuyi, Joshua Akinyemi, Kolawole Wahab, Albert Akpalu, Fred S Sarfo, Lukman F Owolabi, Rabiu Musbahu, Abiodun Bello, Reginald Obiako, Mayowa Ogunronbi, Michelle Nichols, Carolyn Jenkins, Ayodele Jegede, Rajesh Kalaria, Mayowa Owolabi, Bruce Ovbiagele, Oyedunni Arulogun, Rufus Akinyemi
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引用次数: 0

摘要

中风是撒哈拉以南非洲地区(SSA)的主要死因,而遗传因素似乎在其中起到了一定的作用。这促使撒哈拉以南非洲地区开展中风生物库和基因组学研究。现有的中风研究主要集中在病因、发病率、死亡率和影响方面。然而,对该分地区中风生物库和基因组学研究的法律问题关注甚少。因此,本文探讨了如何通过立法规范撒哈拉以南非洲地区的基因组学研究和中风生物库。文章指出,有一些重要问题亟待解决,如适当的同意模式、生物样本的商业使用、生物样本的所有权和研究成果的归还等,但法律在这些问题上的立场并不令人满意,因为没有直接规范这些问题的法规,而这些国家现有的法规要么缺失,要么过时,要么保守,要么难以驾驭。因此,文章运用象征性立法理论,主张通过积极的象征性方法进行立法干预。文章建议,待颁布的法规应仅以法律规则的方式解决政策问题,而无需详细说明,同时应通过解释性说明促进对规则的理解。解释性说明应包含已决案件、庭外和解案件的实例以及非洲人类遗传与健康(H3 Africa)制定的伦理准则。如果这些指导原则不够充分,可根据当地情况的需要,参考其它伦理指导原则。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Symbolic Legislation and the Regulation of Stroke Biobanking and Genomics Research in Sub-Saharan Africa.

Stroke is a major cause of death in Sub-Saharan Africa (SSA) and genetic factors appear to play a part. This led to the development of stroke bio-banking and genomics research in SSA. Existing stroke studies have focused on causes, incidence rates, fatalities and effects. However, scant attention has been paid to the legal issues about stroke bio-banking and genomics research in the sub-region. Therefore, this article examines how genomics research and stroke bio-banking in SSA can be regulated through legislation. The article reports that there are germane issues to be addressed such as appropriate consent model, commercial use of biological samples, ownership right in biological samples and return of research results but that the position of the law on these issues is not satisfactory because there are no statute directly regulating them while existing regulations in these countries are either absent, outdated, conservative or difficult to navigate. The article therefore applies the theory of symbolic legislation and argues for legislative intervention through positive symbolic approach. It recommends that the statute to be enacted should only address policy issues by way of legal rules without being detailed while the understanding of the rules should be fostered in explanatory notes. The explanatory notes should contain examples borne of decided cases, cases settled out of court and the ethical guidelines prepared by Human Heredity and Health in Africa (H3 Africa). Where they are inadequate, recourse may be had to other ethical guidelines subject to the demands of local circumstances.

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