Regulation of genomic and biobanking research in Africa: a content analysis of ethics guidelines, policies and procedures from 22 African countries
Regulation of genomic and biobanking research in Africa: a content analysis of ethics guidelines, policies and procedures from 22 African countries
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DOI：
10.1186/s12910-016-0165-6
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发表时间：
2017-02-02
影响因子：
2.7
通讯作者：
Tindana, Paulina
中科院分区：
文献类型：
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作者：
de Vries, Jantina;Munung, Syntia Nchangwi;Tindana, Paulina
背景：基因组学和生物银行方法在非洲研究领域的引入也引入了基于数据和样本共享和再利用价值的科学研究新方法。这种转变提出了伦理挑战，伦理委员会在审查研究时需要考虑这些挑战，例如涉及广泛同意、个人遗传发现的反馈以及对二次样本获取和使用的监管。然而，非洲现有的伦理准则和法规并没有成功地规范基于共享的研究，导致了关于什么是允许的、在哪里和何时允许的混乱。方法：为了更好地了解基因组研究和生物银行的伦理监管格局，我们对现有的伦理指南、政策和其他类似来源进行了全面分析。我们从22个非洲国家采购了30份伦理规范文件。我们使用协助定性数据分析的软件对这些文档进行专题分析。结果：令人惊讶的是，考虑到广泛同意在非洲是多么有争议，我们发现大多数国家允许使用这种同意模式，只有三个国家禁止使用。可能是出于对剥削的担忧，非洲大陆以外的样品出口受到严格管制，有时还与有关国际合作的规定相结合。我们还发现，虽然确保基因组学研究中伦理最佳实践的基本和关键组成部分与伴随样本和数据共享的治理框架有关，但这在指南中很少涉及。结论：非洲国家的伦理准则需要适应不断变化的科学政策格局，科学政策格局越来越支持开放、储存、共享和二次利用原则。目前的指导方针与这种新方向提出的伦理挑战无关，因此无法为伦理委员会和研究人员提供准确的指导。
Background: The introduction of genomics and biobanking methodologies to the African research context has also introduced novel ways of doing science, based on values of sharing and reuse of data and samples. This shift raises ethical challenges that need to be considered when research is reviewed by ethics committees, relating for instance to broad consent, the feedback of individual genetic findings, and regulation of secondary sample access and use. Yet existing ethics guidelines and regulations in Africa do not successfully regulate research based on sharing, causing confusion about what is allowed, where and when.Methods: In order to understand better the ethics regulatory landscape around genomic research and biobanking, we conducted a comprehensive analysis of existing ethics guidelines, policies and other similar sources. We sourced 30 ethics regulatory documents from 22 African countries. We used software that assists with qualitative data analysis to conduct a thematic analysis of these documents.Results: Surprisingly considering how contentious broad consent is in Africa, we found that most countries allow the use of this consent model, with its use banned in only three of the countries we investigated. In a likely response to fears about exploitation, the export of samples outside of the continent is strictly regulated, sometimes in conjunction with regulations around international collaboration. We also found that whilst an essential and critical component of ensuring ethical best practice in genomics research relates to the governance framework that accompanies sample and data sharing, this was most sparingly covered in the guidelines.Conclusions: There is a need for ethics guidelines in African countries to be adapted to the changing science policy landscape, which increasingly supports principles of openness, storage, sharing and secondary use. Current guidelines are not pertinent to the ethical challenges that such a new orientation raises, and therefore fail to provide accurate guidance to ethics committees and researchers.