National ethics guidance in Sub-Saharan Africa on the collection and use of human biological specimens: a systematic review.
National ethics guidance in Sub-Saharan Africa on the collection and use of human biological specimens: a systematic review.
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DOI：
10.1186/s12910-016-0146-9
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发表时间：
2016-10-22
影响因子：
2.7
通讯作者：
Little MT
中科院分区：
文献类型：
--
作者：
Barchi F;Little MT
收集和使用人类生物标本(HBS)用于研究的伦理和监管指导构成了撒哈拉以南非洲(SSA)国家卫生系统的重要组成部分，在那里，遗传和基因组技术的快速进步正在推动涉及HBS的临床试验和建立大规模生物库。对每个SSA国家进行了广泛的多层次搜索，以获得可公开获得的道德监管指导。第二次审查记录了截至2015年1月在世卫组织国际临床试验注册平台中列出的正在进行的试验，其中HBS收集在方案中指定。综合研究结果，以确定作为哈佛商学院相关研究地点的国家在多大程度上得到了关于生物样品的收集、使用、所有权和储存的监管指导语言的支持。在49个SSA国家中，29个国家有某种形式的国家道德指导，但只有17个国家提供了与哈佛商学院相关研究有关的语言，其中有关于同意(14个)、所有权(6个)、再利用(10个)、储存(9个)和出口/进口/转让(13个)的具体指导。在涉及SSA收集HBS的活跃临床试验中，有10个国家占84%。除一个国家外，所有这些国家都以法规、道德守则和/或标准操作程序的形式提供了一些国家指导；然而，十个国家中只有七个国家提供了哈佛商学院特有的语言。尽管涉及哈佛商学院的SSA注册临床试验的大部分，以及H3非洲倡议下现有和拟议的生物库地点，目前位于道德和监管指导最完整的国家，但法规本身的可变性可能会给计划中的和未来的泛非合作带来挑战，并可能需要国家一级的立法行动来修订。SSA中仍然缺乏HBS监管指导的国家将需要在道德治理方面加强广泛的卫生系统，然后才能成为现代研究企业的完全参与者。
Ethical and regulatory guidance on the collection and use of human biospecimens (HBS) for research forms an essential component of national health systems in Sub-Saharan Africa (SSA), where rapid advances in genetic- and genomic-based technologies are fueling clinical trials involving HBS and the establishment of large-scale biobanks. An extensive multi-level search for publicly available ethics regulatory guidance was conducted for each SSA country. A second review documented active trials listed in the WHO International Clinical Trials Registry Platform as of January 2015 in which HBS collection was specified in the protocol. Findings were combined to determine the extent to which countries that are study sites for HBS-related research are supported by regulatory guidance language on the collection, use, ownership and storage of biospecimens. Of the 49 SSA countries, 29 had some form of national ethics guidance, yet only 17 provided language relating to HBS-related research, with specific guidance on consent (14), ownership (6), reuse (10), storage (9), and export/import/transfer (13). Ten countries accounted for 84 % of the active clinical trials involving the collection of HBS in SSA. All except one of these countries were found to have some national guidance in the form of regulations, codes of ethics, and/or standard operating procedures; however, only seven of the ten offered any language specific to HBS. Despite the fact that the bulk of registered clinical trials in SSA involving HBS, as well as existing and proposed sites for biorepositories under the H3Africa Initiative, are currently situated in countries with the most complete ethics and regulatory guidance, variability in the regulations themselves may create challenges for planned and future pan-African collaborations and may require legislative action at the national level to revise. Countries in SSA that still lack regulatory guidance on HBS will require extensive health system strengthening in ethics governance before they can be full participants in the modern research enterprise.
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影响因子：
4.1
作者：
Andanda, P. A.
通讯作者：
Andanda, P. A.
影响因子：
4.1
作者：
Nyika, A.;Kilama, W.;Ikingura, J.
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影响因子：
2.7
作者：
Barchi, Francis;Matlhagela, Keikantse;Merz, Jon F.
通讯作者：
Merz, Jon F.
影响因子：
4.1
作者：
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通讯作者：
Mfutso-Bengo, J. M.
影响因子：
1.6
作者：
Bruinenberg, Marcel;Frey, Martin;Summers, Annette
通讯作者：
Summers, Annette