Challenges in biobank governance in Sub-Saharan Africa
Challenges in biobank governance in Sub-Saharan Africa
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DOI：
10.1186/1472-6939-14-35
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发表时间：
2013-09-11
影响因子：
2.7
通讯作者：
Moodley, Keymanthri
中科院分区：
文献类型：
--
作者：
Staunton, Ciara;Moodley, Keymanthri
背景：非洲内外的生物样本和数据传输充满争议 H3Africa 项目目前的目标是在非洲建立生物库，因此必须有适当的道德和法律治理结构来监督这些生物库的运营。这种治理对于确保捐助者受到保护、文化观点受到尊重以及研究人员能够随时获得符合道德来源的生物样本至关重要。方法：对撒哈拉以南非洲国家之间有关知情同意、保密和生物样本转移的所有立法、法规、指南和标准操作程序进行了文献综述。此外，还对卫生部门和国家伦理委员会的网站进行了检查。我们联系了非洲各国该领域的研究人员和研究伦理学者寻求帮助。对所有研究参与者对非洲生物样本库相关问题的看法进行了文献综述，发现了五项独立的研究。结果：发现撒哈拉以南非洲地区的生物样本库指南在生物样本库方面存在很大差异，并且经常发生跨境冲突。这可能会对合作产生负面影响。此外，现有的指南往往没有认识到生物样本转移所产生的道德困难，并且不适合监管生物样本库。此外，对于研究参与者和利益相关者对生物/样本使用的看法还没有足够的研究。结论：合作对于确保非洲生物样本库项目的成功是必要的。为了实现这一目标，整个非洲应该统一一些指导方针，这将有助于跨境转移生物样本。这些指南应反映生物样本储存和二次使用所产生的独特伦理问题。最后，有必要进一步研究研究参与者的观点。此类研究应有助于起草任何新的协调指南。
Background: Biological sample and data transfer within and out of Africa is steeped in controversy With the H3Africa project now aiming to establish biobanks in Africa, it is essential that there are ethical and legal governance structures in place to oversee the operation of these biobanks. Such governance is essential to ensuring that donors are protected, that cultural perspectives are respected and that researchers have a ready availability of ethically sourced biological samples.Methods: A literature review of all legislation, regulations, guidelines and standard operating procedures on informed consent, confidentiality and the transfer of biological samples amongst countries in Sub-Saharan Africa was conducted. In addition, an examination of the websites of departments of health and national ethics committees was performed. Researchers and research ethics scholars in the field in various African countries were contacted for assistance. A literature review of all studies examining participants views on issues related to biobanking in Africa was carried out and five separate studies were found.Results: It was found that biobanking guidelines differ substantially across Sub-Saharan Africa regarding biobanking and often conflicted across borders. This has the potential to negatively impact collaboration. Furthermore, the guidelines in place often do not recognise the ethical difficulties arising from the transfer of biological samples and are unsuitable to regulate biobanks. Additionally, there is insufficient research into the views of research participants and stakeholders on the use of biological /samples.Conclusion: Collaboration is necessary to ensure the success of biobanking projects in Africa. To achieve this, there should be some harmonization of guidelines across Africa which would aid in transferring biological samples across borders. These guidelines should reflect the unique ethical issues arising out of the storage and secondary uses of biological samples. Finally, further research into the views of research participants is necessary. Such studies should aid in the drafting of any new harmonization guidelines.