Building blocks for better biorepositories in Africa.
Building blocks for better biorepositories in Africa.
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在非洲更好的生物震荡的构建基础。
DOI：
10.1186/s13073-023-01235-x
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发表时间：
2023-11-06
期刊：
影响因子：
12.3
通讯作者：
Abimiku, Alash'le
中科院分区：
文献类型：
--
作者：
Croxton, Talishiea;Jonathan, Emmanuel;Suleiman, Kareemah;Balogun, Olasinbo;Ozumba, Petronilla;Aloyo, Sharley;Nsubuga, Gideon;Kamulegeya, Rogers;Newton, Lwanga;Mukisa, John;Kader, Mukthar;Damaneite, Vuyo;Nadoma, Sunji;Onyemata, Ezenwa James;Anzaku, Abbas Abel;Nasinghe, Emmanuel;Troyer, Jennifer;Joubert, Bonnie;Beiswanger, Christine;Joloba, Moses;Mayne, Elizabeth;Abimiku, Alash'le
生物储存库存档和分发特征良好的生物标本用于研究，以支持医学诊断和治疗的发展。在疾病负担高得不成比例的低收入和中等收入国家，生物库和相关做法的知识是不完整的。2011年，非洲人类遗传学会（AfSHG）、美国国立卫生研究院（NIH）和威康信托基金会成立了非洲人类遗传与健康（H3 Africa）联盟，以促进非洲的基因组研究，并建立了一个由位于东非、西非和南部非洲的三个生物储存库组成的网络，以支持生物医学研究。这份手稿描述了H3非洲生物储存库建立的过程，以准备研究场地，收集高质量的生物标本，供H3非洲生物储存库存款。生物储存库协调了生物储存库和研究中心之间的做法。生物储存库制定了指导方针，以建立最佳做法并确定生物标本要求;生物标本采集、处理、储存、运输和记录等常见流程的标准操作程序（SOP）作为参考;最低相关数据集和格式的要求;以及管理生物标本交换的材料转移协议（MTA）模板。生物储存库还在相关的生物库流程和程序方面对采集点进行培训和指导，并对生物标本存款流程进行核查。在整个过程中，生物储存库遵循伦理和法律的要求。20个研究项目按照道德和法律的要求以及既定的最佳做法，存放了107 982份生物标本（76% DNA，81 067份）。生物储存库开发和定制资源和人力资源建设，以支持项目。[The生物储存库制定了34项准则、标准操作程序和文件;培训了176名临床医生和科学家，涉及30多个主题;提高了伦理机构的认识;建立了多边贸易协定，审查了所有项目的同意书;获得了进口许可证;评估了试点工作并提供了反馈。在低收入和中等收入国家由当地熟练工作人员建立生物库对于推进生物库和基因组研究至关重要，需要全球伙伴关系的人力和资源。通过与研究人员合作，生物储存库可以帮助建立人力和资源，以支持生物库。可以构建和定制合作伙伴关系，以纳入文件开发，道德，培训，指导和试点，以准备好收集，处理，储存和运输高质量生物标本的地点，以供未来研究。
Biorepositories archive and distribute well-characterized biospecimens for research to support the development of medical diagnostics and therapeutics. Knowledge of biobanking and associated practices is incomplete in low- and middle-income countries where disease burden is disproportionately high. In 2011, the African Society of Human Genetics (AfSHG), the National Institutes of Health (NIH), and the Wellcome Trust founded the Human Heredity and Health in Africa (H3Africa) consortium to promote genomic research in Africa and established a network of three biorepositories regionally located in East, West, and Southern Africa to support biomedical research. This manuscript describes the processes established by H3Africa biorepositories to prepare research sites to collect high-quality biospecimens for deposit at H3Africa biorepositories. The biorepositories harmonized practices between the biorepositories and the research sites. The biorepositories developed guidelines to establish best practices and define biospecimen requirements; standard operating procedures (SOPs) for common processes such as biospecimen collection, processing, storage, transportation, and documentation as references; requirements for minimal associated datasets and formats; and a template material transfer agreements (MTA) to govern biospecimen exchange. The biorepositories also trained and mentored collection sites in relevant biobanking processes and procedures and verified biospecimen deposit processes. Throughout these procedures, the biorepositories followed ethical and legal requirements. The 20 research projects deposited 107,982 biospecimens (76% DNA, 81,067), in accordance with the ethical and legal requirements and established best practices. The biorepositories developed and customized resources and human capacity building to support the projects. [The biorepositories developed 34 guidelines, SOPs, and documents; trained 176 clinicians and scientists in over 30 topics; sensitized ethical bodies; established MTAs and reviewed consent forms for all projects; attained import permits; and evaluated pilot exercises and provided feedback. Biobanking in low- and middle-income countries by local skilled staff is critical to advance biobanking and genomic research and requires human capacity and resources for global partnerships. Biorepositories can help build human capacity and resources to support biobanking by partnering with researchers. Partnerships can be structured and customized to incorporate document development, ethics, training, mentorship, and pilots to prepare sites to collect, process, store, and transport biospecimens of high quality for future research.
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影响因子：
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作者：
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通讯作者：
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