Institute of Human Virology H3Africa Biorepository (I-HAB) ADMIN SUPPLEMENT

人类病毒学研究所 H3Africa 生物样本库 (I-HAB) 管理补充

• 批准号: 10631024
• 负责人: Alash'le G. Abimiku
• 金额: $ 34.58万
• 依托单位: INSTITUTE OF HUMAN VIROLOGY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-16 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10631024
• 关键词: Address; Administrative Supplement; Advisory Committees; Advocate; Africa; African; Aliquot; Bioinformatics; Biological; Businesses; COVID-19 pandemic; Catalogs; Clinical Data; Communities; DNA; Data; Deposition; Disease; Ensure; Ethics; Future; Genes; Genetic Materials; Genomics; Goals; Government; Grant; Guidelines; Health; Human; Human Resources; Infrastructure; Institutes; Leadership; Liquid substance; Mentors; Modeling; Nigeria; Nitrogen; Persons; Phase; Plants; Policies; Population; Process; Public Health; Race; Research; Research Personnel; Research Project Grants; Resources; Rest; Sampling; Schedule; Science; Scientist; Services; Shipping; Signal Transduction; Sister; Time; Training; Translational Research; Work; base; biobank; clinical research site; database query; epidemiologic data; global health; high standard; improved; meetings; pandemic disease; preservation; sample collection; success; virology

PROJECT SUMMARY/ABSTRACT The Institute of Human Virology Nigeria (IHVN) H3Africa biorepository (I-HAB), has successfully upgraded its practices to be ISBER compliant through an iterative quality assessment-based interaction involving capacity building drawing upon Coriell’s proven models and graduated to be the W/Africa H3Africa regional biorepository, During the COVID-19 pandemic, I-HAB lost 18 months of its planned activities due to the disruption of services by the pandemic. So far, I-HAB has only successfully received and aliquoted all DNA biospecimens from only one of the six H3Africa research projects that it supports. Two of the projects deposited 67% and 86% while the rest of the three projects are below 50% submission; at only 0%, 17%, and 29%. The goal of this administrative supplemental submission (1 JULY 2022 TO 30 JUNE 2023) is to ensure that all remaining biospecimens are deposited by H3Africa investigators, aliquoted, and used in the final phase which is to distribute aliquoted biospecimens and data to investigators from the wider scientific community whose application has been approved by the Data and Biospecimen Advisory Committee (DBAC) to conduct high-quality genomics and translational research in Africa using well processed, preserved and quality controlled and redundantly protected human biological samples. To achieve this, I-HAB builds on its past successes to address four specific aims. 1) Engage PIs to complete deposition and create sub-aliquots of primary human biologic samples and genetic materials in compliance with GLP, ISBER guidelines, and QC 10% in line with H3Africa policies/ guidelines. 2) Populate, interrogate, and query the database regularly to ensure that the online catalogue is up to date, interfacing regularly with other two regional H3Africa biorepositories, the H3AfricaBionet team, and relevant stakeholders to review and brainstorm on ways to address gaps during scheduled meetings. 3) Pilot processes for efficient distribution of high- quality biological samples to the wider scientific community, based on Data and Biological samples Access Committee approval and according to H3Africa policies and guidelines. 4) Strengthen I-HAB’s business model as part of a long-term sustainability strategy. Working collaboratively with the other two sister H3Africa biorepositories and the H3Africa Bionet, I-HAB continues to advocate for host government and community support and pilot processes to make the regulatory and ethical process of sharing samples and data easier. The strong institutional support through the expansion of the biorepository to over 3times its size at IHVN’s new facility, the acquirement of a liquid nitrogen plant, and the expansion of its clientele to investigators outside of H3Africa signals a sustainable future for I- HAB.

项目总结/摘要 尼日利亚人类病毒学研究所（IHVN）H3非洲生物储存库（I-HAB）成功地 通过迭代的基于质量评估的互动，将其实践升级为符合ISBER标准 涉及能力建设借鉴科利尔的成熟模式，并逐步成为西非 H3非洲区域生物储备库，在COVID-19大流行期间，I-HAB损失了18个月的计划 由于疫情导致服务中断，本集团的业务活动受到影响。到目前为止，民政事务总署只成功地 从六个H3非洲研究项目中的一个项目中接收并等分了所有DNA生物标本， 支持.其中两个项目的存款为67%和86%，而其余三个项目的存款低于 50%的提交率;只有0%，17%和29%。本行政补充申请的目的是 （2022年7月1日至2023年6月30日）是为了确保所有剩余的生物标本 H3 Africa研究者，等分试样，并用于分发等分试样的最后阶段 生物标本和数据的研究人员从更广泛的科学界，其应用已 数据和生物样本咨询委员会（DBAC）批准进行高质量的基因组学 和转化研究在非洲使用良好的加工，保存和质量控制， 冗余保护的人类生物样本为达致这个目标，民政事务局在过往成功的基础上， 实现四个具体目标。1)让PI完成沉积并创建初级药物的子等分试样 符合GLP、ISBER指南和QC的人体生物样本和遗传物质 10%符合H3非洲政策/准则。2)填充、询问和查询数据库 确保在线目录是最新的，定期与其他两个区域 H3 Africa生物储存库、H3 AfricaBionet团队和相关利益相关者进行审查和集思广益 在排定的会议期间解决差距的方法。3)高效率分配高质量的 根据数据和生物样本，向更广泛的科学界提供高质量的生物样本 访问委员会批准并根据H3非洲政策和指导方针。4)加强I-HAB 作为长期可持续发展战略的一部分。与其他两个合作 通过姐妹H3非洲生物储存库和H3非洲生物网，I-HAB继续倡导宿主 政府和社区的支持和试点进程，使监管和道德的过程， 更轻松地共享样本和数据。通过扩大 在IHVN的新设施中，生物储存库的规模扩大了3倍以上，获得了一个液氮工厂， 其客户扩展到H3 Africa以外的调查人员，标志着I的可持续未来。 HAB.