生物使用授权
Purpose of the 菠菜网lol正规平台 机构生物安全委员会 reviews
The purpose of IBC reviews is to ensure that all activities involving biological agents and the facilities used to conduct such work are in compliance with all external regulations, 及适用的大学政策. The committee will function to ensure that investigators handle biological agents in a safe and responsible manner, and meet criteria as described 由 美国国立卫生研究院指南[pdf] for recombinant DNA research (specifically those defined in section IV-B-2); the 疾病预防控制中心/国家卫生研究院出版 Biosafety in the Microbiological and Biomedical Laboratories; applicable regulations defined 由 state of California; the Cal/OSHA 血源性病原体标准; HHS and USDA final rules for the possession, use, and transfer of 选择药剂和毒素; and other applicable requirements. 最重要的是，IBC的目标应该是确保 that such activities meet the standards of good biological safety practice emphasizing protection of personnel, the public and the environment.
Who needs to submit a 生物使用授权 (BUA) to the 菠菜网lol正规平台 IBC
All 菠菜网lol正规平台 faculty, staff and lecturers need to submit 一个BUA to the IBC for the use of all biological agents or activities described below that are used in research or 教学领域:
A. Activities involving recombinant/synthetic nucleic acid molecules or recombinant/synthetic nucleic acid-containing organisms/viruses/cell cultures;
B. Biological agents above biosafety level 1 (BSL-1), including field activities that 收集环境样本(例如.g.(土壤，水)，或者收集/使用动物 港口人畜共患病原体.
C. Unfixed materials derived from human and nonhuman primates, including human embryonic 干细胞;
D. Activities that collect plants/animals, work with plants/animals/samples with potential zoonotic agents, or cultivate exotic/noxious plants;
E. Biological Toxins with an LD50 of less than 100 micrograms per kilogram of body 脊椎动物的重量;
F. 选择药剂或毒素 subject to 42 CFR Part 73, 9 CFR Part 121, or 7 CFR Part 331;
G. Proposed research subject to the United States Government Policy for Institutional 生命科学的监督 关注的两用研究.
同时提交bua
BUAs may be submitted concurrently with other requirements, such as Institutional Review Board (IRB) or 机构动物护理和使用委员会 submissions. bua不能代替IRB或IACUC的批准.
BUA形式
First complete the 主要BUA form to determine which additional attachments are needed 为了你的工作. 然后,电子邮件 biosafety@jkchealthtech.com to create 一个BUA submission folder in the IBC google drive. 您也可以提交 BUA格式为Word文档.
附件一个 - Project involves recombinant/synthetic nucleic acid molecules, recombinant/synthetic nucleic acid-containing organisms, viruses or cell cultures.
附件B - Project involves potential human, animal, or plant pathogens or infectious agents.
附件C - Project involves unfixed human or non-human primate organs, tissues, or cell cultures (OTCC) with proven or potential hazard to humans, other animals or plants. (所有工作 with human blood, human blood products, human body fluids, or other potentially infectious human materials such as brain, CNS tissues, lymphoid tissues, gut, b一个 marrow, and 人类细胞培养就属于这一类. 注:人源材料即有 been previously fixed are excluded and do not need 一个BUA.)
附件D - Project involves the collection and analysis of environmental samples (e.g.、土壤、 水).
附件E -项目涉及生物毒素. 毒素是细菌产生的有毒物质， fungi, protozoa, insects, animals, or plants that have the capability of causing harmful effects when inhaled, ingested, injected or absorbed. 注:不含毒素 对细胞或动物的影响不能保证BUA. 选择毒素，无论用途如何，都需要 一个BUA.
附件F - Project involves collection of animals and plants; use of animal- or plant-derived 含有人畜共患病原体的样本(如.g.，野生陷阱动物，农场动物和非人类 primates); or cultivation of exotic or noxious plants
附件G - Project involves laboratory animals and/or plants in conjunction with materials 如附件A、B、C或E所述.
附件H - Project involves storage only of biohazardous agents.
补充应急计划 - Emergency relocation plan for live invertebrates, tissues, or cells
共享空间补充审批模板 - authorization by managers of shared spaces for the PI to use the space and hazard communication plans to inform other shared space users
示例文件
伸出手去 biosafety@jkchealthtech.com to request sample documents or to set up a consultation to help you develop your BUA. The following resources may be helpful as you prepare your BUA.
续期及修订
Upon approval of the BUA, Principal Investigators will complete 一个BUA renewal yearly for active biosafety level 2 (BSL-2) research or every 3 years for all other research requiring 一个BUA (including storage only of BSL-2 materials).
要更新或修改已批准的BUA，请联系 biosafety@jkchealthtech.com to create a submission file in the IBC google drive. 然后，你就可以申请了 changes directly to the approved BUA using the "Suggesting" mode in Google Docs. 一次 您的BUA修改包已完成，请告知 biosafety@jkchealthtech.com 展开委员会检讨.
Note, while you do not need to submit an amendment to the BUA each time your lab/course personnel changes, you must maintain a current list of laboratory/course personnel and training documentation that can be produced upon request of the IBC or a lab auditor.
In addition, an amendment must be submitted each semester for the instructor in charge 如果他们不在批准的BUA上.
