院校生物安全委员会

IBC是一个联邦授权的审查机构 涉及重组或合成核酸分子的NIH研究指南 to provide local review and oversight of nearly all forms of research utilizing recombinant DNA. IBC监管的生物危害范围由 涉及重组或合成核酸分子的NIH研究指南 和 微生物和生物医学实验室的生物安全(BMBL).

所有与活细胞有关的研究活动和规程, 组织, 基因工程生物, 基因治疗, and any laboratory- or greenhouse-contained experiments must be reported to the IBC for review and approval. 

IBC每隔一个月的星期一开会一次. 需要提交的材料 至少10个工作日 在每次会议之前.

IBC会议时间表可在此找到 在这里.

的 IBC also has the responsibility of reviewing a variety of experimentation that involves hazardous biological materials (such as human 体液, 细胞系, infectious agents) and other potentially hazardous agents (such as Select Agents and carcinogens).

Please submit an NJIT IBC Application Form with full disclosure if you are using any recombinant DNA, 危险生物制剂(传染性或潜在传染性), 选择代理/毒素, the use of hazardous chemicals used in research with invertebrate or vertebrate animals, 并将纳米材料的使用与上述分类相结合.

提交哪些表格

的 IBC 生物危害登记文件 must be submitted for all projects involving potential biohazards. Please include a biosketch (use the template provided but NIH format is also acceptable). Additionally, the IBC Laboratory Hazard Assessment Form must be submitted for all lab work.

生物危害登记文件.

完成IBC生物危害注册文件的说明

所有申请人必须填写以下部分:

• 首席研究员信息

• 研究地点

• A部分:一般行政信息

• B部分:材料使用清单

• H部:运输

• 第一节:关注的军民两用研究

• 第J部分:特定实验室安全规程

除了上面的部分之外, please complete the appropriate protocol-specific sections that pertain to the proposed research activities:

• C部分:豁免重组DNA实验

• D部分:非豁免重组DNA实验

• E部分:潜在传染性生物制剂的研究

• Section F: Human and Non-human Primate Blood, Body Fluids, Cell Lines, and Tissue Explants

• G部分:生物来源的毒素

注册文件可在此找到 在这里

有关填写表格的技术问题，请联络: 米切尔·盖尔，EHS部门主任 (973-596-5736, gayer@marziodangelo.com).  填妥的表格应提交至IBC邮箱: IBC@NJIT.edu

有关合规性问题, 请联系:Raju Tamot, 副主任, 研究诚信与合规(973-596-5462), 拉.k.tamot@marziodangelo.com).

什么需要由IBC审查?

Federal regulations require all faculty members/principal investigators (PIs) to file a protocol when using recombinant DNA molecules or organisms. 的 use of any potentially hazardous material must also be reported to the NJIT 安全 Officer. 所有涉及重组DNA分子的研究活动, 生物和有害物质, 不管资金来源如何, 必须由IBC审核吗.

DNA重组

所有使用重组DNA分子或生物体的研究人员都必须提交一份协议, although certain types of experiments will qualify as "Exempt from Full Committee Review". 如果您使用的是重组DNA，请参阅 NIH指南:重组DNA分子的定义), a component of the protocol form will require you to identify the sections and appendices of the NIH Guidelines appropriate for your experiments. 

生物危害  

任何活细胞、组织或生物材料都可能造成生物危害. A biohazard is a potentially dangerous infectious or toxic agent or material (such as tissue, 血液或毒素)或危害状况未知的物质. Human or non-human primate-derived 细胞系 are considered biohazards (per OSHA definition). Infectious organisms include all agents (including prions) capable of causing disease in healthy humans or animals, 无论这些在环境中是否常见.

的 BMBL第5版手册 在完成《十大网赌平台》一节时应该使用什么. 研究人员或教师与人类材料工作，如.g. 人类的血液, 体液, 未固定的人体组织, 器官和已建立的人类细胞系必须向十大网赌平台安全官员报告. All individuals dealing with such materials must complete Blood-Borne Pathogens (BBP) training annually (OSHA requirement) and be offered a Hepatitis B vaccination. 如果拒绝接种乙肝疫苗，必须签署一份弃权书. 不管来源是什么, any research involving human or non-human primate tissue or 体液 requires IBC approval.

化学危害和选定药剂

所有使用剧毒化学品的项目, 致癌(已证实或怀疑), 诱变, teratogenic or explosive on its SDS must be reported to the NJIT 安全 Officer and require IBC approval. All students and research personnel dealing with such material must complete the NJIT Biosafety Training Protocol and be certified before working on the project.

Select Agents are biological substances or toxins regulated by the Department of 健康 and Human Services or the US Department of Agriculture. All Select Agent use must be reported to the 安全 Officer and reviewed and approved by the IBC. 选择代理的完整描述可以在 http://www.selectagents.政府. At this time NJIT IBC only allows work with the following Select Agents in quantities that are not restricted (but still need to be reviewed), 如下表所示:

受规管医疗废物

Regulated medical waste (RMW; also known as biohazardous waste or infectious medical waste) is the waste that is contaminated by blood, 体液或其他潜在的传染性物质, 因此具有传播感染的重大风险.  

有几个关键的废物类别通常被归类为受管制的. 每个类别都有特定于各州的特殊处理需求. See the Types of 受规管医疗废物 page for more information on the classification of RMW.

Any research that produces any RMW material requires IBC approval and must also be reported to the NJIT 安全 Officer.

辐射危害

If you are using any radioactive substance or a device or equipment that uses or emits any radiation, please inform the NJIT 安全 Officer and submit an IBC application with full disclosure on radiation equipment, type of radiation and radioactive substance used in research for experimentation or with animal or human subjects.  All radioactive materials must be handled in designated Radiation Areas or Restricted Radiation Areas. Radioactive material should be treated as hazardous substances and handled with all cautionary procedures normally accorded such substances.

纳米材料 

研究 and technology protocols involving structures with at least one dimension less than 100 nanometers (nm), 经常以原子/分子的精度创造或使用结构, 设备, and systems that have unique properties and functions because of their nanometer scale dimension must be submitted to NJIT IBC for approval.

NJIT机构生物安全委员会(IBC)

李恩贞(爱丽丝)(主席)
生物医学工程系副教授 
Mitchell Gayer(联合主席)
环境卫生执行主任 & 安全(安全主任)
Atam Dhawan
高级副教务长(资源)
Eric财富
副教授，生物科学
埃里克·海瑟林顿
赞助研究项目主任
埃德加多·艾尔
化学及环境科学教授
梅根DeJoseph
风险管理办公室主任
桑吉夫•米. Chokshi先生.
专利和知识产权助理总法律顾问
盖尔计
埃塞克斯郡学院护理系主任(社区代表)
加里·萨金
学生2科学项目主任
迪尼史古德利
校园卫生服务主任
Sagnik Basuray
化学副教授 & 材料工程
Raju Tamot
助理主任，研究合规和诚信
理查德E. Arlaus
EHS协调员，生物安全官员

联邦生物安全指南和规程

的 涉及重组或合成核酸分子的NIH研究指南 (NIH Guidelines) detail safety practices and containment procedures for basic and clinical research involving recombinant or synthetic nucleic acid molecules, including the creation and use of organisms and viruses containing recombinant or synthetic nucleic acid molecules. 点击这里 美国国立卫生研究院生物安全指南. 

有关更多信息，请参见 常见问题.