研究者的责任

Principal investigators (PI) working with potentially biohazardous materials and recombinant DNA activities are required by NIH重组DNA指南 和/或大学政策提交一份 生物安全形式 后来被称为IBC的协议. Approval must be obtained in writing from the IBC before proceeding with these activities. The list below is intended as a guideline for the types of activities that require IBC approval. 这不是一个包罗万象的列表. 如有问题，请参阅 ibc@laocui.net.

1. 活动包括 重组DNA分子 (rDNA)
2. Any activity involving the cultivation or production of genetically modified organisms
3. Any activity involving the release or cultivation of genetically modified organisms in the environment (exception for USDA deregulated items)
4. 的任何使用、占有、储存或转让 选择药剂和毒素,
5. 任何涉及使用的活动, 占有, 储存或转移任何生物制剂(细菌), 真菌, 植物, 病毒。, rickettsiae, 衣原体, 寄生虫, 过敏原, 类病毒, 病毒粒子和朊病毒)对人体有害, 牲畜, 植物还是环境
6. 研究活动包括:
• 已知传染性组织/材料, [which includes established human cell lines that present human hazards and as such are classified as Risk Group 2 (RG2) agents (BSL2)],
• 含有感染性物质的物质/标本包括:
  • 传播这些材料的活动(例如.g.(微生物标本的生长); 
  • 可能会使工人接触到这些物质，是吗.g., sifting of soil samples (aerosolizing the soil) when the soil is known to contain an infectious agent or is from a region where there are infectious agents endemic in the soil (Bacillus anthracis is endemic in parts 的 Southwest in the United States, 例如).

All protocols (生物安全形式s) must be submitted by the monthly submission deadline (found on our 委员会会议页面)被列入当月的会议议程. 会议的日期和地点可能会有所不同，因此请联系 研究保证处 有关会议详情. There is some variability in meeting dates during months with holidays or to meet protocol demand. Please plan to submit a protocol at least four to six weeks in advance 的 planned research start date for all BSL-1 and BSL-2 protocols. BSL-3协议和Select Agent协议，请联系 生物安全官 的 研究保证处 寻求帮助.

生物安全表格的批准有效期为三年. 然而, changes in the scope of work that increase risk or saliently alter the scope must be submitted as an amendment to the 生物安全形式. 修正案 to approved 生物安全形式s during the three-year approval period do not alter the original renewal date for the MUA. 如需查询是否需要修改，请发送电子邮件至 ibc@laocui.net. 修订需要提交和处理 维拉.

Some amendments can be handled under the administrative amendment approval process which requires approval from at least two 的 following individuals: 生物安全官, IBC的椅子, 以及生物安全委员会的额外成员. Some examples are provided below to help guide the types of changes that necessitate notification to the IBC. 由于这些只是说明性的，请将所有问题提交给 ibc@laocui.net.

1. Examples of protocol changes that must be provided to the IBC as an amendment for their approval:
1. Biosafety Level 1 (BSL-1) approved protocol that proposes to add Risk Group 2 agents,
2. Addition of procedures with aerosolization risks that are not planned to occur in a Class II Biosafety cabinet,
3. Plans to use a fermenter or batches of organisms greater than 10 liters in volume,
4. BSL-2 approved protocol that proposes to add additional agents with different risks or higher risks, (e.g. approved use of Salmonella typhimurium (RG2) and proposed addition of Salmonella typhi (RG3) or approved use of any Risk Group 2 organisms with the proposed addition of clinical isolates 的 same organism with known antibiotic resistance, (风险).
2. 可能得到行政批准的协议变更示例:
1. PI变更(提供同等专业知识)
2. 额外的实验室空间(经批准的设施审查)
3. 不需要通知IBC的协议变更示例:
1. Addition of procedures to the work that do not pose a risk of aerosolization,
2. Addition of lab personnel provided the protocol does not have required medical surveillance. (PI is responsible for keeping a current list of lab personnel in the Biosafety Manual and ensuring that required annual training including review 的 Biosafety Manual (BSM) is documented in the BSM),
3. 增加风险较低的宿主/媒介模型.

PI必须向所有员工提供IBC批准通知的副本, 经批准的设施审查, 经批准的《365体育滚球》和经批准的规程.

PI必须符合所有要求 国家卫生研究院的指导方针 in the conduct of recombinant DNA work and ensure all lab workers comply with the 国家卫生研究院的指导方针.

The PI is responsible to keep a current list of research staff in the Biosafety Manual and ensure that annual training to include review 的 Biosafety Manual and all other specified training in the manual and other regulatory required training is maintained and documented in the back 的 Biosafety Manual.

PI负责报告任何重大问题, 违反了NIH指南, 或者研究相关的事故或疾病, 或与NIH指南有关的新信息 生物安全官. 一些可报告事件的例子如下:

1. Spills of potentially infectious materials or recombinant DNA outside of containment.
2. 对潜在的生物危险材料处置不当或净化不当.
3. Needle sticks and other personnel injuries involving potentially infectious materials.

Supervise the safety performance of lab staff to ensure appropriate practices are used. 

告知实验室人员建议或要求的预防性医疗措施(e).g. 接种疫苗).

Investigate and report any significant problems in regards to the operations and implementation of containment practices and procedures in writing to the 生物安全官.

Correct work errors and conditions that may result in the release of rDNA or other potentially infectious material in order to ensure biological and physical containment 的se materials.

符合rDNA分子的运输要求 附录H 美国国立卫生研究院指南.

Adhere to the IBC-approved emergency plans in the protocol specific approved Biosafety Manual.

The PI is responsible to ensure that other laboratory and research safety procedures are in place, 例如适当的个人防护装备, 适当的研究设备(高压灭菌器), 生物安全柜, 化学通风柜, 等.), 标志, 方便查阅安全资料，例如物料安全数据表(msds), 以及管理不同废物(生物)的能力, 危险化学品, 专家, 等.).

有关PI NIH的其他要求，请参见“PI职责”第IV节B. 7 . 国家卫生研究院的指导方针.

For more information, feel free to contact the 研究保证处 at ibc@laocui.net.