A project under a biological registration outlines its scientific objectives and the laboratory methods employed to achieve them. Each project specifies biological materials, personnel, and procedures, including safety precautions, hazard management, emergency response plans, and work practices aimed at minimizing and controlling biological risks. The IBC reviews each individual project assigned a unique number under the registration. Registrations can have multiple projects within a laboratory.

1. Descriptions of the biological materials used in the lab, including DNA systems, host/vector systems, and how they are manipulated.

2. Any potential risks to laboratory workers, the public, and the envrionemnt. 

3. Engineering controls being used to contain any biohazardous materials, good laboratory practices, safety, and compliance.

The principal investigator (PI) is:  

• Ultimately responsible for full compliance with NIH Guidelines
• Register with IBC and communicate throughout the project life cycle.
• Be trained in good microbiological techniques
• Train and supervise personnel in safe practices to prevent exposure and illness
• Train and follow best practices to prevent spills and clean up spills
• Comply with biological materials shipping requirements
• Train and supervise personnel to respond to emergencies
• Correct work errors that may lead to safety and compliance lapses
• Report any significant problems, violations, or accidents/illnesses to BSO.
• Correct work errors and conditions that could result in the release of biological materials into the environment.

• Work with PI to ensure biological materials and experiments are approved on Biological Registration in SciShield 
• Complete all required biosafety and lab-specific training
• Follow established microbiological practices in the laboratory
• Become familiar with a process before working with the biological material
• Report significant safety concerns to PI or the Biosafety Program
• Abide by Northeastern University policies

There is no biological research at Northeastern that is exempt from registration. Research that is exempt from the NIH guidelines is registered however may or may not require IBC approval.  

A complete list of the experiments that require IBC approval can be found in section III of the NIH guidelines.  

Under section III–E of the NIH guidelines, biological research experiments require notification to the IBC, and some research can start before receiving approval. However, initial registrations or new projects involving experiments not previously reviewed cannot commence until the IBC approval is in place. 

Normally, this will take between 3-4 weeks. This depends on the complexity of the registration and research, lab commissioning, and the speed at which the PI responds to biosafety inquiries. The process can be described on the flowchart found on our website. 

Expedited review under the NIH guidelines is not allowed. 

If your registration has been given conditional approval, minor changes to your registration will need to be made to maintain compliance with the IBC. These can include administrative changes to your protocol, and greater clarification on certain procedures, among others, compliance items, or facilities-related concerns. You will be notified by the Biosafety Officer about what changes need to be made. 

Once your initial registration is approved by the IBC, you will receive an assurance letter for your registration. This initial registration is valid for a specific time up to 2 years from the original approval date. Your registration will need to be resubmitted after these 2 years for review. If there are any changes to the biohazardous materials used, research goals, procedures, location, or personnel, you will need to submit an amendment for your project under your registration on SciShield for review.

Usually, SciShield will notify you two months before your registration expires. We recommend accessing your registration to review each section and update the information, including personnel, locations, materials, and the addition of projects not previously approved. Please submit to renew your registration. If you have further questions about this process, please contact us at biosafety@northeastern.edu.

Yes. You must add new personnel who will be directly handling and performing research with biological materials. 

Yes. You will need to submit an amendment for working with the new agent, materials, and procedures.  

Contact biosafety (email biosafety@northeastern.edu) to initiate a lab decommissioning process. This will include a lab inspection, waste disposal process, decontamination of equipment, biological materials transfer, research transfers, and protocol termination. 

No. Please reach out to biosafety (biosafety@northeastern.edu) for assistance. 

The process will vary depending on where you are moving. If you are moving within the university, you will need to submit an amendment. If you are moving out of the Boston or Nahant locations into another Northeastern location, please reach out to biosafety (biosafety@northeastern.edu) for assistance. 

Yes, if biological materials are involved, extracted from human subjects, or introduced into human subjects. You will need an initial approval with the IBC in addition to the IRB approval. 

You need to register and gain approval of the IBC before the IACUC can provide approval to move forward with those experiments. PI needs to reach out to biosafety with information about the biological materials used and go through the IBC approval process.