Registration Frequently Asked Questions
IBC Frequently Asked Questions
Do I need to register with the IBC if I am working with unmodified biological materials?
It depends; all biological materials are subject to an assessment by the BSO to determine if you will need to register.
What do I need to get an expedited review of my biological registration?
Any research that falls under the NIH guidelines is not eligible for an expedited review. To keep the registration approval process moving, make sure to submit your registration before the PI Submission Deadline, which is typically two weeks before the monthly IBC meetings.
What do I need to do if my registration is expiring?
A Northeastern IBC registration expires every 2 years. Our platform Bioraft will notify you two months before your registration expires. We recommend you access your registration, review each section, and update the information. The information will include personnel, locations, materials, and addition of any projects that have not been previously approved. Please submit to renew your registration. If you have more questions about this process, please contact us at biosafety@northeastern.edu.
Do I need to add new personnel to my currently approved registration?
Yes, you must add new personnel that will be directly handling and performing research with biological materials and biohazards.
Do I need to amend my registration if I want to work with other agent(s), material(s), or if I am changing procedures?
Yes, you will need to submit an amendment for working with new agent, materials, and procedures.
I am leaving the university, what do I need to do to close out my biological research registration?
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.
How long does it take to process a biological research registration?
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.
I share a research area with another investigator that is registered with the IBC. Does that registration apply to my work in the shared lab?
No, you will need to submit your own registration. Please reach out to biosafety (email biosafety@northeastern.edu) to begin the onboarding process.
I am moving or relocating, what do I need to do?
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 university, you will need to complete the process to terminate your registration. Please reach out to biosafety (email biosafety@northeastern.edu) to initiate the moving process.
What type of research is exempt from registration with the IBC?
There is no biological research at Northeastern that is exempt from registration. Research that is exempt from the NIH guidelines still needs to be registered with the NEU biosafety program and may or may not require IBC approval.
What biological research requires IBC approval or review before experiments can start?
A complete list of the types of biological research that require IBC approval can be found in section III of the NIH guidelines. Examples of research that require approval include experiments using recombinant or synthetic nucleic acid molecules, experiments using risk group 2/3/4 agents as host-vector systems, experiments involving whole animals/plants, among others.
What biological research requires notification to the IBC, but the research can commence before receiving approval?
Under section IIIE 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.
I am a clinical researcher. I use human subjects in my wet lab. Do I need IBC approval?
Yes, you will need to register with the biosafety program, and obtain approval. You will need an initial approval within the IBC in addition to the IRB approval.
I have an IACUC protocol. I introduce biohazards and rDNA into animals. What do I need to do?
You need to register and gain approval of the IBC before the IACUC can provide approval to move forward with those experiments. It is very important for PIs to reach out to biosafety with information about the biological materials used and go through the IBC approval process.
What is does it mean if my registration has a conditional approval?
If your registration has been given a 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, greater clarification on certain procedures, among others. You will be notified by the Biosafety officer about what changes need to be made.
Contact Biosafety
Email: biosafety@northeastern.edu
Phone: 617.373.2769
Northeastern University
Office of Academic and Research Safety/OARS
320 Renaissance Park
1135 Tremont Street