Q. What is IBC?
A. The Institutional Biosafety Committee (IBC) reviews, approves and oversees research involving the use of biohazards. Under UMaine policy, ‘biohazard’ includes recombinant or synthetic nucleic acid molecules (including plants), biological materials/biospecimens (human and animal blood, bodily fluids, and/or tissues), infectious agents* or select agents/toxins. (*The University of Maine has defined “infectious agents” as all bacterial, parasitic, fungal, viral, and prion, included within Class 2 or higher classes; See Appendix B of NIH Guidelines.)
Q. What is the BSO?
A. Biosafety Officer. The Biosafety Officer ensures compliance with various regulations, guidelines, policies, and procedures in laboratories and other areas where biohazards may be present. See the IBC Membership List for the BSO’s contact information.
Q. My work is exempt from NIH Guidelines; does it still require IBC review?
A. The BSO, with the IBC Chair, verifies any exemption, so an IBC registration document must still be submitted. If it is determined it is exempt, it will not need to go through the full IBC review.
Q. What is the IBC review process?
A. The IBC form is received by the Office of Research Compliance (ORC). ORC will pre-review the document to check for completeness. Depending on the nature of the work, it will either be exempted and required no further action from the PI (generally true of work requiring BSL-1 containment) or need to go to the IBC for a full review.
After the IBC review, the application will either be:
- Approved – no action required by the PI.
- Approved with modifications- the PI will need to address comments from the IBC.
- Withheld – the PI will need to address concerns from the IBC and resubmitted to the IBC for another review.
Q. I only work with RG1 agents under BSL-1 conditions; why do I need to register my work?
A. The BSO can meet with you to discuss your research, but you will still need to submit a registration form. The IBC will determine if the research can be conducted under BSL-1 conditions, or if there have been changes to the requirements. Biological research at the University of Maine is required to be registered, but may not require full review and approval.
Q. I will evaluate blood draw samples from a clinic. Do I need to register with the IBC?
Q. What do I need to do if my IBC study has been completed?
A. Please notify the Office of Research Compliance at email@example.com.
Q. Who do I need to contact if I have any questions related to my IBC Registration?
A. You may contact the BSO directly, or contact the Office of Research Compliance at firstname.lastname@example.org.
Q. I receive no NIH funding; do I still have to register my recombinant DNA protocol?
A. Yes. Since UMaine receives NIH funding, all researchers are required to comply with NIH Guidelines regardless of funding.
Q. I receive no funding for my research; do I still need to register with the IBC?
A. Yes. You will still need to complete the IBC registration form.
Q. I share the lab with an investigator that has IBC approval. Since we share the space, can their registration apply to my work?
Q. What responsibility do I have for individuals who access my lab?
A. Whatever happens in the lab is the responsibility of the PI and therefore, those who are in the space should be made aware of any risks that are present.
Q. I am moving my lab to a different location. Do I have to do anything?
A. Yes. You need to modify your registration to indicate the new location. Once your space is set up in the new location, please contact the BSO for an inspection. The lab must be inspected before work can begin.
- University of Wisconsin Milwaukee: Biosafety and IBC FAQs | FAA USA Safety and Health Programs
- University of Rochester: Environmental Health & Safety: Institutional Biosafety FAQs
- University of North Texas: IBC FAQs | Risk Management Services
For references and additional resources, please see the IBC Forms & Resources page.
If you have any further questions, contact the IBC office.