Biosafety Frequently Asked Questions (FAQs)

Definitions

The Institutional Biosafety Committee (IBC) reviews, approves and oversees research involving the use of biohazards. Under UMaine IBC Policy (Word), “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 National Institutes of Health (NIH) Guidelines [PDF] [external link].)

BSO is an acronym for Biosafety Officer. The BSO ensures compliance with various regulations, guidelines, policies, and procedures in laboratories and other areas where biohazards may be present. Contact information for the BSO is available on the UMaine IBC website.

According to the IBC Policy (Word), the definition of Principal Investigator (PI) is to include PIs, lab managers, research supervisors, instructors, or any individuals responsible for work to be conducted.

According to the IBC Policy (Word), the policy is applicable to research or other scholarly activities (including teaching) involving biological materials.

IBC Initial Submissions

In order to ensure all biosafety spaces are inspected and that the IBC has a record of all biosafety work being conducted on campus, all labs (research and/or educational) using biological materials of any kind will fill out an IBC Registration Form (Word) (containing basic information like PI, lab locations, Biosafety Level (BSL), summary of activity). Formal IBC approval is not required for IBC registration forms.

IBC Protocol Form (Word) submission is only required for work involving one or more of the following: non-exempt rDNA, non-exempt BSL-2, animals, and/or human cells/cell lines. Protocol forms are submitted in addition to registration forms.

Please see the IBC Submission Flow Chart (Flow Chart Diagram [PDF], Flow Chart Plain Text [Word]) for more information and contact the BSO with any questions about form submission requirements.

IBC Protocol Forms (Word) are for research projects, not PIs, thus a single PI could have multiple separate protocols. This is true even if the projects are all taking place in the same lab.

IBC Protocol Forms (Word) are for research projects, not PIs, thus a single protocol may have co-PIs (with one PI designated as the primary contact). However, each PI would need to submit their own IBC Registration Form (Word), even if they are working in the same lab.

All PIs working with biological materials of any kind must first submit an IBC Registration Form (Word). You may also be required to complete an IBC Protocol Form (Word), even if your work could be exempt.

If a protocol form is submitted, the BSO and the IBC Chair must then verify any exemption. If it is determined the work is exempt, it will not need to go through the full IBC protocol review process.

The IBC Registration Form (Word) is submitted to umric@maine.edu and reviewed by the Office of Research Compliance (ORC) and the BSO.

IBC Protocol Forms (Word) are also submitted to umric@maine.edu. ORC will pre-review the document to check for completion, then will be reviewed by the BSO and the IBC chair. Depending on work described in the protocol, it will either be exempt and require no further action , or it will 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.

The BSO can meet with you to discuss your research, but you will still need to submit an IBC Registration Form (Word) for IBC records and lab inspection purposes. 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 protocol review and approval.

Yes, you will need to register with the IBC (Word), submit an IBC Protocol Form (Word), and you may also need to seek approval from the Institutional Review Board (IRB). Please contact umric@maine.edu for assistance.

Please notify the Office of Research Compliance at umric@maine.edu.

You may contact the BSO directly or contact the Office of Research Compliance at umric@maine.edu.

Funding

Yes. Since UMaine receives NIH funding, all researchers are required to comply with NIH Guidelines (PDF) (external link) regardless of funding.

Yes. You will still need to complete the IBC Registration Form (Word).

Lab Space

No. Each PI is responsible for complying with the UMaine IBC Policy (Word) and NIH Guidelines (PDF) (external link).

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.

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.

References

For references and additional resources, please see the IBC Forms & Resources page.

Questions?

If you have any further questions, contact the IBC office.