Institutional Biosafety Committee Protocol Submission (new or expiring protocols)
Principal Investigators (PIs) seeking initial IBC approval are required to submit a completed UNT IBC Protocol Registration Form - 2022 at least four weeks prior to the desired IBC meeting date. IBC meetings are generally held on the 2nd Wednesday of each month at 12:30 p.m.
Approvals may be effective for up to 3 years, depending upon the nature of project. All research is required to be closed after 3 years’ time and to be resubmitted if continuation is desired. The PI must submit a UNT IBC Protocol Registration Form - 2022 before the expiration date of the initial protocol to avoid interruption of ongoing research. Protocols may be re-approved only by full committee review when they expire or at the discretion of the committee. The IBC may revoke an approval if it is determined that the research is not in compliance with NIH Guidelines or the UNT biosafety manual.
For the life of the protocol, the PI must submit an UNT IBC Protocol Annual Renewal/Closeout Form 2022 each year. This will ensure that previously approved protocols remain compliant with any new or updated regulations.
A courtesy email will be sent 2 months before the relevant application deadlines. However, it is the responsibility of the PI to make sure that their protocols are approved before the deadlines. If the IBC does not receive and approve the appropriate form by the expiration date, the BSO may issue a Cease and Desist Notice. Any further work on the expired project violates the NIH Guidelines and must be reported to the NIH OBA.
Updating an Existing Protocol
The PI must notify the IBC of any significant changes to an already approved protocol BEFORE implementing said changes using the UNT IBC Protocol Amendment Form 2022. The amendment form will be considered for review at the forthcoming Committee meeting if it was received by the application deadline. Failure to comply will result in a violation of the NIH Guidelines and must be reported to the NIH OBA. Submission of a Biosafety Protocol Amendment Form does not affect the life or expiration date of the original protocol.
Other biological research conducted at UNT that does not meet the above criteria, but uses biological materials (such as animal cells or tissues), must still be registered with the IBC as an exempt project.
If you are planning to submit a new protocol or to amend an existing protocol, and have any questions, please contact the Biosafety Officer who will assist you with this process at IBCprogram@unt.edu or Biosafety Officer email@example.com
Actions by the IBC on a protocol typically involve one or a combination of the following decisions.
• Approve. The protocol is accepted as provided to the committee. An approval letter will be sent by the Biosafety Officer to the PI.
• Approve with contingency(s). The investigator is required to take additional steps before the protocol will be approved. The protocol must be revised to the satisfaction of the OBS and/or the reviewers. Only after all contingencies are met the approval letter be sent to the PI.
• Table. The protocol has significant deficiencies that must be addressed before the committee will reconsider it. The PI should work with the Biosafety Officer to resolve these issues before the protocol is considered again
• Reject. This action is indicative of significant problems with the protocol. The BSO, and/or reviewers, or designee sends a memo to the investigator explaining the action taken by the IBC.
If you plan to work with Select Agents, or research that could fall under Dual Use Research Concern or Human Gene Therapy contact the Biosafety Officer immediately i.e., before you buy, transfer, or start your research at UNT. Additionally, regulations allow for escalation of projects to a more rigorous category and may affect the timeline and the required documentation to be submitted by the PI. Investigators are encouraged to submit in advance of the deadline date to allow for sufficient time for questions to be asked prior to the board meeting.