University of North Texas 
Principal Investigators (PIs) seeking initial IBC approval are required to submit a completed UNT IBC Protocol Registration Form 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 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.
Annual Renewals
For the life of the protocol, the PI must submit an UNT IBC Protocol Annual Renewal/Closeout Form 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. 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.
Exempt Projects
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 veena.naik@unt.edu
IBC Decisions:
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.
UNT INSTITUTIONAL BIOSAFETY COMMITTEE REVIEW PROCESS FLOW CHART