Skip Section Navigation

Institutional Biosafety Committee Protocol Submission (new or expiring protocols)

All research projects involving the use of recombinant and synthetic nucleic acid and potentially biohazardous materials should be registered with the UNT IBC before beginning the project. All new IBC protocols must only be submitted online via the Dynamic Forms System using the IBC Protocol Registration Form. IBC will accept protocols submitted only by a full-time faculty. Students, research staff, visiting scholars, non-full-time faculty at UNT, or their collaborators cannot submit any IBC protocol.

To assist the IBC committee in making a quick and informed decision IBC forms must be accompanied by a comprehensive set of supporting documents (SOPs providing details on the research activities related to that project, Risk Assessment Form for the project, Training certifications, Lab-Specific Biosafety Manual and, most importantly if it involves nucleic acid manipulation – provide list of genes, their locations, Gene maps and plasmid or vector maps, sequences, the protein expressed, etc. Templates for these can be found on our Forms and Templates page.

The IBC office utilizes an initial review screening process, during which IBC Office reviews each submission for completeness and compliance.

IBC Decisions

Decisions by the IBC on a protocol typically involve one or a combination of the following decisions.

  1. Approving without contingencies means the criteria required by federal regulations for IBC approval have been met. It is granted when the IBC has no questions about the submission.
  2. Approve with contingencies that must be addressed means the criteria required by federal regulations for IBC approval have been met partially and any contingencies identified during the meeting must be addressed. No approval letter is issued until the questions and/or concerns of the committee have been satisfactorily addressed and approved by the Chair or designated reviewer(s) or the Biosafety Officer. No work can begin until such an approval letter is issued to the PI.
  3. Table the proposed IBC Protocol means the criteria required by federal regulations for IBC approval have not been met and substantial revisions may be required. The investigator will be issued a Review Response Documents that will list the IBC's stipulations and comments. The investigator's response is then reviewed by the full committee if the PI resubmits with updated form and supporting documents. If the issues/comments/suggestions are not met within the timeframe set by the committee, the protocol will be considered withdrawn and must be re-submitted fresh for further IBC reconsideration.
  4. Disapprove/reject the IBC Protocol means the criteria required by federal regulations for IBC approval have not been met. The committee disapproves of the submission in principle or due to continued lack of PIs ability to address all the concerns of the committee (Continuing noncompliance). 

Decided very rarely, disapprovals occur if:

    • After multiple attempts (i.e., after three reviews) have been made to resolve the issues, the full board and the investigator reach an impasse. Non-satisfactory response or repeated missed deadlines will be considered as grounds for rejection.
    • A laboratory safety audit shows multiple unsafe conditions for handling the biological materials
    • The study is disapproved outright because the full board determines that:
      • The research is unethical or inappropriate.
      • The resources to conduct the study are not available or science is inadequate or vague. In this latter case, the IBC may ask the PI to seek scientific review by other senior colleagues at his/her department and redesign the project which may then be resubmitted as a new study.

Modifications or Amendment requests to an approved protocol

The PI should submit modification requests via submission of UNT IBC Amendment Form when proposing changes to a currently approved non-exempt IBC protocol.

The PI should submit the minor modification requests form at least two weeks before their prosed implementation date; and not implement any proposed changes until they’ve received a written approval from the IBC office of those changes (unless to remove an immediate hazard). The Biosafety Officer may request additional information or materials from the PI if the submission package is not complete. 

Only minor changes can be submitted via the amendment form by the PI [e.g. - administrative changes such as changes to personnel (not including the PI) or other procedural changes that would not increase the risk group or biosafety level. New funding details - only if it is determined by the IBC that the Scope of Work of the new funded research matches the approved original protocol].  Once the PI has received the amendment approval letter, they may implement the approved changes.

Note: Change of PI is a major change and therefore will not be accepted in an Amendment submission. The new PI should submit a New IBC Protocol Registration Form to seek approval from the IBC committee. This is to ensure that the PI has sufficient training as required under the NIH guidelines. 

IBC Annual Renewal

During the life of the protocol, the PI must submit an UNT IBC Protocol Annual Renewal Form each year. This will ensure that previously approved protocols remain compliant with any new or updated regulations. This form must be submitted by the PI on an annual basis at least two weeks before the anniversary date of approval during the three-year period of the IBC protocol. If there are any modifications to the IBC protocol at the time of filing this form, the PI must also submit the modifications on the IBC Amendment Form.

IBC Close-out Procedure

If a PI decides to close out a currently approved IBC protocol due to completion of the research or an Exiting UNT (due to retirement or to join another institute) they can do so via the IBC Annual Renewal/Close-out Form. The form for Annual Renewal and Close-out is the same with both options (i.e. continue or close out the protocol). If the PI decides to close-out the protocol the PI must provide details on how the research materials were appropriately disposed of (date and method) or transferred to another current IBC protocol (the risk and biosafety level should be the same as the current IBC protocol) or if transferred to another UNT faculty the new PI should have a current IBC protocol related directly to that research materials to accept the research materials.

No research materials must be transferred to another PI without prior approval from the IBC committee.

Important Note:

Protocols that are related to human subject research materials will require prior approval from UNT IRB for such a transfer before the IBC allows such a transfer.
Protocols related to animal research materials will need prior approval from IACUC for such a transfer before the IBC allows such a transfer.

If the protocol involves any federal or state permits the PI should contact the relevant federal/state agency to inform them and take relevant actions as required by the permit on its disposal procedure. 

Select Agents or Dual Use Research Concern or Human Gene Therapy

If a UNT faculty plans 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, accept 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

Important Note: the IBC committee meets only once a month and will follow strict deadlines for submission dates.

If you are planning to submit a new protocol or to amend an existing protocol, and have any questions, please contact the Biosafety Officer at IBCprogram@unt.edu or Biosafety Officer veena.naik@unt.edu.