University Research Compliance
Biosafety Office
Protocol Application Submission and Review Process
The Office of University Research Compliance (URC) coordinates the Institutional Biosafety Committee’s (IBC) protocol review process and maintains all pertinent records. IBC application forms are available via OneAegis. Submission of incomplete protocol applications will delay the review process. The IBC meets bi-monthly. The biosafety website provides the current IBC meetings schedule and protocol submission deadlines. Investigators are responsible for keeping lab inspections current. The lab inspection report is required before a protocol will be approved by the IBC. The research activity may not start until approval is granted by the IBC. Biosafety Office staff is available to answer questions regarding IBC applications.
If an investigator or instructor needs to modify an IBC approved protocol, a Protocol Modification must be submitted via OneAegis to the Biosafety Office for review. Changes in project personnel, as well as significant changes to methods or the biological materials to be used after initial IBC approval must be approved by the IBC. Also, if additional research facilities will be utilized or the project will be moved to another laboratory, a Protocol Modification needs to be submitted to the Biosafety Office. The Biosafety Officer, on behalf of the IBC, will review the proposed changes to determine if the changes alter the risk and/or biosafety level assessment. Subsequent review by the IBC may be required.
Protocols that are classified at biosafety level 2 or biosafety level 3 are subject to renewal every three years either through protocol review or through the submission of a 3-year renewal via OneAegis. Protocols that are classified as exempt recombinant or synthetic nucleic acid molecules or BSL-1 research are subject to renewal every five years.
If a project is terminated or concluded, the Institutional Biosafety Committee (IBC) requests that the investigator or instructor notify the Office of University Research Compliance. This action will allow the protocol to be closed. If the investigator or instructor plans to leave the University, he/she should notify the Office of University Research Compliance with a request to terminate the protocol. An investigator or instructor who willfully or negligently violates Federal or State regulations or required guidelines, or Oklahoma State University policies regarding the use of biohazardous materials, including recombinant DNA, may have his/her IBC approval suspended or terminated by the IBC. The IBC has the authority to conduct an inquiry prior to making a final decision regarding suspension or termination of the activities.
Protocol Review Process
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Initial Biosafety Office Review
Protocol is submitted with all required signatures. Biosafety Office receives email notification and does internal review. BSO compiles comments and returns protocol to submitter if changes are necessary.
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Expedited/Full Committee Review
- Once submitter has made the required changes, the BSO sends the protocol for Expedited Review or Full Committee Review.
- Expedited Review consists of the BSO, IBC Chair or Vice Chair, and one additonal IBC committee member. One-week timeline for review. Full committee is notified of review, but only assigned reviewers are required to complete review. Biosafety Office is notified via email once reviews are complete.
- Full Committee Review discussions will take place during next convened IBC Meeting, but committee members will view protocols prior to the meeting.
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2nd Biosafety Office Review
- BSO compiles comments/required changes from Expedited/Full Committee Review and returns protocol to PI for final corrections.
- Pl makes corrections and resubmits the protocol form.
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Post Review Processing
- BSO confirms PI made required corrections, generates approval letter, and submits with final signature.
- Once BSO signs, Approval Letter is automatically emailed to PI, protocol submission is complete.