Any research conducted at the University of Chicago that involves the use of biohazardous materials, including recombinant DNA, agents infectious to humans, animals or plants, and other genetically altered organisms and agents must be reviewed and approved by the Institutional Biosafety Committee.

A principal investigator is a member of the academic staff or faculty who bears responsibility for the intellectual leadership of a project. The principal investigator accepts overall responsibility for directing the research; the financial oversight of the award’s funding, as well as compliance with relevant University policies and sponsor terms and conditions of award. For more information, please read the University Research Administration’s policy on PI eligibility.

Please read the about Risk Group and Biosafety Level determination on the IBC Policies and Guidelines page.

The PI may grant editing privileges to any personnel listed on the protocol. However, only the PI can submit a protocol (new submission, resubmission, or amendments) through the AURA-IBC system.

An amendment must be submitted for review by the IBC prior to any change in research being approved. For directions on how to submit a scientific amendment, please read the instructions on submitting a procedural amendment.

This requires submission of a personnel-funding amendment within the AURA-IBC system.

1. Log in to the AURA-IBC system with your CNet credentials.
2. Go to the Active tab and locate the the main protocol (e.g. IBC1677(1)). Click on the corresponding title of the protocol. This will bring you to the dashboard for this protocol when you can select the option to modify your protocol.
   
3. In the activities menu on the left side of the page, click on “Personnel-Funding Amendment”.
4. You will now be directed to Edit Smartform where you may only edit Section 1.0 [Protocol Team Members and Funding] and Section 1.1 [External Funding Information].
5. In Section 1.0 [Protocol Team Members and Funding], add and/or remove the intended staff in Question 3.0 and then click Save.
   • If you are done, click Exit. This will redirect you to the dashboard for your IBC protocol. The PI must click the “Submit” button in the left activities sidebar for the [personnel] amendment to be officially processed.
   • Approval of the personnel amendment is contingent upon the new staff completing their study staff acknowledgment. Please read the directions on how to complete the study staff acknowledgment.
6. If you need to add funding, Section 1.1 will only appear if you have chosen “Externally Funded” in Question 4.0 of Section 1.0. Complete Section 1.1 for the new funding and then click Save and then Exit.
   • This will redirect you to the dashboard for your IBC protocol. The PI must click the “Submit” button in the left activities sidebar for the [funding] amendment to be officially processed. Once submitted, nothing further is required from the PI or lab personnel as funding amendments are automatically approved in the system.

To transfer ownership of a protocol from PI to another, an amendment must first be submitted. Please follow the steps below.

1. After logging in to the AURA-IBC system, navigate to the Active tab.
2. The original PI or a member of the original PI’s lab group that has editing privileges must click on the name of the protocol that needs to be amended for the PI transfer. This will take the user to the dashboard for the protocol.
3. In the left activities sidebar, select the option to submit an amendment. Important – Do not select the Personnel-Funding amendment option.
4. This will generate a new amendment denoted by AD after the protocol number (e.g. IBC1000-AD02) and allows the user to revise the protocol while in the Edit Smartform stage.
5. Briefly describe the requested change (e.g. change in PI).
6. In Section 1.0 [Protocol Team Members and Funding], change the PI in Question 2.0. Once this change is made, the amendment is automatically transferred into the queue of the recipient PI. The receiving PI then must log into AURA-IBC to submit the amendment.
7. All PI transfers are reviewed during a convened meeting of the Institutional Biosafety Committee. All scheduled Committee meeting dates are outlined at https://ibc.uchicago.edu/ibc-committee-info/.

If you currently have an approved Animal Care and Use Protocol (ACUP), you will be required to amend it. If you do not have an active ACUP, you will need to submit a new ACUP. The ACUP submission form and amendment form can be downloaded from https://voices.uchicago.edu/iacuc/submission-forms. Details related to biohazard administration in animals must be congruent between the IBC protocol and ACUP. Specifically, Sections 5.1-5.3 in the IBC protocol must be consistent with question 12c in the ACUP. An IBC Administrator will work with you to achieve this goal. Review of the IBC protocol and ACUP will then be done simultaneously by the Institutional Biosafety Committee and Institutional Animal Care and Use Committee (IACUC), respectively. Approval of each protocol or amendment will also be contingent on one another.

Training is specific to the agents used in the IBC protocol and training sessions are offered as online modules via the EHSA system or as an in-person classroom-based comprehensive session. Please refer to the Training page for specifics relative to the agent(s), biosafety level, viral vectors, and bloodborne pathogens.

All IBC protocols are approved for 3 years.

The IBC has 2 mechanisms of review/approval for scientific changes to protocols: Chair Review or Full Committee Review.

• Chair Review is reserved for minor amendments such as when a PI is adding rDNA that does not change the risk assessment (e.g. change from RG1 to RG2 or plasmids will be used to alter the tropism for a viral vector).
• Full Committee Review is used for review of all PI transfers, addition of agents (e.g. microorganisms, viral vectors, toxins), in vivo use of agents, or other changes that increase the risk. The Full Institutional Biosafety Committee convenes once a month on the first Friday, however, this is subject to change based on holidays. Special meetings may be called at the discretion of the IBC Chair.

It may take up to 6 weeks for protocol submissions to be reviewed and approved by the IBC, so please plan your submissions accordingly. Protocol submissions (protocols and amendments) undergo the following review process:

• Administrative Review: All submissions are initially reviewed by the IBC staff to determine if they are complete. This may take 24-72 hours to complete and may result in changes that need to be made before any further steps of review can occur.
• Review by a Biological Safety Officer: After the IBC staff has a complete submission, the protocol is submitted to the Biological Safety Office for review. This review may generate questions that need to be resolved by the PI before the protocol is forwarded for additional review. This level of review can take up to 2 weeks to complete.
• IBC Member Review: Following review by the Biological Safety Officer, the protocol is sent to an assigned IBC Committee Member for review. This step of review may generate questions that need to be resolved by the PI before the protocol is cleared for Full Committee Review. This level of review can take up to 2 weeks to complete.
  • Please note that all reviews of clinical protocols require the review of 2 IBC Members.
• Committee Review: Protocols slated for Full Committee Review are reviewed once a month on the first Friday. The Committee may have outstanding issues that need be resolved via pending conditions or the protocol may be approved as written. Final approval is then based on the timely completion of the study staff acknowledgment for all listed staff.

Factors that may impact approval include:

1. Review of the biohazard administration to animals by the IACUC. Generally, the ACUP and IBC protocols are reviewed simultaneously, however, if the IACUC has concerns with the housing of the animals post-biohazard administration or requires scientific justification for special requests (e.g. transport of biohazardous animals from the vivarium to the lab for tissue harvest), then Full [IACUC] Committee Review may be warranted and any pending conditions must be addressed.
2. The Committee has significant concerns with the proposed research and defers the protocol. All deferred protocols must be reviewed by the Committee at a future date following reconciliation of the deferral questions.
3. All training requirements must be fulfilled by all listed staff. For instance, if the protocol was previously approved for the use of viral vectors but has been amended to add biological toxins, then toxin training must be completed for all listed staff.
4. Delayed submission by the PI. Only the PI has the authority to submit the protocol and changes through the AURA-IBC system even if the changes were made by another member listed on the protocol.

Once approved, new and resubmitted protocols are approved for 3 years.

You have 2 options: 1) terminate your protocol(s) or 2) transfer your protocol(s) to another UChicago PI so that the work described in the protocol can continue. If you wish to terminate your protocols, you can request termination of the protocol within the AURA-IBC system or notify the IBC Office so that one of the IBC administrators can terminate the protocol. If you wish to transfer your protocol(s), you will need to submit an amendment to the protocol. Please follow the steps below:

1. After logging in to the AURA-IBC system, navigate to the Active tab.
2. The original PI or a member of the original PI’s lab group that has editing privileges must click on the name of the protocol that needs to be amended for the PI transfer. This will take the user to the dashboard for the protocol.
3. In the left activities sidebar, select the option to submit an amendment. Important – Do not select the Personnel-Funding amendment option.
4. This will generate a new amendment denoted by AD after the protocol number (e.g. IBC1000-AD02) and allows the user to revise the protocol while in the Edit Smartform stage.
5. Briefly describe the requested change (e.g. change in PI).
6. In Section 1.0 [Protocol Team Members and Funding], change the PI in Question 2.0. Once this change is made, the amendment is automatically transferred into the queue of the recipient PI. The receiving PI then must log into AURA-IBC to submit the amendment.
7. All PI transfers are reviewed during a convened meeting of the Institutional Biosafety Committee. All scheduled Committee meeting dates are outlined at https://ibc.uchicago.edu/ibc-committee-info/.

You have 2 options: 1) terminate your protocol(s) or 2) let them naturally expire on the predetermined expiration date. The predetermined expiration date is 3 years from the original approval date so if your protocol was approved 5/30/2018 the expiration date is 5/29/2021. If you wish to terminate your protocols, you can request termination of the protocol within the AURA-IBC system or notify the IBC Office so that one of the administrators can terminate the protocol.

Contact one of the IBC Administrators.

The IBC Office is currently located inside the Animal Resources Center in SBRP P-110. Please note all IBC administrators are remotely working and no one is physically staffing the office. If you have questions about your protocol or proposed experiments that require IBC approval, please contact one of the IBC administrators directly or email the IBC Office.

If you are requesting human cell lines, bacteria, viruses, or any other agent that must be handled at BSL2 from BEI Resources, then you will need to complete the registration packet as described at https://www.beiresources.org/RegisterLevel2.aspx. A Material Transfer Agreement (MTA) should be completed and routed through your Departmental Grant Manager and URA Administrator. To have the Biosafety Level 2 Checklist completed, please contact contact researchsafety@uchicago.edu as a Biosafety Officer must complete and sign this form. For a profile of UChicago on the organization’s letterhead, please contact the IBC Office as we keep a letter on file.