Protocol Submission Guidance

To start a new IBC Protocol:

1. Go to veras.uidaho.edu.
2. Under Study Assistant, select “Create a New Study” then click “Study Application – IBC”
3. Complete the IBC Study Application (protocol form) by addressing all required components and submit before the monthly submission deadline. See VERAS Guide – IBC Protocol Manual for additional guidance.
4. Once submitted, the PI and Study Contact will receive an auto-generated confirmation email of the submission.

Please Note: Other personnel, besides the PI, may author the IBC forms. However, the PI must review the forms and signoff on the submission before it is sent to the IBC for review and approval. The PI is responsible for ensuring the accuracy of the submission, and all regulations and policies are adhered to.

Questions about who can serve as a PI? Review the APM policy for PI eligibility requirements.

IBC Biosafety Manual includes the Biosafety Manual and Biohazard Inventory Form. This will be submitted through VERAS prior to the monthly submission deadline and will be reviewed and approved by the Biosafety Officer.

1. Go to veras.uidaho.edu.
2. Under Study Assistant, select “Study Submission Form” then click IBC - Biosafety Manual
3. Complete the IBC - Biosafety Manual (BSM) by addressing all required components and submit before the monthly submission deadline. See VERAS Guide – IBC Additional Submission Forms for additional guidance.
4. Once submitted, the PI and Study Contact will receive an auto-generated confirmation email of the submission.

Please note, the PI and all lab personnel must read the approved biosafety manual annually. The PI is responsible for providing hands-on, lab-specific training to all staff.

If submitting several weeks in advance of the monthly committee meeting, a pre-review of the protocol’s submission components may occur, and recommendations for clarifications may be requested. The Committee may request additional clarifications and information during the review process.

All requests for clarifications, additional information, and recommendations will be returned to the PI through the VERAS system in the form of Stipulations on a Submission Response form. The PI must respond to and address each stipulation to the satisfaction of the Committee, update/revise the Study Application according to the stipulations, and resend the submission for review before approval is granted. See VERAS Guide – Addressing IBC Stipulations for additional guidance.

1. Go to veras.uidaho.edu.
2. Select the Submission Response task on your VERAS home screen.
3. Review and respond to the stipulations returned to you for the submission in the IBC Review Response Form.
4. Revise the Study Application/protocol addressing all the stipulations.
5. Attach any additional request (e.g. permits, SOP’s…).
6. Submit revisions for review to the IBC.
7. Once submitted, the PI and Study Contact will receive an auto-generated confirmation of submission email.

Final approval is granted once the following have been completed:

• All committee requests are resolved
• The biosafety manual is approved by the Biosafety Officer
• The lab space is inspected and approved by the Biosafety Officer
• Required permits are secured, as applicable
• Occupational health requirements requested by EHS have been met, as applicable

ATTENTION: During transition into VERAS, if you need to submit an amendment and your protocol has not been converted into the VERAs interactive IBC - Study Application yet, please contact biosafety@uidaho.edu before you start on your amendment submission.

Any change to the protocol must be approved by the IBC prior to implementation. Amendments may include but are not limited to, changes in procedures/methods, personnel, agents used, lab location, etc. See VERAS Guide – IBC Amendment Manual for additional guidance.

1. Go to veras.uidaho.edu
2. Select Forms under the “Action” column for the protocol you want to amend.
3. Select IBC - Amendment Form; or if you are making any personnel changes (additions or removals), you must submit an IBC - Personnel Change Only form.
4. Complete the amendment form by addressing all required components
5. Revise the Study Application/protocol so the newest version incorporates the details of your amendment request.
6. Attach any additional documents.
7. Submit the amendment for review to the IBC.
8. Once submitted, the PI and Study Contact will receive an auto-generated confirmation email of the submission.

Please note, not all amendments require full committee review. Some may be approved administratively in accordance with the IBC policy.

To renew a protocol that is reaching its 3-year expiration date, the PI must submit a new IBC - Study Application for IBC’s review and approval.

VERAS will send auto-generated email reminders to the PI and Study Contact 90, 60 and 30 days prior to the expiration date.

Please expect a minimum of a month for review and approval of your new protocol. You must receive approval for the new protocol before the old protocol expires, or all work will need to halt until you have the approval to continue the work.