Biosafety Protocol Submissions

All use of recombinant or synthetic nucleic acid molecules or other biohazardous materials for research or teaching purposes requires submission of a Biosafety Protocol to the IBC. These protocols must be reviewed and approved by the Biosafety Program and, in most cases, the IBC before work can begin.

Before You Submit

1. Make sure all required training is up-to-date. Review the training requirements on the Biosafety Program’s website.
2. Make sure your lab locations have a recent biosafety inspection on file. You can check your latest inspection records in LabCliq. You can contact us if you have questions or need to schedule a new inspection.

Submission Instructions

1. Log in to I-Manager
2. If prompted, select “IBC Biosafety” from the Project Type Switchboard
3. From your home page, click “Start xForm” in the left-hand Actions menu
4. Select the appropriate form type for your submission
5. Fill in all relevant information on all pages of the form, using the dropdown menu at the top of the form and/or the “Next” button to progress through the form
6. If you’d like to exit the form to return at a later time, click “Save for Later”. You can then return to the saved draft from your I-Manager home page by clicking the “x unsubmitted” link in the xForms table
7. When all information is complete, submit the form. Note that if the submitter is not the PI or LCI, the form will first be sent to the PI or LCI for signature before it is submitted to the IBC.

Any changes to existing Biosafety Protocols must be submitted to the IBC for review. Depending on the changes made, Amendments may be reviewed administratively by the IBC Administrator or may be sent to a committee for review.

Minor Amendments

In general, minor amendments can be reviewed and approved by the IBC Administrator. They are typically handled within 1-2 business days. Examples of minor amendments include:

• Adding or removing personnel
• Adding or removing locations
• Adding lines or strains of a previously approved organism (e.g., adding HeLa cells to a protocol that has already been approved for HEK cells)
• Any changes that do not alter the recommended containment level of the experiments and do not require review under NIH Guidelines

Major Amendments

Major amendments are those that significantly alter the scope, risk, or compliance requirements for a study. They are assigned to either Administrative Review, Subcommittee Review, or Full Committee Review using the same criteria as new submissions. Examples of major amendments include:

• Adding a new animal species, infectious agent, or transgene
• Any changes resulting in a change in relevant NIH Guidelines sections
• Any changes resulting in a change of containment level

Amendment Instructions

Note: If you need to make changes to a study within 6 months of the study expiration date, it is recommended that you submit a full Renewal in lieu of an Amendment if you expect the study to continue past the expiration date.

1. Log in to I-Manager
2. If prompted, select “IBC Biosafety” from the Project Type Switchboard
3. Scroll to the bottom of the screen to find your “My Studies” table. Click the Study link for the protocol you would like to modify
4. Navigate to the “Reference xForms” table. In the left-hand Actions column, select the “Copy” icon.
5. If prompted, select “Copy for Amendment or Renewal”
6. On the Amendment Header page, select the “Modification of Approved Protocol” option
7. Modify any information in the subsequent pages as needed
8. If you’d like to exit the form to return at a later time, click “Save for Later”. You can then return to the saved draft from your I-Manager home page by clicking the “x unsubmitted” link in the xForms table
9. When all information is complete, submit the form. Note that if the submitter is not the PI or LCI, the form will first be sent to the PI or LCI for signature before it is submitted to the IBC.

All research and teaching protocols are approved for 3 years. After the initial approval, 3-Year Renewals are required for any protocols that are not being closed. It is recommended that Renewals be submitted within 6 months of a protocol’s overall expiration date.

Renewal instructions

1. Log in to I-Manager
2. If prompted, select “IBC Biosafety” from the Project Type Switchboard
3. Scroll to the bottom of the screen to find your “My Studies” table. Click the Study link for the protocol you would like to renew
4. Scroll to the “Reference xForms” table. In the left-hand Actions column, click the “Copy” icon
5. Select “Copy for Amendment or Renewal”
6. On the Amendment Header page, select the “3-Year Renewal” option
7. Review all pages of the form to ensure information is still accurate, and make any updates needed
8. If you’d like to exit the form to return at a later time, click “Save for Later”. You can then return to the saved draft from your I-Manager home page by clicking the “x unsubmitted” link in the xForms table
9. When all information is complete, submit the form. Note that if the submitter is not the PI or LCI, the form will first be sent to the PI or LCI for signature before it is submitted to the IBC.

If not renewed, all research and teaching protocols are automatically closed after their 3-year approval window has ended. To close a protocol before the approval window is over, contact us, and make sure to include the protocol number in the email subject line to request protocol closure.

The submission will be reviewed by the Biosafety Officer. This review will include a check of training records for all personnel involved in the study, up-to-date lab inspections, and the clarity & appropriateness of all uses of biological materials.

If changes to the submission are required, these revisions will be noted in the protocol form and the protocol form will be returned to the submitter in I-Manager. The submitter will receive an email indicating that their submission has been returned for changes and including a link to access the protocol form. Once changes are made, the protocol will need to be signed by the PI or LCI again before re-submission.

After all required revisions from the Biosafety Officer are resolved, the protocol will be registered as Approved. An approval letter will be emailed to the Submitter and PI or LCI and will be attached to the protocol in I-Manager.

After initial review, the IBC Administrator will assign the protocol to a subcommittee of the IBC for review. This review occurs asynchronously via I-Manager.

Subcommittee members will review the submission within 2 weeks and provide any notes that must be addressed before approval. Each subcommittee member will also submit one of the following decisions for the protocol:

• Approved: Approved as is, no changes required
• Minor Modifications: Conditionally approved, with full approval granted after required revisions are adequately addressed
• Tabled: Major revisions required; resubmission requires review by subcommittee or full committee
• Denied: Not approved; resubmission not permitted

Based on subcommittee member decisions, the Biosafety Officer will summarize required updates and recommend a decision on the protocol. If subcommittee member decisions are in disagreement, a subcommittee meeting may be convened before a decision is provided to the PI/LCI. The Submitter and PI/LCI will be notified of the subcommittee’s decision via email through I-Manager.

If a decision of “Minor Modifications” or “Tabled” is provided, the Submitter will receive access to the protocol in I-Manager and must make the revisions noted by the subcommittee before re-submission. After re-submission, protocols returned for Minor Modifications will be reviewed by the Biosafety Officer, while Tabled protocols will be reassigned to the appropriate committee for additional review.

After all required revisions and/or additional reviews are resolved, the protocol will be registered as Approved. An approval letter will be emailed to the Submitter and PI or LCI and will be attached to the protocol in I-Manager.

After initial review, the IBC Administrator will assign the protocol to the full IBC for review and will add the protocol to the next available IBC meeting agenda. Protocols must be received two weeks in advance to be considered at the next IBC meeting.

IBC members will review the submission at the next available IBC full committee meeting. The PI/LCI will be invited to attend the review to provide context and answer any questions from the IBC. During the meeting, IBC members will vote on a decision for the protocol:

• Approved: Approved as is, no changes required
• Minor Modifications: Conditionally approved, with full approval granted after required revisions are adequately addressed
• Tabled: Major revisions required; resubmission requires review by subcommittee or full committee
• Denied: Not approved; resubmission not permitted

The Submitter and PI/LCI will be notified of the IBC’s decision via email through I-Manager.

If a decision of “Minor Modifications” or “Tabled” is provided, the Submitter will receive access to the protocol in I-Manager and must make the revisions noted by the IBC before re-submission. After re-submission, protocols returned for Minor Modifications will be reviewed by the Biosafety Officer, while Tabled protocols will be reassigned to the appropriate committee for additional review.

After all required revisions and/or additional reviews are resolved, the protocol will be registered as Approved. An approval letter will be emailed to the Submitter and PI or LCI and will be attached to the protocol in I-Manager.