Protocol Amendments

Changing an existing Institutional Biosafety Committee protocol

Any change to your existing Institutional Biosafety Committee protocol at IU must be submitted to the IBC Office for review.

Amendments (major and minor) made to previously approved protocols  should be made directly to the protocol form. When preparing your submission, please make sure to complete Section I-C-2 (Submission Record) and incorporate all changes into the body of the protocol form. All edits should be made using track changes. Amendments submitted without track changes will be returned to the PI as an incomplete submission.

A comprehensive description of the proposed change is necessary for any amendment to be considered.

What is a minor amendment?

  • Adding/removing co-investigators
  • Adding/removing laboratory room numbers
  • Adding/removing cell lines of a previously approved organism*
  • Adding/removing strains of a previously approved transgenic animals (not required for exempt rodents)
  • Adding/removing vector constructs for a previously approved viral vector
  • Any change that does not fall into one of the categories listed above but would not be considered a major amendment can be annotated on the amendment form

*Please note, Investigators may now combine cell lines for a single species into one line in Section V (Biological Materials). For example, use of both HeLa and HEK293 cells may be updated to “Human Cell Lines.” This will allow the PI to add new lines of a previously approved species without submitting an IBC amendment.

Who reviews a minor amendment?

Minor amendments to an existing IBC protocol undergo a brief administrative review by the IBC Office. Updates to Section I: General Project Details, including updates to contact information, office location, other compliance committee approvals, funding, and co-investigator addition or removal, will be approved by the IBC office without additional reviewer comment. All other minor amendments will be assigned to the Environmental Health and Safety, Biological Safety Program for review outside the full IBC, unless the Biological Safety reviewer finds that the proposed change actually falls under the definition of a major amendment.

There are no deadlines for submitting minor amendments.

What is a major amendment?

  • Adding new plant or animal species
  • Adding/changing transgene
  • Adding/changing infectious agents
  • Change in sections of the NIH Guidelines
  • Change in containment level
  • Any change that does not fall into one of the categories listed above but would not be considered a minor amendment can also be annotated on the amendment form

After administrative review by the IBC Office, you will be notified that your major amendment must receive full committee review and the date of the scheduled IBC meeting where that review will take place. If your major amendment does not require full IBC review, it will be assigned to a Biological Safety reviewer for exempt confirmation and review.

To have your major amendment reviewed at the next IBC meeting, the completed amendment must be submitted on or before the protocol submission deadline for that meeting.

Please note, there are additional requirements for BL-3 materials. For information regarding the review and approval process for the use of BL-3 materials and access to the BL-3 facility, please email IBC@iu.edu.

See deadlines and meeting dates

The review process and possible outcomes are the same as for new protocol submissions.

All protocol amendments, major and minor, should be submitted as a Word document to IBC@iu.edu.

Contact the Institutional Biosafety Committee

The Indiana University Institutional Biosafety Office provides support to all IU campuses and maintains a physical office in Bloomington. Contact the IBC Office at IBC@iu.edu or 812-855-0656. You may also schedule an in-person meeting at a campus location convenient to you