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 protocols approved on the current IBC protocol form should be made directly to the protocol form in Section I-C-2 – Amendment Record and incorporated into the body of the protocol.

(Please note, amendments made to protocols approved on the legacy protocol form — IUPUI |  IUB typically before November 2014 — should use the legacy amendment form. Major amendments require the proposed change to be incorporated into the body of the original submission. An updated protocol form must be submitted in addition to the amendment form.)

A comprehensive description of the proposed change is necessary for the 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

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, research location removal, and co-investigators, 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
  • Upgrade 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 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.

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, emailed to your campus biosafety committee address.

Contact an Institutional Biosafety Committee

Bloomington

Indianapolis