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Institutional Biosafety Committee

Amending an Existing Protocol

Any change to an existing IBC protocol must be submitted for review to the IBC Administrator.

  • Amendments made to protocols approved on the legacy protocol form
    (.pdf IUPUI | .pdf IUB), typically before 11/1/2014, should use the legacy amendment form found on the Forms page.
    • Major amendments require that the proposed changes be incorporated into the body of the original submission. An updated protocol form must be submitted in addition to the amendment form.
  • Amendments (major and minor) to protocols approved on the current IBC protocol form should be made directly to the protocol form, Section I-C-2 – Amendment Record, and incorporated into the body of the protocol. The current IBC protocol form may be found on the Forms page.

A comprehensive description of the proposed change is necessary for the amendment to be given full consideration.

Minor Amendment(s)

What necessitates a minor amendment?

  • Adding/removing co-investigators
  • Adding/changing/removing cell lines
  • Adding/changing/removing transgenic animals
  • Adding/changing/removing transgenic animals
  • Any change that does not fall into one of the categories listed above but would not be considered a major amendment can also be annotated on the amendment form.

Who reviews a minor amendment?

Any minor change to an existing IBC protocol will undergo a brief administrative review by the IBC Administrator prior to being forwarded to the BSO for review. All minor amendments are reviewed and approved outside of the full IBC unless the BSO finds that the proposed change actually falls under the definition of a major amendment (see below).

There are no deadlines for submitting minor protocol amendments.

Major Amendment(s)

What necessitates a major amendment?

  • Adding new plant or animal species
  • Adding/changing transgene
  • Adding/changing infectious agents
  • 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.

Who reviews a major amendment?

After an administrative review by the IBC administrator, the principal investigator will be notified that the major amendment must receive full committee review and the date of the scheduled IBC meeting where that review will take place. If the major item does not require full IBC review as per the BSO, then the major amendment will be forwarded to the PI after BSO approval.

The possible outcomes from an IBC review of major amendments are the same as for new protocol submissions. See the Review Process page.

In order to have the major amendment reviewed at the next IBC meeting, the amendment must be submitted, in completion, on or before the protocol submission deadline for that meeting. See the Deadlines & Meeting Dates page.

Please note: All major amendments require that the PI submit a signed amendment form (for protocols on the legacy protocol form), AND a signed, revised IBC Protocol Submission Form incorporating the proposed changes into the body of the protocol, along with any supporting documents. Items received without a revised protocol form will be considered an incomplete submission and cannot be reviewed.

Multiple Amendments

Multiple changes may be included in the same amendment form. The IBC Administrator encourages including multiple amendments on the same form when feasible as it reduces the workload for principal investigators and reviewers alike.

Multiple minor changes:

Theoretically, up to five (5) minor amendments may be included on the same amendment form. Please note that the review of multiple minor items on the same amendment could take slightly longer in order to confirm that a major amendment is not necessary.

Multiple major changes:

As with multiple minor amendments, up to five (5) major changes may be included in the same amendment form as well. Each item will be considered in the full IBC review of the major amendment.

Minor and major changes:

In the case where a combination of minor and major protocol changes are necessary, it is recommended that the minor change(s) are included in one amendment and major change(s) are included in another amendment form. Please note that these amendments would be considered independent of one another and thus assigned different amendment numbers. Due to the fact that the approval process for minor amendments is relatively short when compared to major ones, it would benefit the principal investigator to separate amendments such that minor changes could be approved and implemented quickly. To this end, the minor changes would not have to wait for the full IBC review of the major amendments.

 

Basic Steps Step 1: What needs to be reviewed? Step 2: Pre-Submission Step 3: New Studies Step 5: Reviews & Renewals
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