Institutional Biosafety Committee - Indianapolis

Amending an Existing Protocol

Any change to an existing IBC protocol must be submitted to the IBC administrator via the IBC amendment form 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
    *Note: all new personnel must complete NIH Guidelines training; instructions here
  • Adding/changing/removing cell lines
  • Adding/changing/removing transgenic animals
  • Adding/changing/removing laboratory room locations

    *Note:  the final approval of the minor amendment will
      not be given until a new lab inspection notice is completed.

  • 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 must be reviewed and approved by the primary reviewer of the initial protocol submission and/or a Biosafety Office (BSO) representative (see Multiple Amendments below).  In the case of a personnel change (where training records must be reviewed) or laboratory room changes (where a lab inspection may be necessary), the BSO representative will review the amendment form.  In all other cases of a minor amendment, the primary reviewer from the initial protocol submission will review the change.  If the primary reviewer is no longer affiliated with the IBC or is otherwise unavailable, the IBC chair will review the amendment.

There are no deadlines for submitting minor protocol amendments.

Major Amendment(s)

In the case of a major change to an existing IBC protocol, a revised protocol submission form must be submitted in addition to the amendment form. The new protocol submission form can be found on the Forms page.

What necessitates a major amendment?

  • Adding/changing organism
  • Adding/changing transgene
  • Adding/changing infectious agent
  • 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?

Major changes to an existing IBC protocol must go before the full IBC for review.  The primary and secondary reviewers from the initial protocol submission will be utilized when reviewing any major amendments to that protocol.  If one or more of the reviewers are no longer affiliated with the IBC, a new reviewer will be selected based upon their expertise and the nature of the proposed research outlined in the major amendment.

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

Due to the fact that all major amendments must go before the full IBC, the submission deadline and meeting dates need to be referenced prior to submitting any major amendment.  In order to have the amendment reviewed at the next IBC meeting, the amendment form and new protocol submission form must be submitted on or before the protocol submission deadline for that meeting

See the Deadlines & Meeting Dates page.

Multiple Amendments

Multiple changes may be included in the same amendment form.  The IBC administrator(s) encourage 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 depending upon the nature of the minor changes, both the primary reviewer of the initial protocol and the BSO may have to review and approve the changes (Ex: personnel change and addition of transgenic animals).

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 in the same amendment form, it is recommended that the minor change(s) are included in one amendment form 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