Any change to previously approved materials must be approved by the IACUC prior to implementation. If you need to make any changes to your protocol you must submit an Amendment request for IACUC review and approval before any changes are implemented. Changes include, but are not limited to, changes in procedure, key personnel, or sample size.
Significant Changes
Significant changes to an IACUC-approved protocol must be reviewed and approved by the IACUC before they are initiated (PHS Policy IV.C.1., and AWR §2.31[d][1]). The GVSU IACUC interprets significant changes to mean those that have the potential to impact substantially and directly on the health and well-being of the experimental animals. Examples of significant changes include, but are not limited to, changes:
- in the methods of animal use;
- in the objectives of a study;
- from non-survival to survival surgery;
- resulting in greater discomfort or a greater degree of invasiveness;
- in the species or in approximate number of animals used;
- in PI;
- in anesthetic agent(s) or the use or withholding of analgesics;
- in the methods of euthanasia; and
- in the duration, frequency, or number of procedures performed on an animal.
Proposed significant changes require IACUC review (and approval) prior to initiation.
Non-significant Changes
The GVSU IACUC interprets non-significant changes to mean those that do not have the potential to impact substantially and directly on the health and well-being of animal subjects. Examples of non-significant changes include, but are not limited to, changes in:
- the funding source;
- personnel (other than the PI); and
- the use of a new vivarium housing location.
Proposed non-significant changes require administrative review (and approval) prior to initiation.
Submission Process
1. Go to IRBManager.
2. Enter your GVSU network ID and password. This will take you to your IRBManager dashboard.
3. Select the study from the "My Studies" table at the bottom of the screen.
4. You are now at the study-specific screen. Select, "Start xForm" under the "Actions" menu in the left-hand column.
5. A new window will open. Select, "IACUC Amendment Request Form."