BACKGROUND

This Standard Operating Procedure (SOP) provides a detailed description of procedures followed by the IACUC for review of changes to approved protocols.

IACUC Procedure

Before initiating changes to a protocol, the Principal Investigator (PI) must receive approval by the IACUC Office. Modifications are made by using the amendment function in eProtocol.

*Only one amendment or annual/continuing review can be processed at a time in eProtocol. Approval of any current submissions must be secured before a new modification/amendment can be submitted.

The following language has been adapted from the Office of Laboratory Animal Welfare Significant Changes to Animal Activities:

Significant Changes:

1.  Significant changes described below (a.- i.), must be approved by Full Committee Review (FCR) or Designated Member Review (DMR), including changes:

a.  from non-survival to survival surgery;

b.  resulting in greater pain, distress, or degree of invasiveness;

c.  in housing and or use of animals in a location that is not part of the animal program overseen by the IACUC;

d.  in species;

e.  in study objectives;

f.  duration, frequency, type, or number of procedures performed on an animal;

g.  an increase in previously approved animal numbers;

h.  that impact personnel safety;

i.  in Principal Investigator (PI) (must be approved by FCR)

2.  A significant change that may be handled administratively in consultation with the IACUC Chair, Vice Chair or designee is an increase in previously approved animal numbers (not to exceed a 10% increase as long as study objectives are unchanged); the animals being added cannot be in USDA Category E.

3.  A significant change that may be handled administratively in consultation with the Chair, Vice Chair or designee is a change in strain or gender of animal, provided that the strain does not have potential health problems related to phenotype.

Upon receipt of an amendment request, a member of the IACUC administration office will determine if the proposed change is significant based on the criteria above. If the proposed change falls into category 2 or 3 (above), the IACUC office will consult with the Chair (or designee) who may recommend that it be approved administratively. If there is ever a question as to whether or not a proposed change is significant the Chair (or designee) is consulted.

The Committee is polled as to whether or not an amendment is appropriate for Designated Member Review (DMR). The Committee at large is then allowed a minimum of 24 hours to consider the amendment. If there are no objections to DMR the amendment can be reviewed using that method, as described in the Designated Member Review SOP.

Other Changes:

Changes that may be handled administratively are:

1. changes in personnel, other than the PI. (IACUC Administration Office staff reviews all personnel amendments to ensure that all such personnel are appropriately identified, adequately trained and qualified, enrolled in occupational health and safety programs, and meet all other criteria required by the IACUC.)

2. addition of grants/funding sources, including changes in protocol titles, provided congruency has been confirmed and other modifications are not necessary.

3. correction of typographical errors

4. correction of grammar

5. contact information updates

NOTE: Investigators may use fewer animals than approved. This does not require IACUC approval, notification, consultation, or administrative handling.

Approved: February 2010

Revisions Approved: 3/2012, 12/2012, 11/2014, 12/2015, 4/2016, 1/2017, 12/2017, 12/2019, 3/2022