Review of Significant Changes to Approved Protocols

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 or directly from a veterinarian (for Veterinary Verification and Consultation (VVC) modifications). If approval is granted via VVC, an official modification/amendment to the protocol must be made as soon as possible (i.e. when the eProtocol can be modified*), ideally within 7 business days, for final IACUC approval. Modifications are made by using the amendment function in eProtocol or submitting an amendment form via email, depending on the format of the parent protocol.

*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.-h.), must be approved by Full Committee Review (FCR) or Designated Member Review (DMR), including changes:
    1. from non-survival to survival surgery;
    2. resulting in greater pain, distress, or degree of invasiveness;
    3. in housing and or use of animals in a location that is not part of the animal program overseen by the IACUC;
    4. in species;
    5. in study objectives;
    6. duration, frequency, type, or number of procedures performed on an animal;
    7. an increase in previously approved animal numbers;
    8. in Principal Investigator (PI); and
    9. that impact personnel safety.
  2. Specific significant changes described below (a.-b.), may be handled administratively in consultation with a veterinarian authorized by the IACUC. The veterinarian is not conducting DMR, but is serving as a subject matter expert to verify that compliance with the IACUC-reviewed and -approved policy is appropriate for the animals in this circumstance. The method of review is known as Veterinary Verification and Consultation (VVC). Consultation with the veterinarian will be documented. The veterinarian may refer any request to the IACUC for review for any reason and must refer any request that does not meet the parameters of the IACUC-reviewed and -approved policies. Changes eligible for VVC review include:

a. anesthesia, analgesia, sedation, or experimental substances

b. euthanasia to any method approved in the AVMA Guidelines for the Euthanasia of Animals

The "Modifications Eligible for VVC" section below includes examples of specific changes that can fall into this category.

  1. 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.

  2. 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 amendment request falls into category 2 (above) a veterinarian serving as a subject matter expert will be consulted regarding the proposed change and may recommend that it be approved administratively. If the proposed change falls into category 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.


Modifications Eligible for Veterinary Verification and Consultation (VVC)

Drugs and Drug Doses

1) Change in doses of previously approved drugs to levels known to be safe

2) Addition of clinical medications as prescribed by the veterinarian

3) Change in method of drug administration to another method of equal or lesser invasiveness (limited to SC, IP, IV, PO)

4) Change in frequency of administration (no more than t.i.d.)

Anesthesia, Analgesia and Euthanasia

1) Change or addition of anesthesia, analgesia or sedation defined in "Veterinary Recommendations for Anesthesia and Analgesia – DLAR Guidance"

2) Change in method of euthanasia to an "Acceptable" method in the 2013 AVMA Guidelines for the Euthanasia of Animals

Blood and Tissue Collection for Genotyping

1) Change between approved methods of blood collection (route, frequency, volume) defined in "Blood Collection: Maximum Volumes and Fluid Replacement"

2) Change between tissue types for genotyping or identification (not including toe clips) defined in "Rodent Identification" and/or "Rodent Tail Biopsy"

Procedures

1) Change to acclimation time as long as it is in accordance with the "Acclimation of Animals Guideline".

2) Addition of special husbandry or nursing care as prescribed by veterinarian

3) Variations to previously approved surgeries that do not increase the invasiveness or expected outcomes

4) Change in the method of hair removal (shaving with clippers or depilatory cream)

 

Approved: February 2010

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