IACUC Protocol Amendment Review

Policy

The IACUC has determined that certain changes to IACUC protocols may be reviewed via concurrence between the Veterinarian staff and the IACUC Chair or designee, and approved administratively without full committee review (FCR) or designated member review (DMR).

Background

The Office of Laboratory Animal Welfare (OLAW) issued a Guidance on Significant Changes to Animal Activities (NOT-OD-14-126) which was developed to support the use of performance standards and professional judgment to reduce the regulatory burden on the Institutional Animal Care and Use Committee (IACUC). The purpose of this policy is to enable the IACUC to authorize an AACUP or DAR veterinarian who is a voting member of the IACUC and the IACUC Chair or their designee to review and approve certain significant allowable changes (amendments) to IACUC-approved animal use protocols via an expedited process.

Procedure

Changes to an approved protocol are incorporated into the protocol by the PI or senior protocol staff and submitted for review. Decisions about whether the changes are eligible for this expedited process are made by professional IACUC staff with concurrence of the veterinary reviewer and the IACUC Chair or their designee. In cases of disagreement, or if either one requests, the amendment review will default to the FCR or DMR review process.

The following specific changes (amendments) to an IACUC-reviewed and -approved protocol may be reviewed by a veterinary voting member of the IACUC and the Chair or their designee, and be approved administratively without FCR or DMR:

A. Changes to anesthesia, analgesia, or sedation to referenced drugs and dosages. Examples may include:

1. A change in dosage, route, frequency, or duration within acceptable veterinary parameters.
2. Switching from one analgesic, anesthetic, or sedative agent to another.

B. Changes to experimental substances, including a change in test compound, dose, or route of administration, if the change does not result in a change in study objectives or greater pain, risk of toxicity, distress, degree of invasiveness, or higher biosafety levels.

Note that the addition of a non-pharmaceutical grade drug, or a change from a pharmaceutical grade to a non-pharmaceutical grade drug, requires additional justification and will not be authorized under this mechanism.

C. Changes in euthanasia to any method approved in the current AVMA Guidelines for the Euthanasia of Animals.

Note that personnel performing any new method must be trained to perform it.

D. Changes in duration, frequency, type, or number of approved procedures performed on an animal, if the change does not result in greater potential for pain or distress, or an increase in the degree of invasiveness. Reviewers may use their discretion and professional judgment to authorize procedural changes to previously IACUC-approved protocols providing the change will not alter previously approved effects on animal welfare (i.e., involves equivalent or less pain, illness, acute or chronic stress, distress), is consistent with current standards of veterinary practice, or is specifically addressed in an IACUC policy.

Common examples include:

1. Changes related to blood collection (e.g., frequency, interval, volume, vessel access, or total samples collected), not including a change from venipuncture to indwelling catheter.
2. Altering the duration or interval between procedures (e.g., lengthening an imaging episode or the time between episodes).
3. Addition of new experiment(s) utilizing the same procedures as previously approved.
4. Changing a method of animal identification.
5. Altering or adding behavioral testing methods, providing they do not involve unrelieved pain or distress.
6. Enhancements in enrichment.
7. Programs of post-anesthetic care that are enhanced above IACUC-approved minimums.
8. A change in animal numbers <10%.

E. Changes in stock, strain, or genetic modification, unless the new stock, strain, or modification results in abnormalities or possible clinical elements that require special support. Addition of, or change in, species of wildlife where there is no need to change procedures to accommodate the new species due to similarity to already approved species (e.g. adding a fish or bird species to a protocol that is already approved for similar/closely related species).

F. Change or addition of location of animal use, where the new location has been inspected or is a wildlife field site.