Protocol Amendments: What to Do; When to Do It; What Is the Purpose

Protocol Amendments: What to do. When to do it. What is the purpose? Why is it necessary?

So you have an IACUC approved animal use protocol. You need more animals or wish to try a new drug or add another surgical procedure.

What are you going to do? You need to write a protocol amendment to cover the changes. The amendment can take several formats as discussed below.

When should this amendment be completed? You need to notify the IACUC and receive approval of these intended changes prior to beginning the work. As you are formulating the experimental plans, be sure to contact the IACUC to initiate the amendment.

What is the purpose of an amendment? The purpose of the amendment is to modify a previously approved animal use protocol at times other than at the annual review. All animal procedures, manipulations, and actions must have documented, IACUC-approval prior to beginning the animal work.

Why is an amendment necessary? Any changes or deviations from the approved protocol need to be approved by the IACUC prior to implementing the desired changes. The USDA Animal Welfare Act and the Public Health Service Policy on Humane Care and Use of Laboratory Animals mandate that all activities involving animals receive IACUC review and approval.

Minor changes to your approved protocol can be handled with submission of an amendment.

What changes are considered as Minor?

·  Changes in personnel

·  Addition of faculty collaborator

·  Addition of another strain of same animal species

·  Change in sex of animal to be used

·  Small increase in animal numbers (up to 10% of the original request)

·  Need to repeat experiment

·  Addition of minor surgery

·  Addition of sample collection

·  Additional non-invasive sampling

Major changes to your approved protocol may require submitting a new animal activity protocol for IACUC review. Recommend discussing with IACUC chair/member for guidance.

What changes are considered as Major Changes?

·  Objectives of the study have changed

·  Change in PI

·  Non-survival to survival surgery

·  Degree of invasiveness

·  Increased discomfort to animal

·  Change species

·  Addition of USDA regulated species

·  Change (large increase) in number of animals (An increase of greater than 10% over the original approved animal number)

·  Anesthetic agents

·  Use or withholding of analgesia

·  Change method of euthanasia

·  Duration, frequency of number of procedures performed

Amendment Format

The amendment can take the form of a letter/memo (email) and in some cases attachment of the appropriate Appendix from the Animal Activity Protocol. It should include complete descriptions and justification of the requested changes. These changes include items from the list below.

·  Purpose for the protocol amendment (how does the amendment relate to the originally approved protocol?)

·  Addition/deletion of personnel – (Make certain to enter them into the proper training program prior to allowing them to begin working with the animals)

·  Change of species, sex or strain: include justification for changes

·  Specialized housing requirements: include justification for housing changes

·  Need to increase number of animals: include a justification for the increase

·  Addition of minor surgical procedures (include Appendix C): use of analgesia

·  Additional sampling of body fluids or tissues (include Appendix D): indicate the frequency, the amount and the route used

·  Addition of new procedure – describe in the same level of detail as is required by a new protocol

·  Change in method of anesthesia, analgesia or euthanasia

·  Addition of hazardous agents – make certain of Biohazards approval

·  Change surgical plans from minor to major, multiple major survival (include Appendices C and H)

IACUC approved: May 18, 2004