Amendment Guidance

Amendment is any change to the ongoing approved protocol. Amendment requests may be submitted via email or hard copy, along with appropriate appendices as necessary. All changes must be approved prior to implementation.

Amendments should include the following components:

• Brief summary of the approved protocol (1-2 paragraphs).
• Outline of the proposed changes.
• Scientific justification for the proposed changes.

If you are adding additional funding source(s), the following information is required in addition to the components for an amendment:

• Face/cover page of the proposal/award
• Research plan, including animal use section

(Optional Amendment Form/Format that can be used when submitting amendments.)

There are two categories for amendments: significant change and minor change. The following are examples for each category:

• Significant changes directly impact animals or the research.

Examples include but are not limited to:

• Altered objective of study
• New or modified procedure
• Modification of survival surgery
• Change from non-surgery to surgery, from minor to major surgery, from non-survival to survival, or from single to multiple survival surgery.
• Increased invasiveness or potential discomfort/distress to animals caused by a procedure
• Changes in species or increase by 10% or more in the number of animals approved
• Modified choice of anesthetic or analgesic agent(s), or in the route of administration or dosage of these agents
• Altered method of euthanasia
• Change in duration, frequency or number of procedures performed on an animal

• Minor changes do not directly impact the animal or the research.

  Examples include but are not limited to:

  • Addition of new personnel participating in animal procedures
  • Change in animal housing location
  • A less than 10% increase in the number of animals approved for use
  • Additional rodent genetic strain  

Resources:

• What Investigators Need to Know About the Use of Animals