Amendments and Renewals (PAAs)

Once your Animal Care Protocol (AUP) is approved, it’s essential to manage any changes or renewals through the appropriate Post-Approval Activities (PAA) in ARISE. This process ensures continued compliance with ethical standards and the ongoing protection of animal welfare in your research.

Below is an overview of the amendment and renewal processes.

Amendments

If you need to make any modifications to an approved protocol—such as changes in experiments, location, procedures, or drug administration—you must submit an amendment for approval before implementing the changes. Amendments are categorized as either minor or major, depending on the nature and extent of the changes:

Minor Amendments

These include changes such as equivalent alterations in animal procedures or drug use, small increases in animal numbers, or adding new animal strains without special care requirements. Minor amendments are typically reviewed by the ACUC Chair, but they may be referred to the full committee if deemed necessary.

Examples of Minor Amendments:

• Changes in animal procedures or drugs with equivalent effects on the animals.
• Small increases in animal numbers, depending on the total approved.
• Addition or changes to animal strains without specific care needs beyond those already approved.

Major Amendments

These involve more substantial changes, such as switching species, introducing significant changes to procedures, or large increases in animal numbers. Major amendments are reviewed by at least a subcommittee of the ACUC and may require a full committee review if the changes are particularly significant or complex.

Examples of Major Amendments

• Changes in species or strains that alter procedures or require specific care.
• Large increases in animal numbers.
• Significant changes in housing, procedure locations, or anesthetic/analgesic agents.
• Changes in euthanasia methods or the introduction of new, more invasive procedures.

Renewals

Renewals are necessary to continue your research beyond the initial approval period. There are two types of renewals:

Annual Renewals

These are progress reports that include details on annual animal use, morbidity/mortality data, and justifications for any refinements, reductions, or replacements made in the past year. To avoid lapses in approval, annual renewals should be submitted at least 1-2 months before the protocol’s expiry date.

Full Renewals (4th years)

A complete review of the proposed study, requiring a detailed submission of the Animal Use Protocol (AUP) is required every 4 years, per CCAC requirements. 4th Year Renewals are time consuming to prepare and review; therefore, submit your 4th Year renewal at least 3-4 months prior to the study expiry date to ensure there is no interruption of approval. The ACUC reviews all sections to ensure ongoing compliance with ethical guidelines.