Standard Adverse Effects and Early Removal Criteria
IACUC Policy: 036-08, Effective Date: 11/01/2009, Last Revision: 11/17/2023
Overview/Purpose
This policy provides standard early removal criteria (ERC) which apply to all research and teaching protocols at The Ohio State University unless exceptions have been scientifically justified and approved by the Institutional Animal Care and Use Committee (IACUC).
Early removal criteria are predetermined criteria, utilized as a basis for euthanasia prior to the planned study endpoint in an effort to minimize pain and or distress to the animals while enabling scientific goals to be met. Ideally, experimental endpoints occur with minimal or no adverse effects, pain, or distress to the animal. In some cases however, studies will result in pain/distress in order to accomplish the scientific objectives. Furthermore, the IACUC recognizes that experimentally induced or spontaneous clinical signs in animals may be unexpected or otherwise not specifically identified in the IACUC protocol. Consultation with the veterinary staff is expected when unanticipated adverse effects are observed.
Requirements
- Investigators must ensure humane care of their research animals by checking all animals at least weekly to utilize ERC as listed in their protocol. Some animals will require more frequent oversight due to model/study endpoints and such oversight by the research team must be clearly outlined in the animal use protocol.
- Once an animal meets the ERC, the principal investigator is responsible for promptly (< 24 hrs.) initiating treatment as outlined in the protocol or euthanizing the animal. Alternatively, consultation with a veterinarian would be required to discuss treatment options.
- Experiments that necessitate unrelieved pain and/or distress as approved by the IACUC must be clearly identified to care staff at the cage level. This includes but is not limited to protocols using moribund as sole criteria for removal and death as an endpoint.
- The following criteria are considered standard ERC and apply across all protocols unless alternative criteria are identified and approved within the designated IACUC protocol:
- Weight loss: i. Loss of 20% baseline body weight or compared to an age-matched control (for young growing animals)
- Body Condition Score:
- Rodents
- Poor body condition scores ≤2 or ≥4
- See Mouse Body Condition Score chart (Lab Anim Sci.1999;49(3):319-323).
- See Rat Body Condition Score chart (J Am Assoc Lab Anim Sci. 2010 Mar; 49(2): 155–159).
- Non-rodents
- Poor body condition based on the species-specific reference scale as defined in the protocol.
- Weakness/inability to obtain feed or water:
- Inability or extreme reluctance to stand/ambulate for 24 hours.
- Tumors:
- Tumor size must not exceed 1.6 cm in any dimension in a mouse, or 3.6 cm dimension in a rat. When multiple tumors are present, tumor size must be based on cumulative longest dimensions. The IACUC will consider alternative endpoint criteria if justified and clearly described in your protocol.
- Depending on the anatomic location, animals with tumors that interfere with normal function of vital organs (breathing, etc.) or impede the expression of normal activities (must be able to place all four feet on the ground and walk normally)
- Ulceration greater than 2mm
Additional Information/Guidance
Revision History
- 036-01 – New policy approved 11/01/2009
- 036-02 – This policy was retitled and formerly known as the Early Removal Criteria and Non- CO2 Euthanasia. In addition, the policy was revised and includes criteria from the tumor production policy. IACUC approved this policy on 06/20/2014.
- 036-03 – This revision reflects the early removal criteria for weight loss, body condition scores, and clarifies tumor production models by defining the size of ulcerations. Approved 02/19/2016
- 036-04 – This revision reflects the requirement that investigators must ensure humane care of their research animals by checking animals at least weekly to utilize ERC as listed in their protocol. Revised multiple tumor production to emphasize endpoint criteria being described in the protocol. Approved 06/16/2017
- 036-05 – This revision reflects a requirement being added for experiments that necessitate unrelieved pain and/or distress as approved by the IACUC must be clearly identified at the cage level. This includes but is not limited to protocols using moribund as sole criteria for removal and death as an endpoint. Approved 01/19/2018
- 036-06 – Policy was revised to remove the requirement for immobile and remove the weight limit related with the tumor size for rodent tumor production models; Approved 11/20/2020
- 036-07 – Policy revised requirement 4a for tumor production to clarify that alternative endpoint criteria will be considered by the IACUC if justified and clearly described in the protocol.
- 036-08 – Policy revised and reviewed; approved 11/17/2023
Article ID: 43
Created: May 20, 2024
Last Updated: July 3, 2024
Online URL: https://ohiostateresearch.knowledgebase.co/article/standard-adverse-effects-and-early-removal-criteria-43.html