Changes to Approved Animal Use Protocols (Amendments)
The Animal Welfare Regulations (9th CFR USDA Regulations) and the Public Health Service Policy require that the Institutional Animal Care and Use Committee (IACUC) review and approve any proposed significant change to an Animal Use Protocol (AUP). Proposed changes to an AUP must be reviewed and approved by the IACUC. A proposed change to AUP at The Ohio State University (OSU) may not be initiated until notification of IACUC approval has been received.
Investigators who wish to propose a change to a currently active AUP should submit a request using the most recent version of the IACUC Amendment Request form (available at: http://orrp.osu.edu/animalsubjects/forms.cfm) that, when properly completed, will provide the information needed to enable the IACUC to evaluate the proposed change. The requested amendment must fit with the objectives, purpose, or aims stated in the original protocol. If this requirement is not met, then the IACUC will require submission of a new protocol. After completeness of an Amendment Request is verified, the amendment is scheduled for the appropriate review based on the review criteria outlined below.
Amendments are considered significant (major) when they include (but are not limited to):
- change in species
- addition of animal numbers >10% larger than the approved number of rodents
- any additional number of USDA species
- housing > 12 hours in a non-ULAR facility
- non-survival to survival surgery
- addition of a surgical procedure that results in multiple major survival surgery in any animal*
- change in type of survival surgery in USDA species
- increased invasiveness of a procedure
- any procedure that would fall in the USDA pain category E*
- increase in the duration of pain, discomfort or distress to an animal
- restraint of animals for > 1 hour*
- hazardous agents administered to animals
- Principal Investigator (PI) change
- addition of neuromuscular blocking agents
- change in euthanasia procedures
- any procedures other than observation only studies involving non-human primates*
- death as an endpoint*
- analgesic drug regimens that are less effective in alleviating pain
*Changes that automatically require review at a convened committee meeting.
Amendments may be considered minor when there are changes in:
- anesthetic drug regimen (same class)
- analgesic drug regimen of same class or using drugs that are more effective in alleviating pain
- addition of surgery or procedure that is less invasive than already on the approved protocol
- humane endpoints
- addition of sample collection times
- increase in numbers of rodents less than 10% of the approved numbers
- addition of non-invasive sampling/analysis
- addition of another strain/stock of the same animal species
- addition or removal of personnel other that the PI to or from a protocol
For requests that do not clearly fall into any category, the IACUC Chair will determine whether the amendment request is considered minor or significant.
Review Process for Significant Amendments
Amendment Requests proposing significant activities or changes as outlined above will be be evaluated by the standard IACUC review process.
Review Process for Minor Amendments
Amendments involving minor changes in procedures done on animals will be reviewed by a veterinarian and will be considered approved once a copy of the amendment form signed by both the veterinarian and the PI is received in the IACUC office. Amendments involving minor changes in animal numbers will be reviewed by the IACUC chair or his/her designee. Information on the changes approved by this process will be provided at the time information for designated member review is sent to members. Any member can request further review of any amendment request.
Proposed change requests that only involve adding or removing personnel other than the Principal Investigator on an AUP should be submitted to the IACUC utilizing the IACUC Personnel Addition/Removal Form. Such changes will be considered approved when the IACUC support staff verify compliance with the training requirements and registration in the Occupational Health Registry.
