The full description of any surgery, including preoperative anesthesia, intraoperative monitoring, and postoperative care, to repair or replace instrumentation or other implants in cases where breakage has occurred, or for routine cleaning or replacement, must be part of the investigator’s Animal Care and Use Committee (ACUC)-approved animal use protocol.
The principal investigator must specify in the animal use protocol the maximum number of repair surgeries that is reasonable within the context of the study.
Additional surgery beyond this number will necessitate an ACUC-approved amendment to the protocol.
All repair/replacement surgeries require the approval of the research animal veterinarian before they occur.
Role of the Investigator
The investigator must include a written description in the animal protocol of the repair or replacement surgery with a statement that any repair/replacement surgery will be done only after consultation with a research animal veterinarian.
The investigator must specify in the animal use protocol the maximum number of repair surgeries that is reasonable within the context of the study.
The investigator is responsible for considering existing literature, prior experience, and consultation with appropriate colleagues and research animal veterinary staff in determining an appropriate maximum number of surgeries.
The investigator is responsible for their laboratory staff following the approved procedures.
Role of the Veterinary Staff and Animal Care Staff
The veterinary clinical staff must provide consultation prior to any repair or replacement.
Before successive repair or replacement surgery is performed as described in an approved protocol, a research animal veterinarian must grant clearance and notate the animal’s clinical records accordingly.
Care staff employees are expected to report incidents of noncompliance to the veterinary staff or a member of the ACUC directly.
The ACUC shall review proposed protocols for conformity to these guidelines and enforce compliance.