E-2400, an anti-neoplastic drug, was to be used in a clinical trial for dogs with osteosarcoma, a bone tumor often seen in large breeds such as Irish wolfhounds. The proposed plan was for the dog’s affected limb to be totally amputated and then the drug would be administered intravenously, once every two weeks for four treatments. The control group of dogs would also have the limb amputated but postoperatively would receive the antineoplastic drug carboplatin, the standard treatment for dogs with osteosarcoma that were seen at Great Eastern University, College of Veterinary Medicine.

The study’s principal investigator was Dr. Sheila McCrae and the work was funded through an NIH grant. On her IACUC protocol form McCrae carefully described the general mechanism of action of E-2400, qualifications required for a dog to be entered into the trial, number of animals receiving either E-2400 or carboplatin, blinding procedures, details of the intravenous infusion, observations to be made, possible side effects of E-2400, a copy of the information sheet and consent form to be given to the owner, and so forth. The protocol was destined for full committee review and per the standard procedure of the school’s IACUC, it was pre-reviewed by a laboratory animal veterinarian and another member of the committee. The reviewers were impressed by the amount and quality of the details provided by McCrae, but one item was conspicuously missing: a description of the amputation procedure. When she was asked to add it to the protocol, McCrae replied that the surgical procedure is the veterinary hospital’s standard of care for dogs with osteosarcoma and it would be performed on all osteosarcoma patients, whether they would receive E-2400 or carboplatin. This response was deemed unsatisfactory by the IACUC administrative office and the pre-reviewers, and they again asked McCrae for a detailed description of the surgery and all perioperative procedures, including anesthesia and analgesia. McCrae, who was usually a very non-confrontational and compliant researcher, believed that the IACUC had overstepped its authority and was asking to review a standard oncological procedure used at the veterinary school. She lodged a formal complaint with the IACUC chairperson, alleging that the requested additional information exceeded the authority of the IACUC.

The McCrae protocol and her complaint were discussed at the next full committee meeting. Do you believe that the IACUC exceeded its authority and how should the IACUC proceed to resolve this issue?