Dr. McCrae is proposing a trial to evaluate the efficacy of a novel anti-neoplastic drug, E-2400, by comparing it to the standard therapeutic drug, carboplatin, used in the treatment of osteosarcoma. Although limb amputation of the dog’s affected leg is a step in the overall process of treating osteosarcoma, the question is raised as to whether the IACUC must oversee the surgery as part of the drug trial proposed to the IACUC. The answer to that question depends on whether the surgery is described as an animal activity in the grant submission or when the animals are enrolled in the drug trial.

As described in the scenario, the Principal Investigator (PI) has defined the qualifications required for the animal to be eligible for the study, which is the key to deciding whether the IACUC should oversee the surgery. In addition, through the informed consent process (USDA - Veterinary Services Memorandum No. 800.301), the scientist is ensuring the animal owners understand the risks, potential benefits, and alternatives of enrolling their animal in the study, which is also a critical factor.

Regarding the enrolment of an animal in the study, oversight of the surgical procedure should not be under the purview of the IACUC if the criteria for an animal to be eligible to participate in the drug trial is limited to only those that have undergone the first phase of the standard clinical treatment (i.e., the amputation of the affected leg) for osteosarcoma. In this particular scenario, the onus would be on the PI to ensure only those animals satisfying the enrollment criteria would participate in the blind study with a percent of the animals continuing the standard treatment of receiving carboplatin (i.e., the control group), and others the test drug E-2400. In this case, the IACUC should only consider the potential effects of E-2400 on the welfare of the animals.

Alternatively, if eligible animals include all that have been diagnosed with osteosarcoma, the IACUC may have additional responsibilities. For example, let us assume that after osteosarcoma is diagnosed and during the informed consent process, the animal owner learns that the treatment of the disease includes limb amputation followed by chemotherapeutic treatment. At that time, owners are also informed of a trial intended to evaluate the efficacy of a novel chemotherapeutic drug (E-2400) that they believed will increase the chance of the animal being successfully treated for the disease. In addition, and if the surgical procedure is described in the grant, the owners are informed that because the drug trial is sponsored through the NIH all associated expenses relating to the treatment of the animals will be covered as part of the trial.

In this particular scenario, the IACUC must oversee the effects of the drug trials on the animals since that is the overall scope of the study. In addition, the IACUC has some responsibility associated with the surgical procedure especially since the costs associated with the surgery are being covered by the grant. The IACUC can satisfy this responsibility by asking the PI to assure in the protocol that the surgery will be conducted following an established standard clinical practice in a veterinary hospital by a veterinarian with extensive expertise in the standard treatment of osteosarcoma in dogs. Since the findings from the overall study seeks to identify more efficacious drugs for the treatment of the disease, and not methods for improving the associated standard surgical procedures, the IACUC need only concentrate on the drug trial with the consideration that the surgery is a standard of clinical care that ultimately leads to additional drug treatments.