IACUC approval of a prospective clinical study is required when:
- the way in which an animal might normally be handled is affected by the protocol(i.e. treatment might be withdrawn for a short period to establish a baseline, extra blood or other samples taken, etc)
- the client is not involved in all decisions regarding the care of their pet (i.e. random allocation to a treatment path)
- when funding of the study might alter the treatment chosen by the owner.
The IACUC is responsible for ensuring that animals used by NC State faculty are appropriately cared for. In clinical studies, this responsibility manifests in two ways:
- That enrolling the animal in the study is a reasonable course of treatment
- That, once enrolled and under treatment, they are given good care, and all complications are appropriately managed.
The first issue has a number of aspects. The reason for the study and the rationale for the different treatment arms must be well justified. In particular, if a placebo group is included, it is important to explain why. If a drug is being evaluated for toxicity/reactions, a justification of using client owned animals rather than research animals must be provided.
The application must provide the reasons why the investigator would, or would not, enter a pet into the study. The application must outline how the client is informed of the advantages and disadvantages of enrolling in the study and the other options that they have. The application must show that the client has been informed of the potential complications and what will be done if they develop. Although the client consent form does not necessarily need to have the details requested above, it must state that these discussions have been had and that all questions have been answered. It would help the IACUC if written client educational materials are included with the application.
The second issue is that of how the enrolled patients will be cared for. The investigator must:
- outline the procedure(s)/drug(s)/device(s) to be studied
- describe how they will affect the animal and the disease being treated
- what are the expected complications.
The procedures for detecting potential complications, and for ensuring that any discomfort the patient experiences will be controlled, must be outlined. We recognize that, in some cases this can be an extensive list, but the more likely and/or the more major ones should be addressed.
Please review the Instructions and insure that all portions of the application are completed.