Clinical trials are commonly used during the development of drugs studied for approval by FDA for the use in animals. Similar use in veterinary medicine has been increasing, but there are a number of interesting issues not considered in human clinical trials, where the individual involved in such trials is able to provide consent for inclusion in the trial. Clearly, the animals that may be subject to such studies, cannot provide specific consent—their owner would have to do so on their behalf. Those advocating for a change in status of animals as “property” to “persons” would be expected to object to such clinical trials, even if they benefit animals and people and help save their lives.
This issue was critically analyzed by veterinarians analyzing whether clinical veterinary studies must be reviewed by institutional animal care and use committees pursuant the Animal Welfare Act; the Office of Laboratory Animal Welfare for those studies funded by NIH; and/or reviewed and approved by a Veterinary Clinical Studies Committee established by a research entity, in a JAVMA published study, “Institutional animal care and use committee review of clinical studies.”
The study found
Determining whether activities conducted under the auspices of a clinical study are regulated by the USDA or OLAW, and thus require IACUC oversight, is not always a clear and simple issue. Institutions should develop their own guidance on how the IACUC oversees-or does not oversee-clinical trials.
Whether and to the extent certain clinical trials required review and approval by the IACUC pursuant to the Animal Welfare Act and/or OLAW requirements was dependent on whether the studying entities purchased the animals involved in the clinical trial and whether the proposed procedures would be required for the animal’s care, or were additional procedures only required for the purposes of the clinical trial.
The article presents 6 examples to help determine when USDA or OLAW oversight would be required.
Clearly, clinical trials, as utilized in human medicine, provide critical data related to the final approval of drugs and medical devices that will help prevent, diagnose and/or treat animals affected with life-altering diseases and conditions.