Abstract
Ethical review of both human and animal research is critical to ensuring that studies are conducted with due regard to the welfare and safety of enrolled subjects and to the integrity of the data. However, differences exist in laws, policies, and best practices between human and animal studies. Ethical review is required for most human studies. While the laws and standards are clear for humans and for laboratory animals, the laws and standards for clinical research for client-owned animals are not as well-defined. Here, we discuss gaps in ethical review of clinical animal research in the United States of America and propose expanded functions for veterinary clinical studies committees as a solution.
Highlights
Biomedical research involves progressive and iterative information gathering
We propose that the Veterinary Clinical Studies Committee (VCSC) be responsible for completing the review and approval of [1] the final study documents prior to initiation of the study; [2] any amendments to study protocols or other significant changes during the study; [3] reports of any serious and unexpected adverse events throughout the course of the study, and ensuing actions, if applicable; [4] updated safety information as it becomes available; [5] any asneeded updates for other reasons, including critical staff changes or other concerns; and [6] a regular review of the protocol progress, at a frequency determined by the VCSC
We propose that the optimal VCSC review board composition and charter reflect the goals of the ethical review, including ensuring safety and welfare of the animals to be enrolled
Summary
Biomedical research involves progressive and iterative information gathering. Following initial laboratory studies, clinical research studies in human participants are critical to confirming safety and efficacy of drugs and devices and to successfully translating basic science into novel treatments, techniques, and solutions used in standard medical practice. Ethical Review Veterinary Clinical Trials that the research studies have been designed and will be conducted with the utmost regard to the safety and well-being of humans and/or animals. This paper addresses gaps and potential solutions for ethical review of clinical studies in animals, while recognizing the need for a streamlined approach that will minimally burden researchers, regulators, and sponsors, but still ensure protection of the animals and informed consent of the owners.
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