ABSTRACT

Institutional Animal Care and Use Committees (IACUCs) and equivalent oversight bodies, such as the United Kingdom (UK) Animal Welfare and Ethical Review Body (AWERB), the European Union's Animal Welfare Body (AWB), and Australia's Animal Ethics Committee (AEC), play a central role in ensuring appropriate standards of animal use at the institutional level. In addition to deciding from an ethical perspective whether proposed animal research protocols can be conducted and on what terms, the IACUC also has an important role as gatekeeper for building quality into experiments before animals are used. This helps ensure the research is rigorous and reproducible and data from animal research is useable, meaning animal lives are not wasted.1 , 2 Factors which affect rigor and reproducibility in bioscience research include the quality of experimental design (e.g., choice of model, use of appropriate controls, measures to reduce bias, and appropriate sample sizes), research practices, data analysis, and reporting—all of which IACUC members can scrutinize as part of protocol review.3–5 The extent to which this information is reviewed, however, varies across committees. In assisting investigators to plan, design, conduct, and record research studies appropriately, the IACUC can also contribute to improve the reporting of studies in the published literature. Additionally, the IACUC's role in improving animal welfare and standardizing animal care also impacts the reliability and repeatability of in vivo experiments. Animals with compromised welfare show altered physiology, immunology, and behavior, which can lead to distorted results, unreliable conclusions, and unwanted variation in scientific output.1 , 6 , 7 Most systems of animal research oversight globally require the IACUC, or equivalent, to conduct a harm-benefit analysis, weighing the potential benefits of the study against the animal welfare concerns, and to assess compliance with the 3Rs principles.8–10 Research-funding bodies and accrediting organizations recommend oversight committees assess the rigor and reproducibility of proposed research protocols, although there are few explicit requirements in regulations for IACUCs to do so. 4 Rigor and reproducibility assessment is a key part of conducting harm-benefit analysis, helping to ensure minimization of both animal use and suffering, and increasing the likelihood that the research findings will truly add to the knowledge base and realize anticipated benefits. 11 In so doing, the IACUC can protect the reputation of the institution and those involved in the research. Finally, the IACUC is also uniquely positioned to influence the local research culture and practices, set standards, and ensure researchers are supported to do the best science. This includes disseminating resources developed to improve experimental design, reporting, and reproducibility, such as the Experimental Design Assistant and ARRIVE guidelines (Animal Research: Reporting of in vivo Experiments) from the NC3Rs (the United Kingdom's National Centre for the Replacement, Refinement and Reduction of Animals in Research).12–14 This chapter outlines key considerations for IACUCs in their role in helping to improve rigor and reproducibility in animal research.