84 - ARRIVE Study Plan: including rigour assessment before the conduct of each experiment to maximise output

Background:  Reviewing individual experiments in the animal unit is a critical quality-control step to increase experimental rigour. Beyond details of the procedural and animal care and monitoring plans, it is a missed opportunity not to incorporate an assessment of the reliability of the prospective study.

Methods:  The ARRIVE Study Plan was developed based on the ARRIVE guidelines (an internationally recognised standard to describe animal experiments), current study plan documentation and stakeholder engagement. A separate user guide and reviewer checklist allow the IACUC to assess the rigour and reliability of each proposed experiment.

Conclusion:  The reliability of an experiment is fundamental in the conduct of the IACUC’s harm-benefit analysis of animal research. Benefits are realized by the production of high-quality, rigorous science that is ultimately reported in the literature. As such, each study’s experimental design strategy needs to be reviewed to ensure best practices in animal research are followed and animals are not wasted due to the production of unreliable results. The accompanying reviewer checklist ensures that each study plan assessment is conducted in a robust and accurate manner by directing the reviewer to ask for further justifications on the experimental design strategy presented.
For researchers, the ARRIVE Study Plan provides guidance and direction to conduct animal studies based on best practice. It promotes early adoption of rigor strategies such as randomization and blinding and provides the researcher with a record of the experimental design plan that can be directly translated into a manuscript. Providing explicit detail on the experimental design upfront will further enable the IACUC and animal unit to identify opportunities to support researchers in implementing best practice, e.g. help with blinding and randomizing cage location. Study plans maximize the potential success of a study as robust a planning aide.
The ARRIVE Study Plan provides the infrastructure for all those involved in animal research including animal technicians, veterinarians, animal facility managers, IACUCs and researchers to achieve high-quality studies; maximizing animal welfare and experimental outputs.

Limitations: The ARRIVE Study Plan is designed to audit an individual experiment rather than a programme of work. Where expertise does not exist for the analysis of good experimental design, further training may be required for researchers, IACUC members and study plan reviewers.

Discussion:  High-quality research requires training scientists, technicians, managers and reviewers in a broad set of skills. Providing researchers with prompts to increase experimental rigour and assessors with guidance to check experimental design decisions will facilitate the conduct and reporting of robust and impactful research using animals. With high variation in the amount of information reviewed before the start of a study, the ARRIVE Study Plan, user guide and reviewer checklist offers a standardised approach to maximise the reliability of a well-designed study.